The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Country Reports

Japan International Corporation of Welfare Services (JICWELS)Contents
1. Cambodia

1

2. Indonesia

70

3. Malaysia

91

4. Philippines

116

5. Sri Lanka

141

6. Thailand

161

The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Cambodia-1-KINGDOM OF CAMBODIA
Nation Religion King
Ministry of Health
Department of Drugs and FoodCountry Report
The Study Program on
Quality Management of Essential
Medicines Good Manufacturing Practice(GMP) and Inspection
November 4, 2012 – November 30, 2012
Sponsored by :The Government of Japan
Japan International Cooperation Agency (JICA)

Department of Drugs and Food
Ministry of Health, Cambodia.

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I- COUNTRY PROFILE-3-

A-Geography
Cambodia is an agricultural country located in South East Asia which bordering the Gulf of Thailand,
between Thailand, Vietnam, and Laos. Its approximate geographical coordinates are 13°N 105°E. Its
2,572 km border is split among Vietnam (1,228 km), Thailand (803 km) and Laos (541 km), as well as
443 km of coastline. Cambodia covers 181,035 square kilometers in the southwestern part of the
Indochina, Cambodia lies completely within the tropics; its southernmost points are only slightly morethan 10° above the equator. The country is bounded on the north by Thailand and by Laos, on the eastand southeast by Vietnam, and on the west by the Gulf of Thailand and by Thailand. It consists of the
Tonle Sap Basin and the Mekong Lowlands. To the southeast of this great basin is the Mekong Delta,
which extends through Vietnam to the South China Sea.
Cambodia's climate, like that of the rest of Southeast Asia is dominated by monsoons, which are
known as tropical wet and dry because of the distinctly marked seasonal differences. The temperatures
are fairly uniform throughout the TONLE SAP Basin area, with only small variations from the averageannual mean of around 25 °C (77.0 °F). The maximum mean is about 28.0 °C (82.4 °F); the minimum
mean, about 22.98 °C (73.36 °F), Cambodia is influenced by Monsoon. Every year, the Monsoon winds
blow from the North-East bringing cold weather with some rain from November to March and from May to
October, the Monsoon blow from South-West bringing along with lots of rains and humid weather that
January is the coolest month and April is the warmest.
Cambodia’s populations in 90% are Khmer and the rest are other minority such as Cham,
Vietnamese, Chinese and group of tribe people like PHNONG, STING and KOUY who live with a belief of-4-

Mountain People.
The population of Cambodia was census in 2011 recorded a total of 14.7 million, with a population
growth rate of 1.7% per annum (WB data 2011). The proportion of population living in rural areas is
80.5%; only 19.5 % of country’s residents live in urban areas. The population density in the country as awhole is 75 per square kilometer, with approximately 1.3 million inhabitants living in Phnom Penh.
Since the 1991 Paris Peace Accord, Cambodia’s economy has made significant progress after morethan two decades of political unrest. However, Cambodia still remains one of the poorest and least
developed country in Asia, with the gross domestic product per capita estimate at approximately 3.3
million Riel or $805 in 2010 (International Monetary Fund,2011). Agriculture, mainly rice production, is still
the main economic activity in Cambodia. Small scale subsistence agriculture, such as fisheries, forestry,and livestock, and is another important sector. Garment factories and tourism services are also importantcomponents of foreign direct investments.

B- LANGUAGE:
Khmer or Cambodian, is the language of Khmer people and the official language of Cambodia,
however the people are free of use their mother tongue and other language. Khmer has been
considerably influenced by Sanskrit and Pali, especially in the royal and religious registers, through thevehicles of Hinduism and Buddhism. In old generation, for secondary language is French but after
election in 1993 the Government has adopted the free market policy, we are to use other languages
without limited refer to working places/offices, many investors have came to Cambodia for their businessand also Non-Government Organizations have started their activities in Cambodia. Thus English,-5-Chinese, French, Japanese and Korean are widely spoken, especially in business field and ingovernment offices. Cambodians from different regions of country speak variant accents, but it isunderstood by all people throughout the country.

C- CULTURE:
Cambodia culture has had a rich and varied history dating back many centuries, and has beenheavily influenced by India and China. However, Cambodian have still kept the own culture for longtime such as Khmer weeding, Khmer New Year in April, PHUM BEN, Water festival, etc.

The

Ministry of Culture has concentrated on culture and Khmer custom and tradition. 90% of Cambodian
people have abided by tradition and customs.

PHUM BENKHMER WEDDING

WATER FESTIVAL
APSARA DANCING-6-

D-RELIGION:
Cambodia is predominantly Buddhist with 90% of the population being Theravada Buddhist, 1%
Christian and the majority of the remaining population follows Islam, atheism, or animism, but inHighland tribal groups, most with their own local religious systems, probably number fewer than
100,000 persons. The Khmer LOEU has been loosely described as animists, but most tribal groups
have their own pantheon of local spirits. However, in our national constitution is decided to Buddhist is
the religion of state.

E-EDUCATION SYSTEM:
Education in Cambodia was traditionally offered by Pagodas (Buddhist temples), thus providing
education exclusively for the male population.
The formal educational structure consists of six years of primary school (grades 1–6), three years oflower secondary school (grades 7–9), and three years of upper secondary school (grades 10–12).
The Education field is very mains to create the human resources, develop the National country andeducate people all the rank. The Government pays attention to the human resources and it is always
enhanced by Government.

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There are Education in System and Education out System-

Education in system means that Education in the state school.

-

Education out system means that Education follows organization and private school.

Education in Cambodia divided into 3 kinds
1- State School
2- Private School
3- Organization School
Cambodia has 7 phases Education
1- Kindergarten
2- Elementary School
3- Secondary School
4- High School
5- Faculty / University
6- Master Degree
7- .Doctor Degree-8-II- STATISTICAL DATA

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Department Drugs and Food reported,
September 2012a-

Number of pharmaceutical manufacturers are nine sites:
1-Chea Chamnan
2-Medical supply
3-EUPHAC
4-PPM
5-CPE
6-Bio- Meta
7-GEN PHARMA
8-BRIGHT FUTURE
9-LLCOb-

Number of pharmaceutical Importers are 116 sitesc-Number of pharmaceutical Whosalers are 1601 sites-11-III- HISTORICAL DEVELOPMENT of
PHARMACEUTICAL SERVICE
A-History of the National plan on
Pharmaceutical Services:
The First National Drug Policy published in 1995, then reviewed and endorsed in 1998, and last
update in 2010 by the Minister of health assisted by World Health Organization in Phnom Penh, as
the guidelines of the development about:-Legislation and Regulations of Drugs-Selection of Pharmaceutical products-Drugs supply system-Drugs distribution and Good storage Practices-Drugs quality control system-Financing of drugs and Pricing Policy-Rational drugs use-Traditional Medicines-Monitoring and Evaluation (which will enable progress and adjustment of Strategies)

The main mission of Department of Drugs and Food in 2012
To control and eliminate illegal drug outlets in whole country
To serch the source of counterfeit and substandard medicines to eliminate.

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To assure that manage all medicines at public health services.
To Educate guidance and use all nacotic medicine upon to technicalTo publish all counterfeit medicine and issue of counterfeit medicine
To monotoring and evaluate the usage of medicines at public health services
To strenghtening register system as the same as regional country.
To educate and guidance focus on law that related to food hygien and safety to restaurant
owner.

B-History of GMP
Ministry of Health decided to follow of WHO GMP, and step by step harmonize with regional Asian
GMP. Now Cambodia GMP follows ASEAN GMP guidelines, but we had gradually modified
according to our current situation and through experience from training courses provided byinternational partners such as WHO, especially JICA, JICWELS...
In 1999, the ministry of health advised the local pharmaceutical manufacturers to implement the
principles of GMP as in Prarkas (Decision) number 513 issued in December 1999, the meaning of
GMP is base on the WHO GMP and Japan GMP and flexible of Asian GMP, such as focus on thedefinition, personnel, premises, equipment, sanitation and hygiene, production, quality control,
self inspection, recall product and documentation, etc,
Since then, the department of drugs and food, MoH and WHO started to develop the guideline
and conduct training to key persons of local manufacturers and pharmacist responsible and-13-quality control staffs to get the knowledge of GMP, and some workshops of dissemination wereprepared that corporate with the manufacturers association and WHO expertise,
In 2006, under support of WHO, the guideline of the conducting of GMP inspection wasestablished, and training the inspectors team in the same year,
From year to year, JICA and JICWELS always has supported of department of drugs and foodand national health product quality control center to attend the GMP training course to upgrade of
GMP knowledge and practice of GMP in Japan, and do evaluate in place by JAPAN GMP expert
every year,
While going on inspection, the drugs inspectors from DDF look properly at the personnel,
premises, equipment, Sanitation and Hygiene, production (storage of stating material and bulk
produces, process validation, contamination, batch and lot numbering systems, weighing anddispensing, finished products and quarantine, warehouse) quality controls, documentation,
handing of products (rejected drugs, product complaints and returned drugs, as per GMP
guidelines of ASEAN. However, at present the procedure of GMP inspection uses the notification
on procedure of opening, closing or transferring of Pharmaceutical Pants (Degree N0 505 dated
September 1998).
Until 2008, the national health product quality control center moved from national drugs
quality control was signed by prime minister has a mission to joint with department of drugs andfood inspector of GMP to inspect the local manufacturers to evaluate the GMP follow the ASEAN
inspection guideline that we need to fully harmonized in 2015,-14-

IV- GMP System:
1) Central and local organization in charge ofpharmaceutical affairs administration:
Inter Minirtial Committeeto Eliminate

Ministry of HealthCounterfeit Medicines and Illegal HealthServices
General Directorate for Health

Secretary of Inter Minirtial Committee
Department of Drugs

to eliminate counterfeit Medicines and Illegal

and Food

Health Services

Provincial HealthInter Provincial Committee

Department

to eliminate counterfeit Medicines and Illegal
Health Services-15-

The objective of pharmaceutical affairs is insuring Quality, Efficacy and Safety ofpharmaceutical products to all people who are used of medicinal products to cure or prevent theirhealth.
This first national Pharmaceutical Sector Strategic Plan provides direction to thepharmaceutical sector and to donors interested in supporting pharmaceutical sector development for
the next 5 years. The plan is intended to compliment the National Health Sector Strategic Plan. The
Planning process was led by the Department of Drugs and (DDF) with participation from the National
health product quality control center (NHQC) and others sector institutions. Technical support wasprovided by the World Health Organization (WHO).

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The Ministry of Health (MOH) is committed to creating an environment of ongoing quality
improvement in the pharmaceutical sector. The goal is to provide effective health care for the people ofCambodia, and to equip them to care for themselves by protecting pharmaceutical quality, in turnensuring good quality health care and good quality health care advice. For many people in Cambodia,
especially the poor and those living in rural areas, the first source of modern medical advice andtreatment is usually the drug seller. Evidence suggests that the people of this country are spending alarge proportion of their household income on health care without gaining significant change in theirhealth status. It is likely that most of this spending is on pharmaceuticals.
However, by constant improving the quality of services and products in the pharmaceuticalsector, the morbidity and mortality rate can be reduced, and when successful, contribute to theeconomic, human and overall development of Cambodia.
The commitment to improve quality in the pharmaceutical sector is reflected in the strategies
and outcomes described in this 5-years strategic plan, which includes an implementation framework
and annual operational plans. However, these outcomes cannot be achieved by the pharmaceuticalsector alone. Pharmaceuticals are an important part of the entire health sector. The MOH, othergovernment ministries and Non-Government Organizations (NGO) must support all the dedicatedworkers in the pharmaceutical sector. Continuing technical and financial assistance from our donors isessential and most graciously appreciated.

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GMP guideline:
The ministry of health has given the power to the department of drugs and food to manage andcontrol of medicines include the GMP guideline and inspection,
In 2000, the official of Good Manufacturing Practice Guideline was developed and published bydepartment of drugs and food, that followed by ASEAN GMP, It has 10 chapters and 100 articles, thetraining of this guideline was supported by WHO with 3 days time on course,
The guideline focuses on:-

Definition that explain of technical words and glossary,-

Personnel describe about responsibilities staffs on GMP, and training about GMP-

Premises detail on location of apartment in manufacturer, infrastructure, water supply, power
supply and waste management, etc,-

Equipment include the design and construction, installation, and maintenance,-

Sanitation and hygiene were described on personnel are working with, premises and equipments
include the hygiene practice,-

Production is concentrated on starting material, process validation, contamination, batch and lot
numbering system, weighing and dispensing, returns, recovered material, return goods, control
record of shipment of drugs products and contract manufacture,-

Quality control is focus on control laboratory, validation, reprocessing, production procedure,
product complain, product record and review, etc

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-

Self inspection is report system by internal auditor and supervisor-

Recovery or recall product describe about market report, complain system, return back, andsystem control recall,-

Documentation is detail on documentation keeping, quality of documentation, specification record,
self inspection report, and stock management system, etc,

For inspection division is under control of department of drugs and food, It is a bureau of regulationand inspection, that has around 10 persons working and lead by deputy director of department ofdrugs and food, It is only based in central government,

3) Inspection of Pharmaceutical affairs,
Organization of Inspection Division, Number ofInspectors (Central govment/local govment, theirrole):DDF Inspector(Ministry of Health)

Provincial Inspector-19-

DDF inspector is 15 people
24 Provincial inspectors are 85 people

4) Scope of Pharmaceutical products under GMP
inspection:
The scope of GMP inspection of Cambodia is:- To ensure that our pharmaceutical companies comply with all of the regulations and laws

pertaining

to their business.

- To find out of our pharmaceutical companies non-comply with GMP guideline, regulatory,- To advise their company on the regulatory affairs and climate that would affect proposed activities.
- To contact with the concern person is responsible for providing all technical data topharmaceuticalregulatory agency where he/she want to register the pharmaceutical product for

sale, hence he/she must have knowledge on:.Pharmaceutical Administration and Management,.How to Handling laboratory and manufacturing deviations.Pre approval inspections,.Impact of total Quality performance.Maintenance and Update of Product Master Files ,.Internal Compliance of Documentation.Quality systems,-20-

.Quality Assurance,.Method Validations,.Standard Operating Procedures (SOPs).Auditing and Compliance Functions.Stability as per ICH ,guidelines, International harmonization ,. Pharmacological, Toxicological and Clinical Trial Information, Re-registration Documents
Design,.Clinical Pharmacy,.Drug Trials and Vaccine Trials Guidelines,.Clinical Trials,.Intellectual Property Rights,.Patent Application Procedure,
On other hand is opportunities to fill the check list and evaluate the manufacturers about GMP
implementation in Cambodia as:. Organization and personnel. Premises. Equipment. Materials, sources and waste management. Good practices in production. Quality control-21-

. Sanitation and hygiene. Validation master plan,. Documentation. Complain. Products recall. Self-inspection and quality audits5) Frequency of GMP inspection:
Usually, Cambodia inspection follows the guideline of the Conducting of GMP Inspection thatwas

established and update in 2006 under supported by WHO, the guideline is integrated of WHO,ASEAN and PIC guideline,
The frequency of GMP inspection is at least 1 time per year in general, but they need to inspect oneach ward on one time until the finish job, however, the ministry allow to inspect of several time per
year in case of complain, recall products and damage suspecting of products, and otherFor complex manufacturer, the guideline advice to inspect ward by ward to all,6) Method (s) of GMP inspection (field inspection,
documentary inspection)
In GMP inspection guideline 2006, there are 11 points of methodology for GMP inspecting procedure:-

Planning of inspections: inspection team develop the annual plan for inspection like frequency-22-

timetable, and human resources are responsible to prepare the documents and materials,-

Preparation of inspection: check documents of manufacturer is registering with the ministry ofhealth, pharmaceutical products of manufacturer will visit, check report on last visit, documents
are related to the manufacturers and GMP check list,-

Inspection inform: contact to manufacturer about time and date to visit the manufacturer purposeof visit, and persons will contact during of visit,-

Opening meeting: after welcome, inspectors team need to introduce about purpose of visit amongof meeting persons, pharmaceutical policy, regulations and arrange meeting after finish theirworks,-

Inspect manufacturer facility: visit an around of manufacturer facilities, production chain, quality
control unit, storage places, and finish production warehouse,-

Verify documentation: checking standards operational procedures, specification, work instruction,
master manufacturing formula, batch processing, packaging, batch release procedure,-Complain,-

Self inspection-

Final meeting: inform to key persons or meeting attendances about result on inspection visit,-

Inspection report: keep check list is filled during of visit with signing of inspectors team andmanufacturer responsible,-

Next plan inspection visit arrangement.

7) Qualification of GMP inspectors, education,-23-

training system
The qualification of GMP inspectors is base on WHO supported and JICA, JICWEL andharmonization of ASEAN GMP inspection in 2015, most of GMP inspection are trained in Japan, and
ASEAN meeting or workshops, however, WHO always conduct training on GMP inspection andchecklist every year that called refreshing training such as 2009 training, USP PQM has conductedtraining on “Good Manufacturing Practices Auditing Fundamentals” in 2006 after GMP guideline wasestablished, the training module is designed to assist the Department of drugs and Food (DDF) or
inspectors and internal auditors personnel with the basics of Good Manufacturing Practices (GMP)
auditing techniques that the course corporate with WHO, and also every year, JPMA, JICA
pharmaceutical expert come to evaluate the Cambodia GMP and coach of inspectors team to update
their capacities and share experiences, however this kind of activities do not exactly the training
system, we expect in 2015 that ASEAN become a Union, It is opportunity of Cambodia tostrengthening of capacity to harmonize with ASEAN region as European Union,8) Case of recalled pharmaceutical products arisingfrom compromised quality ( number of cases,
outline of cases over the past 5 years):
In case of recalled pharmaceutical products, example Paracetamol 500mg tablet was sale to central
medical store for distributing to public health facilities in 2005, and also Cotrimoxazole 480mg tablet in
the same situation in 2008, theses products after distribute to health facilities, we note that it ischanging the appearance of tablet, it arise black spots in tablets, and easy to be the powder, the-24-facilities make complain to manufacturer and inform to the ministry of health to change the new batchare suspected fail of quality, the supplier start to collect or call back their products and replace thenew batch and amount to fill up health facilities without charge on transport and other fee, other casefor import products in 2007 (India progesterone birth spacing pill), the pill are cracked in blister duringof storage condition, it pass quality control before delivery, however, suppliers happy to collect anddestroy their products and replace to facilities services stock,
In 2010, some products are selling in the market, after JPMA find out their quality are failed by quality
control on dissolution test at Kanasawa University that study on post marketing surveillance, theministry of health decide to stop import and recall of products stock and destroy after confirming
testing such as compound of Amoxicillin and clavulenic Acid from Indonesia, and Cimetidine domestic
product, within the collect and recall of pharmaceutical products, the ministry of health is announcing
to public and medical professional to stop using these products until renew announcement about thatcase from the ministry informal, this some of case for recalling pharmaceutical and there are …..case
for recall products during of last 5 years include public and privates sectors.

9) Manufacturing, Import and Export ofpharmaceutical products (products name ofmain medicine, kind of preparation: Tablet,
injectable solution)
Since 1994 authorized licensees either manufacturers or importers can apply for drug registration.
All drugs are approved by the Drug Registration Committee. The pharmaceutical products are registered,-25-

they are able to sell in the Cambodia market and be able to export to other countries for domestic
manufacturer, the validation of register license is 5 years and they need to re-register again for 5 years
more,
The required documents for the Registration are:PART I: ADMINISTRATIVE DATA & PRODUCT INFORMATIONSECTION A: INTRODUCTIONSECTION B: OVERALL TABLE OF CONTENT
Table of contents

1- Application Form for Marketing Authorization
2- Letter of Authorisation
3- Certification
4- Labeling5- Product Information
SECTION C: ADMINISTRATIVE DATA & PRODUCT INFORMATIONPART II: QUALITY DOCUMENTSECTION A: Table of Contents
SECTION B: Quality Overall Summary
S: Drug Substance
P: Drug Product
SECTION C: Body of Data
S- Drug Substance
S1: General Information-26-

S1.1: Nomenclature
S1.2: Structural formulaS1.3: General Properties
S2: Manufacture
S2.1: Manufacturer (s)S2.2: Description of Manufacturing Process and Process Controls
S2.3: Control of Materials
S2.4: Controls of critical Steps and Intermediates
S2.5: Process Validation and/or Evaluation
S2.6: Manufacturing Process Development
S3: Characterization
S3. 1: Elucidation of Structure and Characteristic
S3.2: Impurities
S4: Control of Drug SubstanceS4.1: Specification
S4.2: Analytical ProceduresS4.3: Validation of analytical proceduresS4.4: Batch analyses
S4.5: Justification of Specification
S5: Reference Standards or Materials-27-

S6: Container Closure System
S7: Stability
Stability Summary & Conclusion
Post-approval Stability Protocol & Stability Commitment
Stability Summary Data
P- Drug ProductP : Description and Composition
P2: Pharmaceutical Development
P2.1: Information on Development Studies
P2.2: Component of Drug ProductP2.2.1: Active ingredientP2.2.2: Excipients
P2.3: Finished productP2.3.1: Formulation Development
P2.3.2: Overages
P2.3.3: Physicochemical and Biological Properties
P2.4: Manufacturing Process Development
P2.5: Container Closure System
P2.6: Microbial Attributes
P2.7: Compatibility-28-

P3: Manufacture
P3.1: Batch formulaP3.2: Manufacturing Process and Process control
P3.3: Control of Critical Steps and Intermediates
P3.4: Process Validation and/or Evaluation

P4: Control of Excipients
P4.1: Specification
P4.2: Analytical ProceduresP4.3: Excipients of Human and Animal Origin
P4.4: Novel excipients
P5: Control of Drug Product (Finished product)
P5.1: Specification
P5.2: Analytical ProceduresP5.3: Control of Analytical Procedure
P5.4: Batch Analyses
P5.5: Characterization of Impurities
5.6: Justification of Specification
P6: Reference Standards and Materials
P7: Container Closure System-29-

P8: Product Stability
Stability Summary and Conclusison
Post – approval stability and stability commitment
Stability data
P9 : Product Interchangeability
SECTION B: QUALITY OVERALL SUMMARYSECTION C: BODY DATA
Note: For some generic product required for bioequivalent/bioavailability as in the list of DDF
requirement
Part III: Non Clinical document
1. Pharmacology
2. Toxicology
Part IV: Clinical document

From March 2010, Cambodia starts to harmonize Asian registration guideline as we call ACTR/ACTD(Asian Comment Technical Requirement/Asian Comment Technical Dossier).
The common pharmaceutical do import from India in 30% for essential medicine with other products
such as:-Paracetamol syrup or tablet,-

Multivitamin + Mineral syrup or tablet-

Promethazine syrup or tablet

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-

Co-trimoxazole (sulfamethoxazole + trimethoprim, suspension or tablet-

Amoxicillin suspension or tablet-

Ciprofloxacin (as hydrochloride) suspension or tablet, etc

But for French products in 10%, that are always for espial items such as:-

Bupivacaine 0.5% Spinal heavy injection-

Fentanyl injection-

Ceftriaxone injection-

And other medicine for Diabetic, hypertension, Cardiology, etc

-

Etc,

10) Sales and distribution of medicines
products, proportion of imported medicinal
product distribution:
Reported of ministry of health 2011, they are 10171 products are registered and do marketing in
Cambodia market that amount of this number is 969 common products are produced by the local
manufacturers (7 local manufacturers), It is nearly 10% if we compare to import products from othercountries like India 3002 items or 30%, French 846 items or 8%, Thailand 748 items or 7%,
Malaysia 621 items or 6%, Korea 626 items or 6%,Vietname 418 items or 4%,Germany 383 items or
4%, China 347 items or 3%, Indonesia 341 items or 3%, Bangladesh 276 items or 3%,paistan 190
items or 2%, and other countries include USA, Swizeland, Taiwan, Cyprus, Philipines, Belgium,
Australia, England UK ..etc-31-11) Products name of medicines domesticallymanufacturers and products name ofImported medicines in the market (mainproducts):
The main products in the market of domestic products such as:
1- Gynomax®

Metronidazole 250mg, Neomycin sulfate 100mg, Nystatin 100 000IU andHydrocortisone acetate 5mg B/2x6 ovules
2- Kalfen® Ibuprofen 400mg B/10x10 tabs.

3- Omeprazole 20mg Omeprazole 20mg

4- Panol® Paracetamol 250mg/5ml

5- Kinal gelule

B/bottle/100ml

Paracetamol,Cafeine

6- Polymoxyl 250

B/10blx10 caps.

(500mg+50mg) Box/10x10Caps.

Cap. Amoxicilline Box/2x10Caps.

7- Befix-250 Cephalexin 250mg. B/10x10 Tab

8- Erythromycine 500mg Tab. Erythromycine Bottle/500Tab.

9- Penicilline

500.000 UI Phenoxymethylpenicillin B/100 x 10 tab.

10- Ethambutol-INH 400/150

11- Gliclazide®

Ethambutol,Isoniazide Bottle/200Tabs.

80mg Gliclazide

Box/500Tabs.

12- Glucofree® 850mg Metformin Chlorhydrate Box/3x10film coated Tabs.

13- Griséofulvine

500 mg Griseofuvine Box/10x10 Tabs.

14- Haloperidol

1mg Haloperidol Bottle/300Tabs.

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15- Mefloquine

250mg Mefloquine Bottle/100Tabs.

16- Arquine

50

Tab. Artesunate Plastic Bott/100Tabs.

17- Polyvit® Syrup VitB1,B2,B5,B6,B12,A,C,D3,E,PP Box/1bott/100ml

18- Acicloral

CPE

19- Pyrazinamide

200mg Aciclovir

500mg Pyrazinamide Bot./1000Tabs.

20- Rifampicine - Isoniazide

21- Staviro

22- Triviro-30

Bottle/30Tabs.

CPE

CPE Rifampicine 150mg , Isoniazide

15mg Stavudine

100mg Bot./1000Tabs.

Bott/60Caps.

CPE Nevirapine,Lamivudine Bottle/60Tabs.

23- Metronidazole 250mg Metronidazole 250mg B/10x10 tabs.

24- Etc,

However, Cambodia need to other brand of products out of domestics products have such as:
1- Aspirine pH 8TM 500mg Acide acetylsalicylic B/5 x 10 Cp.
2- Dextrose5%

in distilled water , Dextrose

3- Dextrose 5 % + 0,9%4- Dextrose 5% + 1/2

normal saline , Dextrose , Sodium chloride

NaCl, Dextrose , Sodium Chloride

5- Dextrose 5% + 1/3 NaCl, Dextrose , Sodium

Chloride

6- Atropine sulfate 1mg/ml, Atropine sulfate
7- Bupivacaïne Adrénaline 0,25%,

Chlorhydrate de bupivacaïne anhydre-Tartrate d'Adrénaline

8- Lidocaïne Aguettant 2%, Chlorhydrate de lidocaïne anhydre
9- Osmotan-G

5%, Sodium-Potassium-Chlorure-Glucose-33-

10- Mannitol

20% , Mannitol

11- Ringer Lactate (Hertmann's Solution),

Na,KCl,CaCl2 6H2O

12- Macrazyt-500, Azithromycin 500mg
13- Met XL 100mg, Metoprolol Succinate 100mg
14- Azithral-500, Azithromycin
15- 10% Dextrose Inj , Dextrose,

B/1bottle/250ml

16- Monocrin 1g Ceftriaxone 1g B/1vial
17- Efavirenz capsules 50mg Efavirenz 50mg
18- Lamivudine 150mg & Zidovudine 300mg tablets, Lamivudine 150mg, Zidovudine 300mg
19- Utrogestan

100mg, Progesterone

20- Clumox® Tab. 625 Amoxicillin 500mg, Potassium clavulanate 125mg
21- Valium

5mg, Diazepam

22- Emixef® Capsule, Cefixime 200mg Box/3x4Caps.
23- Etc,

12) Legal and institutional regulations on thesales and distribution of pharmaceuticalproducts
Refer to the regulation on medicines management in Cambodia, such as:- Law on creation of Ministry of Health (1996)-34-

- Law on Drugs Management (1996)- Sub-Decree on Drugs Registration (1994)-Sub-Decree on Manufacturing Exporting Importing and selling of Traditional Medicines (1998).
-Regulation on Functions and Responsibilities of Drugs Inspectors at international Ports (1996).
- Registration Book for Potent Drugs (Toxic, dangerous, Psychotropic and narcotic drugs).
- Counterfeit Book for Physician to prescribe narcotic drugs for patient use.
- Counterfeit Book for pharmacist to request drugs for professional use.
- Regulation on procedure of opening closing or transferring of drug selling stores (1996).
- Regulation on procedure of opening closing or transferring of drug Import Export companies(1996).
- Regulation on procedure of opening closing or transferring of pharmaceutical factories (1998).
- Regulation on procedure of opening closing or transferring of traditional medicine sellingstores (1998).
- Regulation on drug leaflets (1997).
- Regulation on implementation of Drug registration (1994).
- Ministerial decision on National Drug Policy (1998).
- Regulation on drug Import Export procedures (1999).
- Regulation on drug products advertisements (1999).
- Regulation on management of narcotic drugs and psychotropic drugs precursors (1999).
- Notification on traditional medicine registration (1998).

-35-

- Notification on cosmetics safety importation (2000).
- Requirements for renewal of drug registration license (2000).
- Decision on medical devices registration (2001).
- Ministerial decision on Prohibition of selling of Counterfeit medicines (01/08/2003).
- Ministerial decision on the sticking of vignette on the Pharmaceutical box (15/03/2005).
- Sub-Decree: Create the Inter-ministerial Committee and Provincial Committee to eliminate
Counterfeit drugs and illegal Health services (29/08/2005)

Private Sector:
The ministry of health has established a committee registration to select and evaluate of all
pharmaceutical products and other health products to giving the register license for selling in
Cambodia market, the committee were composed by the department of drugs and food as register
office is as the secretariat to study the administrative dossiers with technical pharmaceutical dossiers,
the national health product quality control center is responsible for analyzing the dossier and part oftechnical on quality control processing, expertise medical doctor from national hospital areresponsible for study on clinical trial and effect on treatment to patients,
The committee always meet every quarterly to decide or approve on products are completed thecriteria of guideline which under guide from ministry secretarial,
The department of drugs and food as the pharmaceutical trade office are responsible to analysis on
drugs import and drugs approval distribute proposal to ministry of health before selling in the market,
The importer or destructors of pharmaceutical products need to send the documents to department of-36-

drugs and food to check it before make approval from the ministry of health, the documents are:-

Airway bill or Bill of lading from original sources-

Commercial invoice with price attachment-

Parking list with weight of products-

List of pharmaceutical products with number of register license-

Official letter address to the minister of ministry of health

-

Etc,

The ministry of health usually approves after they check that documents are legal and respect theguideline like expiry date is over 18 months when arrival in Cambodia, property storage condition, notinclude other products are effect to medicines, IEC material need to declare and other points ofguideline,
When the pharmaceutical products are selling in the market, the ministry of health established a teaminspection were corporate with police and lawyer to control of medicines products are suspected tocounterfeit which collect the samples to national health product quality control center to check their
quality, if the result are failed, the ministry of health ask to police and lawyer to justice course anddestroy and penalty refer to the medicine management law.

Public Sector:
The central medical store (CMS) of ministry of health is a legal institution for distributing ofpharmaceutical products and other health products to national hospital, referral hospital and theoperational district (OD) or regional store, the operational district (OD) is distribute to health centers,-37-

public clinics and other health posts,
Cambodia is a system of centralization procurement for public health sector, It mean the procurement
Central level public procurement is done by different procurement agents, depending on funding
sources. There are currently 3 main procurement units (PUs) responsible for public procurement ofpharmaceuticals:•

National Budget (NB) PU – uses funds allocated from the National Budget•

Global Fund/Principal Recipients (GF/PR) PU – for GF grants•

Health Sector Support Program (HSSP) PU - uses donor funds (World Bank, ADB, DFID, UNFPA,
JICA etc). However, it is important to note that currently all World Bank procurements, including
pharmaceuticals, is done by an external/international contracted procurement agent – the Grown
Agent.

However, after receiving of commodities from suppliers, CMS is responsible to storage, repackage,and distribute to other public health services by checking the national plan service and screening thequarterly report from referral hospital and operational district,
The ministry of health also have allowed to national hospital, referral hospital and other healthservices procured by themselves but under control processing and auditing budget sources,

13) Existence or nonexistence of recalledsystem of products distributed:
When there are some pharmaceutical products are counterfeited in the market, the inspector-38-

collect the samples to the national health product quality control center to confirm the quality and thedepartment of drugs and food are verify the register license of the product and design to compare theregistered product and samples are taken from the market, if the products need to recall from themarket, the ministry of health make announcement to all health services and pharmacy store takeattention to stop using and sell to patients about the brand name of product, design (include showing
picture), lot or batch number, manufacturing date of product, country produce, and source.., thecompany or importer has a role responsible to turn back their stock and report to department of drugs
and food or ministry of health about stock status and establish a committee to destroy of that productswith is disseminated information by television and newspapers, if there do not know about importer or
distributor, It is nearly the same process but the collection of products from the market are responsible
by department of drugs and food, drugs and food safety office of all provinces and municipality or city
authority to corporate with private sectors as pharmacy association, medical association andpharmacy or medical doctor are responsible on technique on their field to collect the products recall toministry of health or department of drugs and food to destroy,
Every year, the project of Japan Pharmaceutical Manufacturer Association (JPMA) and Kanasawa
University has conducted a post marketing surveillance that corporate with ministry of health,department of drugs and food, national health product quality control center to collect the sample andanalysis of sample in Japan and some part at national health product and quality control center to findout of quality of essential medicines in Cambodia market, If the product are failed testing quality, theministry of health take action to recall of products and do not allow of that product to sell in the market,-39-and some of them delete out the number of license in the register list,

14) Name of organization for analyzing recall
products:
Usually, if there are suspicious samples or products recalled, the national health products quality
control center are responsible to analysis of samples collection to confirm their quality before decideto recall products from the market which 5 analyzing staffs are responsible, in case of national healthproduct quality control center is not enough capacity to analysis, the ministry of health to decide send
that samples to analysis in Viet Nam or Thailand to confirm the quality control and take the action
recall from the market by collect from the pharmacy store, clinic and other stock to destroy which
corporate with the provincial health department and health professional association,-40-

V- Essential Drug List in 2010
The National Essential Drug list is composed of 134 items and 134 items of consumables
excluding drugs specifics for the national programs 231 items such as:
1-

Eye unit…………………….........................12 items

2- Tuberculosis……………..............................22 items
3- Malaria/Shistosomiasis and Helminthiasis/Dengue
Hemorrhagic Fever/Filariasis Programa-Malaria…………………....................14 itemsb-

Shistosomiasis and Helminthiasis ..... 01 itemsc-Dengue Hemorrhagic fever.................03 itemsd-Filariasis .............................................03 items

4- Birth Spacing……………...............................08 items
5- Leprosy ........................................................05 items
6- Psychiatry ....................................................21 items
7- STD ..............................................................05 items
8- Dermatologic……………...............................22 items
9- HIV/AIDS CARE……….................................35 items
10- Oral Health:- Medecines...........................................11 items- Materials .............................................12 items-41-

11- National immunization program ...................09 items
12- Pain Relies medicines/Palliative care ...........17 items
13- Anti cancer Medicines ..................................12 items
14- Anti-Diabetic medicines.................................05 items
15- Endocrinology and Hormonology...................02 items

16- Nutrition ....................................................... 02 items

ESSENTIAL DRUG LIST
This list is updated every two years

Lr lr
Nº

rayeQµaH»sfsMPar³brik çareBTü

kMrit

Description

strengthNºTherapeutic category and/or other uses

RbePT (not intended to serve as a substitute forFormclinical judgement)

I- BASIC MEDICINES
I-1- ORAL MEDICINES
Analgestic, Antipyretic, antimigraine,

1

1

Acetylsalicylic Acid

500mg

Tab
antithrombotic

2

2

Aluminium Hydroxide

500mg

Tab

Antacid3

3

Aminophylline

100mg

Tab

Anti-asthmatic/brochodialator

4

4

Amlodipine

10mg

Tab

Antihypetensive

5

5

Amoxicillin

250mg

Tab

Antibacterial (beta lactam)

6

6

Amoxicillin

500mg

Cap

Antibacterial (beta lactam)

7

7

Amoxicillin + Clavulanic acid500mg+125mg

Tab

Antibacterial (beta lactam)

8

8

Amoxicillin Dry Powder/Granules 60ml

125mg/5ml

Btl

Antibacterial (beta lactam)

99

Atenolol

50mg

Tab

Antihypetensive; antiangino

10

10Bromhexin

8mg

Tab

Broncho mucolytic/antitussive

11

11

Bromhexin Syrup 60ml

4mg/5ml

Btl

Broncho mucolytic/antitussive

12

12Captopril

25mg

Tab

Antihypetensive

13

13

Charcoal Activated (Carbon Absorbent)

125mg

Tab

Antidote (non-specific) for poisoning

14

14

Chlorpheniramine maleate

4mg

Tab

Anti-histamine; anti-allergic

-42-

15

15

Chlorpromazine (as hydrochloride)

25mg

Tab

Psychotic disorders
Antacid (h2-receptor histamine antagonist

16

16

Cimetidine

200mg

Tab

- inhibits production of acid in thestomach)17

17

Ciprofloxacin (as hydrochloride)

500mg

Tab

Antibacterial

18

18

Cloxacillin (as soldium salt)

250mg

Tab

Antibacterial (beta lactam)

19

19

Cloxacillin (as soldium salt)

500mg

Tab

Antibacterial (beta lactam)

20

20

100+20mg

Tab

Antibacterial21

21400+80mg

Tab

Antibacterial

200+40mg/5ml

Btl

Antibacterial

5mg

Tab

Co-trimoxazole(sulfamethoxazole+trimethoprim)
Co-trimoxazole(sulfamethoxazole+trimethoprim)
Co-trimoxazole

22

22(sulfamethoxazole+trimethoprim)
Suspension 60ml

Anxiolytic, sleep disorders, mild muscle

23

23

Diazepamrelaxant

24

24

Diclofenac

50mg

Tab

25

25

Digoxin

0.25mgTab

NSAID, analgesic
Cardiovascular medicines used in heart
failure26

26

Doxycycline (as hydrochloride)

100mg

Tab

Antibacterial
Anti-hypertensive;congestive heart failure

27

27

Enalapril

10mg

Tab

and improvement of survival after a heart
attack.

Erythromycin (as stearate or ethyl

28

28

29

29

30

30

Fenofibrate31

31

Ferrous fumarate Suspension 60ml

250mg

Tab

Antibacterial

125mg/5ml

Btl

Antibacterial

300mg

Tab

Anti-cholesterol and triglyceride

100mg/5ml

Btl

Antianaemic

succinate)
Erythromycin stearate Dry
Powder/Granules 60ml

200+0.40mg (60mg Iron
32

32

Ferrous Sulphate + Folic Acidelement + 0.4 mg Folic
acid)

Red
Nutrition supplement for use in pregnancy

Tab

33

33

Fluconazole

100mg

Tab

Oral antifungal

34

34

Folic Acid

5mg

Tab

Antianaemic

35

35

Furosemide

40mg

Tab

Diuretic and anti-hypertensive; also usedin heart failure
Anti-hypertensive; Should be used in
pregnancy induced acute and severe

36

36

Hydralazine

25mg

Tab
hypertension. Not recommended for thetreatment of essential hypertension.

-43-

Diuretic and anti-hypertensive; also used37

37

Hydrochlorothiazide (scored tablet)

50mg

Tab
in heart failure38

38

Indometacin

25mg

Tab

39

39

Isosorbide Dinitrate

10mg

Tab

NSAID, analgesic
Vasodilator used in , e.g. angina pectoris,
anal fissure and congestive heart failure.

40

40Mebendazole

500mg

Tab

Intestinal anthelminthic
Anti-hypertensive; Should be used in
pregnancy induced acute and severe

41

41

Methyldopa (Aldomet)

250mg

Tab
hypertension. Not recommended for thetreatment of essential hypertension.

Metoclopramide (as hydrochloride)

42

42

10mg

Tab

Antiemetic

43

43

Metronidazole

250mg

Tab

Antibacterial/antiamoebic/antigiardiasis

44

44

Mifepriston + Misoprostol (Medabon)(01x200mg)+(04x200µg)

Tab

Medical abortion

45

45

Misoprostol (Cytotec)

200µg

Tab

Oxytocic

46

46

Multivitamin + Mineral

Tab

Vitamin and minerals supplement

47

47

Nalidixic Acid (Negram)

500mg

Tab

Anti-infective (quinolone)48

48

Niclosamide

500mg

Tab

Intestinal anthelminthic

49

49

Nifedipine Retard

20mg

Tab

(Primperan)Anti-hypertensive (calcium chanel
blocker) also used as an anti-angina.

50

50

Nystatin

500.000IU

Tab

Oral antifungal

SachetOral remedy for rehydation

Glucose: 13.5g/l, Sodium
chloride:2.6g/l, Potasium

51

51

Oral Rehydration Salts (Low osmolarity
chloride 1.5g/l, Trisodium

1L), for glucose-electrolyte solution
citratedihydrate:2.9g/l(20.5g)Analgesic, antipyretic, antimigraine

52

52

Paracetamol

100mg

Tab
(acute); without anti-inflamatory action
Analgesic, antipyretic, antimigraine,

53

53

Paracetamol

500mg

Tab
without anti-inflamatory action
Analgesic, antipyretic, antimigraine;

54

54

Paracetamol

500mg

Supp
without anti-inflamatory action
Analgesic, antipyretic without

55

55

Paracetamol Syrup 60ml

125mg/5ml

Btl
anti-inflamatory action

56

56

57

57

58

58

Phenobarbital
Phenoxymethyl Penicillin (as potassium
salt)

50mg

Tab

Anticovulsant/antiepileptic

250mg

Tab

Antibiotic (beta lactam)

600mg

Tab

Treatment of hypokalemia in patients

Potassium Chloride

predisposed to loss o K+ e.g. patients on-44-

high doses of diuretics
Anti-inflammatory ;59

59

Prednisolone

5mg

Tab
Anti-allergic/anaphylaxis

60

60

Promethazine

61

61

62

62

Retinol / Vitamine A ( red color capsule with nipple)

63

63

Retinol / Vitamine A (blue color capsule with nipple)

64

64

Salbutamol

65

65

Salbutamol for Inhalation 200doses

66

66

Simvastatine

Promethazine (as hydrochloride) 0.1%
syrup 60ml

25mg

Tab

Antihistamine, anti-emetic

5mg/5ml

Btl

Antihistamine, anti-emetic

200,000IU

100,000IU

Soft
Vitamin A supplement

Cap
Soft
Vitamin A supplement

Cap

4mg

Tab

Antiasthmatic/bronchodialator

0.1mg/dose

Btl

Antiasthmatic/bronchodialator

20mg

Tab

Anti-cholesterol; used to prevent cardio
vascular disease

67

67

Tiemonium (Visceralgine)

50mg

Tab

Antispasmodic

68

68

Vitamin B1

50mg

Tab

Vitamin B1 supplement

69

69

Vitamin B6

10mg

Tab

Vitamin B6 supplement

70

70

Zinc Sulphate (Dispersible)

20mg

Tab

Diarrhoea in children used as with/an
adjuct to ORS

I-2. INJECTABLE MEDICINES
71

1

Adrenaline (epinephrine)

1mg/1ml

Amp

Anti-allergic, anti-anaphylaxis

72

2

Ampicillin

500mg

Vial

Antibacterial (beta lactam).

73

3

Ampicillin

1g

Vial

Antibacterial (beta lactam)

74

4

Antisnake Venon Polyvalent

10ml

Vial

Antisnake immunoglobulin

75

5Antitoxin,Tetanus

500IU/1ml

Amp

Antitetanus

76

6

Atropine Sulphate

1mg/1mlAmp

Pre-operation medication; specificantidote for some poisoning

77

7

Bupivacaine 0.5% Spinal heavy

20mg/4ml

Vial

Local/Spinal anaesthetic

78

8

Butylscopolamine (Hyoscin, Buscopan)

20mg/2ml

Amp

Antispasmodic

79

9

Calcium Gluconate 10%

1g/10ml

Amp

Specific antidote for some type of
poisoining
Broad-spectrum (beta-lactam

80

10Ceftazidime (as pentahydrate)

antibacterial) for the treatment of

250 mg(powder for injection)Vialmelioidosis infection caused by
Burkholderia pseudomallei

81

11

Ceftriaxone

1g

Vial

Antibacterial (beta lactam)

82

12

Chloramphenicol

1g

Vial

Antibacterial

83

13

Chlorpromazine (as hydrochloride)

50mg/2mlAmp

Psychotic disorders-45-

Antacid (h2-receptor histamine antagonist

84

14

Cimetidine

200mg/2ml

Amp- inhibits production of acid in thestomach)

85

15

86

16

Cloxacillin (as soldium salt)
Dexamethasone phosphare (as disodium
salt)

1g

Vial

Antibacterial (beta lactam)

4mg/1ml

Amp

Antiallergic, anti-anaphylaxis

Hypoglycemia (low blood sugar) inemergency care; management of coma of87

17

Dextrose 50%

50ml

Vial
unknown origin; andrestoration of energy.
Psychotropic, pre-operation sedation for

88

18

Diazepam

10mg/2mlAmp

short term procedures;anti-convulsant/antiepileptic
Symphomimetic used in heart failure,89

19

Dopamine (as hydrochloride)

200mg/5ml

Ampshock and other conditions where
sympathomimetic action is desirable.
Spinal anaesthesia during delivery to

90

20

Ephedrine (for dilution, as hydrochlorided)

30mg/1mlAmp
prevent hypotension

91

21

Ergometrine Methyl (Methergin)

0.2mg/1ml

Amp

Oxytocic (uterine contraction)

92

22

Etamsylate (Dicynone)

250mg/2ml

Amp

Anticoagulant

93

23

Fentanyl0.1mg/2ml

Amp

Chronic pain management

94

24

Furosemide

20mg/2ml

Amp

Diuretic normaly used in heartfailute

95

25

Gentamycin (as sulfate)

80mg/2ml

Amp

Antibacterial
Antihypertensive: for acute management96

26

Hydralazine Powder + Solvent

20mg/1mlAmpof severe pregnancy-induced hypertension
only.
Anti-inflammatory ;9727

Hydrocortisone ( as Sodium succinate)

100mg

Vial
Anti-allergic/anaphylaxis

9828

Ketamine

99

29

Lidocaine 2%

500mg/10ml

Vial

General anaesthetics – injectable

50ml

Vial

Local anaesthetic – injectable
For treating eclampsia and severe

100

30

Magnesium Sulphate 50% IM/IV

10ml

Amp

pre-eclampsia not other forms of
convulsant disorders

Metoclopramide (as hydrochloride)

101

31

10ml/2ml

Amp

Antiemetic

102

32

Metronidazole

500mg/100ml

Vial

Antibacterial/antiamoebic/antigiardiasis:

103

33

Morphine (as hydrochloride or sulphate)

10mg/1ml

Amp

Chronic pain management

104

34

Neostigmine

0.5mg/1ml

Amp

Muscle relaxant

105

35

Oxytocin

10 IU/1ml

Amp

Oxytocic (uterine contraction)

106

36

Penicillin - G, IM/IV

1MIU

Vial

Anti-infective(Primperan)

-46-

107

37

Potassium Chloride 10%

108

38

Salbutamol

109

39

Sodium Bicarbonate 8.4%

10ml

Amp

Treatment of hypokalemia

0.5mg/1ml

Amp

Antiasthmatic

20ml

Amp

Alkalising agent for the treatment of
acidocis110

40

Suxamethonium (as chloride)

111

41

Thiopental

112

42

Tramadol Chlorhydrate

100mg/2ml

Vial

Muscle relaxant

1g

Vial

General anaesthetics – injectable

100mg /2ml

Amp

Chronic, moderate to severe pain
management

113

43

Vecuronium (bromide) + Solvent

10mg/10ml

Vial

114

44

Vitamin K1 (Phytomenadione)

10mg/1mlAmp

Muscle relaxant/anesthesia
Coagulant: affects blood coagulation;
helps to stop bleeding

115

45

Water for Injections

5ml

Amp

500ml

Btl

Diluent for injection

I-3. IV FLUIDS
Anticoagulant during surgical operations;116

1

Dextran 40 + IV giving set

plasma expander/subsituteRehydration and energy; diluent for other117

2

Dextrose 10% + IV giving set

500ml

Btl
IV medications
Rehydration and energy; diluent for other118

3

Dextrose 5% + IV giving set

500ml

Btl
IV medications
Electrolyte replacement, rehydration, and

119

4

Dextrose 5%+0.45% Saline + IV giving set

500ml

Btl
source of energy
Electrolytes replacement, rehydration, and120

5

N S S 0.9% + IV giving set

1000mlBtlsource of sodium, sugar and energy

121

6

Plasma Substitute + IV giving set

500ml

Btl

122

7

Ringer's Lactate + IV giving set

1000mlBtl

Plasma expanderI-4. EXTERNAL MEDICINES
123

1

Benzoic Acid 6% + Salicylic Acid 3%

500g

Jar

Antifungal (topical)

124

2

Benzyl Benzoate 25%

1L

Btl

Scabicide, pediculicide

125

3

167mg

Tab

Water Purification

126

4

1L

Btl

Sodium Dichloroisocyanurate (Water
Purification)

Antiseptic concentrate; 5% solution used

Chlorhexidine digluconate 20%

as antiseptic
Anti-infective (topical) as a 0.5 aqueous

127

5

Gentian Violet Powder

25g

Jar
solution or tincture

128

6Fluorthane (Halothane)

129

7

Hydrogen Peroxide (20 volumes)

250ml
1L

Btl

General anaesthetics – inhalation

Color

Antiseptic concentrate; 5% solution used

Glass Btl

as antiseptic

130

8

Polyvidone Iodine 10%

200ml

Btl

Antiseptic

131

9Potassium Permanganate

250g

Btl

Anti-infective (topical) as a aqueous-47-

solution 1:10,000

132

10

Soda lime ( Chaux Sodee)

4.5kg

Btl

133

11

Petroleum Jelly (Vaseline)

500g

Jar

Adjuct to general anaesthesia
Emollient (skin lubrication andmosturizer)
Hypoallergenic (minimize itching due to

134

12

Zinc oxide 10%

500g

Jar
skin allergic reactions)

II- CONSUMMABLES
135

1

Adhesive Tape Zinc Oxide perforated

18cm x 5m

Roll

136

2

Adhesive Tape Zinc Oxide perforated

5cmx5m

Roll

137

3

Airway ( ambuls oxygene)

Size 1

Pcs

138

4

Airway ( ambuls oxygene)

Size 2

Pcs

139

5

Bandage, Crepe

8cmx4m

Roll

140

6

Bandage, Gauze Non-sterile

7.5cmx10m

Roll

141

7

Bandage Tubular Elastic

8mm x 4cm

Pcs

142

8

Blades for Surgical Knife

#15

Pcs

143

9

Blades for Surgical Knife

#22

Pcs

144

10

Blood Collection Bag (CPD)

350ml

145

11

Catheter Foley, Ballon 2 ways 10ml, sterile

CH12

Pcs

146

12

Catheter Foley, Ballon 2 ways 10ml, sterile

CH14

Pcs

147

13

Catheter Foley, Ballon 2 ways 10ml, sterile

CH16

Pcs

148

14

Catheter IV

18G

Pcs

149

15

Catheter IV

20G

Pcs

150

16

Catheter IV

22G

Pcs

151

17

Catheter IV

24G

Pcs

152

18

Catheter IV

26G

Pcs

153

19

Colostomy Bag, Disposable

38mm

Pcs

154

20

Cotton Wool Absorbent

500g

Roll

155

21

Cotton Wool Non Absorbent

500g

Roll

156

22

for 22,5 L

Pack

157

23

Developer for X-Ray Film

1 Gallon

Btl

158

24

Drainage Strip (Delbet)

25x3cm

Pcs

159

25

Eye Shields

160

26

Fixer for X-Ray Film (For manual use )for 22,5 L

Pack

161

27

Fixer for X-Ray Film

1 Gallon

Btl

162

28

Dressing for burns with Paraffin

10x10cm

Pcs

90cmx91m

Roll

Developer for X-Ray Film (For manual
use)

Pcs

2

163

29

Gauze, absorbent (BP17g/m )

164

30

Glove examination, non sterile, Latex

Small

Pcs

165

31

Glove examination, non sterile, Latex

Medium

Pcs

-48-

166

32

167

33

168

34

169

35

170

36

171

Glove examination, non sterile, Latex

Large

Pcs

Small

Pcs

Medium

Pcs

Large

Pcs

Glove Surgical, sterile, latex

Small

Pcs

37

Glove Surgical, sterile, latex

Medium

Pcs

172

38

Glove Surgical, sterile, latex

Large

Pcs

173

39

High Quality Printing Paper UPP- 110s

110mm x 20m

Pcs

174

40

Infusion set with burette 100ml, Disposable

60drops/minute

Pcs

175

41

Iol Intra Ocular Lens

#18

Pcs

176

42

Iol Intra Ocular Lens

#19

Pcs

177

43

Iol Intra Ocular Lens

#20

Pcs

178

44

Iol Intra Ocular Lens

#21

Pcs

179

45

Iol Intra Ocular Lens

#22

Pcs

180

46

7cm x 11cm

Pcs

181

47

Medical X ray films, Green sensitive

18cm x 24cm

Pcs

182

48

Medical X ray films, Green sensitive

18cm x 43cm

Pcs

183

49

Medical X ray films, Green sensitive

24cm x 30cm

Pcs

184

50

Medical X ray films, Green sensitive

30 cm x 40cm

Pcs

185

51

Medical X ray films, Green sensitive

35cm x 35cm

Pcs

186

52

Medical X ray films, Green sensitive

35cm x 43cm

Pcs

187

53

Ag/Agcl

Pcs

188

54

MVA Kit189

55

Needle Disposable

19G x 1.½"

Pcs

190

56

Needle Disposable

21G x 1.½"

Pcs

191

57

Needle Disposable

23G x 1"

Pcs

192

58

Needle Disposable

25G x 1"

Pcs

193

59

Needle Spinal Disposable

22G/0.7 x 90mm

Pcs

194

60

Needle Spinal Disposable

25G/0.5 x 90mm

Pcs

195

61

Needle Suture Cutting

Assorted

Pcs

196

62

Needle Suture Round

Assorted

Pcs

197

63

Oxygen mask with reservoir bag

Children

Pcs

198

64

Oxygen mask with reservoir bag

Adult

Pcs

199

65

Paper face mask 2 plies

Glove, sterile, Long Cuff (forGynaecological use)
Glove, sterile, Long Cuff (forGynaecological use)
Glove, sterile, Long Cuff (forGynaecological use)

Medical Plastic Bags (Khmer printing, as
sample)Monitoring electrode with Micropore Tape
Backing and solid gel

Kit

Pcs

-49-

200

66

Plaster of Paris

10cm

Roll

201

67

Plaster of Paris

15cm

Roll

202

68

Plaster of Paris

20cm

Roll

203

69

Red O Pack

Set

204

70

Rubber bulb with Valve for sphygmomanometer

Pcs

205

71

Safety Box for Used Syringe

5L

Pcs

206

72

Safety Box for Used Syringe

10 L

Pcs

207

73

Scalp Vein

23G

Pcs

208

74

Scalp Vein

25G

Pcs

209

75

Scalp Vein

27G

Pcs

210

76

Sterile eyes pads

211

77

Stomach Wash Out tube, Fraucher Type

CH27

Pcs

212

78

Sut/Catgut Chromic25mm½circle Rb75cm

2/0

Pcs

213

79

3/0

Pcs

214

80

0

Pcs

215

81

1

Pcs

216

82

2

Pcs

217

83

2

Pcs

218

84

3/0

Pcs

219

85

2/0

Pcs

220

86

0

Pcs

221

87

1

Pcs

222

88

0

Pcs

223

89

2/0

Pcs

224

90

3/0

Pcs

225

91

6/0

Pcs

226

92

2/0

Pcs

Pcs

Suture/Catgut Chromic30mm½circle
Rb75cmSuture/Catgut Chromic35mm½circle
Rb75cmSuture/Catgut Chromic38mm½circle
Rb75cmSuture/Catgut Chromic40mm½circle
Rb75cmSuture/Catgut Chromic85mm B P Cvd Rb
Suture/Catgut Plain 22mm curved cutting
75cm
Suture/Catgut Plain 25mm½ circle Rb
75cm
Suture/Catgut Plain 30mm½ circle Rb
75cm
Suture/Polyglycolic Acid 30mm½ circle
round body 75 cm (Vicryl)
Suture/ Polyglycolic Acid 30mm½ circle
round body 75 cm (Vicryl)
Suture/ Polyglycolic Acid 30mm½ circle
round body 75cm (Vicryl)
Suture/ Polyglycolic Acid 30mm½ circle
round body 75cm (Vicryl)
Suture/ Polyglycolic Acid double arms
spatulates ( S 24 )Suture/Polyamide 30mm ½ circle cutting
75cm (Nylon)

-50-

227

93

228

94

229

95

230

96

231

97

232

98

233

99

234

100

235

Suture/Polyamide Curved Rev cutting

3/0

Pcs

4/0

Pcs

10/0

Pcs

Suture/Silk 16mm curved 45mm

4/0

Pcs

Suture/Silk 6mm curved 38mm

6/0

Pcs

8/0

Pcs

10/0

Pcs

Syringe Disposable & Needle 26G

1ml

Pcs

101

Syringe Disposable & Needle 25G

2ml

Pcs

236

102

Syringe Disposable & Needle 25G

5ml

Pcs

237

103

Syringe Disposable & Needle 23G

5ml

Pcs

238

104

Syringe Disposable & Needle 23G

10ml

Pcs

239

105

Syringe Disposable

20ml

Pcs

240

106

Syringe Disposable

50ml

Pcs

241

107

Talc

1kg

Box

242

108

Tape Test for Autoclave

Roll

243

109

Tape Umbilical Non sterile 3mm

Roll

244

110

Tape/Strips Test For Poupinel

Roll

26mm (Nylon)
Suture/Polyamide 30mm ½ circle cutting
75cm (Nylon)
Suture/ Black monofilament double arms
spatulates 30cm (Nylon)

Suture/Silk 8mm double needle
micro-point spatula ½ circle 30mm
Suture/Silk double needle micro-point
spatula curved 30mm

o

245

111

Thermometer Oral/Rectal C

Pcs

246

112

Thorax Drain + Trocart

CH12

Pcs

247

113

Thorax Drain + Trocart

CH14

Pcs

248

114

Thorax Drain + Trocart

CH16

Pcs

249

115

Thorax Drain + Trocart

CH18

Pcs

250

116

Thorax Drain + Trocart

CH20

Pcs

251

117

Tongue depressor wood adult

252

118

Tracheal tube

#6.5

Pcs

253

119

Tracheal tube

#7

Pcs

254

120

Tracheotomy tube

#6

Pcs

255

121

Tracheotomy tube

#7

Pcs

256

122

Tube Nasogastric/Feeding

CH5

Pcs

257

123

Tube Nasogastric/Feeding

CH8

Pcs

258

124

Tube Nasogastric/Feeding

CH12

Pcs

259

125

Tube Nasogastric/Feeding

CH14

Pcs

260

126

Tube Nasogastric/Feeding

CH16

Pcs

Pcs

-51-

261

127

Tube Redon Drain

CH12

Pes

262

128

Tube Redon Drain

CH16

Pcs

263

129

Tube Suction Disposable

CH8

Pcs

264

130

Tube Suction Disposable

CH12

Pcs

265

131

Tube Suction Disposable

CH16

Pcs

266

132

Ultra Sound Gel

1 kg

Bttl

267

133

Umbilical cord clamp

268

134

Urine Drainage Bag with non-return valve

Pcs
2litrePcs

III-NATIONAL PROGRAM MEDICINES
III-1.EYE UNIT PROGRAM

269

1

Acetazolamide (Diamox)

250mg

Tab

Opth. Anti-glaucoma

270

2

Atropine Sulphate eye drop 5ml

1%

Vial

Opth. with mydriatic

271

3

Ciprofloxacine eye drop 5ml

0,3%

Vial

Opth.- anti-infective272

4

Fluoresceine eye drop 10ml

Vial

Opth. diagnostic

273

5

Vial

Opth. Anti-infective/anti-inflammatory

274

6

2%

Vial

Opth. with mitotic

275

7

Prednisolone Acetate eye drop 5ml

1%

Vial

Opth. Anti-allergic/anti-inflammatory

276

8

Tetracaine eye drop 5ml

0.50%

Vial

Opth.- anti-infective

277

9

Tetracycline eye ointment 5g

1%

Tube

Opth.- anti-infective

278

10

Timolol eye drop 3ml

0.50%

Vial

Opth. Mitotic

279

11

Tropicamide eye drop 10ml

1%

Vial

Opth. diagnostic

Neomycine + Polymycine B + Dexamethasone, eye drop ( Maxidrol eye drop) 5ml
Pilocarpine (as sodium phosphate) eye drop
5ml

Steril clear viscous solution with elastic property

280

12

Viscoelastic Solution 1ml

Syringeused in cataract, glaucoma and corneal ophthalmic
surgical procedures.

III-2. TUBERCULOSIS MEDICINESFirst Line Ant-TB Medicines
281

1

Ethambutol

400mg

Tab

Anti-tuberculosis

282

2

Ethambutol

100mg

Tab

Anti-tuberculosis

283

3

Ethambutol / Isoniazide

400mg/150mg

Tab

Anti-tuberculosis

284

4

Isoniazide

100mg

Tab

Anti-tuberculosis

285

5

Pyrazinamide

400mg

Tab

Anti-tuberculosis

286

6

Rifampicine

150mg

Tab

Anti-tuberculosis

-52-

287

7

Rifampicine / Isoniazide

150 + 75mg

Tab

Anti-tuberculosis

288

8

Rifampicine / Isoniazide

60+30mg

Tab

Anti-tuberculosis

289

9

Rifampicine / Isoniazide / Pyrazinamide

60+30+150mg

Tab

Anti-tuberculosis

290

10

Rifampicine/Isoniazide/Pyrazinamide/Ethambutol

TabAnti-tuberculosis

291

11

Streptomycine

1g

Vial

Anti-tuberculosis

500mg

Vial

150+75+400+275
mg

Second Line Ant-TB Medicines
2nd line anti-infective (aminoglycoside) -292

1

Amikacin

multidrug resistant gram negative bacteria
2nd antimycobacterials: tuberculosis and293

2

Capreomycin

1g

Vial
leprostatic agents294

3

Cycloserine

250mg

Cap

Anti-infective used as 2nd line anti-TB

295

4

Ethionamide

250mg

Tab

Anti-infective used as 2nd line anti-TB

296

5

Gatitfloxacin

500mg

Tab

Anti-infective used as 2nd line anti-TB

297

6

Kanamycin

1g

Vial

Anti-infective used as 2nd line anti-TB

298

7

Levofloxacin

250mg

Tab

Anti-infective used as 2nd line anti-TB

299

8

Moxifloxacin

400mg

Tab

Anti-infective used as 2nd line anti-TB

300

9Ofloxacin

200mg

Tab

Anti-infective used as 2nd line anti-TB

301

10

Para Amino Salicylic Acid

4g

SachetAnti-infective used in combination withother anti-TB as 2nd line

302

11

Prothionamide

250mg

III-3. MALARIA/Shistosomiasis and Helminthiasis/
a-Malaria Program

Tab

Anti-infective used as 2nd line anti-TB

Dengue Haemorrhagic Fever / Filariasis Program303

1

A+M1 (Artesunate + Mefloquine)

50mg+250mg

Blisterfor severe malaria (1-5yrs)

304

2

A+M2 (Artesunate + Mefloquine)

50mg+250mg

Blisterfor severe malaria (6-10yrs)

305

3

A+M3 (Artesunate + Mefloquine)

50mg+250mg

Blisterfor severe malaria (11-14yrs)

306

4

A+M5 (Artesunate + Mefloquine)

50mg+250mg

Blisterfor severe malaria (> 15yrs)

307

5Artesunate Rectocap

50mg

Tab

for severe malaria

308

6

Artesunate Rectocap

200mg

Tab

for severe malaria

309

7

Artemeter injectable

40mg/mlAmp

for severe malaria

3108Artemeter injectable

80mg/mlAmp

for severe malaria

311

9

Chloroquine base

150mg

Tab

2nd line anti-malaria (P.vivax infection)

312

10

Dihydroartemisinin and Piperaquine phosphate

40mg+320mg

Tab

Proposed new first line ACT for malaria causedby P. faciparum

313

11

Mefloquine

250mg

Tab

314

12

Quinine Sulfate

300mg

Tab

Used in combination with artesunate
Used in severe malaria and should be used in
combination with Doxycycline
P. falciparum malaria; no longer recommended

315

13

Quinine Dihydrochloride

600mg/2ml

Amp
by the WHO as first line treatment for malaria-53-and should only be used when ACTs are notavailable

316

14

Tetracycline

250mg

Cap

600mg

Tab

Anti-infective - with action on malaria parasiteb- Shistosomiasis and Helminthiasis Program
Intestinal

317

1

Praziquantel

anthelminthic:antischistosomal/antitrematodec- Dengue Haemorrhagic Fever Program
318

1

319

2

5% Dextrose in Isotonic Saline Solution + IV

Water, electrolyte replacement and source of

500ml

Giving Set

Blt
energy5% Dextrose in Acetate Ringer's Solution + IV

Water, electrolyte replacement and source of

500ml

Giving Set

Blt
energyWater, electrolyte replacement and source of

320

35% Dextrose in 1/3 Saline + IV Giving Set

500ml

Blt
energyd- Filariasis
321

1

Albendazol

400mg

Tab

Intestinal anthelmenthic

322

2

Diethylcarbamazine (dihydrogen citrate)

100mg

Tab

Antifilarial

323

3

Invermectin (scored tablets)

3mg or 6mg

Tab

Antifilarial

III-4. BIRTH SPACING MEDICINES
324

1

Depo-medroxyprogesterone acetate

150mg/3ml

Vial

Injectable hormonal contraceptive - long acting

325

2Norgestrel (Progestin-Only-Pill)

0.075mg

Blister

Oral Contraceptive

326

30.03/0.15mg

Blister

Combined Oral Contraceptive

327

4

Condom49mm

Pcs

Physical barrier contraceptive

328

5

IUD Copper T 380A

T380A

Pcs

Intra-uterine device (IUD) Contraceptive

160-180mm

Pcs

Physical barrier contraceptive

0.75mgBlister"Morning after" contraceptive

68mg

Implant

Implant hormonal contraceptive - long acting

Ethinyloestradiol + Levonorgestrel(Combined Oral Contraceptive)

Female Condom(Lubricated loose-fitting Polyurethane, pouch329

6closed at one end, open at the other with softrings at each end. 160-180mm width, 41-61µ
thickness, 2.23-2.53mm outer ring,
56.5-58-5mm inner ring330

7

Levonorgestrel 0.75mg (Emergency
Contraceptive Pills, 2 pill per Blister )Etonogestrel (Implant subdermal, small,

331

8

semi-rigid plastic rod, 4 cm in length and 2mm
in diameter, )III-5. LEPROSY MEDICINES
332

1

Clofazimine333

2

MB (multibacillary) Adult

100mg

-54-

Cap

Antileprosy

Blister

Antileprosy

334

3

MB (multibacillary) Child

Blister

Antileprosy

335

4

PB (paucibacillary) Adult

Blister

Antileprosy336

5

PB (paucibacillary) Child

Blister

Antileprosy

III-6. PSYCHIATRY MEDICINES
337

1

Amitriptyline (as hydrochloride)

25mg

Tab

Depressive disorders

338

2

Amitriptyline (as hydrochloride)

50mg

Tab

Depressive disorders

339

3

Carbamazepine

200mg

Tab

Bipolar disorders

340

4

Chlorpromazine (as hydrochloride)

100mg

Tab

Psychotic disorders

341

5

Clomipramine (as hydrochloride)

25mg

Cap

Obsessive compulsive and panic attacks

342

6

Fluoxetine (as hydrochloride)

20mg

Cap

Depressive disorders

343

7

Haloperidol

10mg

Tab

Psychotic disorders

344

8

Haloperidol

5mg

Tab

Psychotic disorders

345

9

Imipramine

25mg

Tab

Antidepressant

346

10

Lithium Carbonate

300mg

Tab

Bipolar disorders

347

11

Methadone Hydrochloride ( Biodone Forte )BottleSubstance dependance program use

348

12

Nortriptiline HCL

25mg

Tab

Antidepressant

349

13

Perphenazine

8mg

Tab

5mg/ml or
10mg/ml

Anti-psychotic, antidepresnt; used to treat
symptoms of schizophrenia

350

14

Phenytoine

100mg

Tab

351

15

Thioridazine

10mg

Tab

Anticovulsants/anti-epileptic
Anti-psychotic, antidepresnt; used to treat
symptoms of schizophrenia

352

16

Trihexyphenidyl (benzhexol)

5mg

Tab

353

17

Benztropine Mesylate

2mg/mlAmp

Antiparkinsonian agent (antimuscarinic class)An adjunct therapy to all forms of parkinsonism.
Sldo useful controlling extrapyramidal disorders

354

18

Fluphenazine decanoate

25mg/mlAmp

Psychotic disorders

355

19

Haloperidol

5mg/mlAmp

Psychotic disorders

356

20

Haloperidol decanoate

50mg/mlAmp

Psychotic disorders

1-2-4mg

Tab

Psychotic disorders (in adult)

Second Line
357

1

Risperidone

III-7.STD PROGRAM
358

1

Azithromycine

500mg

Tab

Antibacterial

359

2

Cefixime

200mg

Tab

Antibacterial (beta lactam)

360

3

Benzathine Penicilline

2.4MIU

Vial

Antibacterial (beta lactam)

361

4

Clotrimazole (vaginal tablets)

500mg

Pessary362

5

Podophyllin solution 25%

5ml

Vial

-55-

Antifungal
Skin differentiation and proliferation

III-8.DERMATOLOGIC
363

1

Aciclovir

400mg

Tab

Antiviral/antiherpes

364

2

Aciclovir Cream

15g

Tube

Antiviral/antiherpes (topical)

365

3

Benzoyl peroxide 5% Gel

40g

Tube

Topical use - affects skin differentiation andproliferation

366

4

367

5

368

6

369

7

Betamethasone (as valerate) Cream / Ointment

30g

Tube

Anti-inflammatory, antipruritic (topical)

30g

Tube

Anti-inflammatory, antipruritic (topical)

Betamethasone 0.05% +Fucidic acid 2%

15g

Tube

Topical Anti-infectives with Corticosteroids

Clobetasole propionate 0.05% cream

10g

Tube

0.1%
Betamethasone (0.05%) Cream +Salicylic Acid(3%) Ointment

Topical corticosteroids with anti-inflammatory,
antipruritic, and vasoconstrictive properties.

370

8Clotrimazole 1% cream

30g

Tube

371

9

Crotamiton 10% cream

30g

Tube

Antifungal (topical)
Scabicidal and antipruritic for treating scabies
and relieving itching

372

10

Fusidic Acid 2% cream

15g

Tube

Topical anti-infectives

373

11

Hydrocortisone (as acetate) 1%

15g

Tube

Anti-inflammatory, antipruritic (topical)

374

12

Ketokonazole 2% cream

15g

Tube

Topical broad spectrum antifungal

375

13

Miconazole 2% gel

40g

Tube

Antifungal (topical) - fungal infections of themouth, throat and gut

376

14

Tretinoin 0.05% cream

30g

Tube

Treatment of acne vulgaris
Topical corticosteroid for the treatment of

377

15

Triamcinolone acetonide Cream 0.1 %

30g

Tube

inflammatory and pruritic manifestations/dermatoses
Skin differentiation and prolifiration (for topical

378

16

Urea Cream 10%

100mg

Tube
use)
Topical adrenocortical steroid - antinflammatory

379

17

Clobetasole lotion

30ml

Bttl
and anti- itching
Topical use - affects skin differentiation and

380

18

Coaltar Lotion (Polyar Liquid)

150ml

Bttl
proliferation

381

19

Cetirizine hydrochloride

10mg

Tab

Antihistamine/anti-allergic

382

20

Griseofulvine

500mg

Tab

Oral systemic antifungal

383

21

Itraconazole

100mg

Tab

Oral systemic antifungal

384

22

Minocycline hydrochloride

100mg

Tab

Anti-infective

300mg

Tab

III-9.HIV/AIDS CARE
ARV: nucleoside/nucleotide reverse transcriptase

385

1

Abacavir (ABC) (as sulfate)inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

386

2

Abacavir (ABC) (as sulfate) 240ml syrup

20mg/mlBttl
inhibitor

-56-

387

3

Amphotericin B

50mg

Amp

Antifungal/antileishmaniasis

388

4

Cotrimoxazol

800 + 160mg

Tab

OI - anti-infective, prophylaxis

389

5

Cotrimoxazole IV 480mg/5ml

5ml

Amp

OI - anti-infective390

6

Calamine lotion 15%

100ml

Bttl

Anti-inflammatory, antipruritic (topical)

391

7

Lamivudine (3TC) + Stavudine(d4T)

150+30mg

Tab

ARV: 2-FDC

392

8

25mg

Tab

393

394

395

396

9

10

11

12

Didanosine (ddl) (buffered, chewable,
dispersible)
Didanosine (ddl) (buffered, chewable,
dispersible)
Didanosine (ddl) (buffered, chewable,
dispersible)
Didanosine (ddl) (unbuffered enteric coatedtablet)Didanosine (ddl) (unbuffered enteric coatedtablet)

ARV: nucleoside/nucleotide reverse transcriptase
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

50mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

100mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

250mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

400mg

Tab
inhibitor
ARV: Non-nucleoside reverse transcriptase

397

13

Efavirenz (EFV or EFZ)

50mg

Tab
inhibitor
ARV: Non-nucleoside reverse transcriptase

398

14

Efavirenz (EFV or EFZ)

200mg

Tab
inhibitor
ARV: Non-nucleoside reverse transcriptase

399

15

Efavirenz (EFV or EFZ)

600mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

400

16

Lamivudine (3TC)

150mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

401

17

Lamivudine (3TC) 100ml Syrup

50mg/5ml

Bttl
inhibitor

402

18

Loperamid

2mg

Tab

OI – antidiarhea

403

19

Lopinavir/Ritonavir (LPV/r)

100mg/25mg

Tab

ARV: Protease inhibitor

404

20

Lopinavir/Ritonavir

200mg/50mg

Tab

ARV: Protease inhibitor

405

21

Lopinavir/Ritonavir 160ml Syrup

80mg/20mg/ml

Bttl

ARV: Protease inhibitor

406

22

Nevirapine (NVP)

200mg

Tab

ARV: Non-nucleoside reverse transcriptase
inhibitor
ARV: Non-nucleoside reverse transcriptase

407

23

Nevirapine (NVP) Syrup

50mg/5ml

Bttl
inhibitor

408

24

Ritonavir

100mg

Tab

409

25

Stavudine (d4T)

15mg

Cap

ARV: pharmacological booster
ARV: nucleoside/nucleotide reverse transcriptase
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

410

26

Stavudine (d4T)

20mg

Cap
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

411

27

Tenofovir (TDF) (disoproxil fumerate)

300mg

Tab
inhibitor

-57-

412

28

413

29

414

30

415

31

416

32

417

33

Baby : Stavudine(d4T) + Lamivudine(3TC) +Nevirapine(NVP)
Baby : Stavudine(d4T) + Lamivudine(3TC) +Nevirapine(NVP)
Adult : Stavudine(d4T) + Lamivudine(3TC) +Nevirapine(NVP)
Lamivudine(3TC) + Zidovudine(AZT)
Lamivudine(3TC) + Zidovudine(AZT) +Nevirapine(NVP)

6+30+50mg

Tab

ARV: 3-FDC

12+60+100mg

Tab

ARV: 3-FDC

30+150+200mg

Tab

ARV: 3-FDC

150+300mg

Tab

ARV: 2-FDC

150+300+200mg

Tab

ARV: 3-FDC

100mg

Cap

ARV: nucleoside/nucleotide reverse transcriptase

Zidovudine (AZT or ZDV)

inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

418

34

Zidovudine (AZT or ZDV)

300mg

Tab
inhibitor
ARV: nucleoside/nucleotide reverse transcriptase

419

35

Zidovudine (AZT or ZDV) 100ml Syrup

50mg/5ml

Bttl
inhibitor

III-10.ORAL HEALTH MEDICINES
1- Medicines
420

1

Calcium Hydroxide

B/2P

Composite light cure highbriand microfiller421

24g( color A3, A3.5 ) for restorative fillingPcs

dental cavity
Toothache and other related uses e.g. mixed

422

3

Eugenol USP

10ml

Vial

with zinc oxide - restorative andprosthodontic

Powder 15g + liquid

423

4Glass ionomer for Rest Gc Fuji II

424

5Glass ionomer for Rest Gc Fuji IX

425

6Glass ionomer for Rest Gc Fuji VII

426

7

Lidocain 2% Adrenaline 0.001%

1.8 mlCart

Local anaesthetic

427

8

Lidocain 2% Non-adrenaline

1.8 mlCart

Local anaesthetic

428

9

Sachets /25ml

SachetInstrument sterilization

429

10

10g
Powder 15g + liquid
10g
Powder 15g + liquid
10g

Polyhexa+didecyl St 72.17 Hexanios forSoaking instruments before Sterilization
Sodium Fluoride (NaF)* powder

Box

Box

Box

Kg
Mixed with Eugenol produce material

430

11

Zinc Oxide Powder

1Kg

Jar

which has restorative and prosthodontic
applications.

-58-

2-Materials
Barbed broach ( tire -nerf) to take the nerf

431

1

Pcs

432

2

Burr cylinder Highspeed

Pce

433

3

Burr cylinder Lowspeed

Pce

434

4

Burr round for contra Angle Highspeed

Pce

435

5

Burr round for contra Angle Lowspeed

Pcs

436

6

437

7

438

8

Matrix bands medium ( Metal Matrix)

439

9

Needle Dental

27G .21mm

Pcs

440

10

Needle Dental

27G . 30mm

Pcs

441

11

Needle Dental

27G . 35mm

Pcs

442

12

from dental canalFiles Complete set length 21 mm ( files used
for root treatment )

#15,

Pcs

#20,#25,#30,#35,#40

Lentulo, Complete set ( used for root canalPcs

treatment )Pcs

Surgical blade #11 ( use for Surgical

Pcs

Procedure )III-11.NATIONAL IMMUNIZATION PROGRAM
443

1

BCG Vaccine with diluent (+VVM)

20doses

Vial

Vaccine444

2

DTP-Hep-Hib Vaccine (+VVM)

0.5ml/Dose

Vial

Vaccine445

3

Hepatitis B Vaccine 10µg/0.5ml (+VVM)

1dosesVial

Vaccine446

4

5 Doses

Vial

Vaccine447

5

Measle Vaccine with diluent (+VVM)

10doses

Vial

Vaccine448

6Oral Polio Vaccine with dropper (+VVM)

10doses

Vial

Vaccine449

7

Tetanus Toxin Vaccine (+VVM)

10doses

Vial

Vaccine450

8Autodestruct Syringe 0.05ml + Needle

27G x 3/8

Pcs

Consumable Supplies

451

9

Autodestruct Syringe 0.5ml + Needle

23G x 1

Pcs

Consumable Supplies

2mg

Tab

Japanesse Encephalitis Vaccine with diluent(+VVM)

III-12.PAIN RELIEF MEDICINES/ PALLIATIVE CARE
Anxiolytic with muscle relaxantion and452

1

Clonazepam

anticonvulsant action
Anxiolytic with muscle relaxantion and453

2

Clonazepam Drop

2.5 mg/ml

Btl
anticonvulsant action454

3

Codeine30mg

Tab

Opioid analgesic

455

4

Codeine Phosphate Syrup

1g/ml

Btl

Opioid analgesic

456

5

Gabapentin

100mg

Cap

Neuropathic pain relief

457

6

Ibuprofene

200mg

Tab

Analgesic – NSAIM

458

7

Ibuprofen (ped)250mg

Rectocap

Analgesic – NSAIM

-59-

459

8

Ibuprofen Drop

2g/100ml

Btl

Analgesic – NSAIM

460

9Macrogol 4000 Powder (ped)

4g

Btl

Laxative461

10

Macrogol 4000 Powder

10g

Btl

Laxative

462

11

Morphine Sulphate (Lasting 4 h)

10mg

Tab

Opioid analgesic, psychoactive

463

12

Morphine Sulphate (Lasting 4 h)

30mg

Tab

Opioid analgesic, psychoactive

464

13

Morphine Sulphate retard

10mg

Tab

Opioid analgesic, psychoactive

465

14

Morphine Sulphate retard

30mg

Tab

Opioid analgesic, psychoactive

466

15

Paracetamol

250mg

Rectocap

Analgesic and antipyretic withoutanti-inflamatory effect

467

16

Tramadol Chlorhydratre

50mg

Tab

468

17

Tramadol Chlorhydratre (Retard)

100mg

Tab

Opioid analgesic - moderate to severe pain
Opioid analgesic - moderate to severe pain slow releaseIII-13.ANTI CANCER MEDICINES
469

1

Bleomycin Sulfate

15mg

Vial

Cancer chemotherapy -various types

470

2

Cisplatin

50mg/50ml

Vial

Cancer chemotherapy -various types

471

3

Cyclophosphamid (endoxan)

500mg

Vial

Cancer chemotherapy -various types

472

4

Dacabarzine 100mg + Solvent

100mg

Vial

Antineoplastic chemotherapy drug - for various
cancers473

5

Doxorubicin Hydrochloride

50mg/25ml

Vial

Cancer chemotherapy -various types

474

6

Etoposide

100mg/5ml

Amp

Cancer chemotherapy -various types

475

7

Fluorouracil

250mg/5ml

Amp

Cancer chemotherapy -various types

476

8

Methotrexate

50mg/2ml

Vial

Cancer chemotherapy -various types

477

9

Mitomycine

2mg

Vial

Cancer chemotherapy

478

10

Ondansetron hydrochloride

8mg/4ml

Amp

Antiemetic - nausea and vomiting duringchemotherapy.

479

11

Tamoxifen Citrate

20mg

Tab

Hormone/anti hormone

480

12

Vincristine Sulphate

1mg/1ml

Vial

Cancer chemotherapy -various types

III-14.DIABETES MEDICINES
481

1

Glibenclamide

5mg

Tab

Anti-diabetic

482

2

Metformine ( Glucophage )

500mg

Tab

Anti-diabetic

483

31000 IU/ 10ml

Vial

Anti-diabetic

484

41000 IU/ 10ml

Vial

Anti-diabetic

485

51000 IU/ 10ml

Vial

Anti-diabetic

Insuline, intermediate acting (8-12 hours
efficacy)
Insuline, rapid acting (3-6 hours efficacy)
Premixed Insuline 70/30 (Semi-lente 70/ Rapid30) or Long acting Insuline-60-III-15.ENDOCRINOLOGY and HORMONOLOGY
486

1

Hydrocortisone

10mg

Tab

Anti-inflammatory and other endocrinal uses

487

2

Neomercazole

5mg

Tab

Anti-hyperthyroidism.

III-16.NUTRITION
60mg Iron
488

1

Iron-Folate Weekly Iron-Folic Supplementation

element +Rose

Weekly Iron-Folic Supplementation (WIFS) in(WIFS)

2.8 mg Folic

Tab

Women of Reproductive Age

acid
Rehydration Solution for Malnutrition(ReSomal) (Glucose 55mmol; Sucrose 73mmol;
489

2

Potassium 45mmol; Chloride 70mmol; Citrate

42.1g

Sachet7mmol; Magnesium 3mmol; Zinc 300μmol;

Treatment of rehydration in severally
malnourished children

Copper 3μmol)

VI-Difficulties and Constrains in Manufacturing Control of
Essential Drugs
Our domestic pharmaceutical plants now are small investments, they are equip with small capacity
machines and their human resources also still have no enough knowledge on GMP.

Mr. KAZUHIRO OMATA, JPMA Technical Adviser was invited to visit and inspect all of the
manufacturers about compliance with GMP requirements.

- In May 2009
After his inspection, he had some records as following:

1. DOCUMENT AND RECORD•

The content of work has been changed without revising the document.

•

The work actually done is not appropriately put into writing.

•

Records actually used are not provided for with the document as a style.

•All necessary records do not remain. Or, there is an empty column.

-61-

•

The revision history doesn't remain though the document is revised.

•

It is filled in with the pencil.

•

There is no correction sign.

•

There is no raw data of the record.

•

Neither the distribution nor the abolition rule of the document is provided.

•

When the document is revised, the original doesn't manage to replace it of the
distribution all duplicates though correctly replaces.

•

The old document abolished to a present manual places, it is crowded, and an old
document is not understood at one view (In a word, a present procedure is notclear).

•All items that are necessary because of the ministerial ordinance and theenforcement notification are not filled about various standard book, manuals,
product master formula, and various records.

2. Manufacturing control and Sanitary control•

Work is not actually done as it is an established procedure in the document.

•

A front room and two doors in the work room are opened at the same time.

•

The mop is put on the room that should be cleaned in baring.

•

There is no garbage box of the paper towel (It doesn't seem to actually wash
one's hand).

•The corrugated cardboard and the wooden boxes are brought in to the work

-62-

room with high clean level.
•

Filters of air-conditioning have not been regularly exchanged.

•

There is not an examination inspection passing no label display of failing or nor
a distinction in the place when the raw material, materials, and the product, etc.
are kept.

•

Neither the provider, those who check nor those who approve sign.

•

The equipment is un-dried, but the display shows "Washed it". (There is apossibility to be used under the un-dried condition.)•

It remains damaging a part of equipment.

•

A person noticed the wrong labeling and corrected it, but this action was notrecorded.

•

The temperature confirmation is insufficient though the product is kept with therefrigerator.

3. Quality control• The record that responds to the fact that the test outcome shifts from the standard
doesn't remain.
• The item of the analysis testing that is regulations by the product master formula is
not corresponding to the item of the test log.
• A necessary measuring instrument machine is not calibrated. The provided
frequency is not observed.

-63-• The check of the measuring instrument machine is not done in daily life.
• “When it was calibrated” and “the next calibration day” were not clear.
• Neither the check nor the calibration rules of the equipment are provided after a
new measuring instrument machine is bought.
• The rule of the re-testing is not decided.
• When the reagent was opened is not understood.
• The reagent is kept under the normal temperature though it must be kept in the cooldark place.
• The reagent out of the expiration date for use is kept.
4. OTHERS•

There is no management manual of the shipment (delivery) that is necessary with
GMP.

•

Because the improvement following is not recorded, the confirmation whether
improved it cannot be taken though it is a self-check and there is a suitable item.

•

The education and training is not done systematically. The action on theabsentee is not taken.

•

Even if the education and training is done, it doesn't record, and correspondence
is asunder according to each time and the lecturer.

•

In the change management, an enough education and training is untried even if
it changes.

-64-

•

The influence on the quality is not evaluated though the temperature of the raw
material keeping refrigerator deviated.

•

The results of retest were all within ranges of the standard against the quality
complaint. Therefore, it is judged that it was not the one that originates at thefactory and the result of executed cause investigation and analysis test was not
put on the record.

•

The reference is not correct though it is described that another manual is referred
to in the product master formula.

••

The validation is not executed as planned.
The validation is not done though the manufacturing apparatus that had a big

influence on the quality was changed.
- In Feb 2010
During this audit he found that the level of GMP now is higher in comparison to the first audit.
He also recommended there is no end in GMP, they must apply the method of PDACE-cycle (P: plan, D:
do, A: action, C: check and E: evaluate).

Refer to Mr. KAZUHIRO OMATA‘s inspection shows that there is an improvement step of GMP in
Cambodia Pharmaceutical Plants after his audit. However, they still have no enough GMP in comparison
to WHO GMP, so they must have plans to get that standard level. So they must equip more reliable
instruments either for manufacturing sections or quality control lab, and update training staff on GMP is-65-

also very important. To assure that all medicines produced are of good quality, all of manufacturers musthave good manufacturing process plus good quality control and strict internal audit as well.
In addition to the development themselves, sequence regular inspections from inspectors/MoH and
WHO experts are indispensable to strengthen and update their GMP grade.

VII- Current situation concerning counterfeit andsubstandard Drugs and its countermeasures
Due to the implementation of Drug Law is now not very strict, many drug smugglers have broughtsome medicines through the borders, and then, distributed to the markets directly. Some smugglers haveparked their own products as similar as other licensed registered products and distributed too. Someregistered products are also found that they were substandard after checking their quality.
To combat counterfeit and substandard medicines, Department of Drug and Food, Ministry of
Health has implemented the following measures:-Eliminate unlicensed drug stores in years 2011
-Registration: pharmaceutical products on the market must be registered.
-Routine inspection: to check unregistered products on the market.
-International cooperation: cooperated with JPMA, USP PQM, Global Fund for post marketingsurveillances.
-Published list of the counterfeit products found either names or pictures to announce among-66-

pharmacies, drugs stores and public.
-Recall the products punished the responsible persons.
- Common items found in Cambodia as counterfeit and Substandard medicines such as Ampicillin,
Amoxicillin, Artesunate, Phenoxymethyl penicillin, Cimetidine, Co-amoxycillin, Ciprofloxacin,
Omeprazole, …etc.
- Five Manufacturers found as counterfeit manufacturers as below:
1. VKP Pharmaceutical Co., Ltd, Thailand
2. Shen Wei Pharmaceutical Co., Ltd, China
3. China Southern Da zhong Pharmaceutical Co., Ltd, Chiana
4. Fu Li Pharmaceutical, China
5. SG. Pharmaceutical, China.

VIII- Overview of relationship with oversea
assistant organization.
- WHO, as International Technical Assistance has worked with the department of drugs and foodsince 2007 in order to strengthen on public medicine management, especially on the essential medicine
assess to patients and also on national medicine policy implementation.
- Global Fund has supported MoH since 2006 as a main supplier for Opportunity Infectious andAnti-HIV medicines, and supported on drug quality testing since 2008 focus on the medicines whichbought by Global Fund budget.

-67-

- USP PQM (Former name was USP DQI) support MoH on drug quality testing, especiallyprovided some analytical instruments to the national laboratory, and Minilabs to sentinel sides for basic
testing- Japan Pharmaceutical Manufacturers Association, JPMA has supported MoH since 1993
through sponsoring staff of National Health Product Quality Control Center (NHQC) former call National
Laboratory for Drug Quality Control and Department of Drug and Food (DDF) for training courses on Drug
Quality Control and Quality Assurance in Japan and Thailand. JPMA has also provided analyticalequipments for National Health Product Quality Control Center and support for conducting post marketingsurveillance in Cambodia since year 2006.

IX- Overview of Technical assistance Program in thefields of Pharmaceuticals GMP, Quality control.
-WHO supported in provide training courses of GMP inspection, Drug registration, Quality control- USP PQM (USP DQI) supported training on basic of GMP inspection and quality control using theminilab (basic testing) in provincial where borders between Thailand, Laos and Viet Name,- UNICEF, WORLD BANK support on supervision of Drugs management and Rational drugs use..
- JICWELS /JICA supported in Provide training course on manufacturing control of Essential Drugs.
- JPMA has provided technical support on drug quality control, and post marketing surveillancecooperated with Kanazawa University and National Health Product Quality Control Center, MoH.
Moreover, JPMA has invited GMP expert, Mr. Kazuhiro Omata to audit the local pharmaceutical plants-68-three times so far, and also trained MoH’s inspectors on GMP and Inspection.

.

- Global Fund support inter-ministerial committee for combating counterfeit and substandard drug
meeting on counterfeit essential medicines, anti-malaria drugs and antibiotics,- KfW Germany support on quality supply of birth spacing

Personal Note:
It is our greatest honor and happiness that we are accepted as participants for the Training
Program on Quality Management of Essential Medicines, Good Manufacturing Practice (GMP) andInspection courses. We hope that the training courses will show us good knowledge on GMP andInspection which are very important for us and MoH. We will try all the best to learn and bring back theexperience to practice in Cambodia in order to combat counterfeit medicines especially for Essential
Medicines, sharing technical support and strengthening the local manufacturers to get GMP.

-69-

The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Indonesia

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The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Malaysia-91-

QUALITY MANAGEMENT OF ESSENTIAL MEDICINEGOOD MANUFACTURING PRACTICE (GMP)AND INSPECTION 2012
Tokyo, Japan

COUNTRY REPORTMALAYSIANATIONAL PHARMACEUTICAL CONTROL BUREAUMINISTRY OF HEALTH, MALAYSIA-92-

1. Country Profile
1.1. Introduction
The Federation of Malaya Agreement was signed in August 1957. At the endof the month, Independence was finally achieved with Tunku Abdul Rahman
as the first Prime Minister. Malaysia was formed on 16 September 1963. Atthat time, Malaysia comprised of Malaya, Sabah, Sarawak and Singapore.
Singapore separated from Malaysia on 7 August 1965.
1.2. Geographical Background
Malaysia, in the region of South-East Asia consisting of Peninsular Malaysia,
the states of Sabah and Sarawak and the Federal Territory of Labuan in thenorth-western coastal area of Borneo Island. Peninsular Malaysia has its
frontiers with Thailand in the North and Singapore in the south, while Sabah
and Sarawak border the territory of Indonesia's Kalimantan province. The
two distinct parts of Malaysia, (Peninsular Malaysia and the states of Sabah
and Sarawak) separated from each other by the South China Sea.

Figure 1.1: Malaysia Map
The capital of Malaysia is none other than Kuala Lumpur. Also, Malaysia
comprises of 13 states and three Federal Territories (Kuala Lumpur, Putrajaya
and Labuan). The 13 states are Johor, Pahang, Negeri Sembilan, Melaka,
Selangor, Perak, Terengganu, Kelantan, Kedah, Pulau Pinang, Perlis, Sabah
and Sarawak.
1.3. Climate
Malaysia lies near the Equator between latitudes 1o and 7o North andlongitudes 100o and 119o East. The year is generally divided into the SouthEast and the North-East Monsoon seasons. The average daily temperature
throughout Malaysia varies from 21oC to 32oC. Humidity is high that is 80%.

-93-

1.4. Population
As of the 2010 census, the population of Malaysia was 28,334,135. The
population of Malaysia consists of many ethnic groups. Malays make up 50.4
per cent of the population, 23.7 per cent of the population are of Chinese
descent, while those of Indian descent comprise 7.1 per cent of the
population while other of other ethnic groups which are the indigenous racesof Sarawak and Sabah, that is, the Dayaks, Kadazans (Dusuns), Bajaus,
Melanaus and Muruts; and the aborigines of Peninsular Malaysia make up
another 11 per cent. There are also Europeans and Eurasians.
1.5. Society and Culture
Malaysia is a multi-racial country with a rich cultural heritage. The base of
the national culture is Malay culture, which is native to this region. Islamicvalues are embedded in Malay Culture. The Malay culture emphasises values
on courtesy, moderation, tolerance, harmony and cordial relations amongfamily members, neighbors and community. As Malaysian respect eachother's beliefs and faiths, cultural and religious festivals such as Hari Raya,
Chinese New Year, Deepavali, Christmas, Gawai Day and other auspicious
occasions are given due importance.
One of the unique features of Malaysia is its multi-racial population which
practices various religions such as Islam, Buddhism, Taoism, Hinduism andChristianity. Each ethnic group has its own beliefs. Under the Federal
Constitution, Islam is the official religion of Malaysia but there is freedom ofworship. The Malay Language (BahasaMelayu) is the national language of thecountry. However, the people are free to use their mother tongue and otherlanguages. English as the second language is also widely used.
1.6. Constitution and Separation of Power
Malaysia practices a system of parliamentary democracy and is ruled as aConstitutional Monarchy, with His Majesty the Yang di-PertuanAgong as the
Head of the country. The Yang di-PertuanAgong is elected to the throne for a
five-year term from one of the hereditary Rulers of the nine states in theFederation which are ruled by Sultans. The states are Perlis, Kedah, Perak,
Selangor, Negeri Sembilan, Johor, Pahang, Terengganu and Kelantan.
Duli
Yang
MahaMuliaAlMu'tasimuBillahiMuhibuddinTuankuAlHaj
AbdulthHalimMu'adzam Shah IniAlMarhum Sultan Badlishah is the 27 Sultan of thestate of Kedah, Malaysia, and the 14th Yang di-PertuanAgong since 13
December 2011.
In the other states, namely Melaka, Pulau Pinang, Sabah and Sarawak, theHead of State is the Yang di-PertuaNegeri of Governor of the State. The Yang

-94-

di-PertuaNegeri is appointed by the Yang di-PertuanAgong for a four-year
term.
The Federal Constitution of Malaysia clearly divides the authority of theFederation into its Legislative Authority, Judicial Authority and Executive
Authority. The separation of power occurs both at federal and state levels, as
in keeping with the concept of federalism, which form the basis of thegovernment administration.
1.7. Executive Authority
Executive Authority that is, the power to govern, is vested by Article 39 in
the Yang di-PertuanAgong/King but is exercised by a Cabinet of Ministers
headed by the Prime Minister. The Cabinet is responsible to the Yang diPertuanAgong. The Yang di-PertuanAgong is the Head of Executive Authority
in the country. Every executive act of the Federal Government flows from theRoyal authority, whether directly or indirectly. But, in accordance with theprinciple of a democratic ruling system, the Chief Executive is the Prime
Minister. Therefore, in this section, emphasis is given to the role of the Prime
Minister, the Cabinet and the government administrative machinery which
has been set up to carry out the executive functions. Datuk Seri
NajibTunRazak was sworn in as Malaysia‟s sixth prime minister, taking overfrom TunAbdullah bin Haji Ahmad Badawi since 3rd April 2009.
1.8. Education System
Education in Malaysia may be obtained from government-sponsored schools,
private schools, or through homeschooling. The education system is highly
centralised, particularly for primary and secondary schools, with state andlocal governments having little say in the curriculum or other major aspectsof education. Standardised tests are a common feature. Education in
Malaysia broadly consists of a set of stages which are:Pre-school
Primary Education (6 years)
Secondary Education (5 years, excluding pre-university education for 2
years)
Tertiary Education
Postgraduate
Primary and secondary education in government schools is handled by the
Ministry of Education, but policies regarding tertiary education are handled by
the Ministry of Higher Education.

-95-1.9. Literacy Rate
According to the Department of Statistic Malaysia, the trend of adult literacy
rate (15 years and above) in Malaysia has showed agradual increase from84.3 per cent in 1989 to 92.8 per cent in 2008.
Generally, the adult literacy rate in urban areas was much higher than in rural
areas. Until 2008, the adult literacy rate in rural areas remained low whichwasless than 90.0 per cent while in the urban areas it reached almost 95.0
per cent.However the gap between urban and rural areas appeared to be
narrowing since2003, i.e. between 6.0 to 8.0 per cent.
In 2000, the adult illiteracy rate in Malaysia declined to 9.7 per cent comparedtothe preceding year at 10.6 per cent. This positive improvement continued
until2008 recording only 7.9 per cent of illiterate population.
2. Statistical Data
Itema. Number of pharmaceuticalmanufacturerb. Number of traditional
medicine manufacturerc. Number of pharmaceuticalimportersd. Number of pharmaceuticalwholesaler

Year

Data

2011

71

2011

184

2011

234

2011

533

3. Historical Development Of Pharmaceutical Services
Medicinal products must be registered with Drug Control Authority (DCA) before
they can be marketed and sold in Malaysia. Only licensed manufacturers canmanufacture registered product and in order for them to be licensed, they haveto comply with GMP.
GMP was introduced in phases with Phase 1 for prescription drugs in 1985,
followed by Phase 2 for OTC products in 1988, Phase 3 for traditional medicines
in 1992 and Phase 4 for cosmetics in 2002. A system of licensing for
manufacturers, importers and wholesalers of pharmaceutical products containing
scheduled poisons was enforced in May 1987 and for products containing nonscheduled poison it was enforced in April 1992. For traditional medicines,
licensing exercise was enforced in January 1999 while for cosmetics it was
enforced in January 2004.

-96-

Just like any other responsible management of an organisation, NPCB had
planned and provided a comprehensive training program to all her staff tostrengthen their competency and knowledge in order to improve the delivery ofservice and also to meet the high expectations of her clients. Besides attending
various courses, seminars and training program organized locally, GMP inspectors
also involved in training program organized by PIC/S, WHO and in ASEAN
Cooperation program.
A. Pharmaceutical Affairs Administration
Administrative Organisation Chart
As a National Drug Regulatory Authority (NDRA), National Pharmaceutical Control
Bureau (NPCB) focused its objective to ensure the quality, safety and efficacy ofpharmaceuticals products. NPCB stand alone but still under the umbrella ofPharmaceutical Service Division while hospital pharmacy administered by thehospital itself.
Vision and Mission of Pharmaceutical Services Division
Vision for Pharmacy
Leading in quality management of medicines through a competent workforce andappropriate science and technology development; in partnership withstakeholders.
MissionEnsuring quality medicines for the nation.
Objective
Ensuring all pharmaceutical and health products in the market are of quality, safeand efficacious, regulated according to relevant legislations and used rationally.

-97-

Figure 3.1: Organization Chart for Pharmaceutical Services Division

Figure 3.2: Organization Chart for NPCB

-98-

Regulatory Control in Malaysia
A) Products Regulations
Pharmacy Legislation in Malaysia
The establishment of the Pharmaceutical Services Division in January 1974,
under the Ministry of Health Malaysia, has remarkably led to the expansion in
the role and functions of the overall pharmacy services, which contributed
towards development of the healthcare sector. The Pharmaceutical Services
Division currently undertakes 3 component activities namely Quality
Assurance of Pharmaceutical Products, Pharmacy Enforcement andLicensing, and Pharmaceutical Care. The enabling powers that allow thedivision to control and regulate the pharmaceutical sector are embodied in thefollowing legislations :RegistrationofPharmacist

Act

1951

which provides theestablishment of the Pharmacy Board and Registration of Pharmacists

Poisons Act 1952 which regulates the importation, possession,

manufacture, compounding, storage, transport, sale and use of scheduled
poisons. Basically this Act determines whether a pharmaceutical product isa prescription item, a pharmacy-only item or an OTC.

Sale of Drugs Act 1952
Control of Drugs and Cosmetics Regulations 1984 which regulates

the sale of pharmaceuticals through a system of product registration andlicensing of manufacturers, importers and wholesalers.

Dangerous Drug Act 1952 which regulates
exportation, manufacture, sale and use of narcotics.

theimportation,

Medicines (Advertisement and Sale) Act which regulates
advertisement of over-the-counter (OTC) medicines in the lay media.
The Pharmaceutical Services Division in the Ministry of Health ensures that
the Malaysian public is accessible to quality, safe, efficacious and affordable
pharmaceutical and healthcare products including advice in using themrationally. In this context, the division plays the following 3 major roles:Contributing directly towards public health through quality assurance
whereby the Pharmaceutical Services Division, through the National
Pharmaceutical Control Bureau, is responsible for regulating thepharmaceutical industry. This is to ensure that pharmaceutical products
conform to acceptable standards of quality, safety and efficacy before they
are registered; and that all premises and practices employed to-99-manufacture, store and distribute these products comply with the required
standards till they are delivered to the end users.
Enforcement of related acts and regulations.
Provision of pharmaceuticals for hospitals and health clinics under the
Ministry of Health. Ensuring a patient-focused service through the conceptof Pharmaceutical Care. The ultimate aim is to ensure provision of
optimum
drug
therapy,
bothbycontributing
tothepreparation/manufacture, supply and control of medicines and associatedproducts, and by providing information and advice to those who prescribe
or use pharmaceutical products.
Drugs and Cosmetics Regulations
The promulgation of the Control of Drugs and Cosmetics Regulations in June
1984 marked the dawn of the regulatory era in Malaysia. This laid thegroundwork necessary towards moulding a systematic pharmaceuticalregulatory system in Malaysia. In January 1985, the Drug Control Authority(DCA) was established under the chairmanship of the Director General of
Health Malaysia, with a mission of ensuring the safety, efficacy and quality ofpharmaceuticals as well as safety and quality of traditional medicines andcosmetics marketed locally. To accomplish this goal, the DCA through its
Secretariat based at the National Pharmaceutical Control Bureau (NPCB)
undertakes several functions which include evaluation and registration of
products; analysis of samples; inspection and licensing of manufacturers,
importers and wholesalers premises; post-marketing surveillance; adverse
drug reaction (ADR) monitoring and dissemination of information.
Food Regulations
Food safety responsibilities throughout Malaysia are executed through asystem of administration including the central, state, district and local
authority levels. Within the Ministry of Health, the Food Safety and Quality
Division, which was established in 1974, is responsible for the overall
technical supervision of food safety activities; formulation of legislation, codesof practice and guidelines; determination of food safety policies; adoption offood sampling and food premises inspection strategies; and coordination ofactivities at the state and district levels. The Food Act 1983 (Act 281 of theLaws of Malaysia) and its regulations are the primary legislative documents
for food safety activities in Malaysia. The regulations deal with such subjects
as food hygiene, labelling, import and export, advertising and laboratories,
and also contain numerous and detailed food standards.

-100-Profession Regulation – Pharmacists
Registration of Pharmacists
The government of Malaysia is already made it mandatory for pharmacists toserve the government for a period of 4 years. This is the compulsory service
and it mimics that which has already been implemented for the medical anddental profession.
The Registration of Pharmacist Act has been amended [Act A1207 - The
Registration of Pharmacists [Amendment] Act 2003] to allow this to be carriedout. In this compulsory service, Pharmacy graduates are required to beprovisionally registered with the Pharmacy Board of Malaysia and on being
provisionally registered, engaged in employment as a public servant in a listed
premise for a period of not less than one year. This is the equivalent of the
training period as a pupil [pupilage] under the old law. Under Act A1207,
there is no “pupilage”. On satisfactory completion of the period of provisional
registration, pharmacists can apply for full registration with the Pharmacy
Board of Malaysia. They would then be required to serve the government for
3 years. Failure to serve the government on full registration may lead to afine not exceeding fifty thousand ringgit.
At the present moment, there is a gross imbalance of pharmacists in the
public sector (about 20%) compared to in the private sector (about 80%).
This limited manpower curtails the types of pharmaceutical services that canbe delivered to the public. With this compulsory service, the government
hopes to fill the many vacancies in the government and thus strengthen theservices.
Health Promotion & Regulations
The Government continues to emphasize primitive and preventive healthservices as important components of the health development
programme. Health promotion, education and awareness programmes are
given priority in order disseminate information to a wider audience. In thisregard, the mass media and the Internet are utilized to disseminate current
information on the health status of the population and health promotion
activities. In addition, the registration of traditional medical practitioners andthe documentation of their medical products will be undertaken to ensure
quality, safety, efficacy and affordability.
Research and Development (R&D)
Pharmacy research has a wide scope with high potentials. Generally
researches done in 2005 were focused on descriptive studies to obtainbaseline data to initiate future studies. Even though research has not resulted
in policy changes, efforts were made to study priority areas such as those-101-pertaining to cost saving, patient safety, consumer‟s education, and clinicalpharmacy.
Post-Marketing Surveillance (PMS)
After the products are registered, the quality of the products in the market iscontinuously monitored by NPCB through its Post-Marketing Surveillance(PMS) programme which was initiated in 1990. A total of 2,483 registeredproducts were sampled for this purpose and this represented 8.13% of thetargeted number of registered products. A total of 1,428 labels and package
inserts had been checked. 42 products were issued warning letters and NPCB
handled 269 complaints. 74 products were recalled from the market; 3
Degree One (within 24 hours) product recalls were issued, all of which weretraditional medicines. There was no Degree Two (within 72 hours) productrecall for the year 2005. A total of 71 product batches were recalled within 30
days (Degree Three) comprising 12 prescription drugs, 3 non-prescription
drugs and 56 traditional medicines.
Adverse Drug Reactions (ADR) Monitoring
The Adverse Drug Reaction (ADR) Monitoring programme was first launched
in 1987. In 1990 a national advisory committee known as the Malaysian
Adverse Drug Reaction Advisory Committee (MADRAC) was established andalso in 1990 Malaysia was accepted by the WHO Collaborating Centre as the34th member of its Drug Safety Programme. In October 1998, a website for
MADRAC was officially launched. Malaysian guidelines for the reporting andmonitoring of ADR have been developed to outline the requirements andprocedures to be followed for submission of reports of adverse drug reactions
to the Drug Control Authority (DCA). Throughout the year 2005, NPCB
received a total of 2,363 adverse drug reaction (ADR) reports, a 42% increase
as compared to the previous year 2004. Out of those reports, 2,009 reports
were evaluated and subsequently submitted to become a part of the WHO
ADR Monitoring Centre database in Uppsala, Sweden. The majority of the
ADR reports were submitted by medical practitioners from government
hospitals.
Pharmacopoeia
Quality control activity is an important element in the evaluation ofpharmaceutical, traditional and cosmetic products. The products tested
include products for registration, post-marketing surveillance of registeredproducts, complaints on registered products and products from enforcement
activities. The tests conducted are based on pharmacopoeias mainly British
Pharmacopoeia (BP) and United States Pharmacopoeia (USP), in-house or
manufacturers‟ approved protocols of analysis and specifications.

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Drug Advertisement
The Medicine (Advertisement and Sale) Act 1956 provides the basis for thecontrol of advertisements of medicines, appliances, remedies, skill andservices that relate to medical and health claims. The Pharmaceutical Services
Division, Ministry of Health as the custodian of this Act has put into place anenforcement mechanism that is committed to eradicating illegal
advertisements. A total of 81 cases were investigated under Medicine(Advertisement and Sale) Act 1956 and 160 warning letters were issued in
2005.
Drug Price Mechanism
Drug price regulation does not exist in Malaysia, and the Government has nocontrol over the prices of medicines. Under the present practice, market
forces are expected to stabilize drug prices. In Malaysia, medicines areavailable from many outlets such as private clinics, hospitals, retailpharmacies and supermarkets (for OTC products only) but however patient
treated in government hospitals will get the medicines almost free of charge.
Ministry of Health Malaysia has set-up a Price Monitoring Unit (PMU) under
the Pharmaceutical Services Division to carry out continuous price monitoring
activity for trending purposes guided by the WHO Consultant.
Classification of Pharmaceuticals and Medicinal Products
In Malaysia, pharmaceuticals and medicinal products are classified into four
categories which are poison, non-poison (OTC), traditional medicines andcosmetics. These products must be registered with Drug Control Authority(DCA) before can be marketed and sold in Malaysia. The product is classified
as:
Poison – if it does contain scheduled poison
Non-Poison (OTC) – if it does not contain scheduled poison
Traditional – if consist material of natural origin such as plants andanimals
Cosmetic – if it‟s intended to be placed in contact with various external
parts of the human body (epidermis, hair system, nails, lips and external
genital organs) or with teeth and the mucous membranes of the oralcavity, with a view exclusively or mainly to cleaning them, perfuming
them, changing their appearance and/or correcting body odors and/or
protecting them or keeping them in good condition
B. Good Manufacturing Practice (GMP) in Malaysia
The promulgation of the Control of Drugs and Cosmetics Regulation in 1984
provided the foundation for development of a systematic pharmaceuticalregulatory system. To maintain standards and safeguard public well-being,measures were undertaken by the National Pharmaceutical Control Bureau-103-

(NPCB) to implement a drug and cosmetic registration and licensing scheme
which covered pharmaceutical manufacturers, importers and wholesalers as well
as clinical trials. NPCB also provided technical assistance to local pharmaceuticalmanufacturers to upgrade manufacturing standards to levels equivalent to therequirements of Good Manufacturing Practice (GMP) as recommended by theWorld Health Organisation (WHO) and other relevant organisations.
With globalisation and trade liberalisation, efforts were made to ensure thecompetitiveness of the pharmaceutical industry through continuous improvement
in standards and quality assurance requirements. Effective from 1st January
2002, Malaysia became the 26th member of the Pharmaceutical Inspection
Cooperation Scheme (PICS), a cooperative arrangement between international
pharmaceutical inspection authorities in the field of GMP. The acceptance of
Malaysia into the PICS paved the way for the local pharmaceutical products to berecognised internationally. The GMP guidelines that are currently applied are
PIC/S Guidelines on GMP for Pharmaceuticals, Malaysian Guidelines on GMP for
Traditional Medicines and ASEAN Guidelines on GMP for Cosmetics. Be a memberof PIC/S, the Quality Management System of manufacturers and the quality ofpharmaceutical products produced must be at par with other member countries.
Manufacturers having a tough time to comply with the high standards, need tospend much to upgrade their facilities and also need to train the personals
involved.
In order for the products to be registered, all manufacturers must comply with
Good Manufacturing Practice (GMP). Poor understanding of GMP and registration
procedures, communication breakdown, used of undeclared ingredients i.e.
premixes in production and increasing number of adulteration cases were someof the major problems encountered. Nevertheless, several initiatives have beentaken by the Ministry to assist the local industries. Regular dialogues, guidance
and advice, training programmes and dissemination of information have led to
fruitful outcomes. Ministry is also proactively making wide surveillance on the
products in the market and would continue to monitor the situation. Should any
product found to contain harmful substances, there would be an immediate recallof these products from the shelves.

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4. GMP System
4.1. Central and local organization in charge of pharmaceutical affairs
administration

Organization chart for Pharmaceutical Services Division
4.2. Legal and intuitional position of GMP in your country, GMP guidelines
Pharmaceutical product lifecycle is continuous process. It began withresearch and development (GLP) and then followed with preclinicaldevelopment (GCP) and then continued with manufacturing (GMP).
Manufacturing is define as making or assembling of the product, enclosing
or packing of the product in any container in the form suitable foradministration or application, and the labelling of the container or carryingout any process in the course of any of the foregoing activities (CDCR1984).

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GMP guidelines according to product category:
Product category
Pharmaceutical
Traditional Medicine
Supplements (TMHS)
Cosmetic

4.3.

and

Guidelines
PIC/S GMP Guide
Health Guidelines on Good Manufacturing
Practice for Traditional Medicinesand Health Supplements
Annex 1, Part 9 : Guidelines on
Good Manufacturing Practice (GMP)
for Cosmetic : Guidelines for Control
of Cosmetic Products in Malaysia

Inspection and guidance of pharmaceutical affairs, organization of
inspection division, numbers of inspectors (central government/local
government, their role).
4.3.1. Pharmaceutical Enforcement Division
Intelligence-gatheringIntelligence gathering is an effort to gather, process and utilize
specific information about an identified individual/organization for
ensuring successful raids and for the benefit of the organization. As
an important activity of enforcement organizations, it enables them
to focus on potential criminal activities and understand the offences
being done or future threats/trends.
Operation
The main objective of this unit is to conduct raids at theindividual/company/business with
inputs fromthe intelligencegathering unit, diversion control unit, precursor unit and theothers. The unit also receives the information from public complaints,
media reports, all state enforcement branches and otherenforcement agencies. Raids are carried out from time to time either
by each state single-handedly or with the co-operation of
enforcement officers from the state enforcement branches in largescale operations.
All pharmaceutical and traditional products in Malaysia must be
registered with Drug Control Authority, Ministry of Health. Therefore,
the purpose of conducting raids is to ensure that the pharmaceuticaland traditional products available in the market comply with therules and regulations and also to eradicate unregistered, counterfeit
and adulterated pharmaceutical and traditional products.

-106-Investigation
The investigation unit is responsible to investigate any case that
violates any of the provision of the laws enforced by the Pharmacy
Enforcement Division. Investigations cover various media and are also
based on public complaints. Moreover, the unit also carries out theinvestigation of advertisement that violates the Medicines(Advertisement and Sale) Act 1956 (Act 290) and Regulations.
Investigation starts by collecting of exhibits (documents) from various
agencies such as Companies Commission of Malaysia, Road Transport
Department, National Registration of Malaysia, Chemistry Department,
National Pharmaceutical Control Bureau etc, and taking statementsfrom the suspects and the raiding officers. The charge will be preparedand the investigation file will be submitted to the Deputy Public
Prosecutor office to obtain the sanction for prosecution. Once thesanction is issued, the file or case will be registered in court for legal
action.
4.3.2. National Pharmaceutical Control Bureau
The NPCB conducts inspections on manufacturers of pharmaceutical,
traditional and cosmetic products to ensure compliance with Good
Manufacturing Practice (GMP). Besides that, in an effort to ensurecompliance with Good Storage Practice (GSP) among the importers andwholesalers, the NPCB collaborates with the State Pharmacy
Enforcement Branch in conducting GSP inspections. The NPCB also
strives to ensure that clinical research conducted in Malaysia areinternationally accepted and recognised by carrying out inspections on
clinical research centres. Research carried out in Malaysia must be inaccordance to the Good Clinical Practice (GCP) and Good Laboratory
Practice (GLP) guidelines as well as applicable legislations.
4.4. Scope of pharmaceutical product GMP inspection
All pharmaceutical products for all dosage forms including sterile and nonsterile products.
4.5. Frequency of GMP Inspection
The conclusion of the routine GMP audit report should state the overall GMP
compliance which is graded as „Good‟, „Marginal‟ or „Poor‟. The grading of
GMP compliance and the frequency of routine audit is depicted as below:--107-

Compliance/Risk
Good
Marginal
Poor

High
18 months
12 months
6 months

Medium
24 months
18 months
6 months

Low
36 months
24 months
6 months

Risk of products
Risk
High
MediumLow

Types of products
Injectable products
All drugs listed in the Scheduled Poison Drugs List
(prescription drugs) and internal preparations of nonScheduled Poison Drugs (OTC), and other sterile
products, except injectable products.
External preparations of OTC products, Traditional
medicines and cosmetic products.

4.6. Method(s) of GMP inspection (field inspection, documentary inspection)
4.6.1. Inspection of plant facilities
4.6.2. Review of documentation
4.7. Qualification of GMP inspectors, education, training system
4.7.1. Candidates should have the following education and academic
qualifications:4.7.1.1. Degree in Pharmacy
4.7.1.2. Registered with the Malaysian Pharmacy Board as a
Pharmacist
4.7.1.3. Appointed by the Malaysian Public Services Department asa Pharmacist
4.7.2. Candidates should undergo training to develop the knowledge andability required for conducting audits. Training provided may be
conducted by NPCB or other external organization. Training may
include the following areas :4.7.2.1. Familiarization of the relevant GMP guidelines, standards
and regulations
4.7.2.2. Techniques of examining, questioning, recording
information, evaluating and reporting
4.7.2.3. Abilities required for communicating and planning,organizing and directing an audit
4.7.2.4. Knowledge, abilities and personal attributes may beachieved through training and possession of these may bedemonstrated orally or written, direct observations or
peer review.

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4.8.

Cases of recalled pharmaceutical products arising from inferior quality (noof cases, outline of cases over the 5 years)-

4.9. Manufacturing, import and export of pharmaceutical product, proportion ofimported medicinal products distributed
4.10. Sales and distribution of medicinal products, proportion of imported
medicinal product distributed.
Pharmaceutical product registered 2010 =13,067products
OTC product registered 2010
= 9,918products
4.11. Product name of medicinal drug domestically manufactured and productname of imported medicinal drugs in the market (main products)
Category of productPrescription
Non-prescription
Traditional

Numberofregistered(cumulative) for year 2010
13,067
9,918
20,775product

4.12. Legal and institutional regulations on the sales and distribution ofpharmaceutical products[Refer paragraph 3]
4.13. Existence or nonexistence of recalled system of product distributed
The recall system for product distributed is exist.
4.14. Name of organization for analyzing recalled products, no. persons in charge
for analysis
National Pharmaceutical Control Bureau
Ministry of Health Malaysia
5. Essential Drug List
5.1. Introduction
Essential medicines are those that satisfy the priority health care needs ofthe population; thus should be easily available in adequate quantities and in-109-

suitable dosage forms. The Essential Medicine List [EML] is a tool that canhelp manage the purchasing and distribution of medicines and the selectionof quality assured and cost-effective products and thus one of the vital tools
needed to improve and maintain health.
5.2. The WHO concept of essential medicines
A limited range of carefully selected essential medicines leads to better
health care, better drug management, and lower costs
Selection criteria: Essential medicines are selected with due regard to diseaseprevalence, evidence on efficacy and safety, and comparative costeffectivenessPurpose: Essential medicines are intended to be available within the context
of functioning health systems at all times, in adequate amounts, in theappropriate dosage forms, with assured quality, and at a price the individual
and the community can afford.
Implementation: The implementation of the concept of essential medicines isintended to be flexible and adaptable to many different situations; exactly
which medicines are regarded as essential remains a national responsibility.
5.3. The Essential Medicines Target

5.4. Malaysian NEDL
The suggestion to create Malaysia‟s National Essential Drugs List [NEDL] foruse both in the private and public sectors was first mooted in 1996, as one of
the strategies to ensure that the public could afford to purchase drugs. The
NEDL was formulated after consultation with all the stakeholders in the health-110-care industry and based on the Ministry of Health‟s (MOH) Drugs List, which
serves as the essential drugs list for the Ministry of Health since 1983.
The Honourable Minister of Health launched the first edition of NEDL in
January 2000. The first part of the NEDL consists all preparations needed forprimary, secondary and tertiary health care treatment. It consists of 358
chemical entities and 605 preparations. The second part of the NEDL is the
supplementary list consisting of drugs used for tertiary treatment andcontains 257 chemical entities and 391 preparations.
The NEDL was formulated with the following objectives:1. Ensure the cost-effectiveness of treatment through suitable therapy, theuse of generic drugs and cheaper alternatives.
2. Encourage the rational use of drugs by avoiding over-prescribing and misprescribing.
3. Make the healthcare system more transparent.
4. Control the rising cost of healthcare and thus help control inflation.
5. Ensure the patient‟s right to obtain adequate information, especially:i. The right to complete information that is easily understood
regarding the drugs that are prescribed and sold.
ii. The right to choose among competitive products.
The concept of essential medicines is forward-looking. It incorporates theneed to regularly update medicines selections to reflect new therapeutic
options and changing therapeutic needs; the need to ensure drug quality; andthe need for continued development of better medicines, medicines for
emerging diseases, and medicines to meet changing resistance patterns.
Updating of the first NEDL started in year 2005 by the Drug list Review Panel,with the help of the Technical Drug Working Committee, Ministry of Health.
The Technical Drug Working Committee of MOH can get the feedback fromtheir counterparts in the private sector on the selection of the list in their
particular discipline. The Drug List Review Panel finally accepted the list in
September 2008.
6. Difficulties and Constrains in Manufacturing Control of Essential Drug
Challenges faced in improving Good Manufacturing Practice (GMP) and Good
Storage Practice (GSP) standards of manufacturers, importers as well as
wholesalers:i)

To further improve the standard of local manufacturers in terms of Good
Manufacturing Practice (GMP) requirementsii)

To expand the coverage of Good Storage Practice (GSP) inspections toimporters‟ and wholesalers‟ premises outside the Klang Valley area

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iii)

To strive towards implementing GMP requirements on veterinary productmanufacturersiv)

To regulate GMP requirements on the manufacture of biological/blood
products

7. Current situation concerning Counterfeit and Substandard Drugs andits countermeasures
7.1. Background
Malaysia has a counterfeit market value of $378 million, with software
dominating $289 million of that market value. In 2007, the Malaysian
software industry lost $311 million to pirated software sales. The range ofcounterfeit products available includes all the usual suspects such as music,
movies, luxury brands and, more recently, pharmaceuticals but also everyday
items such as batteries, engine oil, toothpaste and consumables.
Back in 2003, Abdullah Nawawi, Director General of Enforcement at the
Ministry for Trade and Consumer Affairs, commented “Counterfeit products
are available widely and involve many consumer items - garments, electrical
items, pharmaceuticals, shoes, bags, leather goods, branded watches,
cigarettes, and detergents. It's difficult to quantify how widespread themarket for imitation goods is”. The general feeling is that, since 2003, theproblem has only escalated and is infiltrating and tainting the lives andprospects of the Malaysian people.
2007 was the Malaysian Tourist Board‟s “Visit Malaysia” year and there isacute awareness that Malaysia‟s reputation could be sullied through the illicit
activities of counterfeiters; as a tourist it is relatively easy to avoid buying
fake handbags and sunglasses but another matter when it comes to
consumables and pharmaceuticals. In addition to the public safety risks,
there is also a fear that the commercial trade sector could be affected, as
well as the potential for foreign investment.
Persistent raids on the behalf of the Ministry for Trade and Consumer Affairs
enforcement division have reaped results and uncovered counterfeit rings,
but have also opened a “can of worms”. Microsoft and the Business Software
Alliance (BSA) have also instigated crackdowns and raids by the authorities
to discourage software counterfeiters.
In his article Counterfeit Goods in Daily Malaysian Lives, IP specialist
PatrikMirandah suggests that these officials “lack expertise in identifying anddistinguishing the fake from the original” and goes on to promote theconcept that intellectual property owners in Malaysia need to get more-112-

closely involved and work together with the Ministry to fight thecounterfeiters and bring them to justice.
However, on a local level, the current awareness programmes and efforts to
educate the public are having a trickle-down effect and the issue ofcounterfeiting will be emphasised by government initiatives such as therecently launched Malaysian IP Day. For tourists and locals alike, ultimately
the only way to prevent the spread of counterfeit trade in Malaysia is to beaware of the risks and what to look out for.
7.2. Legislation
As far as concerns the issue of IP law, amongst the measures taken toprotect registered trademarks, the Trademarks Act of 1976 has been
amended to contain provisions for border measures prohibiting counterfeit
trademark goods from being imported into the country. Click here to readmore about how IP rights are being enforced in Malaysia. So how does thisaffect tourists? In his key note address at the third Global Congress on
Combating Counterfeiting and Piracy in 2007, the Malaysian Minister ofDomestic Trade and Consumer Affairs noted that “a significant proportion of
those purchasing counterfeit and pirated goods were not Malaysians but
tourists!” Basically the government realises the importance of preventing
tourists from purchasing and exporting pirated and counterfeit goods. To thisend, a special export unit was established in 2005, with officers stationed atexit points to prevent attempts to export illegal products. High-tech scanners
machines have also been placed at the major airports in the country.
Random and „tip off‟ checks are also being carried out.
In September 2008 the Malaysian Government proposed a new bill to combat
pharmaceutical counterfeiters, urging the establishment of stiffer penalties,
including heavier fines and mandatory jail sentences. The bill came out ofroundtable discussions held under the auspices of the Special Taskforce toCombat Counterfeit Products, a unit established this year and overseen by
the Ministry of Domestic Trade and Consumer Affairs, and thePharmaceutical Association of Malaysia.
Counterfeiting of drugs is a significant issue in Malaysia and is being taken
very seriously be the Malaysian Ministry of Health. Steps to combat the
problem have included the introduction of the Meditag system in 2005,
increased consumer awareness, tightening of legal provisions and stepping
up of market surveillance. The prevalence of counterfeit drugs in the market
has greatly reduced but the problem still persists. Things to look out for are:over-the-counter drugs such as Panadol pills and Eye-Mo drops, both ofwhich have been counterfeited in the past. A 1997 survey on cough and cold
medication carried out in Malaysia found that 5% of such medicines in themarket were counterfeits. In a 2007 New Straits Times article, Pfizer Malaysia
Corporate Affairs Director claimed that there were counterfeit versions
available of many of their drugs, including Viagra, Diflucan and the antidepressant Zoloft.

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As of 1st May 2005, the Ministry of Health has implemented Phase 1 of thecompulsory ruling requiring manufacturers and importers of pharmaceuticalproducts to fix security hologram labels onto their products or packaging.
When affixed, the hologram labels raise the expectation that these products
have been duly registered with the Drug Control Authority (DCA). This latest
move by the Ministry was motivated by the need to curb counterfeit
problems with pharmaceutical products and augment enforcement efforts
against imitation of such products. The hologram label will have a uniqueserial number that can be traced to the licensed manufacturer or importer ofthe product, which makes it easier for monitoring purposes.
8. Overview of relationship with Overseas Assistance Organization
The NPCB continues to play an active role in harmonization efforts through theASEAN Consultative Committee for Standards and Quality (ACCSQ)
Pharmaceutical Product Working Group (PPWG), Traditional Medicines and HealthSupplements Product Working Group (TMHS PWG) as well as the ASEAN
Cosmetic Committee (ACC). Other international involvements include
Pharmaceutical Inspection Co-operation Scheme (PIC/S) activities.
Under the ASEAN Technical Co-operation among Developing Countries (ASEAN
TCDC) Program, NPCB has been chosen and recognised by the ASEAN countries
as the regional training centre for quality control of pharmaceuticals. NPCB has
been the host for the training program in quality control and has successfully
conducted such training since 1986. Apart from that, NPCB has been receiving
trainees from ASEAN and other countries including Myanmar, Bangladesh,
Vietnam, Pakistan, Philippines, Indonesia, India, Sri Lanka, Thailand, Macao,
Singapore, Hong Kong, Laos, Cambodia and Mongolia.
In view of the technical expertise and training capabilities of NPCB, it received
the recognition as a "WHO Collaborating Centre in the Regulatory Control of
Pharmaceuticals" since 10 May 1996.
9. Overview of Technical Assistance Programs in the field of
Pharmaceutical, GMP, Quality Control organized by International
Organizations and NGO
As a member to PIC/S, NPCB is entitled to participate in PIC/S training
programme under its own expenses.
9.1. Annual Seminar
The annual PIC/S training Seminar is attended by GMP inspectors from
Participating Authorities and other interested Drug Regulatory Authorities.
The Seminar is hosted by a different PIC/S Participating Authority each year.

-114-Each Seminar focuses on a particular aspect of GMP, with the aim ofproviding training and harmonisation in the field.
9.2. Expert Circles
PIC/S has formed several Expert Circles to enable specialised inspectors to
discuss and exchange information in a specific area of GMP. Expert Circles on
Active Pharmaceutical Ingredients (APIs), Computerised Systems, Human
Blood & Tissue and Quality Risk Management (QRM) are currently active andmeet at least annually. The aim of the Expert Circles is to develop guidance
documents (e.g. recommendations or aide-memoires) or to draft / revise
Annexes to the GMP Guide. Expert Circle meetings are open to inspectors
from PIC/S Participating Authorities and Applicants, but also to inspectors
from non-PIC/S Regulatory Authorities (provided that the meeting also
provides training to inspectors).
9.3. Joint Visits Programme“Another avenue for the training of inspectors from PIC/S Participating
Authorities is the joint visits programme for the training of inspectors. Under
this program, three inspectors from three different countries are teamed up
to observe typical inspections in each country with a view to comparing
inspection procedures and techniques. Any differences in inspection
procedures and techniques are reported to the PIC/S Working Group on
Training for appropriate action. Joint visit groups are also encouraged torecommend specific training needs for inspectors, including topics for future
PIC/S Seminars”.
9.4. Coached Inspections
In order to provide training to new inspectors or inspectors who wish to
improve their inspection skills in a specific field, PIC/S introduced in 2009 a
programme on coached inspections. The programme consists in teaming up
a junior inspector with an experimented inspector during a routine
inspection. The programme is open to inspectors from Participating
Authorities and Applicants.

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The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Philippines-116-

REPUBLIC OF THE PHILIPPINESCOUNTRY REPORT

Training on Good Governance ofMedicines for Pharmaceutical
Regulation Authorities

04 November to 29 November 2012

Food-Drugs Regulation Officer- III
Food and Drug Administration
Department of HealthPhilippines-117-

I. The Philippines: Background
The Philippines is located in Souteast Asia and divided by 7,107 various islands and speaks
the varied attitude but with a common culture of being hospitable. This is located in between
the South China Sea on the west and the Philippine Sea on the east. The major islands are
Luzon in the north, the Visayan Islands in the middle, and Mindanao in the south. The total
area is about 300,000 square kilometers, including about 298,000 square kilometers of land
and about 2,000 square kilometers of water.

The Philippines has a tropical marine climate, with the northeast monsoon, which produces acool, dry season from December to February, and the southwest monsoon, which brings rain
and high temperatures from May to October. Between March and May, hot, dry weather
prevails. Manila is the capital city and Baguio City as the summer capital of this country.
Temperatures in Manila range from 21˜2˜C to 3C, with an average annual temperature of 27˜C.
Temperatures elsewhere in the Philippines have been recorded at more than 37˜C. The
average monthly humidity ranges from 71 percent in March to 85 percent in September.
Annual rainfall is heavy but varies widely throughout the Philippines, ranging from 965
millimeters in some sheltered valleys and the southern tip of the island of Mindanao to 5,000
millimeters along the mountainous east coasts of the islands of Luzon, Samar, and thenorthern tip of Mindanao. The Philippines lies astride the typhoon belt and experiences 20 to
25 typhoons a year from July through October, of which five or six may cause serious
destruction and death. About 83 percent of the population is Roman Catholic; 9 percent
Protestant, including Presbyterian, Methodist, Philippine Independent Church, and Philippine-118-

Church of Christ; 5 percent Muslim; and 3 percent Buddhist and other religions. The
constitution guarantees freedom of religion and separation of church and state. But Christianity
predominates, and Muslims historically have been marginalized.

The group constituting more than 90% of the population is predominantly Roman Catholic,although the Philippine Independent Church and the Iglesia ni Cristo command significant
followings. The hill tribe practice tribal religions and Islam is strongest in the Sulu Archipelago,
Southern Palawan, and parts of Southern Mindanao.

The Philippines has two official languages, Pilipino (Tagalog) and English, while in Visayas
and Mindanao the common language is Bisaya (or Cebuano speaking). Filipinos has eight
major dialects, in order of use: Tagalog, Cebuano, Ilocano, Hiligaynon or Ilonggo, Bicol,
Waray-waray, Pampango, and Pangasinense. Filipino, based on Tagalog, is related to Malay
and Indonesian and is part of the Malayo-Polynesian subgroup of the Austronesian language
family. Filipino is the common language used between speakers of different native languages,
which are closely related but not mutually intelligible. English and Pilipino are used in thegovernment and as the medium of instruction in higher education.

This year, Department of Education commenced Grade Seven making it seven years ofprimary education which is basically free and compulsory; the four-year secondary education
program is free but not compulsory. The Philippines has one of the highest literacy rates in
Asia. The many colleges and universities include the University of the Philippines (1908) and-119-

the University of Sto. Tomas (1611). Higher education is greatly valued, although the economy
cannot absorb all college graduates.

Article II of the 1987 Constitution of the Republic of the Philippines explicitly states that theFilipino political system is both democratic and republican, placing the right to govern with thepeople. The Philippines has a government that is elected by the people who retain some formof control over the running of the state.

Republican - Article VI of the Philippines Constitution vests "legislative power" in the Congress,
giving Congress the power to create laws. The President's power is derived from Article VII of
the Constitution, allowing him the authority to appoint Congressmen during recesses as well as
the executive departments similar to the President's cabinet in the United States. As
commander-in-chief, the Filipino President ensures civilian control of the military.

Democratic - The government of the Republic of the Philippines is elected by the people, andany authority given to the government comes from the people as stated in the Philippine
Constitution. Members of the executive and legislative branches of government are elected by
the people to serve predetermined terms of office. Article VII mandates that the President andVice President of the Philippines be elected through a direct election by the people. The
President may only serve one six-year term. Members of Congress are elected by the citizens
in their individual districts.

All economic activities in the country give yearly a final output of goods and services. This
'GNP per capita' shows the general economic achievement of a country. The figure of the-120-

GNP for the Philippines shows that the country is ranking somewhere in the middle position of
all countries in Pacific Asia.

The rich body of indigenous artistic traditions includes folktales, music, and the folk dances
made famous by the Bayanihan Dance Troupe. Painting and Sculpture often combine Asian &Western elements. Spanish and English have been the vehicles for such writers as Jose Rizal,
N.V.M. Gonzalez, Bienvenido Santos, and F. Sionil Jose.

II. STATISTICAL DATA
II.A. Philippines Demographics Profile as of 2012
Population
Age structure

Median age

Population Growth Rate
Net migration rate
Urbanization

Sex ratio

Total fertility rate
HIV/AIDS - adultprevalence rate
HIV/AIDS - people living

103,775,002 (July 2011 est.)
0-14 years: 34.6% (male 17,999,279/female 17,285,040)
15-64 years: 61.1% (male 31,103,967/female 31,097,203)
65 years and over: 4.3% (male 1,876,805/female 2,471,644)(2011 est.)
total: 22.9 years
male: 22.4 years
female: 23.4 years (2011 est.)
1.873% (2011 est.)-1.27 migrant(s)/1,000 population (2011 est.)
urban population: 49% of total population (2010)
rate of urbanization: 2.3% annual rate of change (2010-2015
est.)
at birth: 1.05 male(s)/female
under 15 years: 1.04 male(s)/female
15-64 years: 1 male(s)/female
65 years and over: 0.76 male(s)/female
total population: 1 male(s)/female (2011 est.)
3.15 children born/woman (2011 est.)
less than 0.1% (2009 est.)
8,700 (2009 est.)-121-

with HIV/AIDS
HIV/AIDS - deaths
Major infectious
diseasesNationality
Ethnic groups

Religions

Languages

Literacy

School life expectancy(primary to tertiary
education)
Education expenditures
Health Expenditures

fewer than 200 (2009 est.)
degree of risk: highfood or waterborne diseases: bacterial diarrhea, hepatitis A,
and typhoid fever
vectorborne diseases: dengue fever, malaria, and Japanese
encephalitis
water contact disease: leptospirosis (2009)
noun: Filipino(s)adjective: Philippine
Tagalog 28.1%, Cebuano 13.1%, Ilocano 9%, Bisaya/Binisaya
7.6%, Hiligaynon Ilonggo 7.5%, Bikol 6%, Waray 3.4%, other
25.3% (2000 census)
Roman Catholic 80.9%, Muslim 5%, Evangelical 2.8%, Iglesia ni
Kristo 2.3%, Aglipayan 2%, other Christian 4.5%, other 1.8%,
unspecified 0.6%, none 0.1% (2000 census)
Filipino (official; based on Tagalog) and English (official); eight
major dialects - Tagalog, Cebuano, Ilocano, Hiligaynon orIlonggo, Bicol, Waray, Pampango, and Pangasinan
definition: age 15 and over can read and write
total population: 92.6%
male: 92.5%
female: 92.7% (2000 census)
total: 12 years
male: 12 years
female: 12 years (2008)
2.8% of GDP (2008)
3.8% of GDP (2009)

II.B. VITAL STATISTICS
1. Rate of vital Statistics (per 1,000
population)

1.1 Infant Mortality Rate

total: 18.75 deaths/1,000 live births
male: 21.21 deaths/1,000 live births
female: 16.18 deaths/1,000 live births(2011 est.)

2. Five Main Diseases Causing Morbidity
2.1.

Acute

Lower

Respiratory

Tract

-122-

No. of Cases

Rate/100,000

776,562971.6

Infection & Pneumonia
2.2.
Bronchitis/Bronchiolitis
2.3.
Acute Watery Diarrhea
2.4.
Influenza
2.5.
Hypertension
3. Five leading causes of mortality
3.1.
Diseases of the Heart
3.2.
Diseases of the Vascular System
3.3.
Malignant Neoplasms
3.4.
Pneumonia
3.5.
Accidents
4. Life expectancy at birth719,982
577,118
379,910342,284
No. of Cases
70,13849,51938,821
34,21833,617

900.8
722.0
475.3
428.2
Rate / 100,000
17.7
12.5
9.8
8.6
8.5

Total population: 71.94 years
male: 68.99 years
female: 75.03 years (2011 est.)
94 deaths/100,000 live births (2008)

5. Maternal Mortality Rate
6. Children under the age of 5 years
underweight

20.7% (2003)

7. Physician’s Density
8. Hospital Bed Density

1.153 physicians/1,000 population(2004)
0.5 beds/1,000 population (2006)

9. Obesity - adult prevalence rate

4.3% (2003)-123-

2 MEDICAL CARE POLICY
1.1 Estimated No. of Patients who Received
Medical Treatment on the Specified Date
3.1.1. Government Hospital
3.1.2. Public Hospital
3.1.3. Private Hospital
1.2 No. of Hospitals by Establishing Organ(1999-2009)
721
3.2.1. Government Hospitals
1,074
3.2.2. Private Hospitals
1.3 No. of Health Manpower
3.3.1. Physicians (year)
2005-2010
3.3.2. Dentists (year)
2005-2010
3.3.4. Pharmacists (year)
2005-2010
3.3.5. Nurses (year)
2005 - 2010
3.3.6. Medical Technologists (year)
2005- 2010
3.3.7. Midwives (year)
2005 -2010
3.3.8. (Licensed)Pharmaceutical
Manufacturing(year)
2012
3.3.9. (Licensed) Traditional Medicine
Manufacturers (year)2012
3.3.10. (Licensed) Drug Importers(year)
2012
3.3.11. (Licensed) Wholesalers (Year)
2012

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106,450
47,33752,312
382,624
49,605
242

302

8

748
5,090

3 PHARMACEUTICAL AFFAIRS ADMINISTRATION
IV.1. ADMINISTRATIVE ORGANIZATION CHARTS(Please see attached pages)
IV-1.1 DEPARTMENT OF HEALTH
IV-1.2 FOOD AND DRUG ADMINISTRATION-125-

-126-ORGANOGRAM OF FOOD AND DRUG
ADMINISTRATION

 Bureau of Food and Drugs (BFAD)•

Republic Act No. 3720 was passed into law known as the “ Food, Drug andCosmetics Act” on June 22, 1963 ; “ To ensure the safety, purity, and quality offoods, drugs and cosmetics being made available to the public”

 Legal Basis•1987 Philippine Constitution-127-Sec. 12, Article XIII “The state shall establish and maintain an effective food and drug
regulation system and undertake appropriate health, manpower development, and research,
responsive to the country’s health needs and problems.”
 STRATEGIESInspection and licensing of establishments dealing with food, drugs, medical
devices, cosmetics, in vitro diagnostic reagents, and household hazardous
substances.



Evaluation, testing and registration of products.

Approval of product label prior to marketing.



Monitoring of quality of products in the market.



Evaluation and monitoring of sales promotion and advertisements of regulated
products and establishments.

 FUNCTIONSDevelops plans, policies and programs pertaining

to the regulation ofprocessed foods, drugs, and other related products.
Provides technical information and assistance to clients and the general public
on matters pertaining to food drug, and cosmetics laws, regulations, functions
and services.

 Republic Act No. 9711
 An Act Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Foodand Drugs (BFAD) by Establishing Adequate Testing Laboratories and Field Offices,
Upgrading its Equipment, Augmenting its Human Resource Complement, Giving-128-

Authority to Retain Its Income, Renaming it the Food and Drug Administration (FDA),
Amending Certain Sections of Republic Act No. 3720, As Amended, and Appropriating
Funds Thereof.

3.1

LAWS/REGULATIONS COVERING PHARMACEUTICAL AFFAIRS

3.1.1 PRODUCT REGULATIONS
3.1.1.1

Republic Act 3720 - Food, Drug and Cosmetic Act later amended by EO 175
otherwise known as Foods, Drugs, and Devices and Cosmetics Act- an act toensure the safety and purity of food and cosmetic and the purity, safety, efficacy andquality of drugs and devices being made available to the public vesting BFAD withthe authority to administer and enforce the law.

3.1.1.2

Republic Act 6675 - Generics Act of 1988- it is an act to promote, require to ensure
the production of an adequate supply, distribution, use and acceptance of drugs andmedicines identified by their generic name.

3.1.1.3

Republic Act 8203 - Special Law on Counterfeit Drugs - it is the policy of the state
to protect andpromote the right to health of the people and still healthconsciousness among them. It further declared the policy of the state that in order tosafeguard the health of the people, the State shall provide for their protection against
counterfeit drugs.

-129-3.1.2 PROFESSIONAL REGULATIONS
3.1.2.1

Republic Act 5921 - Pharmacy Act as amended by E.O. 174 s. 1987 - the act
regulating the practice of pharmacy and setting standard of pharmaceuticaleducation in the Philippines and other purposes.

3.1.3 HEALTH PROMOTION & REGULATIONS
3.1.3.1

Health Establishments Regulations

3.1.3.1.1 Republic Act 4226- an act requiring the licensure of all hospitals in the Philippines
and authorizing the Bureau of Licensing and Regulations.
3.1.3.1.2 Administrative Order 55- ( for laboratory clinics )- revised rules and regulation in
the licensing of laboratory performing HIV testing. The licensure of laboratory clinic
is done by the Bureau of Research and Laboratory.
3.1.3.1.3 Administrative Order No. 56 s. 1989- Licensing requirements for securing BFAD
License to Operate.
3.1.3.1.4 Administrative Order No. 43- s. 1999- an amendment of A.O. 220 s. 1974,
Current Good Manufacturing Practice. With the development in the Science andtechnology, industry and public health interest, the Current Good Manufacturing
Practice Guidelines for Drugs was adopted and implemented.
3.1.3.1.5 Administrative Order No. 90 s. 2002- current Good Manufacturing Guidelines for
Cosmetics Products- linient guidelines for cosmetics as compared with A.O. 43-A s.
1999.

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3.1.3.2

TRADITIONAL MEDICINES

3.1.3.2.1 Republic Act 8423- an act creating the Philippine Institute of Traditional Medicine
and Alternative Health Care to accelerate the developments of traditional andalternative health care in the Philippines.
3.1.3.2.2 Administrative Order 12 s. 1993- Traditional Medicine Program for promotion anddevelopment of traditional medicines that has been found safe and effective.
3.1.3.3

HEALTH ECONOMICS

3.1.3.3.1 Section 2.3 BFAD Regulation No. 5 s. 1987 and A.O 65 s. 1989- No
pharmaceutical products classified by BFAD as a Prescription or Ethical Drug shallbe advertised or promoted in any form of mass media except through medical
journals, publications and/or literature solely intended for medical and allied
professions.
3.1.3.3.2 Article 116 of Republic Act 7394 or the Consumer Act of the Philippines- That
any sales promotion campaign using medical prescriptions in any part thereof or
attachment thereto for raffles or a promise of reward shall not be allowed, nor permit
be issued thereof.
3.1.3.3.3 Section 4 of BFAD regulation No. 5 s. 1989- Press releases, editorials, healthcolumns and features and public service announcements on health and medicines
shall not specify brand/ trade names. Generic names are, however, permissible. For
prescriptions drugs, it should be clearly stated that this product can be bought onlywith a prescription and a doctor’s advice shall be sought.

-131-

3.1.3.3.4 A.O 119 s. 2000 (item no. 1)- Consistent with the rational drug use policy, thepromotion of OTC drug to the public will only be allowed if its known adverse effectare also cited. Moreover, it is the intention of R.A 6675 or the Generic Act of 1988, to
promote drug safety by minimizing duplication medications and/or use of drugs withpotentially adverse drug reaction.

3.2

LICENSING SYSTEM

4.3.1. PHARMACEUTICAL INSPECTION AND GMP
The Food and Drug Administration is the regulatory agency under the Department of Health,
responsible for ensuring that the products distributed in the market by licensed establishments
has met the basic GMP requirements based on A.O. 43 s. 1999 and the ASEAN Code of GMP.
Through the assistance of AUSAID, a Senior GMP Auditor of Therapeutic Good Administration(TGA) came to Manila to conduct a comprehensive training on GMP and other relevant codes
were extensively renewed and discussed. It was in this occasion that drug inspectors realizedthat the written supplement to the existing guidelines was deemed vital both to thepharmaceutical industry and the regulators since BFAD also envisions to be a world class
regulatory agency.

Basic GMP Guidelines:
4.3.1.1. Personnel – should be adequate in number and qualified at all levels and provided
with skills and capabilities relevant to their respective functions.
4.3.1.2. Premises – it must be of suitable size, design, construction and location to facilitate
proper operation, cleaning and maintenance.

-132-4.3.1.3. Equipment – it shall be of appropriate design, construction, size and suitably located inorder to assure product quality, process reproducibility and facilitate cleaning & maintenance.
4.3.1.4. Sanitation & Hygiene – high level of sanitation shall be practiced in every aspect ofmanufacturing drug products.
4.3.1.5. Storage of Starting & Packaging Materials, Intermediate Bulk Products & Finished
Products
4.3.1.6. Production
4.3.1.7. Packaging
4.3.1.8. Finished Product Quarantine & Delivery to Warehouse – the finished product isquarantined before the product is transferred to the warehouse and becomes available for
distribution to the market.
4.3.1.9. Quality Control - it is essential part of GMP to provide assurance that products will beconsistently of quality appropriate to their intended use.
4.3.1.10. Documentation it is part of management information system, which includes –specifications, procedures, methods and instructions, reports & records & other documents
required for planning, organizing & controlling & evaluating the whole activities of drug
products manufacturing
4.3.1.11. Self – Inspection – the purpose of self-inspection is to evaluate the manufacturer’s
compliance with GMP on all aspects of production and quality control
4.3.1.12. Guidelines for Handling of Product Complaint, Product Recall and/or Returned
Product – a system for handling each of these shall be designed and include written standard
operating procedures, stating who is responsible, the investigation conducted & results-133-

evaluated and actions taken up and shall record all details relevant to the product complaint,
product recall or product returned.

4.3.2. PHARMACEUTICAL INSPECTION AND GUIDANCEIn the Philippines, there are about 117 drug inspectors stationed all over the country. There are
36 inspectors from the National Capital Region (central office) and 81 inspectors detailed in the
different regions. In the National Capital Region, drug inspectors are assigned in two (2)Divisions:
Regulation Division I - drug inspectors are responsible for the inspection of retail drugstores,
non-prescription drug retail outlets, Chinese drugstores, hospital pharmacies, drug distributors(importers,

exporters and wholesalers) of food, drug, cosmetic, medical devices andhousehold hazardous substances.
Regulation Division II - drug inspectors are responsible for the inspection of establishmentsthat deals with the manufacture and repacking of foods, drugs, cosmetics, medical devices andhousehold hazardous substances.
Inspectors regularly make on the spot inspection on all licensed establishments andestablishments applying for a license. Based, on the outcome of the inspection, if there is noncompliance with CGMP, they will require the establishment to correct the deficiencies noted
within the specified period. A follow- up inspection will be made and if there were no changes
or corrections done, the inspector will recommend for the suspension of license to operate of
the establishment to the Bureau’s Legal and Compliance Division.
4.3.3 POST MARKETING SURVEILLANCE (PMS)-134-

One of the functions of the Food and Drug Administration is Post Marketing Surveillance. PMS
is a close observation of drug effects, whether beneficial or adverse, following the marketing ofa drug. The Bureau ensures that all products regulated by the agency conform to thestandards and its specifications. One way of surveillance is by routine sampling of products inthe market during inspection. Samples are submitted to the laboratory for testing. Appropriate
actions or product recall is decided by the legal division depending on the result of the analysis.
4.3.4

DRUG DISTRIBUTION SYSTEM

4.3.5 Drug distribution is done by a Licensed Drug Distributor (importer, exporter, andwholesaler) by licensed Drug manufacturer and Drug Traders. Usually, the Drug
Distributors are authorized by Drug Manufacturers and Traders to distribute theirproducts. Distribution Agreement between each client is provided. Documentation
system such as records of delivery receipts and invoices are required between the
distributor and the supplier. Such records are needed for easy traceability in case ofa product recall.

(Same as to from distributors to retail drugstores/ hospital

pharmacies)
No medicine, pharmaceutical or drug whatever nature and kind or devices shall becompounded, dispensed, sold or resold, or otherwise be made available to theconsuming public except through a prescription drugstore or hospital pharmacy duly
established in accordance with the provision of Republic Act 5921 section 25.
Pharmaceutical, drug or biological manufacturing establishments, importers andwholesalers of drugs, medicines or biological products are authorized to sell theirproducts only at wholesale to duly established retail drugstore or hospital pharmacy.

-135-

Every pharmacy, drugstore or hospital pharmacy whether owned by the government
or a private person or firm shall at all times when open for business be under thesupervision of a registered pharmacist. In cases, when a drug establishment
operates in more than one shift, each shift must be under the supervision andcontrol of a registered pharmacist.
Products distributed should always be registered by the Bureau and should have an
individual distribution record regardless of dosage strength and availability. The
purpose of providing

distribution records is to assure a systematic procedure of

distribution and a prompt recall from outlets if products are found to be defective
and violative.
Proper generic dispensing of drugs and pharmaceuticals in retail outlets should
always be evaluated by the pharmacist. Incorrect prescriptions are not to bedispensed and patients/customers should be instructed to secure a properprescriptions from physicians.
4.4.5 STABLE SUPPLY OF VACCINES
The Philippines has only one manufacturer of vaccines- the Biological and Vaccine
Production Division which is directly under the Department of Health. Currently theagency has produced the BCG vaccine. The vaccines are already imported tosupplement the needs of the people.

-136-10. PRESENT SITUATION IN THE NATIONAL DRUG POLICYINCLUDING ESSENTIAL DRUGS AND TRADITIONAL MEDICINES
From the continuous implementation of the GMP in the Philippines, FDA still finds some
Drug Companies not in compliance to the guidelines. Due to the economic crisis arisingfrom the country, more drug companies opted to just have their products toll
manufactured. The issue of the local pharmaceutical laboratories is that they cannot
easily cope up with the advanced technology of the multinationals. The knowledge,
skills and capability of the personnel in every manufacturing facility can be pirated byother laboratories or they may have the opportunity to go to other countries. Other
manufacturing companies still have not improved or established quality management
system. The proliferation of the counterfeit drugs by unknown “fly by night”
manufacturers still exists.
On the part of the implementing agency both in the FDA Central and Regional Health
Offices, the main problem is the insufficient number of food and drug regulation officers
particularly in the regions. The expertise is not fully acquired due to the limited budget of
the FDA Central to conduct seminars to reecho the latest updates on the GMP
inspections. Insufficient numbers of vehicles to locate and reach some drug
manufacturing facilities is also a problem.

At the moment, FDA Philippines is on the strengthening process to be able to function
as mandated by R.A. 3720, as amended, and RA 9711, to fulfill the vision. The agency
is very strict in issuing License to Operate to Drug Establishments and Outlets. The-137-

continuous coordination of the Central Office to the Regions has been done using thezonal approach.

Other solutions, being considered by FDA Philippines are the additional plantilla,
technical training and technical competency enhancement, and competitive salarystandards.

11.

DRUG PRICE MECHANISM

In the Philippines, high prices of drugs and other products do not only alarm the public
but also the government. High prices are usually based by manufacturers on the cost ofimported raw materials, taxes, labor fee, etc. For this, the government has createdRepublic Act 7581 on June 7, 1992, otherwise known as the “Price Act.” The Act
provides protection to consumers by stabilizing the price and supply of the basic
necessities and prime commodities and by prescribing measure against undue priceincrease especially during the emergency situation.

The Department of Trade & Industry controls the prices of medicines. The Republic Act
7432 - the Senior Citizen Act gives a 20% discount on all senior citizens card holders.
In 2009, Republic Act 9502, otherwise known as the Universally Accessible andCheaper Medicines Bill, which reduced the prices of 21 drug products to 50% of their
original prices, hence, is making them more affordable and accessible to the consuming
public.

-138-

The Food and Drug Administration and the National Drug Policy conduct monthly
monitoring of prices of drugs, especially essential drugs.
The Department of Health also, through the National Center for Pharmaceutical Accessand Management (NCPAM) conducts monthly monitoring of drug prices through electronic
Drug Price Monitoring System where in all community and hospital pharmacies both private
and government upload the drug

prices of essential drugs after registering their drug

establishments through the Data Encoder hired by DOH Central Office and assigned ineach Regional Offices. (Dept. Order No. 2010-007)

12.

PHARMACOPOEIAThe Philippine Pharmacopeia Project is an undertaking of the Department of Health andis being implemented by FDA Philippines, in collaboration with various government andnon-government organizations.

Under Executive Order No. 302 dated 29 March 2004, the Philippine Pharmacopeia(PP) 1st edition 2004 and any supplement thereto, has been declared and adopted as theofficial book of standards and reference for the determination of the identity, purity, andquality of pharmaceutical products and crude plant drugs in the Philippines. Thirty (30)synthetic pharmaceutical products, thirty - one (31) crude plant drugs and twenty - two (22)crude powdered drugs have been identified for monograph development.

-139-

The Government of Japan, through the Japan International Cooperation Agency (JICA)
extends technical assistance and financial support to the Project.

13.

LIST OF REFERENCESCountry Report on the study programme on Manufacturing Control of Essential Drugs,
Mary Ann R. Malicse, 2008
National Demographic and Health Survey - 2008
List of Licensed Establishments and their classification under Regulation Division I 2012 –Food and Drug Administration, Philippines.
List of Licensed Drug Manufacturers 2012 – Food and Drugs Phil. Regulation Division II
Philippines.
List of accredited Government Hospitals and Private and Other Health Facilities for the
Calendar Year 2006 – Department of Health Philippines.
National Objectives for Health Philippines 1999 – 2004, Department of Health Philippines.
National Health Plan 1995 – 2020, Department of Health Philippines
National Health Statistics 2002 – 2004, Department of Health Philippines.
Compilation of Administrative Orders and Memorandum Circulars with Summaries andAnnotations 1992 Edition.

-140-

The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Sri Lanka-141-

QUALITY MANAGEMENT OF ESSENTIAL MEDICINESGOOD MANUFACTURING PRACTICE (GMP) AND INSPRCTION
04 – 30 NOVEMBER 2012
TOKYO, JAPANSRI LANKA COUNTRY REPORTSTATE PHARMACEUTICALS MANUFACTURING CORPORATION-142-

Training and Dialogue Program

JICA

COUNTRY PROFILE
Sri Lanka is an island in the Indian Ocean, lying off the southeastern tip of the Indian
subcontinent. It is positioned between latitudes 5° and 10°N, and longitudes 79° and 82°E.
Island is separated from India by Palk Strait and Gulf of Mannar and the Arabian Sea lies tothe west, the Bay of Bengal to the northeast, and the Indian Ocean to the south.

In the ancient times, Sri Lanka was known by various names: such as Lanka or Sinhala
according to the Indian history, ancient Greek geographers called it as Taprobane and Arabs
referred to it as Serendib. As a British crown colony, the island was known as Ceylon, andachieved independence under the name Dominion of Ceylon in 1948. In 1972, the officialname of the country was changed to "Free, Sovereign and Independent Republic of Sri
Lanka". In 1978, the name of the country was changed to the "Democratic Socialist Republicof Sri Lanka".

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Training and Dialogue Program

JICA

The island consists of flat-to-rolling coastal plains, with mountains rising only in the southcentral part. Amongst these, Pidurutalagala is the highest point, reaching 2,524 meters (8,281
ft.) above sea level. The climate of Sri Lanka can be described as tropical and warm. Its
position endows the country with a warm climate moderated by ocean winds andconsiderable moisture. The mean temperature ranges from about 17 °C (62.6 °F) in thecentral highlands and to a maximum of approximately 33 °C (91.4 °F) in other low-altitude
areas.
Although the country is relatively small in size, it has the highest biodiversity per 10,000
square km in Asia. Remarkably high proportion of the species among its flora and fauna,
27% of the 3,210 flowering plants and 22% of the mammals, are endemic. Sri Lanka has
declared 24 wildlife reserves, which are home to a wide range of native species such as Asianelephants, leopards, sloth bears, and a variety of deer and etc.
Sri Lanka is a democratic, socialist republic and a unitary state which is governed by a semipresidential system, with a mixture of a presidential system and a parliamentary system. It
has 3 branches:
Executive: The President of Sri Lanka is the head of state, the commander in chief of thearmed forces, as well as head of government, and is popularly elected for a six-year term. In
the exercise of duties, the President is responsible to the parliament.
Legislative: The Parliament of Sri Lanka is a unicameral 225-member legislature with 196
members elected in multi-seat constituencies and 29 by proportional representation. Members
are elected by universal (adult) suffrage based on a modified proportional representation
system by district to a six-year term. The president may summon, suspend, or end a
legislative session and dissolve Parliament any time after it has served for one year.
Judicial: Sri Lanka's judiciary consists of a Supreme Court – the highest and final superior
court of record, a Court of Appeal, High Courts and a number of subordinate courts. The-144-

Training and Dialogue Program

JICA

Criminal law is almost entirely based on British law. Basic Civil law relates to the Romanlaw and Dutch law. The President appoints judges to the Supreme Court, the Court of Appeal,
and the High Courts. A judicial service commission, composed of the Chief Justice and twoSupreme Court judges, appoints, transfers, and dismisses lower court judges.

Administrative divisions
For administrative purposes, Sri Lanka is divided into 9 provinces and 25 districts. In 1987
under 13th Amendment to the 1978 Constitution of Sri Lanka, provincial councils were
established to serve increasing demand for a decentralization of the Government of Sri
Lanka.
The provincial council is an autonomous body and is not under any Ministry and it
undertakes activities which had earlier been undertaken by the Central Government
Ministries, Departments, Corporations and Statutory Authorities. But importantly, land andpolice authorities are not given to provincial councils in practice. Sri Lanka is also divided
into 25 districts and each district is administered under a District Secretariat. The districts arefurther subdivided into 256 divisional secretariats and these in turn, to approximately 14,008
Grama Niladhari divisions.
There are 3 other types of local authorities: Municipal Councils (18), Urban councils (13) andPradeshiya Sabha.

EconomyAccording to the International Monetary Fund, Sri Lanka has a yearly gross domestic output
of US$59 billion as of 2010. It has a GDP of US$116 billion in terms of purchasing power
parity and it recorded a GDP growth of 8.3% in 2011.

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Training and Dialogue Program

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In the 19th and 20th centuries, Sri Lanka was famous for its production and export ofcinnamon, rubber and Ceylon tea. In 1977 the free market economy was introduced to thecountry, incorporating privatization, deregulation and the promotion of private enterprise.
While the production and export of tea, rubber, coffee, and agricultural commodities remains
important, the nation has moved steadily towards an industrialized economy with thedevelopment of food processing, textiles, telecommunications and finance. At present maineconomic sectors of the country are tourism, tea export, clothing, and rice and otheragricultural products. In addition to these economic sectors, overseas employment contributes
highly in foreign exchange, most of them from the Middle East. As of 2010, the service
sector makes up 60% of GDP, the industrial sector 28% and the agriculture sector 12%.

Demographics
Sri Lanka annual population growth rate is 0.73% and population density is highest in
western Sri Lanka, especially in and around the capital. The largest ethnic group is Sinhalesewith 74.88% of the total population and Sri Lankan Tamils are the second major ethnic groupin the island, with a percentage of 11.2. Sri Lankan Moors comprise 9.2%. There are also
small ethnic groups such as the Burghers (of mixed European descent) and Austronesian
peoples from Southeast Asia. Moreover, there is a small population of Vedda people who are
believed to be the original indigenous group to inhabit the island.
Sinhalese and Tamil are the two official languages of Sri Lanka and the Constitution defines
English as the link language. English is widely used for education, scientific and commercial
purposes. Sri Lanka is also a multi-religious country. Buddhism constitutes the religious faithof about 70% of the population of the island, most of whom follow the Theravada school of
Buddhism. Buddhism was introduced to Sri Lanka in the 2nd century BCE by Venerable
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Lankan to "protect and foster the Buddha Sasana". Hinduism is the second most prevalentreligion in Sri Lanka and Islam is the third most dominant religion in the country, having firstbeen brought to the island by Arab traders. Christianity was also brought into the country byWestern colonists in the early 16th century. Around 8% of the Sri Lankan population are
Christians.

Education
Sri Lanka has one of the most literate populations amongst developing nations with a literacy
rate of 92.5%. Its youth literacy rate stands at 98%, computer literacy rate at 35%, andprimary school enrolment rate at over 99%. An education system which dictates 9 years ofcompulsory schooling for every child is in place. The free education system established in
1945, and is one of the few countries in the world that provide universal free education fromprimary to tertiary stage.
National Schools are controlled directly by the Ministry of Education and the provincial
schools by the provincial government. Sri Lanka has approximately 9675 government
schools, 817 private schools and Pirivenas. The number of public universities in Sri Lanka is
15, however, lack of responsiveness of the education system to labour market requirements,
disparities in access to quality education, lack of an effective linkage between secondary andtertiary education remain major challenges for the education sector. A number of private,degree awarding institutions have emerged in recent times to fill in these gaps.

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STATISTICAL DATA
Year

SourceMid-year population

20,6532010

Annual report 2011(‘000 persons)

20,8692011

Central Bank of Sri Lanka

7.9

2010

8.4

2011

Annual report 2011

8.0

2010

Central Bank of Sri Lanka

8.3

2011

Hospital beds per 1,000 persons

3.3

2011

Persons per Doctor (number)

1,274

2011

Annual report 2011

Nurses per 10,000 persons

13.9

2011

Central Bank of Sri Lanka

Government expenditure on health

1.4

2011

Large Scale

8

2012

Ministry of Health

Small Scale

21

2012

CDDA (refer Annexure I)

98

2009

Number of pharmaceutical Importers

228

2011

CDDA

Number

771

2011

CDDA

Real Output
GNP

GDP

Public Health(per cent of GDP)
NumberofPharmaceutical

Manufactures / manufacturing sites

Numberoftraditional

medicine

manufactures / manufacturing sites

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HISTORICAL DEVELOPMENT OF PHARMACEUTICAL SERVICES
The history of medicine in Sri Lanka has been reported over the centuries and it is unique tothe country. The traditional system is referred as Ayurvedic medicine and it has muchinfluence from India. In this system, decoctions are prepared by boiling 10 – 15 varieties ofplants materials, apart from that some animal extracts as well as mineral products such as
gold, mercury etc. were also used in treatment. The literature on this medical system iswritten in Sanskrit and it has been widely practiced in Sri Lanka for more than 2000 years.
The modern medicine was introduced to the country by British about 150 years ago, and theearly phase of British medicine belonged to the military that controlled both the military andcivil health institutions. A new phase was started with creation of separate Civil Medical
Department in 1858, by which medical facilities were provided to the civilian by a
department free of military control. The British were very much concerned about the healthof the local population and as a result, the consumption of imported modern drugs was
swiftly increased.
“Pharmacopoeia of Ceylon Hospitals” was established in 1876 of its first edition underauthority of civil medical department. There were 10 later editions, and the 10th was
published in 1951. In this publication, all drugs were classified according to the basic natureand then available in hospitals.
Before 1950’s, the Ministry of Health imported all the drugs to fulfill the public demand of
the country, however in 1957, a committee was appointed to solve the problems in supply ofhealth services in the country. As a result of this, “The Ceylon Hospital Formulary 1959” wasdeveloped and it was a powerful tool for the control of pharmaceuticals in the entire country
at that moment.

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In 1963, government published a gazette notification illustrating a list of approved drugs, andthereafter, import and manufacture of drugs by the private sector was restricted to only
approve drugs.
The government which came into power in 1970, appointed a committee to formulate anational plan on pharmaceuticals. Today, this committee is known as Bibile Wickramasinghe
Committee and as a result of this State Pharmaceuticals Corporation was established in 1971
and it became that sole importer of all the drugs imported into the country. The price of thedrugs was controlled by the regulations imposed under the control of price act.
With the changes of the government in 1977, economy was liberalized and price control on
drugs was removed, and the private sector was also allowed to import drugs into the country.
These changers resulted in wider availability and also wider variety of drugs. With thesechanges a new set of regulation was enacted to protect the consumers and to regulate thesupply of pharmaceuticals.
1)

Introducing of the cosmetic devices and drugs act number 27 of 1980 and regulations
under the act of 1985

2)

Development of essential drug list (1980 to 1988)

3)

Establishment of State Pharmaceuticals Manufacturing Corporation (SPMC) in 1987

4)

Development of standard treatment schedule in 1987

5)

Publication of manual on Management of Drugs

6)

Price control of drugs in 1989

7)

Establishment of new drug quality assurance laboratory in 1990

8)

Monitoring of all drug advertisements in 1992

Sri Lanka had a partly written Drug Policy from the 1960s; however there was nocomprehensive document developed. Therefore, an attempt to develop a National Medicinal-150-

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Drug Policy (NMDP) has been started in 1991 & 1996; while the documents were acceptedby the Ministry of Health, they did not reach the final step of cabinet approval. The present
effort building upon previous efforts brings together the elements of a National Medicinal
Drug Policy (NMDP) in one document and has been developed based on WHO documents
through discussion with all stakeholders.
The objectives of the Sri Lankan National Medicinal Drug Policy (NMDP) are;1)

To ensure the availability and affordability of efficacious, safe and good quality
medicines relevant to the health care needs of the people in a sustainable andequitable manner.

2)

To promote the rational use of medicines by healthcare professionals and consumers.

3)

To promote local manufacture of Essential Medicines.

In this policy making, it has been consider the overall health policy of the country, concept ofEssential Medicines, focusing on the health sector coordinating with relevant areas such as
education, finance, agriculture, animal husbandry, pharmaceutical industry and trade and also
consider the safeguard of patients / consumer rights. An NMDP will be covered all systemsof medicine including allopathic, homeopathy, ayurveda, sidda, unani and any other systems
recognized in the country. It was suggested to cover the following elements;
1.

Selection of essential medicines

2.

Affordability and Equitable Access3.

Financing options

4.

Supply systems and Donations

5.

Regulation and quality assurance

6.

Quality Use of Medicines

7.

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8.

Human resources

9.

Viable Local Pharmaceutical Industry

10.

Monitoring and evaluation

Currently the Health Ministry of Sri Lanka is progressing with development of Health Master
Plan (HMP) to solve past challenges in the entire health service. These challenges include:changing demographic and disease patterns, limited resources, increased demand andexpectations by the public, the need for equity and the development of a management ethosthat ensures good governance and value for money in delivering quality services.
The HMP will be carefully designed to support Sri Lanka's overall economic and social
goals. It aims to facilitate equity through ease of access to health services, improve
productivity and ensure that resources allocated to health result in a healthier population thatis able to contribute to the economic and social well-being of the country. This is to beachieved by responding to the people's needs and working in partnership to ensure access tocomprehensive, high-quality, equitable, cost-effective and sustainable health services. The
overarching aim of improving health status and reducing inequalities will be achieved by thefive strategies, namely:
1. To ensure the delivery of comprehensive health services, which reduce the disease, burden
and promote health;
2. To empower communities (including households) towards more active participation inmaintaining their health;
3. To improve the management of human resources for health;
4. To improve health financing, resource allocation and utilisation; and5. To strengthen stewardship and management functions of the health system.

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Sri Lanka provides free healthcare services to all the citizens irrespective of their status,
income or geographic location, and has achieved remarkable health outcomes, particularly
relative to neighboring countries with a similar income range. At the same time, there arecertain drawbacks in the hospital-based healthcare delivery system which have affected thequality and efficiency of its services as demonstrated by overcrowding in the higher levelinstitutions, deficiencies of amenities and patient dissatisfaction. The National Guidelines for
Improvement of Quality and Safety of Healthcare Institutions provide a comprehensive set of
quality and safety standards and affordable measures to improve the hospital services. All the
hospitals in Sri Lanka are therefore expected to be fully oriented on these Guidelines andprepared to improve their service delivery structure and process. Japan International
Cooperation Agency (JICA) has provided valuable technical assistance throughout thisprocess development.
State Pharmaceutical Manufacturing Corporation (SPMC) was incorporated in June 1987
under the State Industrial Corporation Act no 49 of 1957 with the commitment tomanufacture quality, effective and safe medicinal drugs at affordable price to public of Sri
Lanka. SPMC has already completed 25 years of continuous service producing drugs ofsuperior quality conforming to the highest international standards, and have achieved aformidable position in the field of pharmaceutical manufacture in Sri Lanka, with a gradual
growth in pharmaceutical business. This has made possible through the advance technology
provided by the Japanese Government by way of a grant to the Government of Sri Lanka. In
the beginning, SPMC technical staff trained under the supervision of Japanese experts and
JICA and JICWELS training programmes very much help to develop Good Manufacturing
Practices (GMP) concept among the Sri Lankan Pharmaceutical manufacturers.

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GMP SYSTEMIn Sri Lanka, both the public and private sector provide health care. The Department of
Health Services (DHS) which comes under ministry of Health and provincial health sector
encompass the entire range of preventive, curative and rehabilitative health care provision.
Refer the organizational structure of Ministry of Health in Annexure II.
The Cosmetic, Devices and Drugs (CDD) Act No 27 of 1980 (as amended by Act No. 38of
1984, No 25 of 1987 and No. 12 of 1993) provides the legislative framework to control theuse of cosmetics, medical devices and medicinal drugs in the country. This act controls theregistration, manufacture, importation, transportation, sale (retail and wholesale), labelling,
advertising, distribution of drugs, testing and disposal of outdated or spoilt drugs.
The Director General of Health Services (DGHS) is the head of the Cosmetic, Devices andDrugs Authority and a Technical Advisory Committee (TAC) has been operated under thisAct to advise the Hon. Minister of Health on matters pertaining to the implementation of theAct. There are four Sub Committees set up by TAC to implement the CDD Act, namely;
1)

Drugs Evaluation Sub-Committee (DESC) to review and make recommendation on
drugs submitted for registration,

2)

Cosmetics Evaluation Sub-Committee to review and make recommendation on
cosmetics submitted for registration,3)

Devices Evaluation Sub-Committee to review and make recommendation on devices
submitted for registration,

4)

Advertisement Sub-Committee (DESC) to screen advertisements of drugs and to
make recommendation on the information given in the advertisements.

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To implement the CDD Act and the regulations therein, Hon. Minister of Health has
appointed authorized officers from flowing categories;
Provisional Directors and Regional Directors of Health Services
Medical Offices of Health
Divisional Pharmacists
Food & Drug Inspectors
Public Health Inspectors
To support implementation of these activities, an organizational framework exists within the
Ministry of Health that comprises of the followings;a) CDDA (Office of D/MT&S) for registration of drugs.
b) The Medical Supplies Division at the central level for estimation, storage, distribution andmonitoring of drugs.
c) National Drug Quality Assurance Laboratory (NDQAL) for quality assurance of drugs.
d) The State Pharmaceuticals Corporation (SPC) for procuremente) Regional Medical Supplies Divisions (RMSD) at regional level (26 in number) for storage
and distribution for provincial council institutions.
f) A drug store in each health care institution.
Organizational structure of drug management of Sri Lanka is elaborated in the Annexure III.

WHO Good Manufacturing Practices (GMP) have been adopted to ensure the quality
assurance of products controlled to the quality standards appropriate to their intended use.
GMP covers all aspects of the manufacturing process: defined manufacturing process;validated critical manufacturing steps; suitable premises, storage, transport; qualified andtrained production and quality control personnel; adequate laboratory facilities; approved
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been taken; full traceability of a product through batch records and distribution records; andsystems for recall and investigation of complaints. Under Director- Medical Technology andSupplies there are four food and drug inspectors to carry out inspection of GMP further tothem there are trained regulatory pharmacists who have undergone overseas training on GMP
auditing and inspection (refer Annexure IV).

They carry out field inspection anddocumentary inspection in once a year.
In Sri Lanka there is no official designation as a GMP Inspector. Generally GMP inspection
team will compromise of a Pharmacists, drug inspectors and doctors. They conduct on the job
training for fellow pharmacists and Drug inspectors. Basic required qualification for the postof pharmacist is GCE Advanced level and registration as a pharmacist. Drug inspector is apromotional grade for public health inspectors.
Since the manufacturing of pharmaceutical products is not well developed in Sri Lanka,
country requirement of many products namely; injectable solutions, tablets and capsules andother preparations are imported through State Pharmaceuticals Corporation (SPC). Only few
number of products in the category of tablets and capsules are formulated strictly control
GMP environment at State Pharmaceuticals Manufacturing Corporation (SPMC). Apart fromthat there are very few private manufactures in the country that produce tablets, capsules andoral solutions. Refer annexure V for the list of domestically manufactured products.
Essential Medicines are selected with due regards to clinical needs and disease prevalence,
together with evidence on efficacy and safety, and comprehensive cost effectiveness. To
develop this list of medicines, it has been followed the WHO Model list of essential
medicines and modified in according to the Sri Lankan population.
There are twenty eight categories of medicines listed under essential medicines and it isavailable http://www.cdda.gov.lk/images/stories/new/pdf/EML_2009.pdf-156-

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Approximately 9000 drug products are registered and out of that 80% are imported drugs andonly other 20% manufacture in locally (refer Annexure VI for DHS annual requirement).
Quality assurance of drugs is the total sum of the organized activates performed with theobject of ensuring that pharmaceutical products are of required quality for their intended use.
The principal institutions responsible for examining recalled products are; Office of Director
Medical Technology & Supplies (D/MT&S) and National Drug Quality Assurance
Laboratory (NDQAL). The primary function of the NDQAL is to conduct laboratory tests
necessary for determining compliance with product safety and quality requirements. Quality
testing of drug products is carried out on samples collected on random basis at different
points of the distribution; namely at pre-marketing and post marketing stages, and issue
reports/recommendations based on the analyses/evaluations. There are about fifteen persons
in charge of testing at NDQAL.
There are 51 reported cases of drug recalls up to August in 2012 according to CDDA web site
(Annexure VII) and 04 drug recalls in December 2011. As the computerisation of CDDA
data is still in progress it is hard to trace the history in this regard.
Medical supplies division (MSD) provides Pharmaceuticals including Narcotics &Radioactive items, Surgical dressings, Surgical Consumables & Non consumables,
Laboratory items including Chemicals, Devises & Glass ware & Medical gasses togovernment health Institutions Island wide. State Pharmaceutical Corporation (SPC) is the
procurement agent for MSD and in addition MSD has its own supply branch for emergency
local purchases for selected items. These Medical items are distributed directly to line
Ministry institutions & to institution under provincial council administration throughRegional Medical Supplies Divisions (RMSD) based on their annual estimates or on therequests of these institutions. Items are distributed directly to 26 RMSD and major hospitals
and healthcare institutions administered by Central Government. These 26 Regional Medical-157-

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Supplies Divisions (RMSD) are responsible for the supplying medical items to General
Hospitals, base hospitals, District Hospitals, Peripheral Units, Rural Hospitals, Central
Dispensaries, Maternity Homes & Central Dispensaries and other small Hospitals under thepurview of Provincial Councils.

DIFICULTIES AND CONSTRAINS IN QULAITY ASSURENCE OF
ESSENTIAL MEDICINESa) mainly SPMC as a government organization undertake formulation of few number of
essential drugs, there is resrictions to procure qulaity starting materials due to governmet
procument procedure.
b) high value of refernce standards and there is no facility to procure those items directly by
the NDQAL. Thereofere, many reference standards needed for quality checking are notavailble in the NDQAL at the required time.
c) lack of trained staff of inspectors, regulatory pharmacists to implement, regular monitoringof drug quality assurance procedure and GMP.
d) The first step of drug registration procedure is the evaluation of the manufacturer forcompliance to Good Manufacturing Practices (GMP) standards. Applications for registrationof drugs are accepted only if the production facilities of the relevant manufacturer conform torequired standards of GMP. Evaluation of foreign manufactures is done by evaluating theircompany profiles while local manufactures are inspected by a team of officers attached to the
Office of MT&S and the National Drug Quality Assurance Laboratory (NDQAL) for GMP
compliance. Every foreign manufacture has to appoint an agent in Sri Lanka who is
responsible for registration and other activities related to their products in Sri Lanka.

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However, it has been identified the facility of foreign manufacture must be inspected prior toregister their products and already action taken to implement by the D/MT&S.
e) In Sri Lanka Pharmacy degree programme was started very recently in year 2000. Even
though there are several batches of graduate pharmacist who have passed out still there is no
significant contribution by them in the government health sector.
d) lack of trained staff for maintenance of laboratory instruments.
f) there is no carder positions for Graduate Pharmacists in Government sector.

CURRENT SITUATION OF SUBSTANDARD MEDICINES
The PDHSS, RDHSS and Head of Institutions are responsible for destroying stocks
according to the WHO guidelines after receiving circulars for withdrawals from the D/MSD.

OVERVIEW OF RELATIONSHIP WITH OVERSEAS ASSISTANCE
ORGANIZATIONSWHO Collaborated Activities of Human resource training at Drug regulatory Authority(DRA);
Training for 2 senior staff.
Formation of a multi-stakeholder committee and developing a mechanism and guidelines forthe regulation and monitoring of medicines prices.
Awareness programmes for pharmacies and pharmacy owners and Authorized officers
Training of 2 DRA staff in pre and post marketing quality assurance of vaccines andbiological products for 2 weeks in a regional country.
Consultative workshops to develop SOP’s on pre and post marketing surveillance ofpharmaceutical products including vaccines and biologicals.

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Promotion of rational use of medical products by strengthening the drug advertisement
regulating unit of the DRA.
Apart from that Japanese government help to develop Sri Lankan pharmaceuticalmanufacturing industry by various way; for example SPMC was an outright gift of Japanese
government and the organizations JICA and JICWELS had arranged many training
programmes for technical staff of SPMC in the beginning. The Japanese government also
grants their corporation to expand Medical research Institution, to establish nurses’ training
school and many other system developments.
Indian government occasionally offers two week training programme on Advanced Quality
assessment of Drugs & Pharmaceuticals and there is very rare opportunity to complete master
degree in pharmaceutics (Manufacturing Pharmacy) for two years under TICA programmewith the collaboration of Thailand government.
However, there is very limited Technical Assistance Programs organized in the fields ofPharmaceuticals, GMP and Quality Control by the International Organizations may be due
limited budgetary allocations. We believe as a developing country the Technical assistant
progarmmes conducted by the international organization like WHO, JICA helped us toenhance knowledge by interacting people in developed counties and we very muchappreciated this kind of assistance ships in future.

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The Study Programme
for the Quality Management of Essential Medicines- Good Manufacturing Practical (GMP) and Inspection -Thailand-161-

Country Report
ThailandStudy Programme on Quality Mangement of Essential
Medicines – Good Manufacturing Practice (GMP)
Tokyo,Japan
4– 30 November 2012

Ministry of Public Health
Kingdom of Thailand-162-

Index

1. Country Profile
2. Statistical data
3. Historical Development of Pharmaceutical Services
a.History of the National Plan on Pharmaceutical Services
b.History of GMP in your country
4.GMP System
1) Organization charge2) Legal and institutional position of GMP in Thailand, GMP guideline3) Inspection of pharmaceutical affairs, Organization of Inspection division, Numberof inspectors (central government/local government, their role)4) Scope of pharmaceutical products under GMP inspection5) Frequency of GMP Inspection6) Method(s) of GMP Inspection (field inspection, documentary inspection)7) Qualification of GMP inspectors, education, training system
8) Cases of recalled pharmaceutical products arising from compromised quality (No.
of cases, outline of cases over the past 5 years)
9) Manufacturing, import and export of pharmaceutical products
10) Sales and distribution of medicinal products, proportion of imported medicinal
products distributed11) Product name of medicines domestically manufactured and product name ofimported medicines in the market (main products)12) Legal and institutional regulations on the sales and distribution of pharmaceuticalproducts
13) Existence of recalled system of products distributed14) Name of organization for examining recalled products, no. of persons in charge oftesting
5. Essential Medicine List
6. Difficulties and constraints in Quality Assurance of Essential Medicines
7. Current situation concerning Substandard Medicines and its countermeasures.
8. Relationship with Overseas Assistance Organization
9. Technical Assistance Programs in the fields of Pharmaceuticals, GMP,
Quality Control organized by International Organizations, NGOs

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Country Profile
1. Country
Location, Territory and Boundary
Thailand’s territory, its shape like a conventionally hand-made ladle or an ancient axe,
covers an area of approximately 514,000 square kilometers. Thailand is the third largest country
among the ten Southeast Asian nations, ranking after Indonesia and Myanmar. Thailand’s borders
cover a distance of the about 8,031 kilometers, of which 5,326 kilometers are inland and 2,705
kilometers are coastlines.
North: the northernmost part of Thailand is in Mae Sai District, Chiang Rai Province,
bordered by Myanmar and the Lao People’s Democratic Republic.
South: the southernmost part is in Betong District, Yala Province, bordered by Malaysia andthe Gulf of Thailand.
East: the easternmost part is in Phibun Mangsahan District, Ubon Ratchathani Province,
bordered by the Lao People’s Democratic Republic and the Kingdom of Cambodia.
West: the westernmost part is in Mae Sariang District, Mae Hongson Province, bordered by
Myanmar, the Andaman Sea and the Strait of Malacca.
The whole Kingdom is in the same time Zone, seven hours ahead of the Greenwich Mean
Time.
Population, Language and Religion
As of the Year 2008, the population of Thailand was approximately 63.21 million. The men
population was approximately 31.18 million and the women population was approximately 31.13
million. About 95 percent of the citizens are Thais. The remainder include ethnic Chinese, Indians,
and other ethnic minorities.
The official national language, spoken and written by almost 100 percent of the population, is
Thai. However, English language is increasingly playing a greater crucial role, notably in thebusiness sector.
Buddhism, the national religion, is the professed faith of 94.6 percent of the population. Islam
is embraced by 4.6 percent of the Thai people while the rest of the population practice Christianity,
Hinduism and other religions.
Culture and Arts
Thailand’s classical arts have developed almost exclusively (and anonymously) in the serviceof theravada Buddhism. Accordingly, the best showcase is the wat, where traditional architecture,typified by sweeping, multi-tiered roofs, countless Buddha images and murals, and decorative arts,
such as woodcarving, stucco relief, gilt, lacquer, colored glass mosaic and mother – of – pearl inlay,
are all used to striking effect.
Education System
For education in a school-related system, it is provided by educational Institutions,characterized by a class system, and the use of curriculum specified for the level and type of
education so as to develop learners in accordance with curriculum objective. In other hand,
education from way-of-life learning process is self-learning from various sources of knowledge andenvironment related to ways of life naturally existing or modified to enhance and service learning.
Education in a school-related system is divided into four levels: pre-school education,
primary education, secondary education and higher education.
Society and Politics
In spite of the pressures of change, Thai society is relatively stable. The Concept of theextended family is important in Thailand, as in other parts of Asia. Children live with their parents,
often sleeping in the same room, until marriage. Elders are always accorded respect within families
and in society. There are beautiful etiquette that Thais practice in their life, such as Wai (saluting
by placing the hands palm against palm and raising them to the face) and approach their superior on-164-their knees. Thais are renowned for their tolerance of other cultures and friendliness to visitors.
Offence is taken only if there is any perceived disrespect to the king or Buddhism.
The monkhood (sangha), some 250,000 strong, plays a crucial social role. Most teenage boys
become monkhood properly later in life and may choose its austere precepts for life. Monks conduct
numerous Buddhist rites, ranging from festivals to everyday blessings and other social events. In
rural areas, they traditionally play an important role as school teachers, a profession that in Thailand
is perhaps held higher in regard than anywhere else in the world.
There is no criticism of the king in Thailand’s press. Constitutional since 1932, the monarchy
is revered almost as much as when king were chakravatin, or “lords of life”. In contrast, politicians
are held in far less respect, and the Thai press makes no hesitation in criticizing the running of thecountry. The present monarch , King Bhumibol Adulyadej (Rama IX) is the longest – reining
living monarch in the world, having ascended to the throne in 1946, and has won widespread
respect for his devotion to welfare and environmental projects throughout Thailand.
Education information for Pharmacist in Thailanda) System of education
Primary School:__6___ years system

Age at enrollment:__7___ years old

Secondary School:__3___ years system

High School:__3___ years systemb) System of university or college education
University or college years:__5___ years

Professional education:__6___ years

Practical training:__12___

weeks

Duration of training by each facility:__3___ weeks

Hospital Pharmacy:__3___ weeks

Pharmacy:__3___ weeks

Pharmaceutical Company:__3___ weeks

Age at graduation:__24___years oldc) National examination system for pharmacist in your country
Academic Exams:__-___ days

Clinical Exams:__-___ days

None

:

__-___d) Requirement to obtain pharmacist’s license (Please check)/- Be a university or college graduate/- Pass the national examination- Conclude practical training after graduatione) Graduates number of pharmaceutical university or college.
People per year (as of :)f) Percentage of alumni’s progressive (as of : 2001 )Hospital__46.6___%

Community Pharmacy__13.8___%Government Organization___7.1___%Enterprise__25.6___%

Others(Education sector)___6.9___%-165-

2. Statistical dataa) Number of pharmaceutical manufacturers / manufacturing sites
Year

Number of modern pharmaceutical manufacturers

2012

169

b) Number of traditional medicine manufacturers / manufacturing sites
Year

Number of traditional medicine manufacturers

2012

1,122

c) Number of pharmaceutical importers

Year

Number of modern
pharmaceutical importers

2012

Number of traditional
pharmaceutical importers

650

196

Number ofpharmaceutical importers
(sum)
846

d) Number of pharmaceutical wholesalers

Year

2012

Number ofmodernpharmaceuticalsalers/ Wholesalers
11,603

Number ofmodern readypackedpharmaceuticalsalers/ Wholesalers3,838

Number of
traditional
pharmaceuticalsalers/ WholesalersNumber ofveterinary
pharmaceutica
l salers/ WholesalersNumber ofpharmaceutic
al salers

731

2,022

18,194

3. Historical Development of Pharmaceutical Services
A. History of the National Plan on Pharmaceutical Services
Before 1936, there was practically no control of drugs. The Sale of Drug Act B.E.2479(1936) was the first legislative measure implemented in the field of drug control which dealt onlywith the sale practices regardless the formulas nor the ingredients. The control of drug was much
improved following an enactment of the Sale of Drug Act B.E.2493 (1950). This law encompassed
many more aspects of drug control other than the control of sale practices, for instance, production
control and registration of pharmaceutical products. Standard requirements of drug quality werealso included.
After endeavoring for several years in order to replace the existed law of B.E.2493(1950), theDrug Act B.E.2510 (1967) was promulgated. For almost three decades which this act has been
employed, it brought in quite substantial improvement in all aspects of drug control. However, four
subsequent additions were made in order to cope with the fast growing industry and present global
situation and to a large extent to facilitate development in pharmaceutical services.
B. History of GMP in Thailand
The project of developing manufacturing standards in pharmaceutical industry is stipulated in
the 6th National Economic and Social Development Plan (1987-1991) and the 7th plan (19921996). The aim of the project is to promote and support drug manufacturers for implementation ofGood Manufacturing Practices. The current code of Thai Good Manufacturing Practices has been
published in 1987 as a recommendation.
To encourage drug manufacturers for implementation of GMP, the Ministry of Public Healthhas stipulated in the purchase regulation that the government hospitals can purchase drug products-166-

only from drug manufacturers comply with GMP since 1992. In addition, FDA has requested retailpharmacies to purchase drug products from drug manufacturers comply with GMP as well.
In 2003, GMP for modern pharmaceutical product has become to the law for the first time on
March 2003. As the result every modern pharmaceutical manufacturers must comply with GMP.
GMP code is developed in accordance with the WHO GMP 1992 guideline.
Thai FDA plans to become PIC/S membership by the year 2012. Both domestic
manufacturers and public sector need preparations before becoming PIC/S member. For this matter,
Thai FDA had informed and educated manufacturers since April 2005. In addition, Thai FDA has
made an operation plan for 2005-2008 and extend the plan to 2012 regarding- Preparation for inspection- Capacity building- Establishment of quality system- Development of related regulations
In the year 2000, Thai Government was settle down to cope the economic problem so there
was a project for supporting and developing product in communities called OTOP (One Tumbon
One Product). This project encourage communes to produce the special products and services fromtheir own local intelligence and raw materials. So there are many varieties of OTOP ie. food,beverages, handicraft including traditional medicine. In order to prepare for PIC/S membership the
producers in the rural area should be assisted to comply with GMP standard by making step by stepdevelopment. The Good Sanitation Practice for those products was performed
In October 2011, GMP code for modern pharmaceutical products has be revised inaccordance with the PIC/S guideline.
The GMP code for traditional pharmaceutical product s is during the process to the law. It
hope to be the law in early 2012.
Thai FDA has strongly determined to develop and increase capacity of staffs to cope withchanging environment of pharmaceutical industry to assure that people will have the access to goodquality, safety and efficacy of drugs. The participation in many international co-operations such as
Developing Countries Vaccine Regulators Network (DCVR), JICA, JICWELS KFDA, TGA andother co-operations or networks under World Health Organization all assist in improvement of our
drug regulatory system and capacity building in evaluation of safety and efficacy of the products
filed for market authorization.
4. GMP System
1) Organization Chart
Pharmaceutical affairs administration
1.1) Administration organization chart
The Administration of Ministry of Public Health have been divided into two parts
that are The Central Administration and The Provincial Administration.
1.1.1 )The central administration
The Central Administration of Ministry of Public Health comprises of the Office of thePermanent Secretary for Public Health, the Office of the Secretary to the Minister and six
departments and the Food and Drug Administration.
In addition there are two more organizations under the supervision of the Ministry. One is theGovernment Pharmaceutical Organization ( GPO ) which is the state enterprise, the other is Health
Systems Research Institute ( HRSI ) which is autonomous agency.
1.1.2) The provincial administration
Systems Research The Provincial Administration of Ministry of Public Healthcomprises of Provincial Public Health Offices, District Public Health Offices and Health Centers
respectively.

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ADMINISTRATION ORGANIZATION CHART

Ministry of Public Health

Health Systems
Research InstituteDept. of Traditional
Medicine

1 Bureau
7 Divisions
3 Hospital
Institutions

Dept. of
DiseaseControl

Minister
Deputy Minister 1

Office of the Minister
Secretary

Permanent Secretary
Deputy Minister
Secretary

The Government
Pharmaceutical
Organization

Office ofPermanent
SecretaryDept. of
MedicalSciences
Director
General1 Bureau
2 Institutions
14 Divisions

11 Divisions
4 Hospitals
12 Regional Communicable Disease
Control Offices
5 Vector-Borne Disease Control
Offices

Dept. pf
Health1 Bureau
2 Institutions
9 Divisions
12 Regional
Medical Sciences
Centers

2 Bureaus
10 Divisions
12 regional Health Promotion Centers
12 Regional Environmental Health Centers
International Health center
Hill tribe Health Development
Center

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Food
and
drug
Administration

10 Divisions
1 Sector- Office of theSecretary- Public Relation &Advertisement
Control Division- Cosmetic Control
Division- Drug Control
Division- Narcotic Control
Division- Food Control
Division- Technical Division- Legal Affairs Task
Group
- Medical Device
Control Division- Inspection
Division- Toxic an
Hazardous
Substances Control- Promotion Task
Group
on Regional
Consumer’s

Dept. ofMentalHealth1 Bureau
4 Divisions
16 Hospital
Institutions
4 Regional
MentalHealthCenters

The Ministry of Public Health ( MOPH )According to the Ministry and Department Reorganization Act of B.E.2534 ( 1991 ), The
MOPH has authority and functions related to medical care, public health, health promotion anddevelopment, food and drug control, anything toxic or hazardous to the public health, and the Red
Cross supervision and support.
The major functions of the Ministry of Public Health include the promotion, support, control
and coordination of all activities related to physical and mental health including well-being of thepeople, and the provision of health services with four principal objectives as follows: To make the Thai people healthy physically and mentally, and live happily in society.
 To make the Thai people free of illnesses that will cause suffering, labour loss or
physical disability ( by providing services related to disease prevention, early diagnosis,
prompt treatment, disability limitation, and rehabilitation ).
 To make the Thai people have a long life expectancy, without any premature death.
 To protect Thai people’s well-being from misfortunes ( environmental pollution, foodor drug poisoning, etc. ).
Food and Drug Administration ( FDA )The main function of FDA is quality and standard control of manufacturing, imports anddistribution of food, drugs, cosmetics, hazardous substances, psychoactive substances, narcotics,
medical equipment, and volatile substances. FDA’s operations include business licensing for
operation and use of products or active ingredients in production, in accordance with eight Acts, andsix international conventions and agreements.
The Government Pharmaceutical Organization (GPO)
GPO is a state enterprise established in 1966 under the Minister of Public Health whose
primary mission is - produce pharmaceutical products and medical supplies that contribute to the
public health in Thailand.
- Research and development on drugs including raw materials for production.
- Control the quality of pharmaceutical products.
- Drug price balancing.
GPO manufactures and distributes pharmaceutical products and medical supplies
more than 300 items. GPO has about 2,300 staffs, thereof 440 pharmacists and scientists.
GPO Products 1.Biological product2.Injection
3.Oral preparation : tablet, capsule, liquid preparation
4.External preparation : ointment & cream, liquid preparation for external use
5.Antiretroviral drugs
6.Natural products & cosmetic
7.Chemical and others
8.Household remedy
GPO has been asked by the Thai Ministry of Public Health and consequently byThai FDA to become the lead model for the Thai pharmaceutical industry in regards to PIC/S
GMP compliance.

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future.

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2) Legal and institutional position of GMP in Thailand, GMP guideline
The Thai modern medicine GMP code is under Ministerial Regulation describe the methodof the production on modern medicines Issued : B.E. 2554 (2011). There are 528 compulsory topics
in the code which are detail in Notification of the Ministry of Public Health about the rules andprocedures in the production of modern medicine. Issued : B.E. 2554. (2011). For new modern
pharmaceutical manufacturers in Thailand, full implementation was accomplished in October 2011.
For Old modern pharmaceutical manufacturers in Thailand full implementation will accomplish in
October 2012 (one-years transition period).
The GMP code for traditional pharmaceutical product s is during the process to the law. It
hope to be the law in early 2012.
3) Inspection of pharmaceutical affairs, Organization of Inspection division, Number ofinspectors (central government/local government, their role)
Since the Thai inspection division of FDA was promoted to Bureau of Import and Export
Inspection. The responsibilities of the officers are mainly in the area of health products import andexport surveillance, inspection and recall the substandard product. There are 47 ports of entry.
After establishment of Bureau of Import and Export Inspection, the main mission forpharmaceutical consumer protection in the area of post marketing system in the country wastransferred to Division of Post-marketing Control (DPostC) or Inspectorate Unit under Bureau of
Drug Control, Thai FDA. Now, the Inspection of pharmaceutical affairs in Bangkok is performing
by DPostC which has around 24 inspectors. The Inspection of pharmaceutical affairs in 76
provincial areas is performing by health office of each province. There are around 2-6
pharmaceutical inspectors for each provincial health office. The Rural and Local Consumer Health
Products Promotion Protection Division of Thai FDA is perform as health products regulation
consultancies in order to support technical information and coordinate activities of consumer
protection with provincial area. There are around 42 pharmaceutical inspectors for this Division.
So, there are around 370 postmarketing pharmaceutical inspectors in Thailand. The role activities ofinspectors on pharmaceutical area are conforming to related pharmaceutical regulation such as Drug
Act, B.E. 2010. They inspect pharmaceutical premises, collect the samples for surveillance every
year. When customer complain to FDA or provincial health office or any sigh of illegal activities
occur the inspectors will perform action such as collect illegal evident, seize the illegal
pharmaceutical products e.g. smuggling drug, counterfeit drug, substandard drug, unregistered drugin collaborate with policemen. When any pharmaceutical product is approved to be substandard, theinspectors will also order the stake holder to perform recall action
In the central or Bangkok, the pharmaceutical inspectors of Bureau of Drug Control areboth perform as pharmaceutical inspectors and GMP auditors. The organization of DPostC forpharmaceutical post marketing surveillance is overlap with GMP as the picture show below :-171-4) Scope of pharmaceutical products under GMP inspection.
From SOP-S-D3-103 declare the scope of modern medicinal GMP audit in dosage forms below
1. STERILE PRODUCTS
1.1 LARGE VOLUME LIQUID DOSAGE FORMS- ASEPTICALLY PREPARED- TERMINALLY STERILISED
1.2. SMALL VOLUME LIQUID DOSAGE FORMS- ASEPTICALLY PREPARED- TERMINALLY STERILISED
1.3 SEMI-SOLID DOSAGE FORMS
1.4. POWDERS
2. NON-STERILE PRODUCTS
2.1. POWDERS
2.2. TABLETS
2.3. CAPSULES
2.4. LIQUID DOSAGE FORMS
2.5. SEMI-SOLID DOSAGE FORMS
2.6. SUPPOSITORIES
2.7. INHALERS
2.8. MEDICATED PLASTERS
3. BIOLOGICAL PRODUCTS
3.1. VACCINES
3.2. SERA
3.3. BLOOD PRODUCTS
3.4. OTHERS describe: e.g. HORMONES, ENZYMES OF HUMAN OR ANIMALORIGIN, GENETICALLY ENGINEERED PRODUCTS
4. PACKAGING ONLY
4.1. LIQUID DOSAGE FORMS
4.2.SEMI-SOLID DOSAGE FORMS
4.3. SOLID DOSAGE FORMS
The dosage form other than all above products such as special group of drug which high risk e.g.:
Penicillin products, Cephalosporin products, Sex hormones, Anti-cancer products, the special
inspection will be performed case by case and in the certificate will show the status of eachmanufacturer for special group of drug.
5)Frequency of GMP Inspection
Since the frequency GMP audit adjustment of some E.U. country such as England. Thailand
has revised SOP P-D3-102, GMP inspection procedure, in the area of frequency of GMP inspection
since January 2011. For High risk group such as sterile products, Biological products, Bloodproducts, Penicillin products, Cephalosporin products, Sex hormones, Anti-cancer products theinspection will perform every 18 months. For low risk products such as non-sterile products, theinspection will perform every 36 months.
6)Method(s) of GMP Inspection
Thai FDA monitors the quality assurance programme of pharmaceutical products in the market
by collaboration with Department of Medical Sciences (DMS c). The results of analysis from DMS c
would be compiled and the recommendation would be made for the authorities to take over someactions in order to correct the existed deficiencies. There are 4 types of inspection programme : regularinspection (planned), follow-up inspection, abbreviated inspection, suspected or petition inspection.
The details of inspection method(s) are perform step by step as follow:- Make yearly plan for GMP inspection by using Risk based assessment- Select Lead Inspector for each manuacturer and select Inspector for each team
- Select Special Inspector (if needed.)- Read site Master File (updated)- Read the last inspection report or any other cases of the manufacture report ( e.g. productquality problems)- Prepared Inspection schedule by Lead Inspector- Prepared for necessary documents such as: Aide-memoire: Inspection Note
: GMP Inspection record-172-

: List of manufacturing dosage forms: Name list record of persons who attend to opening and closing meeting.
Inspection Steps- Opening Meeting by lead inspector , introduce GMP inspectors , watch presentationfrom manufacture (briefly)- On site inspection e.g. Production area , Laboratory, Water production area , HVAC
system , Warehouse, Water treatment area.
- Break for lunch (1 hour)- Continued inspection on documentation and other system such as risk management,
validation master plan, trend analysis, change control. computerized system, training, self
inspection ect.
- Discussion between inspectors- Classify Critical , Major , Minor defects- Closing Meeting- Do formal report within 30 working days.
- Send inspection letter include Critical , Major , Minor Defects to manufacture- Manufacture do CAPA for Critical and Major Defect and send CAPA plan to TFDA.
- Lead Inspector and QSM accept CAPA
- Approved CAPA by QSM .
In case of different opinion for CAPA between lead inspector and QSM, have to discuss in
the GMP committee .
If the ex-major defects still occur after manufacturer sent CAPA to FDA in the lastinspection , this defects will bring to working group for GMP audit for discussion theninform manufacturer if against regulation.
Types of inspections :- Routine inspection- Follow-up inspection- Concise inspection- Special inspection
1 Routine Inspection
A routine inspection is a full review of all aspects and components of GMP within a facility.
The inspector should also be aware of the licensing provision. Routine inspections may be announced orunannounced, depending on the history of the company, previous inspections and the policy of thecountry. It is appropriate to perform a routine inspection under the following circumstances: When there is an application for a new manufacturing license for a newly establishedmanufacturer
 When a manufacturing license is due for renewal.
 If there have been significant changes such as new products or new product lines,
modification to manufacturing methods or processes, or changes in key personnel, premises, and or
equipment.
 If the company has an history of non-compliance with GMP.
2 Follow-up Inspection
A follow-up inspection is also referred to as a re-inspection or a re-assessment of the
manufacturer. A follow-up inspection is performed specifically to monitor the result of corrective
actions of the manufacturer following a previous inspection. The manufacturer would notnecessarily know in advance about the follow-up inspection. Depending on the nature of the defects
and the work required, the follow-up inspection could be carried out between 6 weeks and 6 months
after the original inspection had taken place.
The inspection is limited to specific GMP requirements that have not been observed orthat have been inadequately implemented by the manufacturer.
3 Concise Inspection
A concise inspection is the evaluation of limited aspects relating to GMP compliancewithin a facility. (It is known as an abbreviated inspection in some countries.) A limited number of
GMP requirements are selected by the inspector to serve as indicators of overall GMP complianceby the manufacturer. The inspector also has to identify and evaluate any significant changes that
could have been introduced by the manufacturer since the last inspection.
Collectively, the selected indicators and identified changes indicate the manufacturer’s attitude
towards GMP.
Depending on national practice, a company would normally not be warned in advance about aconcise inspection.
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A concise inspection is applicable under the following circumstances: Where a manufacturer has a consistent record of GMP compliance through routine
inspections in the past.
 Where a sample of aspects can be taken as a good indication of the overall level of
GMP compliance.
However, if the concise inspection uncovers evidence that the level of GMP compliance has fallen,a more comprehensive or full GMP inspection should then be performed soon after the concise
inspection.
4 Special Inspection e.g. after receiving a complaint, etc
There are a number of circumstances in which special visits or inspections may benecessary. A special inspection is undertaken to do spot checks. Spot checks could focus on one
product, a group of related products, or specific operations e.g. mixing, or labeling.
The manufacturer may or may not be aware in advance of the inspection, depending on the reason
for it.
If there have been complaints about a specific product that suggest there may be defects,
then a special inspection could be performed to investigate the quality defects of the product. It is
unlikely that the company would be warned in advance in this case.
If there has been a product recall, this can also trigger an inspection, as would adverse drug
reactions.
In the above cases, the inspection would focus on the specific product or aspect of production that issuspect.
An application for a marketing authorization or an export certificate may also trigger suchan inspection.
A special inspection could also be performed to gather specific information, or toinvestigate specific operations of the manufacturer. In some cases, this opportunity is used to advise
the manufacturer on specific regulatory requirements.
7) Qualification of GMP inspectors, education, training system
Types of Thai GMP inspectors are
1. Lead Inspector/Auditor
2. Inspector/Auditor
3. Special Inspector/Auditor
Qualification
The GMP Inspectors must comply with Personnel Qualification in SOP : S-D3-104.
The qualification need for Lead inspector are :- Thai FDA personnel- Professional Pharmacist Level (Level 7)- Graduated from Faculty of Pharmaceutical Science- Experienced in GMP inspection not less than 5 years and 72 GMP inspections or 144 days forinspections within the latest 3 years- Have GMP knowledge- Attended to Lead inspector course not less than 20 hours- Approved by Quality System Manager- No conflict of interest
The qualification need for inspector are :- Thai FDA personnel- Professional/Practitioner Pharmacist Level- Graduated from Faculty of Pharmaceutical Science- Experienced in GMP Inspection not less than 1years and 10 GMP inspections or 20 days forinspections within the latest 6 months.
- Pass all training programs in P-D3-105 (Training course for GMP Inspector)- Approved by Quality System Manager- No conflict of interest
The qualification need for special inspector e.g. biological products manufacturer are- Qualified Person by QIT committee.
- Pass all training in P-D3-105 or Training course for GMP Inspector- No conflict of interest
Training system• All inspectors must be well trained in the field of their responsibilities, especially how to
do GMP inspection and all necessary knowledge• must be followed Procedure for personnel training P-D3-105
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•
•

Training programme should be annually prepared by QSM & approved by the Director
Survey for training need must be done completely, before the preparation of training
programme• Training profile/ history must be thoroughly documented and kept for each person• Conclusion report should be proposed for management review once a year
Type of trainingI) Basic training- newly recruited person & external expert- basic training issues include at least;: Duties & Responsibilities of Thai FDA & the Inspectorate Unit
: Law and Regulations (Drug Act B.E.2510, Ministerial Order and Notification): Drug system/ quality management system: GMP Guideline & Related issues: training for following all procedures especially about GMP inspection: Inspection Techniques
II) In-service/ On-the-job training- After obtain the basic training, newly recruited person must be trained as the observer in the
GMP inspection done by the qualified inspectorใ
- Topic for training includes at least;: doing GMP inspection together with the inspection team at least 12 times (24 workingdays) within 6 months.
: preparing the GMP inspection report not less than 6 times within 3 months.
III) Continuous training- All qualified persons (QSM, Lead inspector and Inspector) should be re-trained, in order toreview and improve their knowledge up-to-date- Frequency: at least 10 working days/ person/year
Example:: all details of pharmaceutical manu.& QC, Quality management system, GMP, inspection
techniques, quality system, etc.
: External training: Mock inspection & Joint-inspection (cooperation with other NRA)
IV) Training when change(s) occur in Quality system of the Inspectorate Unit
- new revision/ correction/ obsolete of document- separated into 2 kinds of change;: Major/ Complicated change: Minor change
Training evaluation• Training evaluation on GMP will use the evaluation form, in order to examine & assess all
trainees whether they understand completely or not• Training evaluation on GMP assessment will perform by the head of each person, in orderto ensure that all trainees understand and be able to do their work correctly8) Cases of recalled pharmaceutical products arising from compromised quality :The table below show number of cases for voluntary Recall compare to compulsory Recall
over the past 5 years
Year
2007
2008
2009
2010
2011

Voluntary Recall
9
6
7
10
-

Compulsory Recall
35
34
29
69
7

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Sum
44
40
36
79
7

The table below show number of cases problem for over the past 5 years
2007
1

2008
1

Year
2009
2

Physical problem
Adverse Drug
Reaction (ADR)
problem

5
7

3
2

6
1

10
1

2
-

26
11

Quality problem
Others problem
Counterfeit problem
Sum

26
3
2
44

32
2
40

24
3
36

66
2
79

5
7

153
6
6
206

ProblemFilling/ packing/labeling problem

2010
-

2011
-

sum
4

The table below show number of recall cases for each country origin for over the past 5 years asshow below :Yearcountry
Argentina
Austria
Belgium
China
CyprusDenmark
EnglandFranceGermany
India
Japan
Pakistan
Singapore
Slovenia
ThailandThe United state
Sum

sum
2008

2009

2010

2011

2012

1
4
2
1
9
22
39

2
1
7
2
21
3
36

1
1
2

1
3
3
7

1
1
3
5

1
1
17
1
1
51
3
79

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1
1
3
4
2
1
3
1
2
37
1
2
1
0
100
6
165

9) Manufacturing, import of pharmaceutical products
The main of manufacturing medicines in the country are show in the table below:
Rank

Generic Name

Bath

1
2
3

paracetamol
amoxicillin
metformin

1,920,090,568.51
1,725,977,220.22
1,521,914,119.63

4

sodium chloride

1,178,378,202.76

5
6ceftriaxone
ketoconazole

878,788,998.25
759,183,784.20

7roxithromycin

698,170,997.99

8

simvastatin

691,750,986.93

910

cefazolin
stavudine, lamivudine and nevirapine

679,263,564.23
616,993,320.00

The main of import medicines in the country are show in the table below:
Rank
1
2
3
4
5
6
7
8
9
10

Generic Name

Bath3,775,477,745.95
2,831,224,791.15
1,826,949,094.62
1,760,221,444.83
1,472,902,404.90
1,271,279,198.83
1,147,172,362.77
1,138,462,554.78
1,094,710,836.41
936,265,160.12

atorvastatin
anastrozole
erythropoietin alfa
glucosamine
rosuvastatin
clopidogrel
erythropoietin beta
cyproterone+ethinylestradiol
hyaluronic acid
nifedipine

10) Sales and distribution of medicinal products in Thailand, proportion of imported
medicinal products compared to manufacture medicinal products distributed.
For modern medicine, the proportion shows in the table below.

Year

Sales and distribution of modern
medicine Manufactured in
Thailand (Million Bath)Sales and distribution of modern
medicine Imported to Thailand(Million Bath)

2007
2008
2009
2010
2011

Human
Veterinary
Human
Sum
Medicine Medicine
Medicine
41,232.43
1,473.91 42,706.34 53,000.10
35,322.85
1,517.68 36,840.53 64,148.13
37,525.38
2,182.58 39,707.96 70,607.22
46,895.75
1,927.37 48,823.13 99,660.24
30,910.92
1,831.21 32,745.13 45,004.55-177-

Veterinary
Sum
Medicine
3,237.14 56,237.23
3,169.97 67,318.09
4,139.10 74,746.32
7,734.01 107,394.25
3,584.50 48,589.05

Proportion
imported/
manufactured
1.32
1.83
1.88
2.20
1.48

Below table show sales and distribution of Traditional medicinal products in Thailand,
proportion of imported Traditional medicinal products compared to Traditional manufactured
medicinal products distributed.

Year

2007
2008
2009
2010
2011

Sales and distribution of
Traditional medicine
Manufactured in Thailand(Million Bath)Human Veterinary
Sum
Medicine Medicine
2,183.73
2,543.15
2,799.29
3,139.87
2,197.26

4.39
4.15
4.86
6.86
3.432

Sales and distribution of Traditional
medicine Imported to Thailand(Million Bath)2,188.12
2,547.30
2,804.15
3,146.73
2,200.72

Human
Medicine

Veterinary
Medicine

270.48330.62398.19359.01
244.251

0
0
0.01
0.14
0.097

Sum

Proportion
import/manufacture

270.48330.62398.2
359.15244.349

0.12
0.13
0.14
0.11
0.11

11) Product name of medicines domestically manufactured and product name ofimported medicines in the market (5 main products) are Tylenol, Augmentin, Glucophage,
Rulid, Zocor.
12) Legal and institutional regulations on the sales and distribution of pharmaceuticalproducts
The laws under the responsibility of FDA which relevant to pharmaceutical affairs are atotal of three acts which are laws issued by the legislative power, plus ministerial regulations,notices or decrees issued by virtue of the acts, as follows:
1. Drug Act B.E.2510 (1967), Drug Act (2nd revision) B.E.2518 (1975), Drug Act (3rdrevision) B.E.2522 (1979), Drug Act (4th revision) B.E.2527 (1984) and Drug Act (5th revision)
B.E.2530 (1987)
2. Narcotic Act B.E.2522 (1979), Narcotic Act (2nd revision) B.E.2528(1985) and Narcotic
Act (3rd revision) B.E.2530 (1987)
3. Psychotropic Substance Act B.E.2518 (1975)
Under Drug B.E.2510 (1967), there are others mandatory regulations to enforce the stakeholder related to the distribution of pharmaceutical products such as:
Ministerial regulations on medicines.
- Ministerial regulation No. 15. Content about how to permit premise license formodern medicine pharmacy. Issued : B.E. 2525
- Ministerial regulation No. 16.Content about how to permit premise license formodern medicine importer. Issued : B.E. 2525 (1982)- Ministerial regulation No. 17. Content about how to permit premise license fortraditional manufacturer , pharmacy, importer. Issued : B.E. 2525(1982)- Ministerial Regulation No. 18. Content about the registration method and edit method
for modern medicine and traditional medicine registration. Issued : B.E. 2525 (1982)- Ministerial Regulation No. 19. Content about officers identity conform to Drug Act
BE. 2510. Issued : B.E. 2525 (1982)- Ministerial Regulation No. 20. Content about medicine recall. Issued : B.E. 2525.
(1982)- Ministerial Regulation No. 21. Content about the duty of modern medicine pharmacy
to prepare for the sale of medicine and equipment to support a licensed pharmacy . Issued : B.E.
2528 (1985)- Ministerial Regulation No. 22. Content about the duty of traditional medicine
pharmacy to prepare for the sale of medicinesand equipment for prescribe the traditional medicine.
Issued : B.E. 2528(1985)- Ministerial Regulation No. 24. Content about examining modern medicine or
traditional medicine import to the Kingdom of Thailand and practicing of the officers at thecheckpoint or the port of entry. Issued : B.E. 2537 (1994)- Ministerial Regulation No. 25. Content about the production of traditional medicines
by means of percussion pellet, a coating, terms of additives and preservatives as well as how tocheck traditional medicine produced by the above method. Issued : B.E. 2537 (1994)-178-

- Ministerial Regulation No. 26. Content about the fee License / substitution at thepharmacy, Drug registration, the applicant for registration of medicines, for modern and traditional
medicines . Issued : B.E. 2537(1994)- Ministerial Regulation No. 27. Content about the application for drug import premise
relocation or a place to store import medicines relocation specified in the license' permit. Issued :B.E. 2537(1994)- Ministerial Regulation No. 28. Content about the application for relocation of the drug
premise specified in the license' permit for all types of traditional medicine. Issued : B.E.
2537(1994)- Ministerial Regulation describe the duty of the licensee to bring or order medicine to
the Kingdom of Thailand in respect of pharmaceutical chemicals, active ingredients or semifinished pharmaceutical products containing the active ingredient Issued : B.E. 2547 (2004)- Ministerial Regulation describe Lot release process to ensure the production of
biological medicine Issued : B.E. 2553. (2010)- Ministerial Regulation describe the method of the production on modern medicines
Issued : B.E. 2554 (2011)

Notification of the Ministry of Public Health on medicines.
- Notification of the specific details about the rules and procedures in the production ofmodern medicine. Issued : B.E. 2554. (2011)- Notification of port of entry for health products.
- Notification of special controlled substance- Notification of Dangerous drug.
- Notification of medicine to be used in the warning label and the leaflet and the text of
the warning.
- Notification of Household remedies for modern medicine.
- Notification of Household remedies for traditional medicine.
- Notification of the treatises on medicine for Thai regulation.
- Notification of the object that has been except to be medicine.
- Notification of the specific details about the rules and procedures in the production of
biological products. Issued : B.E. 2549 (2006)- Notification of the rules, procedures and conditions relating to the manufacture or
import of medicines to the Kingdom of Thailand. These medicines are Anti-Inflammatory
medicines, Analgesics, Antipyretics in combination with Corticosteroids.
- Notification of the rules, procedures and conditions relating to the manufacture or
import of medicines to the Kingdom of Thailand for Amidopyrine or Aminophenazone
combination.
- Notification on the pharmacy of ready packed medicine premises in the provincial
area.
- Notification of the declaration of expiration date on the label.
- Notification of the object identifier to be the drug or medicine. Under the Drug Act.
BE 2510.
- Notification about the prohibit disease of the licensee.
- Notification about disease or symptoms of disease or medication that prohibited toadvertise.
- Notification about rules, procedures and conditions prescribed to import medicine into
the Kingdom of Thailand without registration licenses.
- Notification of the declaration of expiry date on Chloramphenicol eye drop.
Notification of the Thai Food and Drug Administration on medicines .
- Notification of the prescribed control method for medicine combine withDiphenhaydramine, Promethazine, Dextromethorphan.
- Notification of the prescription control method for cold medine compose of
Pseudoephredrine.
- Notification of the FDA method for sale report of Sildenafil, Tadalafil and Vardenafil- Notification of the FDA method for sale report of liquid dosage form medicinescompose of Diphenhydramine or Promethazine- Notification of the FDA method for sale report of Dexamethasone and Prednisolone-179-- Notification of ASEAN Guidelines for the Conduct of Bioavailability andBioequivalence Studies- Notification of ASEAN Harmonization Product on Pharmaceutical Registration- Notification of the FDA method for sale report of liquid dosage form medicinescompose of Diphenhydramine or Promethazine
The order of Ministry of Public Health.
- The Ministry of Health order the amendment of drug registration.
- The Ministry of Health order the cancellation of drug registration.
Notification of the Thai Food and Drug Administration- Notification of license revocation or suspension- Notification of the procedure to conduct with Certificate of Free Sale : CFS
Regulation of the Ministry of Public Health.
- The processing for common property in dispute which is not a drug. Issued : B.E.
2521. (1978)- The method of maintaining trade secrets of the drug for Issued : B.E. 2550 (2007)
13) Existence of recalled system of products distributed
There is an existence of medicinal recall system or rapid alert system conform to SOP-PD3-110. The recall system operated by Rapid Alert Working Group of Bureau of Drug Control. The
working group make the decision to classify or ranking the severity status of defected medicinal
products. The severity of pharmaceutical problems are classified in to 3 levels., The working groupalso specify type of recall action duration and has close cooperation with other Thai FDA officesuch as Technical and Planning Division which help the working group to distribute recall
information to other pharmaceutical network area e.g. ASEAN country. In the recall system, it
enforce the product owner to perform recall action and enforce to report back to FDA to evaluate
the recall activities. The activities to destroy defected products also in this system. More over , thesystem has the chanal to distribute recall information by announce on other media such as oninternet, FDA Safety-Alert web-site, in order to inform the customer as much as possible. The recall
information letter also distribute directly throughout health government service and other private
health service such as hospitals retailers in the country.
14) Name of organization for examining recalled products, no. of persons in charge oftesting
Bureau of Drug and Narcotic and Institute of Biological Product, Department of Medical
Sciences (DMS c) have the main mission not only testing , examining pharmaceutical and biologicalproducts but also making lot release for biological products. The pharmaceutical laboratory
examining the sample collected from the market system including retailers, manufacturers,
importers, government and private hospitals. Not only examine the legal products but also identify
or assay all complained pharmaceutical products or illegal products such as recalled, counterfeit,
smuggling, unregistered pharmaceutical products. There are around 150 analysts in DMSc forpharmaceutical and biological products testing.
When all examination finished and approved that the pharmaceutical product issubstandard, they will inform Thai FDA to order the owner of the substandard pharmaceuticalproducts to remove those products from the market by perform recall action.
5. Essential Medicine List
The Thai Essential Drug List is considered by the Essential Drug List Comitee establishedby Drug comitee. There are others 17 expert comitees for each therapeutic sytem of Essential Drug .
In the year 2011, Essential Drug List divide in to 2 main groups. The first group is traditional
medicine. It compose of 21 herbs developed medicines and 50 Thai traditional medicines. The
second group is modern medicine. Essential Drug List for modern medicine is classified medicine
according to therapeutic classification for human use. There are 17 therapeutic systems in Essential
Drug List for modern medicine as below:
1. Gastro-intestinal system
2. Cardiovascular system
3. Respiratory system
4. Central nervous system
5. Infections-180-

6. Endocrine system
7. Obstetrics, gynaecology and urinary-tract disorders
8. Malignant disease and immunosuppressant
9. Nutrition and blood
10. Musculoskeletal and joint diseases
11. Eye12. Ear, nose, or pharynx and oral cavity
13. Skin
14. Immunological products and vaccines
15. Anaesthesia
16. Antidotes
17. Contrast media and Radiopharmaceuticals
The list of modern medicines are sow below:
1. Gastro-intestinal system
1.1 Antacids and other drugs for dyspepsia- Aluminium hydroxide : chewable tab, tab, susp, susp (hosp)- Aluminium hydroxide + Magnesium hydroxide chewable tab, tab, susp, susp (hosp)- Simeticone (Simethicone) chewable tab, susp
- Aluminium hydroxide + Magnesium hydroxide + Simethicone 25-50 mg chewable tab, tab- Compound Cardamom Mixture sodium bicarbonate (Mist Carminative) mixt, mixt (hosp)
1.2 Antispasmodics and other drugs altering gut motility- Dicycloverine hydrochloride (Dicyclomine hydrochloride) tab- Domperidone tab (as base/maleate), susp (as base/maleate)- Hyoscine butylbromide (Hyoscine-n-butylbromide) tab, syr, sterile sol- Metoclopramide tab, syr, sterile sol- Mebeverine hydrochloride tab
1.3 Ulcer-healing drugs and drugs used in variceal bleeding- Omeprazole EC cap (as base)- Ranitidine hydrochloride film coated tab- Omeprazole sodium sterile pwdr
- Ranitidine hydrochloride sterile sol- Pantoprazole sodium sterile pwdr
- Sucralfate tab, susp
- Somatostatin acetae sterile pwdr
- Lauromacrogol 400 (Polidocanol) sterile sol- Ranitidine bismuth citrate tab
1.4 Drugs used in acute diarrhoea- Oral rehydration salts (ORS)- oral pwdr, oral pwdr (hosp)- Zinc sulfate oral sol (hosp)- Loperamide hydrochloride cap, tab
1.5 Drugs used in chronic bowel disorders- Sulfasalazine tab, EC tab- Mesalazine (Mesalamine) EC tab , rectal supp
1.6 Laxatives- Bisacodyl EC tab, rectal supp
- Castor oil- Glycerol rectal supp
- Senna tab- Magnesium hydroxide susp, susp (hosp)- Magnesium sulfate mixt, mixt (hosp), sol, sol (hosp)- Sodium phosphates enema- Lactulose syr- Macrogols with electrolytes (Polyethylene glycol, PEG) oral pwdr (hosp)- Sodium phosphate oral sol-181-

1.7 Local preparations for anal and rectal disorders- Local anesthetic + Corticosteroid with/without astringent cream, oint, rectal supp
1.8 Drugs affecting intestinal secretions- Colestyramine (Cholestyramine) oral pwdr
- Ursodeoxycholic acid (Ursodiol) cap- Pancreatic enzymes cap, tab , EC cap , EC tab
2. Cardiovascular system
2.1 Positive inotropic drugs- Digoxin tab, elixir, sterile sol- Milrinone lactate sterile sol
2.2 Diuretics- Furosemide tab, sterile sol- Hydrochlorothiazide (HCTZ) tab- Mannitol sterile sol- Spironolactone tab- Amiloride hydrochloride + Hydrochlorothiazide (HCTZ) tab ( only 5 + 50 mg)
2.3 Anti-arrhythmic drugs- Adenosine sterile sol- Atropine sulfate sterile sol- Lidocaine hydrochloride (preservative free) sterile sol (hosp)- Magnesium sulfate sterile sol- Verapamil sterile sol- Amiodarone hydrochloride tab, sterile sol- Flecainide acetate tab- Propafenone hydrochloride tab
2.4 Beta-adrenoceptor blocking drugs- Atenolol tab- Metoprolol tartrate immediate release tab- Propranolol hydrochloride tab- Carvedilol tab
2.5 Drugs affecting the renin-angiotensin system and some other antihypertensive drugs
2.5.1 Vasodilator antihypertensive drugs- Hydralazine hydrochloride tab, sterile pwdr
- Sodium nitroprusside sterile pwdr
2.5.2 Centrally acting antihypertensive drugs- Methyldopa tab
2.5.3 Alpha-adrenoceptor blocking drugs- Prazosin hydrochloridetab- Doxazosin mesilate immediate release tab
2.5.4 Angiotensin-converting enzyme inhibitors- Enalapril maleate tab- Captopril tab
2.5.5 Angiotensin-II receptor antagonists- Losartan potassium tab (only 50, 100 mg)
2.6 Nitrates, calcium-channel blockers and other vasodilators
2.6.1 Nitrates- Glyceryl trinitrate sterile sol- Isosorbide dinitrate tab, sublingual tab- Isosorbide mononitrate tab
2.6.2 Calcium-channel blockers- Amlodipine besilate tab- Diltiazem hydrochloride slow release cap/tab ( only 120 mg) (not include controlled release)-182-

- Verapamil hydrochloride tab, SR tab ( only 240 mg)- Diltiazem hydrochloride immediate release tab- Nimodipine tab, sterile sol
2.6.3 Other vasodilators- Beraprost sodium tab
2.7 Sympathomimetics
2.7.1 Inotropic sympathomimetics- Dopamine hydrochloride sterile sol- Isoprenaline hydrochloride (Isoproterenol hydrochloride) sterile sol- Dobutamine hydrochloride sterile sol
2.7.2 Vasoconstrictor sympathomimetics- Norepinephrine (Noradrenaline) sterile sol (as bitartrate or hydrochloride)- Ephedrine hydrochloride sterile sol
2.7.3 Drugs used in cardiopulmonary resuscitation- Epinephrine (Adrenaline) sterile sol
2.8 Anticoagulants- Warfarin sodium tab- Heparin sodium sterile sol- Enoxaparin sodium sterile sol
2.9 Antiplatelet drugs- Aspirin (Acetylsalicylic acid) tab ( 75-325 mg), EC tab (75-325 mg)- Ticlopidine hydrochloride tab- Clopidogrel bisulfate tab- Dipyridamole sterile sol- Eptifibatide sterile sol
2.10 Fibrinolytic drugs- Streptokinase sterile pwdr
- Alteplase (Recombinant tissue - type plasminogen activator)sterile pwdr
2.11 Haemostatics- Human thrombin + Calcium chloride + Fibrinogen +Tranexamic acid sterile sol- Factor VIII concentrate, dried sterile preparation for intravenous use- Factor IX concentrate, dried sterile preparation for intravenous use- Factor IX complex (coagulation factors II, VII, IX, X) concentrate, dried sterile preparation for
intravenous use
2.12 Lipid-regulating drugs- Gemfibrozil cap (only 300, 600 mg), tab ( only 600 mg)- Nicotinic acid immediate release tab- Simvastatin tab (only 10, 20 & 40 mg)- Colestyramine (Cholestyramine) oral pwdr
- Fenofibrate cap (100, 160, 200, 300 mg)
3. Respiratory system
3.1 Bronchodilators
3.1.1 Adrenoceptor agonists- Procaterol hydrochloride syr- Salbutamol sulfate tab, syr, DPI, MDI, sol for nebulizer- Terbutaline sulfate tab, syr, sterile sol- Terbutaline sulfate DPI, MDI, sol for nebulizer- Procaterol hydrochloride tab
3.1.2 Compound antimuscarinic bronchodilators- Ipratropium bromide + Fenoterol hydrobromide MDI, sol for nebulizer
3.1.3 Theophylline- Aminophylline tab, sterile sol- Theophylline SR cap , SR tab- Theophylline + Glyceryl guaiacolate syr (50+30 mg in 5 ml)-183-

3.2 Corticosteroids- Beclometasone dipropionate DPI, MDI- Budesonide DPI, MDI, susp for nebulizer- Fluticasone susp for nebulizer- Fluticasone MDI- Budesonide + Formoterol DPI- Fluticasone + Salmeterol DPI, MDI
3.3 Leukotriene receptor antagonists- Montelukast sodium chewable tab ( 4 & 5 mg ), film coated tab ( 10 mg )3.4 Antihistamines- Brompheniramine maleate tab, syr- Chlorpheniramine maleate (Chlorphenamine maleate) cap, tab, syr, sterile sol- Diphenhydramine hydrochloride cap, sterile sol- Hydroxyzine hydrochloride tab, syr- Cetirizine hydrochloride tab, syr- Loratadine tab, syr
3.5 Pulmonary surfactants- Phospholipids (type: Poractant alfa or Beractant) sterile intratracheal susp
3.6 Cough preparations
3.6.1 Cough suppressants- Dextromethorphan hydrobromide tab, syr- Opium and Glycyrrhiza Mixture Compound (Brown Mixture ; Mist. Tussis) mixt (hosp)- Squill and Ammonia Mixture mixt (hosp)- Codeine phosphate + Glyceryl guaiacolate tab/cap (only 10+100 mg)
3.6.2 Expectorant and demulcent cough preparations- Ammonium carbonate and senega mixture mixt (hosp)- Glyceryl guaiacolate tab, syr
3.7 Systemic nasal decongestants- Pseudoephedrine hydrochloride tab, syr
3.8 Other respiratory preparations- Aromatic Ammonia Spirit spirit ,spirit (hosp)
4. Central nervous system
4.1 Hypnotics and anxiolytics- Chloral hydrate oral sol (hosp)- Chlordiazepoxide cap,tab- Diazepam cap, tab, sterile sol- Lorazepam tab- Clonazepam tab- Dipotassium clorazepate cap, tab- Hydroxyzine hydrochloridetab, syr- Alprazolam tab
4.2 Drugs used in psychoses and related disorders
4.2.1 Antipsychotic drugs- Chlorpromazine hydrochloridetab, sterile sol- Fluphenazinetab (as hydrochloride), sterile sol (as decanoate)- Haloperidoltab (as base), oral sol (as base), sterile sol (as base or decanoate)- Perphenazine tab- Trifluoperazine hydrochloridetab- Thioridazine hydrochloride tab- Clozapine tab- Pimozide tab- Risperidone tab-184-

- Flupentixol (Flupenthixol) tab (as hydrochloride), sterile sol (as decanoate)- Risperidone oral sol, oral sol/syr (hosp)- Zuclopenthixol tab (as hydrochloride), sterile sol/sterile emulsion (as acetate or decanoate)
4.2.2 Antimanic drugs- Carbamazepinetab- Lithium carbonate cap, tab- Sodium valproate EC tab, oral sol- Carbamazepin SR tab- Sodium valproate SR tab- Lamotrigine tab ( only 25, 50, 100 mg)
4.3 Antidepressant drugs- Amitriptyline hydrochloride film coated tab- Fluoxetine hydrochloride cap, tab- Imipramine hydrochloride tab- Nortriptyline hydrochloride tab- Mianserin hydrochloride tab- Clomipramine hydrochloride tab- Sertraline tab(50 mg)- Trazodone hydrochloride tab
4.4 Central nervous system stimulants- Methylphenidate tab (10 mg)
4.5 Drugs used in nausea and vertigo
4.5.1 Drugs used in nausea and vomiting- Domperidonetab (as base/maleate), susp (as base/maleate)- Metoclopramide tab, syr, sterile sol- Ondansetron tab (as base or hydrochloride), sterile sol (as hydrochloride)4.5.2 Drugs used in vestibular disorders- Dimenhydrinate compressed tab, film coated tab, syr, sterile sol- Betahistine mesilate (Betahistine mesylate) tab (only 6, 12 mg)
4.6 Analgesics and antipyretics- Paracetamol (Acetaminophen) tab, syr- Aspirin (Acetylsalicylic acid) compressed tab, film coated tab (only 300 mg up)- Ibuprofen film coated tab, susp
4.7 Analgesics
4.7.1 Opioid analgesics- Buprenorphine hydrochloride sublingual tab, sterile sol- Codeine phosphate tab- Fentanyl sterile sol (as citrate), transdermal therapeutic system (as base)- Methadone hydrochloride tab, oral sol- Morphine sulfate cap, tab, SR cap, SR tab, sterile sol- Nalbuphine hydrochloride sterile sol- Pethidine hydrochloride sterile sol- Tramadol hydrochloride cap, tab, SR cap, SR tab, sterile sol
4.7.2 Drugs for neuropathic pain
- Amitriptyline hydrochloride film coated tab- Carbamazepine tab- Nortriptyline hydrochloride tab- Carbamazepine SR tab- Gabapentin cap (only100, 300, 400 mg), tab (only600 mg)
4.7.3 Antimigraine drugs
4.7.3.1 Drugs for acute migraine attack- Paracetamol (Acetaminophen) tab- Aspirin (Acetylsalicylic acid) compressed tab, film coated tab (only300 mg up)- Ibuprofen film coated tab- Ergotamine tartrate + Caffeine compressed tab, film coated tab (only 1 + 100 mg)
4.7.3.2 Drugs used in the prophylaxis of migraine-185-

- Amitriptyline hydrochloride film coated tab- Propranolol hydrochloride tab- Cyproheptadine hydrochloride tab- Metoprolol tartrate immediate release tab- Pizotifen malate tab- Sodium valproateEC tab, SR tab- Topiramate tab
4.8 Antiepileptics
4.8.1 Drugs used in the control of epilepsy- Carbamazepine tab, syr, susp
- Magnesium sulfate sterile sol- Phenobarbital tab (as base or sodium)- Phenytoin (as base) chewable tab- Phenytoin sodium cap, SR cap- Sodium valproate EC tab, oral sol- Carbamazepine SR tab- Clonazepam tab- Sodium valproate SR tab- Lamotrigine tab (only 25, 50, 100 mg)- Levetiracetam tab (only 250 & 500 mg)- Nitrazepam tab- Topiramate cap, tab- Vigabatrin tab
4.8.2 Drugs used in status epilepticus- Diazepam sterile sol- Phenobarbital sodium (Phenobarbitone sodium) sterile pwdr
- Phenytoin sodium sterile sol- Sodium valproate sterile pwdr
- Midazolam hydrochloride sterile sol
4.9 Drugs used in movement disorders- Atenolol tab- Diazepam cap,tab- Levodopa + Benserazide as hydrochloride (Co-beneldopa) cap/tab (200+50 mg)- Levodopa + Carbidopa as monohydrate (Co-careldopa) tab (100+25 mg, 250+25 mg)- Propranolol hydrochloride tab- Trihexyphenidyl hydrochloride tab- Baclofen tab- Clonazepam tab- Levodopa + Benserazide as hydrochloride (Co-beneldopa) CR cap/dispersible tab (100+25
mg)- Bromocriptine mesilate tab- Entacapone tab- Piribedil SR tab(only 50 mg)- Botulinum A toxin sterile pwdr (only 100 & 500 IU)
4.10 Drugs used in substance dependence- Clonidine hydrochloride tab- Methadone hydrochloride oral sol
5. Infections
5.1 Antibacterial drugs
5.1.1 Penicillins- Phenoxymethylpenicillin potassium (Penicillin V) cap, tab, dry syr- Benzylpenicillin (Penicillin G) sterile pwdr (as sodium or potassium)- Benzathine benzylpenicillin (Penicillin G benzathine) sterile pwdr
- Procaine benzylpenicillin (Penicillin G procaine) sterile sol, sterile susp
- Dicloxacillin sodium cap, dry syr- Cloxacillin sodium sterile pwdr
- Amoxicillin trihydrate cap, dry syr-186-

- Ampicillin sodium sterile pwdr
- Amoxicillin trihydrate + Potassium clavulanate (Co-amoxiclav) tab (only 250/125, 500/125
mg)- Amoxicillin trihydrate + Potassium clavulanate (Co-amoxiclav) tab (only 500/125, 875/125mg), dry syr (only 200/28.5, 400/57 mg)- Amoxicillin sodium + Potassium clavulanate (Co-amoxiclav) sterile pwdr
- Ampicillin sodium + Sulbactam sodium sterile pwdr
- Piperacillin sodium + Tazobactam sodium sterile pwdr
5.1.2 Cephalosporins, cephamycins and other beta-lactams- Cefalexin (Cephalexin) cap, dry syr- Cefazolin sodium sterile pwdr
- Cefuroxime axetil tab, dry syr- Cefotaxime sodium sterile pwdr
- Ceftriaxone sodium sterile pwdr
- Ceftazidime sterile pwdr
- Cefixime cap, dry syr- Cefoperazone sodium + Sulbactam sodium sterile pwdr
- Cefoxitin sodium sterile pwdr
- Imipenem + Cilastatin sodium sterile pwdr
- Meropenem sterile pwdr
5.1.3 Tetracyclines- Doxycycline hyclate (Doxycycline hydrochloride) cap, tab- Tetracycline hydrochloride cap, tab
5.1.4 Aminoglycosides- streptomycin sulfate, amikacin sulfate & kanamycin sulfate>Antituberculous drugs- Neomycin sulfate tab- Gentamicin sulfate sterile sol- Amikacin sulfatensterile sol- Netilmicin sulfate sterile sol
5.1.5 Macrolides- Erythromycin estolate susp /dry syr- Erythromycin stearate or succinate dry syr- Roxithromycin cap / tab (only 100 & 150 mg)- Azithromycincap (not include sustain release) , dry syrup (not include sustain release)- Clarithromycin tab, dry syr
5.1.6 Quinolones- Norfloxacin tab- Ofloxacin tab- Ciprofloxacin hydrochloride tab- Ciprofloxacin lactate sterile sol- Levofloxacin hemihydrate sterile sol- Levofloxacin hemihydrate tab (only 500 mg)
5.1.7 Some other antibacterials- Chloramphenicol sodium succinate sterile pwdr
- Metronidazole cap/tab (as base), susp (as benzoate), sterile sol (as base)- Clindamycin cap (as hydrochloride), sterile sol (as phosphate)- Lincomycin hydrochloride sterile sol- Nitrofurantoin tab- Colistimethate Sodium (Sodium colistinmethanesulphonate) sterile pwdr
- Fosfomycin sodium sterile pwdr
- Sodium fusidate tab- Vancomycin hydrochloride sterile pwdr
5.1.8 Sulphonamides and trimethoprim- Sulfadiazine tab- Sulfamethoxazole + Trimethoprim (Co-trimoxazole) cap, tab, susp, sterile sol- Trimethoprim tab
5.1.9 Antituberculous drugs- Ethambutol hydrochloridefilm coated tab- Isoniazid tab- Pyrazinamide tab- Rifampicin cap, tab, dry syr, syr, susp
-187-

- Streptomycin sulfate sterile pwdr
- Isoniazid + Rifampicin cap/tab (only 100+150 mg & 150+300 mg)- Isoniazid + Rifampicin + Pyrazinamide tab (only 75 + 150 + 400 mg)- Isoniazid + Rifampicin + Pyrazinamide + Ethambutol hydrochloride tab (only 75 + 150 + 400+ 275 mg)
- Amikacin sulfate sterile sol- Cycloserine cap- Ethionamide tab- Para-aminosalicylic acid (PAS) EC tab- Kanamycin sulfate sterile pwdr
- Ofloxacin tab
5.1.10 Antileprotic drugs- Clofazimine cap- Dapsone tab
5.2 Antifungal drugs- Fluconazole cap- Griseofulvin tab- Ketoconazole tab- Nystatin oral susp
- Saturated solution of potassium iodide (SSKI) sol (hosp)- Itraconazole cap- Amphotericin B sterile pwdr (only conventional formulations)- Fluconazole sterile sol- Itraconazole oral sol- Liposomal amphotericin B sterile pwdr
5.3 Antiviral drugs
5.3.1 Non-antiretrovirals- Aciclovir (Acyclovir) tab- Aciclovir sodium (Acyclovir sodium) sterile pwdr, sterile sol- Ganciclovir sodium sterile pwdr
- Lamivudine (3TC) tab (only 100, 150 mg)- Oseltamivir phosphate cap, dry syr
5.3.2 Antiretrovirals- Atazanavir sulfate cap- Didanosine (ddI) tab, oral pwdr
- Efavirenz cap, tab- Indinavir sulfate cap- Lamivudine (3TC) tab (only 100, 150 mg), syr- Lamivudine + Stavudine + Nevirapine tab (only 150+30+200 mg & 150+40+200 mg)- Lopinavir + Ritonavir cap, oral sol- Nelfinavir mesilate tab, dry syr- Nevirapine tab, susp
- Ritonavir cap, oral sol- Saquinavir cap (as base or mesilate)- Stavudine (d4T) cap, dry syr- Tenofovir disoproxil fumarate tab- Zidovudine (AZT) cap, oral sol- Zidovudine + Lamivudine (AZT+3TC)tab (only 300+150 mg)- Zidovudine + Lamivudine + Nevirapine tab (only 250 + 150 +200 mg)
5.4 Antiprotozoal drugs
5.4.1 Antimalarials- Chloroquine phosphate tab- Primaquine phosphate tab- Quinine compressed/film coated tab (as sulfate), sterile sol (as dihydrochloride)- Artesunate tab (not include lactab & rectocap), sterile pwdr
- Mefloquine hydrochloride tab
5.4.2 Other antiprotozoal drugs- Metronidazole cap/ tab (as base), susp (as benzoate), sterile sol (as base)-188-

- Pyrimethamine tab- Pentamidine isetionate (Pentamidine isethionate) sterile pwdr
5.5 Anthelmintics- Albendazole tab, susp
- Diethylcarbamazine citrate tab- Mebendazole tab, susp, susp (hosp)- Niclosamide tab- Praziquantel tab- Pyrantel embonate (Pyrantel pamoate) tab, susp
- Ivermectin tab
5.6 Antiseptics- Chlorhexidine gluconate sol (aqueous), sol (only 2% , 4% & 5%) , sol/sol (hosp)(only 2% , 4%
in 70% alcohol)- Ethyl alcohol sol, sol (hosp), gel (hosp)- Gentian violet sol (paint)- Hydrogen peroxide sol- Potassium permanganate pwdr (hosp)- Povidone-iodine sol, sol (hosp)- Tincture of iodine (Iodine in alcohol) sol, sol (hosp)
6. Endocrine system
6.1 Drugs used in diabetes
6.1.1 Insulins- Biphasic isophane insulin (Soluble insulin + Isophane insulin) sterile susp
- Isophane insulin (NPH; Isophane protamine insulin) sterile susp
- Soluble insulin (Neutral insulin; insulin injection) sterile sol- Insulin aspart sterile sol- Biphasic insulin lispro (Insulin lispro + Insulin lispro protamine) sterile susp
6.1.2 Oral antidiabetic drugs- Glibenclamide tab (only 2.5, 5 mg)- Gliclazide tab (only 80 mg)- Glipizide tab- Metformin hydrochloride tab- Acarbose tab- Pioglitazone hydrochloride tab (only 15, 30 mg)- Repaglinide tab (only 0.5, 1, 2 mg)
6.1.3 Treatment of hypoglycemia- Diazoxide tab
6.2 Thyroid and antithyroid drugs
6.2.1 Thyroid hormones- Levothyroxine sodium (L-thyroxine sodium) tab- Liothyronine sodium tab
6.2.2 Antithyroid drugs- Lugol 's solution (Aqueous iodine oral solution, Strong iodine solution) oral sol (hosp)- Propylthiouracil tab- Saturated solution of potassium iodide (SSKI) oral sol (hosp)- Thiamazole (Methimazole) tab
6.3 Corticosteroids- Dexamethasone cap/tab (as base), sterile sol (as sodium phosphate or acetate)- Hydrocortisone tab (as base) , sterile pwdr (as sodium succinate), sterile susp (as acetate)- Prednisolone cap, tab- Fludrocortisone acetate tab- Methylprednisolone sterile pwdr/sterile susp (as hemisuccinate or sodium succinate or acetate)
6.4 Sex hormones
6.4.1 Female sex hormones Medroxyprogesterone acetate tab (only 2.5 , 5 & 10 mg)- Norethisterone tab- Conjugated estrogens tab-189-

- Estradiol valerate tab- Hydroxyprogesterone caproate sterile oily sol for inj- Conjugated estrogens sterile pwdr
6.4.2 Male sex hormones and antagonists- Testosterone enantate (Testosterone enanthate) sterile oily sol for inj- Cyproterone acetate tab
6.5 Hypothalamic and pituitary hormones
6.5.1 Hypothalamic and anterior pituitary hormones- Chrorionic gonadotrophin (Human Chorionic Gonadotrophin ; HCG) sterile pwdr
- Tetracosactide (Cosyntropin)sterile pwdr
6.5.2 Posterior pituitary hormones and antagonists- Chlorpropamide tab- Desmopressin acetate (DDAVP) tab, nasal spray, nasal sol, sterile sol
6.6 Drugs affecting bone metabolism- Calcitonin-salmon sterile sol- Disodium pamidronate sterile pwdr ,sterile sol
6.7 Other endocrine drugs
6.7.1 Bromocriptine and other dopaminergic drugs- Bromocriptine mesilate tab
6.7.2 Drugs affecting gonadotrophins- Leuprorelin acetate sterile pwdr (only 3.75 mg)
7. Obstetrics, gynaecology and urinary-tract disorders
7.1 Drugs used in obstetrics
7.1.1 Prostaglandins, prostaglandins antagonists and oxytocics- Methylergometrine maleate sterile sol- Oxytocin sterile sol- Alprostadil sterile sol (only 0.5 mg/ml)- Indomethacin sodium sterile pwdr
- Sulprostone sterile pwdr
7.1.2 Myometrial relaxants- Salbutamol sulfate tab- Terbutaline sulfate tab, sterile sol
7.2 Treatment of vaginal and vulval conditions- Clotrimazole vaginal tab- Nystatin vaginal tab- Conjugated estrogens vaginal cream
7.3 Contraceptives- Ethinylestradiol + Levonorgestrel tab (only 30 + 150 mcg)
- Levonorgestrel tab (only 750 mcg)
- Medroxyprogesterone acetate sterile susp
- Ethinylestradiol + Desogestrel tab (only 20 + 150 mcg)
- Ethinylestradiol + Gestodene tab (only 20 + 75 mcg)
- Lynestrenol tab (only 0.5 mg)
7.4 Drugs for genito-urinary disorders
7.4.1 Drugs for benign prostatic hyperplasia- Alfuzosin hydrochloride SR tab (only 10 mg)- Doxazosin mesilate immediate release tab (only 2 & 4 mg)- Finasteride tab (only 5 mg)
7.4.2 Drugs for urinary frequency, enuresis, and incontinence- Oxybutynin hydrochloride immediate release tab- Trospium chloride tab
7.4.3 Drugs used in alkalinisation of urine- Potassium citrate oral sol (hosp), dry pwdr for oral sol (hosp)- Sodium citrate + Citric acid (Shohl’s solution) oral sol (hosp)-190-

- Sodium citrate + Potassium citrate oral sol (hosp)
8. Malignant disease and immunosuppressant
8.1 Cytotoxic drugs
8.1.1 Alkylating drugs- Busulfan tab- Chlorambucil tab- Cyclophosphamide tab, sterile pwdr
- Melphalan tab- Ifosfamide sterile pwdr
8.1.2 Cytotoxic antibiotics- Bleomycin sterile pwdr (as sulfate or as hydrochloride)- Dactinomycin sterile pwdr
- Doxorubicin hydrochloride sterile pwdr,sterile susp ,sterile sol- Idarubicin hydrochloride sterile pwdr
- Mitomycin sterile pwdr , sterile sol- Mitoxantrone hydrochloride sterile pwdr, sterile sol
8.1.3 Antimetabolites- Cytarabine sterile pwdr, sterile sol- Fluorouracil sterile sol- Mercaptopurine tab- Methotrexate tab (as base or sodium), sterile pwdr / sterile sol (as sodium)- Capecitabine tab- Gemcitabine hydrochloride sterile pwdr
- Tioguanine (Thioguanine) tab
8.1.4 Vinca alkaloids and etoposide- Etoposide cap (as base), sterile sol (as base)- Vinblastine sulfate sterile pwdr, sterile sol- Vincristine sulfate sterile pwdr, sterile sol
8.1.5 Other antineoplastic drugs- Asparaginase (Crisantapase) sterile pwdr
- Cisplatin sterile pwdr, sterile sol- Carboplatin sterile pwdr, sterile sol- Hydroxycarbamide (Hydroxyurea) cap- Paclitaxel sterile sol- Docetaxel sterile sol- Imatinib mesilate tab (only 100 & 400 mg)
8.2 Drugs affecting the immune response- Dexamethasone cap (as base) , tab (as base), sterile sol (as sodium phosphate or acetate)- Prednisolone cap, tab- Azathioprine tab- Ciclosporin (Cyclosporin) cap, oral sol, oral susp, sterile sol- Methylprednisolone sterile pwdr/sterile susp (as hemisuccinate or sodium succinate or acetate)- Antithymocyte immunoglobulin, rabbit (ATG) sterile pwdr , sterile sol- Basiliximab sterile pwdr
- Mycophenolate mofetil cap- Tacrolimus cap, sterile sol (concentrate for infusion)- BCG freeze-dried pwdr for bladder instillation- Human normal immunoglobulin, intravenous (IVIG) sterile pwdr, sterile sol- Sirolimus (Rapamycin) oral sol (only 1 mg/ml), tab (only 1 mg)
8.3 Sex hormones and hormone antagonists in malignant disease
8.3.1 Progestogens, anti-estrogens and enzyme inhibitors- Tamoxifen citrate tab- Letrozole tab (only 2.5 mg)- Megestrol acetate tab
8.3.2 Prostate cancer- Flutamide tab-191-

9. Nutrition and blood
9.1 Whole blood, blood products and drugs used in some blood disorders
9.1.1 Whole blood and blood products- Fresh dried plasma- Fresh frozen plasma- Frozen cryoprecipitate- Leukocyte depleted platelets concentrate- Leukocyte depleted pooled platelets concentrate, random donor (LD-PPC) Lyophilized
cryoprecipitate- Packed red cell
- Packed red cell, leukocyte depleted- Packed red cell, leukocyte poor
- Platelets concentrate, random donor- Platelets concentrate, single donor- Whole blood- Leukocyte depleted platelets concentrate, single donor- Packed red cell, leukocyte depleted single donor 2 units- Packed red cell, irradiated- Packed red cell, leukocyte poor, irradiated- Platelets concentrate, irradiated- Packed red cell, leukocyte depleted, irradiated9.1.2 Drugs used in hypoplastic, haemolytic and renal anaemias- Folic acid tab (not less than 5 mg)- Oxymetholone tab- Deferoxamine mesilate (Desferrioxamine mesilate) sterile pwdr
- Iron sucrose sterile sol- Antithymocyte immunoglobulin, rabbit (ATG) sterile pwdr, sterile sol- Deferiprone tab (only 500 mg)- Epoetin alfa (epoetin alpha) sterile pwdr/ sterile sol (only 1000, 2000, 3000, 4000, 5000 IU)- Epoetin beta sterile sol (only 2000, 3000, 5000 IU)
9.1.3 Drugs used in bone marrow transplantation- Filgrastim sterile sol- Lenograstim sterile pwdr
9.2 Fluids and electrolytes- Dextran in normal saline with/without dextrose sterile sol- Glucose with/without sodium chloride sterile sol- Intermittent peritoneal dialysis sterile sol- Potassium acetate sterile sol (hosp)- Potassium chloride syr (hosp), sterile sol- Potassium citrate oral sol (hosp), dry pwdr for oral sol (hosp)- Sodium acetate sterile sol (hosp)- Sodium bicarbonate tab, sterile sol- Sodium chloride tab (only 300 mg), sterile sol- Sodium lactate intravenous infusion compound (Hartmann's solution for injection; Ringer Lactate solution for injection) sterile sol- Water for injection sterile sol- Calcium polystyrene sulfonate oral pwdr
- Continuous ambulatory peritoneal dialysis basic bag sol, double bag sol
9.3 Vitamins- Folic acid tab (only 400 mcg & 5 mg)- Multivitamins syr c- Multivitamins drop
- Multivitamins cap, tab- Vitamin A cap, tab (only 25,000-50,000 IU per 1 cap/tab)- Vitamin B1 tab (only 100 mg), sterile sol- Vitamin B12 (cyanocobalamin , hydroxocobalamin) tab (not less than 100 mcg), sterile sol(only 1 mg)- Vitamin B2 tab (not less than 10 mg)- Vitamin B6 (Pyridoxine hydrochloride) tab (not less than 50 mg), sterile sol-192-

- Vitamin C tab (only 50, 100 mg)- Vitamin D2 (Ergocalciferol) cap- Vitamin K1 (phytomenadione) sterile sol- Vitamin B complex cap, tab- Vitamin C sterile sol- Vitamin B complex sterile sol composition of Vitamin B1, B2, B6 & Niacinamide- Alfacalcidol (1 alpha-hydroxyvitamin D3) cap, tab- Vitamin E emulsion (hosp)
9.4 Intravenous nutrition- Amino acid solution for newborns sterile sol composition of isoleucine, leucine, lysine,
methionine, phenylalanine, threonine, tryptophan, valine, histidine & contain tyrosine, cysteine &arginine & No sugar alcohol- Amino acid solution : high branched chain amino acid sterile sol composition of i branchchain amino acid 35-45% ของ total amino acid
- Amino acid solution : high essential amino acid sterile sol composition of iessential aminoacid > 60% of total amino acid
- Amino acids with/without minerals sterile sol- Complete water-soluble and fat soluble vitamins preparation preparation for intravenous use(sterile pwdr, sterile sol, sterile emulsion)- Complete water-soluble and fat soluble vitamins preparation from formulation of Fat soluble
vitamins 4 types : A, D, E, K & water soluble vitamins 9 types : B1, B2, B6, B12, niacinamide,
folic acid , pantothenic acid , biotin , Vitamin C- Dextrose solution with minerals with electrolytes sterile sol- Fat emulsion sterile emulsion (only 10%, 20%)
- Fat emulsion composition of long chain triglycerides & phospholipids have/not have medium
chain triglycerides (MCT)- Multiple trace minerals solution , sterile sol
9.5 Minerals- Aluminium hydroxide tab, susp, susp (hosp)- Calcium carbonate cap, tab- Calcium gluconate sterile sol- Ferrous sulfate cap, tab, oral sol, drop
- Iodine cap- Magnesium hydroxide tab, susp, susp (hosp)- Magnesium sulfate sterile sol- Sodium fluoride tab, oral sol- Trace element solution oral sol (hosp)- Zinc sulfate oral sol (hosp)- Ferrous fumarate cap, tab, oral sol, susp
- Copper sulfate solution sterile sol (hosp)- Dipotassium hydrogen phosphate sterile sol- Oral acidic phosphate solution (Joulie’s solution), Oral sol (hosp) composition of Potassium
phosphate and/or Sodium phosphatemonobasic/dibasic- Oral neutral phosphate solution oral sol (hosp) composition of Potassium phosphate and/or
Sodium phosphate monobasic/dibasic- Zinc sulfate cap, tab, sterile sol (hosp)
9.6 Vitamin and Minerals for pregnancy- Ferrous fumarate tab (only 65 mg as iron)- Ferrous sulfate tab (only 60 & 65 mg as iron)- Folic acid tab (only 400 mcg)
- Potassium iodide tab (only 150 mcg as iodine)- Ferrous salt + Folic acid tab (only 60 mg as iron + 400 mcg)
- Ferrous salt + Folic acid + Potassium iodide tab (only 60 mg as iron + 400 mcg + 150 mcg as
iodine)-193-

10. Musculoskeletal and joint diseases
10.1 Drugs used in rheumatic diseases and gout
10.1.1 Non-steroidal anti-inflammatory drugs- Aspirin (Acetylsalicylic acid) tab, EC tab- Diclofenac sodium EC tab, sterile sol- Ibuprofen film coated tab, susp
- Indomethacin cap- Naproxen compressed tab (as base)- Piroxicam cap (as base), compressed tab (as base), film coated tab (as base)
10.1.2 Disease-modifying antirheumatic drugs (DMARDs)- Chloroquine phosphate compressed tab, film coated tab- Hydroxychloroquine sulfate tab- Azathioprine tab- Methotrexate tab (as base or sodium), sterile pwdr/sterile sol (as sodium)- Penicillamine (D-Penicillamine) cap- Sulfasalazine EC tab- Sodium aurothiomalate sterile sol- Ciclosporin (Cyclosporin) cap, oral sol, sterile sol
10.1.3 Drugs for treatment of gout and hyperuricaemia- Colchicine tab- Allopurinol tab- Probenecid film coated tab- Benzbromarone tab
10.2 Drugs used in neuromuscular disorders
10.2.1 Drugs which enhance neuromuscular transmission- Pyridostigmine bromide tab- Neostigmine methylsulfate sterile sol
10.2.2 Skeletal muscle relaxants- Diazepam cap, tab, sterile sol- Baclofen tab- Tizanidine hydrochloride tab
10.3 Drugs for relief of soft-tissue inflammation
10.3.1 Rubifacients- Methyl salicylate cream compound cream (hosp)- Methyl salicylate ointment compound (Analgesic Balm) oint (hosp)
11. Eye11.1 Anti-infective eye preparations
11.1.1 Antibacterials and eye wash solution- Boric acid eye wash sol- Chloramphenicol eye drop, eye oint
- Tetracycline hydrochloride eye oint
- Gentamicin sulfate eye drop, eye oint
- Polymyxin B sulfate + Neomycin sulfate + Gramicidin eye drop
- Fusidic acid eye drop (in gel base)
11.1.2 Antibacterials with corticosteroids- Dexamethasone sodium phosphate + Neomycin sulfate eye drop
- Dexamethasone sodium phosphate + Chloramphenicol + Tetrahydrozoline hydrochloride eyedrop- Dexamethasone + Neomycin sulfate + Polymyxin B sulfate eye oint
11.1.3 Antifungals- Natamycin eye susp
11.1.4 Antivirals- Aciclovir (Acyclovir) eye oint
11.2 Corticosteroids and other anti-inflammatory preparations- Antazoline hydrochloride + Tetrahydrozoline hydrochloride eye drop
- Fluorometholone eye susp (as base)-194-

- Prednisolone acetate eye susp
- Sodium cromoglycate (Cromolyn sodium) eye drop
11.3 Mydriatics and cycloplegics- Atropine sulfate eye drop
- Cyclopentolate hydrochloride eye drop
- Phenylephrine hydrochloride eye drop
- Tropicamide eye drop
11.4 Drugs for treatment of glaucoma- Glycerol oral sol (hosp)- Acetazolamide tab- Pilocarpine eye drop (as hydrochloride or nitrate)- Timolol maleate eye drop
- Betaxolol hydrochloride eye susp, eye sol- Brimonidine tartrate eye drop
- Brinzolamide eye susp
- Bimatoprost eye drop
11.5 Local anaesthetics- Tetracaine hydrochloride eye drop
11.6 Tear deficiency, ocular lubricants and astringents- Hypromellose (with preservative) eye drop
- Carbomer (with preservative, with/without sorbitol) eye gel- White petrolatum + Mineral oil + Liquid lanolin anhydrous (preservative free) eye oint
- Hypromellose + Dextran 70 (preservative free) eye drop
- Acetylcysteine (N-acetylcysteine) eye drop
- Dried protein-free dialysate of calf blood eye gel
11.7 Ocular diagnostic and peri-operative preparations and photodynamic treatment- Balance salt sol for ocular irrigation, sol for intraocular irrigation- Carbachol sterile sol for intraocular use- Diclofenac sodium with preservative eye drop
- Fluorescein sodium sterile sol for inj- Sodium chondroitin sulfate + Sodium hyaluronate sterile sol for intraocular use- Sodium hyaluronate sterile sol for intraocular use- Verteporfin sterile pwdr for intravenous infusion
12. Ear, nose, or pharynx and oral cavity
12.1 Drugs acting on the ear
12.1.1 Otitis externa & otitis media- Chloramphenicol ear drop
- Dexamethasone + Framycetin sulfate + Gramicidin ear drop/ear oint (only 0.5 mg+5 mg+0.05
mg in 1 ml or 1 g)
- Hydrocortisone + Neomycin sulfate + Polymyxin B sulfate ear drop (only 10 mg + 3400 U +10000 U in 1 ml)
12.1.2 Drug used in otomycosis- Acetic acid ear drop (hosp) (only 2% in aqueous & 2% in 70% isopropyl alcohol)- Boric acid ear drop (hosp) (only 3% in isopropyl alcohol)- Gentian violet sol (hosp)- Clotrimazole ear drop
12.1.3 Other drugs acting on the ear- Ofloxacin ear drop
- Sodium bicarbonate ear drop (hosp)
12.2 Drugs acting on the nose
12.2.1 Drugs used in nasal allergy- Beclometasone dipropionate nasal spray- Budesonide nasal spray- Fluticasone propionate nasal spray-195-

- Triamcinolone acetonide nasal spray
12.2.2 Topical nasal decongestants- Ephedrine hydrochloride nasal drop (hosp) (only 0.5-3%)- Sodium chloride sterile sol (for irrigation) (only 0.9%)- Oxymetazoline hydrochloride nasal drop, nasal spray
12.3 Drugs acting on the oropharynx and oral cavity
12.3.1 Drugs used in treatment of oral ulcer- Borax (in glycerin) sol, sol (hosp)- Chlorhexidine gluconate mouthwash sol (only 0.1-0.2% w/v)
- Fluocinolone acetonide oral cream (hosp), oral gel (hosp), sol (hosp)- Talbot's solution sol (hosp)- Iodine Paint, compound sol (hosp)- Iodofrom (in ether) sol (hosp)
12.3.2 Oropharyngeal antifungal drugs- Clotrimazole lozenge- Miconazole nitrate oral gel- Nystatin oral susp
12.3.3 Antiseptics for root canal treatment- Camphorated parachlorophenol sol (hosp)- Camphorated phenol sol (hosp)- Chlorhexidine gluconate sol (hosp) (only 2% )- Clove oil- EDTA sol (hosp) (only 14% or 17% )- Formocresol (Cresolated formaldehyde, Formaldehyde and Cresol solution) sol (hosp)- Sodium hypochlorite sol (hosp)
12.3.4 Drugs used in prevention and treatment of dental plaque and caries- Chlorhexidine gluconate mouthwash sol (only 0.1-0.2%w/v)- Sodium fluoride tab, oral sol
12.3.5 Other dental preparations- Epinephrine (Adrenaline) sterile sol- Artificial saliva (Saliva substitutes) sol (hosp)- Hydrogen peroxidemouthwash sol (1.5% w/v )- Sodium chloride sterile sol- Special mouthwash mouthwash sol (hosp)- Tincture of iodine (lodine in alcohol) sol, sol (hosp)- Zinc oxide pwdr (hosp)- Zinc oxide with zinc acetate pwdr (hosp)- Carnoy's solution sol (hosp)- White head varnish varnish (hosp)
13. Skin13.1 Anti-infective skin preparations
13.1.1 Antibacterial preparations- Sulfadiazine silver (Silver sulfadiazine) cream- Fusidic acid cream- Sodium fusidate oint
- Mupirocin oint
13.1.2 Antifungal preparations- Benzoic acid + Salicylic acid (Whitfield’s ointment) oint, oint (hosp)- Sodium thiosulfate sol, sol (hosp)- Clotrimazole cream- Ketoconazole cream
13.1.3 Parasiticidal preparations- Benzyl benzoate emulsion/lotion (only 25%)
- Sulfur (Sulphur) oint
- Lindane (Gamma benzene hexachloride) cream
13.2 Emollient and barrier preparations- Aluminium acetate (Aluminium subacetate)sol (hosp)- Mineral oil (hosp)-196-- Olive oil- Urea cream (hosp), oint (hosp)- White petrolatum oint (hosp)- Zinc oxide oint (hosp), paste (hosp)- Zinc sulfate lotion (hosp)
13.3 Topical antipruritics- Calamine lotion, lotion (hosp)- Menthol + Phenol + Camphor topical dosage form (hosp)
13.4 Topical corticosteroids- Hydrocortisone acetate cream- Prednisolone cream- Betamethasone dipropionate cream, oint
- Betamethasone valerate cream- Triamcinolone acetonide cream, lotion- Clobetasol propionate cream- Betamethasone valerate lotion, sol- Desoximetasone (Desoxymethasone) cream- Betamethasone dipropionate + Salicylic acid oint (only 0.05% + 3%)- Clobetasol propionate oint
- Clobetasol propionate lotion- Mometasone furoate cream
13.5 Other preparations for psoriasis (excluding topical corticosteroids)- Coal tar topical dosage form (hosp)- Salicylic acid lotion (hosp)- Dithranol (Anthralin) paste (hosp)- Methotrexate tab (as base or sodium)- Methoxsalen tab, topical sol (paint)- Calcipotriol oint
- Acitretin cap- Ciclosporin (Cyclosporin) cap, oral sol
13.6 Preparations for warts and calluses- Podophyllin (Podophyllum resin) paint, paint (hosp)- Salicylic acidoint (hosp), paste (hosp)- Silver nitrate sol (hosp), crystal (hosp),stick (hosp)- Trichloroacetic acid sol (hosp)- Salicylic acid + Lactic acid colloidal sol
14. Immunological products and vaccines- Anti-D immunoglobulin, human inj- BCG vaccine (Bacillus Calmette-Gu`rin) inj- Diphtheria antitoxin (DAT) inj- Diphtheria-Tetanus vaccine , DT(children type) & DT (adult type) inj- Diphtheria-Tetanus-Pertussis vaccine (whole cell) (DTPw) inj- Diphtheria-Tetanus-Pertussis-Hepatitis B vaccine (DTP-HB) inj- Hepatitis B vaccine (HB) inj- Influenza vaccine (trivalent) strain conform to WHO formulation inj- Influenza vaccine pandemic strain influenza strain conform to WHO formulation inj- Japanese encephalitis vaccine (JE) inj- Measles-Mumps-Rubella vaccine (MMR) inj- Measles vaccine inj- Poliomyelitis vaccine, live attenuated (OPV) oral sol, oral susp
- Rabies immunoglobulin, horse (ERIG) inj- Rabies vaccines except for human diploid cell vaccine (HDCV) inj- Rubella vaccine inj- Tetanus antitoxin, horse inj- Tetanus vaccine (Tetanus toxoid) inj- Rabies immunoglobulin, human (HRIG) inj-197-

- Tetanus antitoxin, human (Anti-tetanus immunoglobulin, human) inj- Hepatitis B immunoglobulin, human (HBIG) inj
15. Anaesthesia
15.1 General anaesthesia
15.1.1 Intravenous anaesthetics- Propofol sterile emulsion- Thiopental sodium (Thiopentone sodium) sterile pwdr
- Ketamine hydrochloride sterile sol
15.1.2 Inhalational anaesthetics- Halothane volatile liquid- Isoflurane volatile liquid- Sevoflurane volatile liquid
15.1.3 Muscle relaxants (Neuromuscular blocking drugs)- Atracurium besilate sterile sol- Cisatracurium besilate sterile sol- Pancuronium bromide sterile sol- Rocuronium bromide sterile sol- Suxamethonium chloride (Succinylcholine chloride)sterile pwdr, sterile sol- Vecuronium bromide sterile pwdr
15.1.4 Sedative and analgesic peri-operative drugs- Diazepam cap, tab, sterile sol- Fentanyl citrate sterile sol- Morphine sulfate sterile sol- Pethidine hydrochloride sterile sol- Midazolam hydrochloride sterile sol- Midazolam maleate tab
15.1.5 Anticholinesterases and antimuscarinic drugs used in anaesthesia- Atropine sulfate sterile sol- Neostigmine methylsulfate sterile sol
15.2 Local anaesthesia- Benzocaine gel, oint
- Lidocaine + Prilocaine cream- Lidocaine hydrochloride gel, oint, spray, sterile sol (dental cartridge), sterile sol (local
infiltration), viscous sol- Lidocaine hydrochloride + Epinephrine sterile sol (local infiltration), sterile sol (dental
cartridge)- Mepivaciane hydrochloride sterile sol (dental cartridge)- Mepivaciane hydrochloride + Epinephrine sterile sol (dental cartridge)- Bupivacaine hydrochloride sterile sol (local infiltration)- Bupivacaine hydrochloride sterile sol (spinal, epidural)
16. Antidotes- Acetylcysteine (N-acetylcysteine) sterile sol- Antivenom sera sterile preparation: King Cobra antivenin: Cobra antivenin: Banded Krait antivenin: Malayan Krait antivenin: Malayan Pit Viper antivenin: Green Pit Viper antivenin: Russell’s Viper antivenin- Atropine sulfate sterile sol- Bentonite magma susp (hosp)- Benzatropine mesilate (Benztropine mesylate) sterile sol- Calcium gluconate sterile sol- Charcoal, activated pwdr
- Diazepam sterile sol- Diphenhydramine hydrochloride cap, sterile sol- Ethanol sterile sol-198-

- Macrogols with electrolytes (Polyethylene glycol, PEG) oral pwdr (hosp)- Naloxone hydrochloride sterile sol- Pralidoxime chloride (2-PAM) sterile pwdr
- Sodium bicarbonate sterile sol (only 44.6 mEq)
- Vitamin K1 (Phytomenadione) sterile sol- Sodium calcium edetate (Edetate calcium disodium, Calcium EDTA) sterile sol- Cyclophosphamide sterile pwdr
- Deferoxamine mesilate (Desferrioxamine mesilate) sterile pwdr
- Penicillamine (D-Penicillamine) cap- Protamine sulfate sterile sol- Sodium nitrite sterile sol (hosp)- Sodium thiosulfate sterile sol (hosp)- Vitamin B6 (Pyridoxine hydrochloride) sterile sol (only 50 mg)- Calcium folinate (Leucovorin calcium) cap, tab, sterile pwdr, sterile sol- Flumazenil sterile sol- Mesna sterile sol- Norepinephrine (Noradrenaline) sterile sol (as bitartrate or hydrochloride)- Phenobarbital sodium (Phenobarbitone sodium) sterile pwdr
17. Contrast media and Radiopharmaceuticals
17.1 X - ray contrast media, iodinated17.1.1 Drugs used in urography and computed tomography- Iopromide sterile sol (only 300 & 370 mg/ml as iodine), (50 ml, 100 ml)- Meglumine ioxitalamate + Sodium ioxitalamate sterile sol (only 350 mg/ml as iodine), (50 ml)
17.1.2 Drugs used in angiography- Iohexol sterile sol (only 300 mg/ml as iodine), (100 ml)- Iopromide sterile sol (only 300 mg/ml as iodine), (100 ml)
17.1.3 Drugs used in myelography- Iopamidol sterile sol (only 300 mg/ml as iodine), (10 ml)
17.1.4 Drugs used in cardiovascular catheterization- Iobitridol sterile sol (only 300 & 350 mg/ml as iodine), (50 ml)- Iopromide sterile sol (only 300 & 370 mg/ml as iodine), (50 ml, 100 ml)- Meglumine ioxitalamate + Sodium ioxitalamate sterile sol (only 350 mg/ml as iodine), (50 ml,
100 ml)17.1.5 Drugs used in Intracavitary, Hysterosalpingography (HSG), Urethrography, Voiding cystourethrography- Meglumine ioxitalamate + Sodium ioxitalamate sterile sol (only 350 mg/ml as iodine), (50 ml,
100 ml)17.2 X - ray contrast media, non - iodinated- Barium sulfate pwdr for oral susp
17.3 Magnetic resonance imaging contrast media (MRI diagnostic agents)- Meglumine gadopentetate sterile sol (only 469 mg/ml of gadopentetic acid ), (10 ml, 15 ml)
17.4 Radiopharmaceuticals- Tc-99m dextran sterile sol for inj (hosp)- Tc-99m diethylene triamine penta acetic acid (DTPA) sterile sol for inj (hosp), aerosol for
inhalation (hosp)- Tc-99m dimercaptosuccinic acid V (DMSA [V]) sterile sol for inj (hosp)- Tc-99m dimercaptosuccinic acid (DMSA) sterile sol for inj (hosp)- Tc-99m iminodiacetic acid (IDA) sterile sol for inj (hosp)- Tc-99m methylene diphosphonate (MDP) sterile sol for inj (hosp)- Tc-99m phytate sterile sol for inj (hosp), aerosol for inhalation (hosp)- Tc-99m sulfur colloid sterile sol for inj (hosp)-199-

6. Difficulties and constraints in Quality Assurance of Essential Medicines (e.g. GMP, etc.)that Thailand facing these days and clear directions in the future.
1) Substandard pharmaceutical products
1.1 Herbal medicines
Herbal medicines play an important role in the everyday life of the Thai people. The use of
herbal medicines has increased remarkably in line with the global trend of people returning tonatural therapies. The Government and authorities concerned have taken part in the promotion andregulation of local herbal medicines in order to ensure that their quality, efficacy and safety meetinternational requirements and those they are used rationally. Manufacturers are also encouraged by
the Government to improve their production standards to meet the requirements of Good Sanitation
Practice for traditional medicine which adopt from PIC/S core GMP chapter 2-5, ASEAN Good
Manufacturing Practices (ASEAN GMP) and to conform to the higher specifications needed for the
global market such as PIC/S standard. Now, Thailand has participated in the development of the
new ASEAN Guidelines on GMP for Traditional Medicines and Health Supplement which adopt
from full PIC/S GMP standard.
Good Sanitation Practice for herbal and traditional medicine in Thailand is the beginningstep for herbal or traditional medicine manufacture. It is currently being implemented andrecommended that herbal medicinal products should be manufactured in a Good Sanitation Practiceenvironment to ensure acceptable quality.
The problem affecting the quality of traditional drugs about microbial contamination
usually found since herbal medicinal products must therefore comply with the accepted limits for
microbial stability specified in the Thai Pharmacopoeia, although the use of synthetic preservatives
is permitted and heavy metal contamination. The exceeding contamination of heavy metal in herbal
or traditional medicinal products was found sometime especially the contamination of Arsenic,
Lead, and Cadmium. An adulteration of modern medicine in traditional medicine such as Steroid,
Sibutramine and Sildenafil analogue occasionally found.
Thai traditional medicine is a valuable heritage of the Thai people. The Royal Thai
Government has tried to revitalize its significance as an effective alternative treatment.
1.2 Modern medicines
In order for the country’s healthcare system to become more self-reliance and costeffective. The National Policy on Drugs is elaborated on avocations on local manufacturing of raw
materials from locally available resources for domestic supply and for export and upgrading alongwith promoting of domestic pharmaceutical industry and generic drug usage. However, Thailand
still faces the problem from substandard products of essential medicines that destroy confidence inusing domestic pharmaceutical products of Thailand.
Out of the total number of 169 pharmaceutical manufacturers in Thailand , 159 are
producing finished products , only 10 are producing 25 different kinds of raw materials. The
proportion of locally produced drugs as compared imported ones experienced a downward trend
from 40 : 60 in 2006 to 31 : 69 in 2010.
2) Technology advance and legislation
Nowadays, advanced technology applied in pharmaceutical industry, especially in jointventured company. Although Thai FDA has the role in evaluating and monitoring medicinal
products before and after placing in the market, in order to reach the goal, Thai FDA have built
network together with academe, NGO, importers and manufacturers. However, Thai FDA is facing
the lack of knowledge and skill on developing drug system. The current Thai GMP is adapted fromPharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Manufacturing Practices for
Medicinal Products PE 009-9 1 September 2009, which is not cover for traditional medicine
manufactured in the country. Moreover, the Thai GMP regulation does not cover some particular
topics in annexes of PIC/S such as manufacture of immunological veterinary medical products,
manufacture of medicinal gases, manufacture of investigational medicinal products, manufacture of
products derived from human and parametric release. So the GMP regulation needs to be revised.
The opportunity to gain technique and knowledge from leading country by attending thetraining course. All the obtained experience can guide the optimal way in development.

-200-3) Manufacturing
There are somes problems of the manufactures such the GPO,as followings;- Lack of human resources, instrument and place.
- Increase output affects improvement GMP.
- More workload of human and machine.
- The old production building is difficult to make adjustment.
- Most equipments, raw materials and reference standards use in quality control are imported
and expensive.
- Quality management is not complete because of work is mostly not done according to
The SOPs/work instructions or other documentation.
7. Current situation concerning Substandard Medicines and its countermeasures.
The current substandard situation in past 3 years are shown in the table as below:
Year
Collected Case/ office
Surveillance of Hospital
Cooperation Surveillance of DMSc & Bureau
of Drug Control, FDA
Cooperation Surveillance of DMSc & Bureauof Import and Export Inspection, FDA
Special Case/ Complaint
Other case
RBM (Roll back Malaria Project)

2009
19%
11%

2010
8%
14%

2011
8%
13%

6%

9%

8%

23%

11%

12%

3%
8%

12%
-

10%
-

The out of specification products are collected form various sources. The cooperation
surveillance of DMSc & Bureau of Drug control or Bureau of Import and Export Inspection collectthe sample form local manufacturer and port of entry, respectively. The defect of quality problems
are not only the assay but also dissolution, related substances, uniformity of content, etc. The main
problems are dissolution, related substances and deforming activity of antacid medicines.
For Traditional medicines, the main problem affecting the quality of traditional drugs is
microbial contamination which is about 25% are substandard from this problem. The other problem
is from heavy metal contamination which is about 5%.
8. Relationship with Overseas Assistance Organization
In the analytical area, Ministry of public health has close relationship with others foreigncountry organization such as USP which in 2009 the DMSc was performed cooperation on the
project of Quality Assurance of Antimalarial Drug in the Mekong Region. The Roll Back Malaria(RBM) in the Mekong Region was initiated by WHO in 1999 with the objective to reduce mortality
and morbidity due to malaria in Mekong countries. It has been identified thatcounterfeit/substandard drugs are one of the serious problems that hamper the achievement of thegoal of rolling back malaria. WHO in collaboration with United States Pharmacopoeia (USP)
conducted a survey in 2002 on the drug quality assurance capacity of existing laboratory facilities infive Mekong countries. Bureau of Drug and Narcotic, Thailand national laboratory for drug quality
control was also visited by WHO-RBM and USP Drug Quality Information (USP-DQI) for theevaluation of the competency in the analysis of antimalarial drug products. As a result of theevaluation the Bureau was selected to be an international center for antimalarial drug analysis inSoutheast Asia.
In the analytical area, there are other relationship with JPMA (Japan pharmaceutical
Manufacture Association). DMSc has cooperation in the project on ASEAN Reference Substances.
This project is established as part of regional cooperation among the ASEAN countries to ensure thequality, safety and efficacy of pharmaceuticals in the ASEAN region. ASEAN Reference
Substances Project was technically supported by WHO and financially supported by UNDP and
JPMA, with Thailand as the coordinating center. These standards are validated in the national-201-

laboratories of the ASEAN member countries; Indonesia, Malaysia, Philippines, Singapore,
Thailand and Vietnam and are formally adopted after stringent qualitative and quantitative tests arecarried out on the candidate substances. These substances provide the ASEAN laboratories withreadily available and affordable reference materials for their routine quality control analysis andalso available to the pharmaceutical industries
On the GMP area, Thai FDA has relationship with overseas government organization suchas Therapeutic Good Administration (TGA), U.S. Food and Drug Administration (US FDA) ,Malaysian National Pharmaceutical Control Bureau (NPCB), Singapore's Health Sciences Authority(HSA), Korea Food and Drug Administration (KFDA) and other private organization such as ISPE
(International Society for Pharmaceutical Engineering).
9. Technical Assistance Programs in the fields of Pharmaceuticals, GMP, Quality Control
organized by International Organizations show in the table beow :Program Name/ Outline
The cGMP Influenza Vaccine
Manufacturing training program
Project of Quality Assurance ofAntimalarial Drug in the Mekong
RegionStudy Programme on Manufacturing
Control of Essential Drugs
GMP study program
The project on the Production andUtilization of ASEAN Reference
Substances
Communicable Disease Prevention

Duration
3 weeks

Organizer
US FDA

Aims
Training/ site visit

1 year

USP

Surway Research

28 days

JICA

Training/ site visit

1 month
4 years

JICWELSJPMA

29 days

KOICA Korea

Training/ site visit
Make available of
ASEAN Reference
Substances (ARS)
Training/ site visit

GTN on Vaccine Quality "GMP"
courseGlobal training for vaccine quality
course on Good Manufacturing
Practices (GMPs) Inspection for
vaccines
Drug Information In Australia andGMP

9 daysWHO/ Korea

Training

11 days

KFDA /Korea

Training/ site visit

6 weeks

Training/ site visit

5 days4 daysDIA (Drug
Information
Association)-TGA
TOEL/ USAKFDA /Korea

5 daysWHO

Training

GMP Inspection training course
BIOKOREA Conference &Exhibition
Upstream Bioprocessing training andworkshop-202-

Training
Meeting出典：平成 24 年度 JICA 集団研修カントリーレポート

平成 24 年度 JICA 集団研修「必須医薬品製造品質管理（GMP）」

Japan International Corporation of Welfare Services (JICWELS) was established with the sanction of
the Minister for Health, Labour and Welfare in July 1983 and implements international technicalcooperation programmes with purpose of contributiing to the promotion of health and social welfare
activities in the friendly nations.
Japan International Corporation of Welfare Services (JICWELS)
Toranomon YHK Bldg. 4F, 2-3-20, Toranomon
Minato-ku, Tokyo 105-0001 JAPAN
Phone: +81-(0)3-6206-1137
Fax: +81-(0)3-6206-1164
http://www.jicwels.or.jp

公益社団法人国際厚生事業団（JICWELS）は、国際的な保健・福祉分野の国際協力に貢献することを目的として、1983 年（昭和 58 年）7 月 7 日に厚生省（現厚生労働省）から社団法人の認可を受け設立されました。開発途上国の行政官研修や WHO フェローの受入れ、調査
企画や研究開発並びに情報の交換及び広報活動など、海外諸国との国際交流活動を推進しています。

広報活動委員会〒105-0001
東京都港区虎ノ門 2-3-20 虎ノ門ＹＨＫビル 4 階
電話 03-6206-1137（事業部） Fax03-6206-1164
http://www.jicwels.or.jp