Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

Country Reports

Japan International Corporation of Welfare Services (JICWELS)Contents
1. AFGHANISTAN
2. IRAQ (1)3. IRAQ (2)4. MALAYSIA
5. MYANMAR
6. SRI LANKA (1)
10. SRI LANKA (2)11. TANZANIA

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

AFGHANISTAN

1Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

IRAQ (1)8Inception report

Regulatory Affairs Department Kurdistan
Medical Control Agency Ministry Of Health
Kurdistan Regional Government.

Part I
1- Organization chartof( Kurdistan Medical Control Agency )9Office of the
Director

Engineering
department

LaboratorydevicesmaintenancesectionRegistration
sectionPost marketing
sectionSale license
section

KMCA section incargo part of
ERBIL
INTERNATIONALAIRPORT

Sampling
sectionServicesectionNational
pharmaceuticalfactory section

Microbiology
sectionTechnical
sectionServicemaintenancesectionAdministrative
department
Accounting
sectionPharmcovigilance
sectionDrugmanufacturer
company
sectionRegulatory
department

Biochemistry
sectionCommunication
sectionEntrance
Permission ofpharmaceuticaldevice section

Legality
sectionLaboratory
department

Entrance
permission of
drug products
committee

ComputersectionIT section
Identity
sectionAuditing
section2- Legislation on pharmaceuticaladministration--National level:• Law of Practicing the profession of pharmacy, in 1972
which is administered by Ministry of health of Iraq.
--Local level:• Ministry of health instruction number 1 ( drug
regulations ) in 2011.
• Ministry of health instruction number 2 ( drug
regulations ‘ revised’ ) in 2013.
Both are administered by Kurdistan region ministry ofhealth.
--PIC/S: not joined.

10

3-Regulatory services--Drug import/export:• Drug import starts with giving entrance
allowance for each batch, which isadministered by Entrance permissioncommittee of regulatory affairs department.
• No drug exportation.

--Pharmaceutical manufacturing:• Rules for establishing pharmaceuticalmanufacturer .
• Periodic site inspections according to GMP.
These are administered by regulatory affairs
department.
. Random batch selection for analysis according
to GLP, which is administered by Laboratory
department.

11

--Marketing authorization:• Drug Manufacturing company registration,with special instructions in form A1.
• Medical devices company registration, withspecial instruction in form B.
• Pharmaceutical products registration, withspecial instructions in form A2.
All these actions are administered byregistration section of regulatory department.

--Drug distribution:• Drug selection is no more related to KMCA,
there is a committee in MOH regarding thisprocedure.
• Procurement is the duty of Directorate ofhealth.
• Sale, sampling, routing analysis then salepermission, are administered by laboratory
department of KMCA.

12

--Medicine safety :• Parallel import monitoring.
• Counterfeit medicine monitoring.
These actions are administered by post
marketing monitoring team.
. Customer complain record bypharmacovigilance section.

--Relief system for adverse drug reactions:• Focal points in public hospitals.
• Patient complains follow up.
Administered by Pharmacovigilance section.

13

4-Drug pricing• On October 2014 a committee of 7 members
including KMCA pharmacists established in
Ministry of health, revising the price structure
to control the market.

5-Statistic data
1-Number of pharmacists in KMCA ( 25 ) in 2014, and allpharmacists in KRG is more than ( 600 ) pharmacists.
2- Number of GMP inspector ( 2 ) since ( 2011 ).
3- Number of pharmaceutical manufacturer ( 2 ) , one in
Erbil city since ( 2008 ) & one in Sulaimaniya city since (2011 ).
4- Number of traditional medicine manufacturer, notavailable.
5- Number of pharmaceutical importers,( 120 ) till (2014).
6 – Number of pharmaceutical wholesalers, ( 50 ) till
( 2014 ).

14

PART II
Category A: ( Introduction of work )• --KMCA /Regulatory affairs department• --Deputy Manager• --Head of regulatory affairs department

Category B
Good practice• --Good manufacturing practices•
Good distribution practices•
Good storage practices• --certificate of intendance for GMP
inspection according to WHO requirements• (Alkem laboratories….india….april 2011)• Certificate or intendance for GMP
Guidelines (WHO…march…2014)15

• Other local trainings …
• --KMCA founded in 2006, I employed in 2008, started with the beginningof controlling medicines in the region (Safety, efficacy, quality, importcontrol….etc)• --Capacity building, training courses, implementing the rules thatgoverning medicines in well developed countries(agencies) and evaluating
which rules are applicable with our situation.
• --started controlling the marketing by post marketing surveillance• Then giving import license based on registration of Baghdad• Then opening our own registration unit, registering the pharmaceuticalmanufacturers• Then giving import permit for every batch entering Kurdistan region.
• Then activating pharmacovigilance.
• Taking samples from each batch entering Kurdistan for analysis.
• Auditing pharmaceutical manufacturers according to our instructions forthe purpose of registration.

Category c:
Bad practice• --presence of medicines which entered Kurdistan
without our permission• --price control. Till now a day we are trying to put rules
for controlling the margin of benefit for importers,
whole sailors, pharmacies.(it is open market).
• --we made a contract with an external laboratory to
made gap analysis then decide how to build capacities,
the contract period was 2 years, during this period theanalysis and registration was their duty, was a badpractice because they didn’t finished all their duties ontime, the contract finished on 12th November 2014.

16

Category D
Interests• --visiting a pharmaceutical facility.
• --applying worldwide regulations for medicine
control to be up to date.
• --e-CTD format for marketing authorizations.

Thank you17Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

IRAQ (2)18Inception report
Registration section
Regulatory department Kurdistan Medical
Control Agency Kurdistan Region / Iraq

Part I
1- Organization chartof( Kurdistan Medical Control Agency )19Office of the
Director

Legality
sectionServicemaintenancesectionSampling
sectionSale license
sectionAdministrative
department

Auditing
sectionRegistration
sectionPost marketing
section

KMCA section incargo part of
ERBIL
INTERNATIONALAIRPORT

Microbiology
sectionNational
pharmaceuticalfactory section

Entrance
Permission ofpharmaceuticaldevice section

Technical
sectionBiochemistry
sectionPharmcovigillance
sectionDrugmanufacturer
company
sectionLaboratorydevicesmaintenancesectionRegulatory
department

Laboratory
department

Communication
sectionEngineering
department

Accounting
sectionServicesectionComputersectionEntrance
permission of
drug products
committee

IT section
Identity
section2- Legislation on pharmaceuticaladministration--National level:• Law of Practicing the profession of pharmacy, in 1972
which is administered by Ministry of health of Iraq.
--Local level:• Ministry of health instruction number 1 ( drug
regulations ) in 2011.
• Ministry of health instruction number 2 ( drug
regulations ‘ revised’ ) in 2013.
Both are administered by Kurdistan region ministry ofhealth.
--PIC/S: not joined.

20

3-Regulatory services--Drug import/export:• Drug import starts with giving entrance
allowance for each batch, which isadministered by Entrance permissioncommittee of regulatory affairs department.
• No drug exportation.

--Pharmaceutical manufacturing:• Rules for establishing pharmaceuticalmanufacturer .
• Periodic site inspections according to GMP.
These are administered by regulatory affairs
department.
. Random batch selection for analysis according
to GLP, which is administered by Laboratory
department.

21

--Marketing authorization:• Drug Manufacturing company registration,with special instructions in form A1.
• Medical devices company registration, withspecial instruction in form B.
• Pharmaceutical products registration, withspecial instructions in form A2.
All these actions are administered byregistration section of regulatory department.

--Drug distribution:• Drug selection is no more related to KMCA,
there is a committee in MOH regarding thisprocedure.
• Procurement is the duty of Directorate ofhealth.
• Sale, sampling, routing analysis then salepermission, are administered by laboratory
department of KMCA.

22

--Medicine safety :• Parallel import monitoring.
• Counterfeit medicine monitoring.
These actions are administered by post
marketing monitoring team.
. Customer complain record bypharmacovigilance section.

--Relief system for adverse drug reactions:• Focal points in public hospitals.
• Patient complains follow up.
Administered by Pharmacovigilance section.

23

4-Drug pricing• On October 2014 a committee of 7 members
including KMCA pharmacists established in
Ministry of health, revising the price structure
to control the market.

5-Statistic data
1-Number of pharmacists in KMCA ( 25 ) in 2014, and allpharmacists in KRG is more than ( 600 ) pharmacists.
2- Number of GMP inspector ( 2 ) since ( 2011 ).
3- Number of pharmaceutical manufacturer ( 2 ) , one in
Erbil city since ( 2008 ) & one in Sulaimaniya city since (2011 ).
4- Number of traditional medicine manufacturer, notavailable.
5- Number of pharmaceutical importers,( 120 ) till (2014).
6 – Number of pharmaceutical wholesalers, ( 50 ) till
( 2014 ).

24

PART II
Category A: ( Introduction of work )• --KMCA /Regulatory affairs department• Since April 2009.
• Expert pharmacist in registration section.

Category B
Good practice
Achievements:. Prompt registration of manufacturers.
. Prompt Registration of medical devices
companies.
. Prompt registration of pharmaceuticalproducts.
. Auditing pharmaceutical facilities.

25

Solutions for past problems. Revising our instructions about registration
procedure of both manufacturers andpharmaceutical products.
. Good manufacturing practice implementation.
. Hiring more pharmacists and training them.

On-going projects to deal with current
problems• Insistence on non-entry of unregistered
medicines.
• Re-informing the distributers withgeneralization letters about any new
instructions regarding registration process.
• Primary registration of pharmaceuticalproducts.

26

Successful countermeasures againstproblems• No entering permission for un-registered drugs.
• No drug import license for un-registered drugs
and drugs need re-registration.
• Controlling the market from counterfeit medicine
by routine tour of post marketing team.
• Enforcement of sanctions and penalties to
distributers.
• Imposing price structure.

Category c:
Bad practice• Illegally entered drugs.
• No price control.
• Un-registered drugs.
• Counterfeit, substandard & falsely labeled
drugs.
• Absence of qualified pharmacists .

27

Category D
Interests• Visiting a pharmaceutical facility.
• Registration process of manufacturer andmedicines.
• CTD format for marketing authorizations.

END OF THE REPORTSPECIAL THANKS

28

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

MALAYSIA

29

GOOD GOVERNANCE OF MEDICINES FOR
NATIONAL PHARMACEUTICAL REGULATORYAUTHORITIES(JFY 2014)

INCEPTION REPORTCountry
Organization::

Malaysia
Pharmaceutical Services
Division,
Ministry of Health Malaysia

30

31

(a)

Organization Chart of Ministry of Health Malaysia

1) Organizational Chart

Part 1: INFORMATION SHARING
Appendix A

2

(b)

Organization Chart of Pharmaceutical Services Division(i)

Appendix B

National Level

3

32

(ii)

State Level

Appendix C

State Health Director

DeputyDirector(Public
Health)DeputyDirector(Medical)

DeputyDirector(Oral Health)

DeputyDirector(Pharmacy)

DeputyDirector(Food Safety& Quality)

Pharmacy
Practice andDevelopment

Pharmacy
Policy andManagement

Pharmacy
Enforcement

DeputyDirector(Management)

Licensing andInspection

Entry PointIntelligence
andOperation

Investigation

Prosecution

Protection
andConsumerAwareness

433

Role and responsibility on pharmaceutical administration:
The Pharmaceutical Services Division as one of the main divisions under the
Pharmacy programme carries out its responsibility through three (3) main activities
namely Pharmacy Policy & Management, Pharmacy Practice & Development, andPharmacy Enforcement. (Appendix A, B and C)(a)

Pharmacy Policy and Management is responsible for ensuring thatpharmacy services strategic plan and policies are implemented accordingly.

(b)Pharmacy Practice and Development is responsible for ensuring optimised
drug therapies and provides comprehensive pharmaceutical care.

(c)

Pharmacy

Enforcement

plays

an

important

role

to

ensurethatpharmaceutical, traditional, and cosmetic products that are available in themarket are genuine in terms of registration and notification.
2) Legislation on pharmaceutical administration
There are five (5) Acts enforced by the Pharmacy Enforcement under the
Pharmaceutical Services Division, Ministry of Health Malaysia namely:(a)Registration of Pharmacists Act 1951 (Act 371) and Regulations - relating
to the establishment of a Pharmacy Board and the registration of pharmacists.

(b)

Poisons Act 1952 (Act 366) and Regulations - regulate the importation,possession, manufacture, compounding, storage, transport, sale and use of
poisons.

(c)

Sale of Drugs Act 1952 (Act 368) and Regulations - relating to the sale ofdrugs.

(d)Medicines (Advertisement and Sale) Act 1956 (Act 290) and Regulations- prohibiting certain advertisements relating to medical matters and to
regulate the sale of substances recommended as a medicine.

(e)Dangerous Drugs Act 1952 (Act 234) and Regulations - regulating theimport, export, manufacture, sale, and use of opium and of certain otherdangerous drugs and substances.

 These acts are administered at both national and local level by the Pharmacy
Enforcement Division.
5

34

 PIC/S – National Pharmaceutical Control Bureau is a member of PIC/S and hadjoined since 2002.
3) Regulatory Services
The National Pharmaceutical Control Bureau (NPCB) carries out the regulatory control ofpharmaceutical. The function of NPCB is to ensure safety, efficacy and quality of drugs;
safety and quality of traditional medicines and cosmetics marketed locally.
There are seven centers under NPCB:
No.

Center1.

Centre For Administration

2.

Center For Product Registration

3.

Center For Post Registration

4.

Center For Compliance And Licensing

5.

Centre For Quality Control

6.

Centre For Organizational Development

7.

Centre Investigational New Product Drug Import/Export
Drug import/export is mainly regulated under the Sale of Drugs Act 1952 (Act368) and Regulations and the Poisons Act 1952 (Act 366) and Regulations.
All importers need to obtain an import licence from the Director of
Pharmaceutical Service in order to import the drugs.
As a member of The Convention on Psychotropic Substances of 1971 andConvention Against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances of 1988, each exportation of narcotic drugs will be approved to a
country who issued the import permit and importation of precursors will be
notified to the country of importing via pre-export notification.
 Pharmaceutical Manufacturing –GMP
A manufacturer’s licence will be issue to a company to manufacture theregistered products in the premises specified in the licence and to sell by
635

wholesale or supply the products. The manufacturer must comply with theGood Manufacturing practice as specified in the license conditions. According
to the Control of Drugs and Cosmetics Regulations 1984, complaince to Good
Manufacturing Practice is a pre-quisite for the application of a manufacturing
license as well as product registration/ cosmetic notification . Good
Manufacturing Practice (GMP) is a standard that should be followed bymanufacturers to ensure that the product manufactured is safe, efficaciousand of quality.
The inspection of Good Clinical Practice (GCP) maybe carried out throughroutine inspection or maybe triggered by issues arising during theassessment of the dossier or by other information such as previous inspection
experience. The DCA has set up a guidelines for the inspection to be carriedout.
The Control of Drugs and Cosmetics Regulations 1984 (CDCR) requires thatthe standard of manufacture and quality control of medicinal products
manufactured outside Malaysia be taken into consideration before theproducts are registered with the authority namely Drug Control Authority(DCA). NPCB as the secretariat to the DCA is responsible to ensure all
manufacturers of registered products in Malaysia are able to provide
acceptable evidence that the manufacturing premises conform to current
GMP requirements. Hence, foreign manufacturers are also subjected to GMP
conformity assessments through acceptable GMP evidence or GMP
inspection
The Principles of GLP should be applied to the non-clinical safety testing oftest items contained in pharmaceutical products, pesticide products,
cosmetics products, veterinary drugs as well as food additives, feed additives,and industrial chemicals. These test items are frequently synthetic chemicals,
but may be of natural or biological origin and, in some circumstances, may beliving organisms. The purpose of testing these items is to obtain data on theirproperties and/or their safety with respect to human health and/or theenvironment. Non-clinical health and environmental safety studies coveredby the Principles of GLP include work conducted in laboratory, greenhouses,
and in the field.
 Marketing Authorization
A wholesale licence will be issue to a company to sell by wholesale or supply
the registered products from the address of the business premises specified
in the license. Meanwhile, a pharmacist will be issue a Type A Poison Licence
under the Poisons Act in order for them to supply drugs from their premises.
The responsibilities of a Marketing Authorization Holder in terms ofpharmacovigilance activities are:i) Establishment of an ADR monitoring system
736ii) Submission of spontaneous ADR reports to National Centre for Adverse
Drug Reaction Monitoringiii) Submission of reports from published scientific literature & post-registration
studiesiv) Evaluation of benefit-risk profile of registered productsv) Compliance with circulars and directives issued by DCA Drug Distribution(including drug selection, procurement, sale)-GDP
Drugs distributor must comply with the Good Distribution Practice. GDP isdefined as important steps that should be considered in the storage,transportation and distribution of registered products / notified cosmetics,
including associated materials in order to preserve its characteristics andquality until it reaches the consumer .
 Medicine Safety (post-marketing)
Active product monitoring via the Post Market Surveillance (PMS) program isconducted by the authority to ensure that only safe products are being
marketed. The activities consist the following:i) Screening of product formulation and informationii) Audit on the Product Information File (PIF) for compliance with theregulationsiii) Sample collection, testing and monitoring of label complianceiv) Audit of premises to ensure compliance with Guidelines Investigation ofcomplaintsv) Initiation of warning and information sharing system between ASEAN
countriesvi) Monitoring of adverse reactions reported by Healthcare Professionals or
consumers.
vii) Monitoring of product advertisement

 Relief System for Adverse Drug Reaction
Every Adverse Drug Reaction must be report to the NPCB. The manufacturer,
importer and wholesaler are required to have a procedure for product recall toremove or withdraw a particular material and/or product and/or cosmetic fromall links of distribution due to critical quality defects discovered or serious
adverse drug reactions reported which might cause health risks to users. The
degree of recall is classified according to the severity of quality defects andadverse reactions of the products and/or cosmetics.
837

Degree I

Materials and/or products and/or cosmetics with major healthrisks that might caused serious injuries or death. Should beunder an embargo within 24 hours

Degree II

Materials and/or products and/or cosmetics with minor healthrisks or are substandard. Should be under an embargo within
72 hours.

Degree III

Materials and/or products and/or cosmetics with other reasons
for recall. Should be under an embargo within 30 days or as
specified.

The level of recall depends on the nature of problem, extent of the material or
product or cosmetic’s distribution and degree of hazard involved.
Level ATo all consumers (end users). When there is imminent danger,
the public are warned by a media release which is meant to urgently alert the
public by radio, television and the press.
Level BTo all points of sales (e.g Hospitals, Pharmacies, Clinics,
Specialist Centres). Recall notices will be sent to all points of sales. At thesame time, representatives from the company will be sent to these points ofsale to retrieve the stocks.
Level CTo all sub-distributors (wholesaler and stockist). The
wholesalers and stockists will be contacted by the company representatives
so that arrangement can be made to retrieve all stocks concerned from thewholesalers and stockist.

4) Drug Pricing
Pharmaceutical Pricing Mechanism for Universal Health Coverage
As drugs price is a contentious issue the government is of the opinion that it should be
handled very carefully. The Pharmaceutical Services Division (PSD) has set up a Price
Monitoring Unit to conduct price monitoring for the country. Expert was brought to thecountry to train pharmacists on how to conduct price monitoring.
The price monitoring activities will ensure that as the price of drugs become transparent toprescribers and users, and this will encourage self-regulation by the distributors. At thesame time, the authorities are also looking into other mechanisms of drug control.
The Medicine Price Database is being developed. Currently, the medicines price data,comprising of categories as below, are continuously compiled and updated.
i.

Fee Act (Full Paying Patient)vi

National Essential Drug Price List (Public)ii

Private Retail Pricevii

National Essential Drug Price List (Private)
9

38

iii

Public Wholesale Priceviii

Traditional Wholesale Priceiv

Private Wholesale Priceix

Recommended Retail Price (RRP)x

Government Procurement (GP) Price(Controlled Medicines)v

Private Wholesale Price (OTC)

Newly listed medicines in the Ministry of Health (MOH) Drug Formulary are subjected toprice monitoring. To further strengthen this monitoring procedure, firms requested for their
medicines to be listed in the MOH Drug Formulary are required to submit their quotation of
selling price to MOH facility if the aforementioned medicines have been successfully listed in
the MOH Drug Formulary. The medicine price sold to MOH facilities should not exceed thesaid quotation for at least one a year. After that, any price increments will be monitored by
the Medicines Price Determination Unit. The review is done once a year continuously byobtaining feedback from MOH hospitals. In the event where the medicines price is more thanthe predetermined price, the related firm is obliged to provide explanation regarding thisissue and take corrective actions such as credit notes provision or reimbursement in theform of medicines5) Statistic Data
No.

Subject

Data

Year

11810

September
2014

(a)

Number of Pharmacists(b)

Number of GMP Inspectors (National and Local)

21

September
2014

(c)

Number of Pharmaceutical Manufacturers/ Manufacturing Sites

84

September
2014

(d)

Number of Traditional Medicines Manufacturers/ Manufacturing Sites

161

September
2014

(e)

Number of Pharmaceutical Importers

231

September
2014

(f)

Number of Pharmaceutical Wholesalers

1001

September
2014

10

39

GOOD GOVERNANCE OF MEDICINES FOR PHARMACEUTICAL REGULATIONAUTHORITIES (JFY2014)

INCEPTION REPORTPRESENTATION
Pharmaceutical Services
Division Ministry of Health
MALAYSIAORGANISATION CHART MINISTRY OF HEALTH MALAYSIA

2National Pharmaceutical Control Bureau MOH Malaysia

40

PHARMACEUTICAL ADMINISTRATIONDIRECTOR GENERAL OF HEALTHSENIOR DIRECTOR
PHARMACEUTICALSERVICES

DIRECTORPHARMACY
ENFORCEMENTDIRECTORNATIONAL
PHARMACEUTICALCONTROL BUREAU

DIRECTORPHARMACY
PRACTICE &DEVELOPMENT

STATE HEALTH
DEPUTY DIRECTOR(PHARMACY)

ENFORCEMENT DIVISION
DIVERSIONCONTROL

LICENSING SECTIONLEGISLATION SECTIONINNOVATION &ADVERTISEMENTDIRECTORPRECURSOR CONTROLPROSECUTION
ADVERTISEMENTCONTROLINNOVATIONOPERATIONOPERATION ANDINVESTIGATION SECTIONSURVEILLANCEINVESTIGATIONPREVENTION &PROTECTION SECTION41

CUSTOMER PROTECTION
R&D

Recent achievement:
New features of the Hologram
Logo to indentified registeredproduct
Establishment of Enforcement
Forensic Laboratory
Establishment of Digital Forensic
Pharmacy Unit to handle
challenges in IT
Shorten process period foradvertisement approval (from 7
days to 5 days)

Recent achievement:Increase awareness of medicines advertising
controlIncrease cooperation amongst enforcement
agenciesEstablishment of Good Governance Of
Medicines Training Module
The New Pharmacy Bill to replace the current
5 Acts42

Global Anti-counterfeiting Awards 2013,
Paris, 28 May 2013
• The Ministry of Health Malaysia has taken several initiatives in protecting
the public from dangerous and counterfeit medicines. These exceptional
efforts have been accorded international recognition with thepresentation of the “Global Anti-Counterfeiting Award 2013” in the public
sector category by the Global Anti-Counterfeiting Group Network (GACG),
an international anti-counterfeit organization based in London, UK. The
award was presented in conjunction with the World Anti-Counterfeiting
Day organized by Union des Fabricans in Paris, France on the 28th of May
2013. The award was received by Dato’ Eisah bt. A. Rahman, SeniorDirector of Pharmaceutical Services Division on behalf of the Ministry of
Health Malaysia.
• This 15th annual GACG award ceremony has positioned the Pharmacy
Enforcement Division, MOH Malaysia at par with world renowned law
enforcement agency like the INTERPOL, which also received the similaraward in the international public body category. The Ministry of Health
Malaysia will continue our commitment in protecting the public by
combating counterfeit medicines in the marketplace.

43

PROBLEMS AND CHALLENGES• Diversion of pharmaceuticals in the
production of narcotic drugs• Unregistered and counterfeit drugs are still
rampant in the market• Food adulterated with poison• Interphase products- FDI, MDD• Unethical medicine advertising• Uncontrolled internet advertising and sales

Topics of interest
Approach on public education to increase
consumer awareness about the risk ofusing unregistered and adulterated
products in the market.
Implementation of Self-regulatory Guideline
to Regulate Sale of Pharmaceutical Products
via Internet
Measures to Address Adulteration in
Pharmaceutical Products and Food
Supplements

44

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

MYANMAR45

DEPARTMENT OF FOOD AND DRUG
ADMINISTRATION , MYANMARGOOD GOVERNANCE OF
MEDICINES FOR NATIONAL
PHARMACEUTICALREGULATORY AUTHORITIES(JFY 2014)
INCEPTION REPORT

46

Country’s Profile
Location
The Republic of Union of Myanmar is the westernmost country in South East Asia,
located on the Bay of Bengal and Andaman Sea. It is bordered by the Lao, Thailand,
Republic of China and the Republic of India and on the west by the People’s Republic ofBangladesh.

Geography
The country is divided administratively into
Naypyidaw Union Territory,
7 Regions(Yangon, Mandalay, Sagaing, Magway, Bago,Ayeyawaddy &Tahnintharyee)and7 States(Kachin, Kayar, Kayin, Chin, Mon, Rakhaing & Shan)
It consists of (70) Districts, (330) Townships, (84) Sub-townships, (398) Towns,(3063) Wards, (13,618) Village tracts and (64,134) Villages.
Demography
The population of Myanmar in 2014 is about 51 .42 millions. About 70.4% of the
population resides in the rural areas whereas the remaining are urban dwellers.
Religion
The Republic of the Union of Myanmar is made up of (135) national races speaking
over 100 languages and dialects.

47Inception Report
1.Organization
1.1. Ministry of Health
The Ministry of Health (MOH) is the major organization responsible for upgrading
the health status of the people and accomplish this through provision of comprehensive healthservices: promotive, preventive, curative and rehabilitative measures.
The Ministry of Health is headed by the Union Minister who is assisted by two Union
Deputy Ministers. The Ministry has seven functioning departments, each under a Director
General. They are
Department of Health Planning
Department of Health
Department of Medical Sciences
Department of Medical Research ( Lower Myanmar)
Department of Medical Research ( Upper Myanmar)
Department of Traditional Medicine
Department of Food and Drug Administration
The Ministry of Health laid down the following objectives
1. To enable every citizen to attain full life expectancy and enjoy longevity of life
2. To ensure that every citizen is free from diseases.
To realize these objectives, all health activities are implemented in conformity withthe following strategies:
1. Widespread disseminations of health information and education to reach the rural
areas.
2. Enhancing disease prevention activities
3. Providing effective treatment of prevailing diseases.

48

1.2. Department of Food and Drug Administration
The Food and Administration (FDA) established since 1995, takes care of the safety
and quality of Food, Drug, Medical Devices and Cosmetics. Food and drug control activities
expanded with establishment of branches in Nay Pyi Taw, Yangon and Mandalay. The FDA
division has been upgraded to a separate Department in April 2013.
FDA is responsible for issuing Health Recommendation for local food manufacturingbusinesses, import and export recommendation, import and export health certification.
Drug Control activities have been conducting for marketing authorization for new
products, variations of existing authorization, quality control laboratory testing, adverse
effect reaction monitoring, Good Manufacturing Practice inspection and Licensing of
manufacturers, wholesalers and enforcement activities, drug promotion and advertisement.
FDA issues notification and import recommendation of medical devices and notification of
cosmetics.

49

50

2.Legislation of Pharmaceutical Administration
2.1. National level(a) Public health law (1972)

It is concerned with protection of people’s health bycontrolling the quality and cleanliness of food , drugs ,environmental sanitation, epidemic diseases andregulation of private clinics.

(b) National Drug Law (1992)

Enacted to ensure access by the people safe andefficacious drugs. Describe requirement for licensing in
relation to manufacturing, storage, distribution and saleof drugs. It also includes provisions on formation andauthorization of Myanmar Food and Drug Board of
Authority.

( April, 2014 Amendment)(c) Narcotic Drugs andPsychotropic Substances
Law (1993)

Related to control of drug abuse and describe measures
to be taken against those breaking the law. Enacted toprevent danger of narcotic and psychotropic substances
and to implement the provisions of United Nations
Convection Against Illicit Traffic in Narcotic Drug andPsychotropic Substances.

(d) Traditional Drug Law (1996) Concerned with labeling, licensing and advertisement oftraditional drugs to promote traditional medicine anddrugs. It also aims to enable public to concern genuine
quality, safe and efficacious drugs. The law also deals
with registration and control of traditional drugs andformation of Board of Authority and its functions.
(e) National
Food(1997,2014)

Law Enacted to enable the public to consume food of genuine
quality, free from danger, to prevent public fromconsuming food that may causes danger or are injurious
to health, to supervise production of controlled foodsystematically and to control and regulate theproduction, import, export, storage, distribution and saleof food systematically. The law also describes formationof Board of Authority and its functions and duties.

2.2 PIC/SNO

51

3.Regulatory Services
FDA is responsible for issuing Heath Recommendation for local food manufacturing,businesses, import and export recommendation, import and export health certification. FDA
has issued Health Recommendation for drinking water factories (621) and food production
establishments (342) which comply with Good Manufacturing Practice (GMP) and small
traditional food production facilities (65) which comply with Good Hygienic Practice (GHP)so far.
In 2012, post market survey was done for non permitted coloring in chili powder,lentil, colored drinks, fish paste, chili sauce and meat sausage etc. (1806) samples were testedand (195) samples were found to be dyed with non permitted color and destroyed
accordingly.
Drug Control Activities have been conducting for marketing authorization for new
products, variation of existing authorization, quality control laboratory testing, adverse drug
reaction monitoring, Good Manufacturing Practice inspection and licensing of manufacturers,
wholesalers, enforcement activities, drug promotion and advertisements. Sustainablefinancing is essential to promote effective drug regulation. FDA issues notification andimport recommendation of medical devices and notification of cosmetics. During 2013, under
the guidance of Drug Advisory Committee and Central Food & Drug Supervisory
Committee, Food & Drug Administration issued 2506 Drug Registration Certificates (DRC),
77 Drug Importation Approval Certificates (DIAC) and also rejected 167 drugs forregistration from the aspect of quality, safety and efficacy. The number of Pre/ Post Market
Drug Samples was 2240 and these samples had been tested in Drug Quality Control
Laboratory in 2013. FDA also issued 711 cosmetic notification certificates. Under guidanceof Ministry of Health, FDA regularly notifies the public as well as State/ Regional Food andDrug Supervisory Committees about alert news of counterfeit and illegal medicines.
Food and Drug Administration takes necessary measures to ensure that only drugs
that are registered are imported. Food and Drug Administration is closely cooperated with
Custom Department, Directorate of Trade and Myanmar Police Force.

52

4.Statistic Data
1. No: of Pharmacists>2000 pharmacists (2014)

2. No: of GMP Inspectors

10-20

3. No: of Pharmaceutical Manufactures

7

Manufacturing sites

Yangon, Pyin Oo Lwin, Kyaut Sae, Sagaing

4. No: of Traditional Medicine Manufactures
Manufacturing sites

About 100
Capital cities

5. No: of Pharmaceutical Importer

186

6. No: of Pharmaceutical Wholesalers

700

53

INCEPTION REPORT( MYANMAR)

Department of Food & Drug
Administration

1

Country Profile
Location The Republic of Union of Myanmar is the westernmost country
in South East Asia,
 located on the Bay of Bengal and Andaman Sea.

54

Country Profile
Location

It is bordered by
 the Lao
 Thailand, Republic of China
 Republic of India and Republic of Bangladesh.

Country Profile• Geography
The country is divided administratively into
Naypyidaw Union Territory,
7 Regions(Yangon, Mandalay, Sagaing, Magway,
Pago,Ayeyawaddy &Tahnintharyee)
7 States(Kachin, Kayar, Kayin, Chin, Mon, Rakhaning & Shan)

55

Country Profile• Demography
The population of Myanmar in 2014 is about 51 .42 millions.
About 70.4% of the population resides in the rural areas whereas
the remaining are urban dwellers.
• Religion
The Republic of the Union of Myanmar is made up of(135) national races speaking over 100 languages and dialects.

Inception Report• Ministry of Health
Department of Health Planning
Department of Health
Department of Medical Sciences
Department of Medical Research ( Lower Myanmar)
Department of Medical Research ( Upper Myanmar)
Department of Traditional Medicine
Department of Food and Drug Administration

56

Ministry of Health – Organization Chart

Legislation of Pharmaceutical Administration
•

No.
1.
2.
3.
4.
5.

Law
Public Health Law
National Drug Law
Amendment
Narcotic Drugs and Psychotropic
Substances Law
Traditional Drug Law
National Food Law

57

Year
1972
1992
(April 2014)
1993
1996
1997

Statistic Data
1. No: of Pharmacists

M.Pharm 76

2. No: of GMP Inspectors

B.Pharm 2908
10-20

3. No: of Pharmaceutical Manufactures

7

Manufacturing sites
4. No: of Traditional Medicine Manufactures

Yangon, Pyin Oo Lwin, Kyaut
Sae, Sagaing
About 100

Manufacturing sites
5. No: of Pharmaceutical Importer

Capital cities
186

6. No: of Pharmaceutical Wholesalers

700

Department of Food and Drug Administation• established since 1995, takes care of the safety andquality of Food, Drug, Medical Devices andCosmetics.
• Food and drug control activities expanded withestablishment of branches in Nay Pyi Taw, Yangon
and Mandalay.
• The FDA division has been upgraded to a separate
Department in April 2013.

58

Department of Food and Drug Administation
Organization Chart

Bad Experiences• Developing country• Inadequate man power• High demand for a lot of training• Lack of knowledge in public – difficult in
educating the public• Accusations on our department

59

Good Experience• Market Survey and Notify the public

Good Experience• Countermeasure against Fake Drugs

60

Good Experience• Control of Quality ,Safety and Efficacy
of Drugs, Cosmetic and Food

Good Experience• Management of Expired Products

61

Good Experience• Training ( Drug inspector, Drug retailerselling rule and regulation )Our Interest• Pharmaceutical Analysis

62

Our Interest
GMP Inspections

Our Interest
GMP Inspections

63

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

SRI LANKA(1)

64

Good Governance of Medicines for National Pharmaceutical Regulatory Authorities(JFY 2014)
Job Report as a part of Requirements of the Programme
Of
State Pharmaceutical Manufacturing Corporation of Sri Lanka‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐Part 01
Over view of country and organization
Sri Lanka is an Island in South Asia surrounded by the Indian Ocean with a Population of 21 675
648 and65610 sq Km land. Politically it is country govern by parliament Democracy andheaded by an Executive President selected by people of the country.
Sri Lanka is practicing a Government provided free Healthcare System which is providing
Healthcare facilities ( including the Hospital care ) to people irrespective of their wealth ,income or social status. Apart from the Government Healthcare system, there are private
Healthcare institutions also operating all over the country where countrymen have access only
on payments. Majority of the pharmaceuticals (Western Medicines) are coming as imports tothe country and comparatively few items are manufactured by local manufacturers.
1. Organizational chart at National/State and Local level on pharmaceutical administration

Figure 1 Organization Chart of drug management
 Minister of Health‐ Policy making such as introducing necessary amendments tothe act and making regulations.
 Director General of Health Services‐ DGHS is the “Drug Authority” of the country
responsible for forming Drug Therapeutic Committees. Functions of the committee
would be to monitor supply, distribution and consumption of drugs at
national, provincial, and institutional levels. Similarly there are Drug therapeutic
Committees for both provincial levels and regional levels.

65

 Medical Supplies Division‐The MSD of the Ministry of Health is responsible for the
consolidation of annual requirements of drugs for the institutions under the Central
Ministry and the Provincial Councils. Director, MSD and his staff periodically visit
and monitor the activities in relation to drug management in the respective
provinces / institutions.
 Director Medical Technology and Supply (D/MT&S) ‐Issuing of certificates ofregistration of the drugs and licenses to import, distribute, sell and manufacturedrugs under the regulations of
the Act,areimplemented
bytheDirector/MT&S
 Director National Drug Quality Assurance Laboratory (D/NDQAL)‐The primaryfunction 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 ofthe distribution; namely at pre‐marketing and post marketing stages, and issue
reports/recommendations based on the analyses/evaluations.
 State Pharmaceuticals Corporation (SPC) ‐ The SPC has been designated as
the sole procurement agency for pharmaceuticals and surgical consumables
items required by the government health institutions. These items are imported or
locally purchased and supplied to the MSD of the Department of Health Services
from where they are distributed to government health institutions.
 Regional Medical Supplies Divisions (RMSD)‐ MSD functions as the sole supplier of
all the medicinal items to the public sector and these items are distributed via the
RMSD’S located in 26 divisions island wide.
2. Legislation Govern the Pharmaceutical Administration in Sri Lanka.
Manufacturing, Importing, Selling and Distributing of Pharmaceuticals in Sri Lanka is govern by
the Cosmetic Devices and Drugs Act No. 27 of 1980 ( CDDA Act) (with subsequent
amendments) and regulations made under provisions of this Act.
Cosmetic Devices and Drugs Authority Act has provisions on regulating
1. Registration of Pharmaceuticals
2. Monitoring and approving changes to those products already approved.
3. Monitoring and Implementing good Manufacturing practices.
4. Licensing and monitoring of importation, manufacturing, sales
advertisements and distribution surveillance of quality of drugs available inthe market.
5. Reviewing and approving of advertisements.
6. Approving and Monitoring of clinical trials.
7. Recalling Pharmaceuticals from the market on safety grounds and all otherrelevant areas.
8. Approving, registering. Monitoring and regulating Pharmacists, wholesale
and retail outlets, distributors and stockiest.

66

Cosmetics Devises and Drugs Authority (CDDA) established under provisions of the Act
mentioned above is the implementing authority of provisions of the Act.
3. Regulatory Service
Issues on pharmaceutical regulatory services –In view of State Pharmaceuticals
Corporation and State pharmaceuticals Manufacturing Corporation of Sri Lanka(i) Inflow of substandard pharmaceuticals to the country has an impact on national
health care system, proper therapeutic administration and fair play in the market(ii) Lack of sufficient number of trained personnel for regulatory affairs of the industry
and issues arising out of lack of adequate actions on regulating the industry.
(iii) Lack of facilities for scientific testing /researches on acceptability of products forregistration, quality related issues, post market surveillance

I.

Drug import / export
Drug import to Sri Lanka can be divided into two categories such as imports topublic sector and private sector. For the public sector drugs are imported mainly
through State Pharmaceuticals Manufacturing Corporation. They procure all theessential drugs, devices, surgical items for the Medical Supplies Division, whichlies as the main unit responsible in distributing drugs and related items togovernment sector hospitals.

II.

Pharmaceutical Manufacturing
Both public and private sectors are involved in pharmaceutical manufacturing in
Sri Lanka. Any manufacturer must obtain a license for manufacturing from Drug
Regulatory Authority. The items to be manufactured should obtain separate
license for such manufacturing from the Drug Regulatory Authority. This license
can be provisional which is valid for one year, and can be a full registration.
Good Manufacturing Practices for manufacturing processes are monitored andgiven by Drug Regulatory Authority.

III.

Marketing Authorization
Marketing authorization is either taken by the manufacturer to market the
products manufactured or by importers from Drug Regulatory Authorities. All
these functions are monitored and authorized by the Drug Regulatory Authority
under the Cosmetic Devices and Drugs Act.
67

IV.

Drug Distribution
For public sector, drug distribution is mainly controlled and monitored by
Medical Supplies Division (MSD). This is a centrally located governmentorganization under Ministry Of Health, and there are provisional supplies
divisions to supply medicines to other regional hospitals. MSD is responsible for
procuring medicines, surgical items and devices for government sector hospitals
For procuring private sector hospitals and pharmacies there is no such
distribution channel operating at the moment. Private hospitals can procure
their requirements directly from available drug manufacturers or suppliers.
Apart from this there is government own pharmacies known as “Osusalas”
managed by State Pharmaceuticals Corporation (SPC). SPC is responsible insupplying medicines and other additional pharmaceutical products for all thepharmacies (Osusala) located island wide.

V.

Medicine Safety/Post Marketing Surveillance
In Sri Lanka there is no such organized system for post marketing surveillance.
But we have an independent laboratory to check the quality of all the drugs
manufactured in Sri Lanka and all the drugs imported to Sri Lanka termed
National Drug Quality Assurance Laboratory (NDQUAL). They monitor the safety
and efficacy of drugs prevails within the island.

VI.

Relief system /adverse drug reactions
In an event of an adverse drug reaction a doctor or the patient can submit thedetails of adverse drug reactions to the pharmaco vigilance unit located at the
Department of Pharmacology, Faculty of Medicine, and University Of Colombo.

4. Drug Pricing
Public sector in Sri Lanka is free of charge. They procure drugs according togovernment tender procedures. Therefore, those who bid for the tender will
govern the price. However apart from this the government also procures drugs
directly from SPMC. Prices for these drugs are negotiated between the two
governmental organizations. In the case of private sector there is no such
regulation in prices. Same drug is available in different prices in the market.

685. Statistical Data
Category

Data

Year

a) Number of pharmacists

6311

2013

b) Number of inspectors

40

2013

30

2013

c) Number of pharmaceuticald) Manufacturerse) Number of traditional
medicine manufacturersf) Number of pharmaceuticalimportersg) Number of pharmaceuticalwhole sellers

Statistical data not available

69

211

2013

57

2013

SPMC
SPMC-State Pharmaceuticals Manufacturing
Corporation is the sole state sector manufacturer ofpharmaceuticals to the Sri Lankan nation.
• Donation from Japanese government and JICA
• We have a product list about 66 drugs and annually
about 48 products are manufactured.
• Out capacity now exceeds 2000 million tablets andcapsules annually.

70

INTRODUCTION OF WORK
Manufacturing and quality control of products
Production department is responsible in manufacturingand quality control of tablets and capsules in SPMC.
Therefore our key objective is to carry out all theprocesses up to the standards stated in thepharmacopeias without any quality defect. To obtain thequality level we try our best to follow the Standard
Operating Procedures, implement and follow GMP
regulations.

VALIDATION OF MANUFACTURING
PROCESS•Our ultimate goal is to manufacture a quality
product. With that aim the production
department together with the formulation andquality control departments involve invalidation of the manufacturing processes oftablets and capsules.

71

MAINTAINING STABILITY DATA FORREGULATORY PURPOSES• Store samples from each product as well as stability
records to produce data to the Drug Regulation
Authority .
• Testing of stability samples are carried out within thetime frame given by the Drug Regulation Authority.

GOOD PRACTICES• Quality checking of raw materials at 4 intervals

At the tender sampling –initial tender samples arechecked Pre-shipment sampling- samples from the exactly thesame batches to be sent.
Full analysis Testing-one sample from each batch
Identification test-testing of each drum72

GOOD PRACTICES• In-process quality checking• Tablet weights are statistically controlled during
manufacturing to ensure the dose of the tablets.
• Weights of tablets are monitored by narrowing down
the pharmacopeia standards• Finished good quality checking• Finished goods are checked before releasing the
products to the market.

BAD PRACTICES• Procuring of raw materials by not selecting
suppliers but through Government Tender
Procedures.
•Process validation is not convenient.
• Selecting suppliers through questionnaires without
visiting the suppliers.
•Supplier reliability is questionable• No post marketing –surveillance• lack of data after marketing the product73

INTEREST TOPICS
GMP audits- one of my primary interests is to learn

how to carry out a GMP audit. As a manufacturing
firm we are directly involved in implementing infollowing GMP regulations within the factory
premises. If we have a fair knowledge about GMP
auditing that would be an added advantage for us tocorrect our shortcomings. Also this would upgrade thelevel of standards in our organization.

Health insurance system proceed injapan• How the health insurance system proceed inJapan according to the government regulations.
• Carry out of clinical trials of the drugs and bio
equivalence testing74

Product recall proceduresas manufacturers sometimes we have to recall our
products. It is mandatory to establish a correct recall
procedure. Therefore, I would like to know thecorrect procedures of recalls and how we should
handle a quality failure of a product.

Regulations in Herbal medicine in Japan• How the herbal drugs are manufacture and how tocontrol the storing conditions for herbal products.
• Clinical trials of herbal products.

75

Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

SRI LANKA(2)

76

GOOD GOVERNANCE OF MEDICINES FOR NATIONAL PHARMACEUTICALREGULATORY AUTHORITIES(JFY 2014)
COURSE NO: J 1404123

INCEPTION REPORT ‐PART 1
by

STATE PHARMACEUTICALS CORPORATION OF SRI LANKA

77

1.

AN OVERVIEW OF PHARMACEUTICAL LAWS ,REGULATIONS IN SRI LANKA
1.1 INTRODUCTION
The Government of the Democratic Socialist republic of Sri Lanka, with a population of
21,675,648, provides free healthcare services to the nation and a fair portion of the budgetary
allocation for the health sector is invested in procurement of medicines.
Medicines are a vital and expensive component in the provision of health services hence
ensuring an adequate supply of safe and effective drugs of acceptable quality is an integral partof the health policy in Sri Lanka.
Appropriate legislation and regulations are provided to implement such a policy.
Provision of Essential Medicines is one of the elements in the primary Healthcare Package.
Even though the Government is committed to the provision of drugs free to the nation all
officials in the health system who engage in procuring, distributing, storing , prescribing anddispensing whether at national, provincial, regional or institutional level are responsible for the
supply of medicines that meet the required parameters with regards to the quality of medicines.

1.2 Organizational Chart of State Drug Management
Figure 1 depicts the Organizational Chart for State Drug Management
Roles and Responsibilitiesa) Hon. Minister of Health
Policy making such as introducing necessary amendments to the Cosmetics Devices & Drugs Act
No. 27 of 1980 which govern the regulation and administration of medicines in Sri Lanka.
b) Secretary, Ministry of Health
Implementing the Regulations and Policies
Chief Accounting officer of the Ministry of Healthc) Director General of Health Services – DGHS
DGHS is the “Drug Authority” of the country responsible for forming Drug Therapeutic
Committees. Functions of the committee would be to monitor supply, distribution andconsumption of drugs at national, provincial and institutional levels. Similarly there are Drugtherapeutic Committees for both provincial levels and regional levels.

78

Hon. Minister of Health

Secretary
Ministry of HealthDirector General of HealthServices

Deputy Director General(Lab Services)

D/MSD

Line Ministry
Health Institutions

D/MT & S/(D/CDDRA)(Drug Regulation)

SPC
Procurement

D/MSD – Director, Medical Supplies Division
D/MT & S – Director, Medical Technology & Supplies
D/CDDRA – Director Cosmetic Devices & Drugs
Regulatory Authority.
D/NDQAL – Director National Drug Quality
Assurance Laboratory
R/MSD – Regional Medical Supplies Divisions

R MSD

Provincial HealthInstitutions

Fig. 1D/NDQAL(Quality Assurance)

Organization Chart of State Drug Management79d) Medical Supplies Division ‐ MSD
The MSD of the Ministry of Health is responsible for the Consolidation of annual requirementsof drugs for the institutions under the Central Ministry and the Provincial Councils. Director,
MSD and his staff periodically visit and monitor the activities in relation to drug management in
the respective provinces/institutions.
e) Director Medical Technology & Supplies ‐D/MT & S
Head of the Drug Regulatory Authority, issuing of certificates of registration of the drugs andlicenses to import, distribute, sell and manufacture drugs under the regulations of the Act, areimplemented by the Director/MT and S.
f) Director National Drug Quality Assurance Laboratory – D/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 iscarried 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 theanalyses/evaluations.
g) State Pharmaceuticals Corporation (SPC)
The SPC has been designated as the sole procurement agency for pharmaceuticals and surgicalconsumables items required by the government health institutions. These items are imported or
locally purchase and supplied to the MSD of the Department of Health Services from where they
are distributed to government health institutions.
h) Regional Medical Supplies Divisions (RMSD)
MSD functions as the sole supplier of all the medicinal items to the public sector and these
items are distributed via the RMSD’s located in 26 divisions island wide.

2. LEGISLATION GOVERN THE PHARMACEUTICAL ADMINISTRATION IN SRI LANKA
2.1

Cosmetics Devices & Drugs Act (CDDA Act)
Cosmetics Devices & Drugs Act No. 27 of 1980 (as amended by Act No. 38 of 1984, No.
25 of 1987 & No. 12 of 1993) provides the Legislative framework to control the use ofcosmetics, medical devices & medicinal drugs in the country.
The regulations under the CDDA Act were published in Gazette Extraordinary No. 378/3
of 02.12.1985 and further amendments had been made from time to time.

80This Act controls
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.

Registration
Manufacture
Importation
Transportation
Sale (Retail & Wholesale)
Labelling
Advertising
Distribution of Drug Samples
Testing
Disposal of out dated or spoilt drugs

The main provisions of the CDDA Act with regard to Drugs
i.

ii.
iii.
iv.

Only drugs which are registered with Cosmetic Devices & Drugs Regulatory
Authority (CDDRA) can be manufactured, imported, offered for sale or used in
the country.
Licences are required for importation, manufacture, wholesale trade/retailtrade and transportation of drugs
All drugs registered with the CDDRA should confirm to specified standards.
Labelling on the packs and advertisements regarding drugs should conform to
the relevant regulations

The Cosmetics, Devices & Drugs Regulatory Authority (CDDRA) is the institution in which
the Ministry of Health has vested the authority to ensure that the Pharmaceuticals andMedical Devices and Cosmetics available to the public meet the required standard /quality and are within the existing legislative framework with respect to the Production,
Marketing and Dispensing of these items.
2.2

Poisons, Opium & Dangerous Drugs
Poisons, Opium and dangerous drugs ordinance (Chapter 218) as amended by Act No.
13 of 1984 regulation
a)
b)
c)
d)

Importation
Storage
Distribution
Use of poisons, opium and dangerous drugs.

813. REGULATORY SERVICES
3.1 Drug Import/Export
Drug import to Sri Lanka can be divided in to two categories such as imports to public sector andprivate sector. For the public sector drugs are imported mainly through State Pharmaceuticals
Corporation by adhering to International Competitive Bidding procedure. They procure all
Pharmaceuticals Surgical Devices for the Medical Supplies Divisions, which is the main unit
responsible in distributing drugs and related items to the State sector hospitals.
The following conditions are laid down in the Bidding Document /Procurement Guidelines forthe purchase/Importation of Pharmaceuticals by SPC.


CDDA Registration
Pre Qualification
Technical Evaluation
Inspections/Testing of samples

International Competitive Bids are called from Pre‐qualified sources.

A) Registration with CDDAI.

All pharmaceuticals imported to Sri Lanka should be registered with theCosmetics Devices & Drugs Authority of Sri Lanka.

ii.

SPC shall request the prospective bidders to attach a notarially certified copy ofthe original registration certificate and any registration certificate whereapplicable to the bidding document which should be valid until at least six
months after the last consignment of the pharmaceutical to be procured are
due to be received in Sri Lanka.

iii.

The requirement may be waived off in exceptional circumstances which isreferred to as Emergency & Urgent procurement upon the issue of a ‘No
Objection Letter” (NOL) by CDDA.
Documents to be submitted to issue a No Objection Letter
1.
2.
3.
4.
5.

Generic name and Trade name
Information on the dosage form
Product information leaflet
Storage and stability information
Certificate of Analysis

82

6. Information on the manufacturer such as
I.
II.
III.
IV.
V.

Address, contact details, etc.
GMP certification
COPP
List of countries where the drug is registeredSample of the drugB) Pre Qualification of Suppliers for Multi‐Source Productsi.

Pre‐qualification is carried out for Multi‐Source products only for the purposes of
evaluating supplier/manufacturer capacity and reputation before bids are solicited forspecific products, and is product specific and linked to specific manufacturing units.

ii.

Pre‐qualified Suppliers/Manufacturers
The list of pre‐qualified suppliers/manufacturers for each product is revised at least
once in every three years.

Continuous efforts are made by SPC to seek out potential suppliers/manufacturers in order tomaintain competitive pressure on established suppliers/manufacturers that had been pre‐qualified previously.
The pre‐qualification process is based on documentation only.
C) Technical Evaluation
Technical Evaluation is carried out by an expert committee appointed for each and every
procurement.
D) Inspection/Testing of Samples
i. Tender/Bid Samples
Tender Samples are tested of new suppliers to SPC.
ii. Pre‐shipment Samples
Pre‐shipment samples are tested depending on the nature of the product and thereliability of the supplier reliable of new supplier to SPC.
iii. Post Delivery Samples
In instances where pre shipment samples testing could not be permitted due to urgencyof the requirement posted delivery samples are tested of new suppliers to SPC.

83

3.2 Pharmaceutical Manufacturing
Both public and private sectors are involved in pharmaceutical manufacturing in Sri Lanka. A
manufacturer must obtain a license for manufacturing from the Drug Regulatory Authority. A
separate license for manufacturing each item should be obtained from the Drug Regulatory
Authority. This license can be provisional which is valid for one year, and can be a full registration(5 years). Good Manufacturing Practices for manufacturing processes are monitored and given by
DRUG Regulatory Authority.
3.3 Marketing Authorization
Marketing authorization is either taken by the manufacturer to market the products
manufactured or by importers from Drug Regulatory Authorities. All these functions aremonitored and authorized by the Drug Regulatory Authority under Cosmetic Devices and Drugs
Act.
3.4 Drug Distribution
For public sector, drug distribution is mainly controlled and monitored by Medical Supplies
Division (MSD). This is a centrally located government organization under Ministry of Health, andthere are provisional supplies divisions to supply medicines to other regional hospitals (RMSD).
SPC is responsible for procuring medicines, surgical items and devices for government sector
hospitals. Private hospitals procure their requirements directly from available drug manufacturers
or suppliers. Apart from this there is government own pharmacies known as “Osu Sala out lets”
managed by State Pharmaceuticals Corporation (SPC). SPC is responsible in supplying medicinesand other additional pharmaceutical products for all the pharmacies (Osu Sala out lets) locatedisland wide and to its distributors and Franchise Osu Sala out lets.
3.5 Medicine Safety/Post Marketing Surveillance
In Sri Lanka there is no such organized system for post marketing surveillance. But the National
Drug Quality Assurance Laboratory (NDQAL) check the quality of Drugs Manufacture in Sir Lanka
and Imported to Sir Lanka randomly or on a complain . NDQAL monitor the safety and efficacy ofdrugs in circulation within the island.
3.6 Relief system/adverse drug reactions
In an event of an adverse drug reaction a doctor or the patient can submit the details of adverse
drug reactions to the pharmaco vigilance unit located at the Department of Pharmacology, Facultyof Medicine, and University of Colombo.

843.7 Issues on pharmaceutical regulatory services – in view of State Pharmaceuticals Corporationand State Pharmaceuticals Manufacturing Corporation of Sri Lanka
(i)
(ii)
(iii)
(iv)

4.

Inflow of substandard pharmaceuticals to the country has an impact on national healthcare
system, proper therapeutic administration and fair play in the market.
Lack of sufficient number of trained personnel for regulatory affairs of the industry andissues arising out of lack of adequate actions on regulating the industry.
Lack of facilities for scientific testing/researches on acceptability of products for registration,
quality related issues, post market surveillance.
Lack of proper storage facilities in Regional Drug Stores and Drug Stores of Government
Hospitals.

DRUG PRICING
Public sector in Sri Lanka is free of charge. They procure drugs according to government tender
procedures. Therefore, those who bid for the tender will govern the price. However apart fromthis the government also procures drugs directly from SPMC. Prices for these drugs are negotiatedbetween the two governmental organizations. In the case of private sector there is no such
regulation in prices. Same drug is available in different prices in the market.

5.

STATISTICAL DATA

Categorya) Number of pharmacistsb) Number of inspectorsc) Number of Pharmaceuticald) Manufacturerse) Number of traditional medicine
manufacturersf) Number of pharmaceutical importersg) Number of pharmaceutical whole sellers

85

Data
6311
40
30

Year
2013
2013
2013

Statistical data not available
211
57

2013
2013

Good governance of medicines for pharmaceutical regulatory authorities

Current situation and experiences of good and bad practices

State Pharmaceuticals Corporation of
Sri Lanka

Contents• Primary Functions of SPC and functions ofprocurement and imports Division of SPC• Regulatory services pertaining to SPC• Recent achievements in regulatory services• Experiences about bad practices• Topics of interest

86Primary Functions of SPC and functions ofprocurement and imports Division of SPC
Vision:To become the prime partner indeveloping a Healthier Nation.
Mission:To be the leading healthcare organization
serving the general public of Sri Lanka byproviding safe, effective and high-quality medical
products and health services at affordable prices,while promoting the usage of generic drugs.

Primary Functions of SPC and functions ofProcurement and Imports Division of SPC
1. Procurement of Pharmaceuticals, Surgical
Devices, laboratory items for all government
hospitals.
2. Retail selling of pharmaceuticals and surgicalitems through private retail network (31 SPC
Pharmacies – Osu Sala outlets), Franchise dealers(101) and wholesale distributors (52).

87

Primary Functions of SPC and functions ofprocurement and imports Division of SPC Contd..
Procurement and Imports Division• Making recommendations for policy formulation,
preparation of plans pertaining to procurement ofPharmaceuticals and surgical items• Sole Procurement Agent of Pharmaceuticals andSurgical Items to the State sector• Procurement of pharmaceuticals to the Open Market
for SPC pharmacies (Osu Sala outlets ) and SPC
distributors island wide
• Preparation of bidding documents with conditions tobid including regulatory procedures for the inflow ofsafe effective and quality assured medicinal products.

Flow chart depicting State Sector
Procurement
Receive Requisition
from MSD

Flow chart depicting Open Market
Procurement
File received by IMPORTS(with Approved Speck &Qty. Confirmation)

Obtain Approval
to invite Bids

Head
Of Dept.

D.P.C

MPC

R/Q invited & Published inNews Papers

SCAPC

Appoint a
TEC

Tender Closed and Offers
are Scheduled

Get theSpeck & T/I
approved

Publish T/I in
web & News
Papers (W/W)

Post /Fax T/I toselected Parties
via Rgd. Post
(R/Q)

ICD Information Sheet+Pvt. Sector Supplier
Details

Post / Fax T/I
to the only
source (D/Q)

Approval fromMarketing

Close theTender
Open Tender
Box & announce

Schedule
Tenders

Technical
Evaluation

Procurement Unit
Tender Award

Award
Processing

88

Requisition raised by
I.C.D

Drug Regulation in Sri Lanka• Cosmetics Devices and Drugs Act No 27 of1980 with subsequent amendments provides
the legislative framework to control the use ofcosmetics, medical devices and medicinaldrugs in the country.
• The regulations under the CDD Act were
published in gazette extraordinary no 378/3 of
02/12/1985 and further amendments weremade from time to time.

• CDD Act controls– Registration– Manufacture– Importation– Transportation– Sale (Retail and whole sale)– Labelling– Advertising– Distribution of Drug Samples– Testing– And Disposal of outdated and spoiled drugs.

89

Main provisions of the CDD Act withregards to drugs.
•Only drugs which are registered with the authority canbe manufactured, imported, offered for sale or used in
the country•Licenses are required for importation, manufacture,
whole sale trade / retail trade and transpiration ofdrugs.
•All drugs registered with CDDA should conform tospecified standards.
•Labelling on the packs and advertisements regarding
drugs should conform to the relevant regulations.

A technical Advisory committee (TAC) has been setup under this act toadvise the Hon. Minister of Health on matters pertaining to theimplementation of the Act.

Regulatory services pertaining to SPC• Pre-Qualification of suppliers of multisource
products for invitation of bids.
• Bidding Documents impose Conditions toregulate the supply of quality assured drugs.
• At the time of submission of bids, thefollowing documents are requested.

90

Documents to be attached to the bid• A Copy of CDDA Registration Certificate – (Notary certified)• Registration with Dept of Registrar of Companies.
• Letter of Authorization ( if any party other than manufacturer isthe bidder / tenderer)• Power of Attorney if any other party other than the bidder (eglocal agent ) has signed the bidding form.
• Certificate of Pharmaceutical Product (CPP)• Sample submission acknowledgement obtained from
Administration Division of SPC• Form to be filled by Local Manufacturers who claim Domestic
Preference (Annex V of Global Bid Document)• An Affidavit to certify the genuineness of all documents s

A Copy of CDDA Registration Certificate – (Notary certified)12

91

Technical Evaluation of Bids
• Tender Samples are tested of new suppliers /suppliers with previous batch withhold /withdrawals.
• A technical Evaluation Committee appointed
comprising of Technical Expertise evaluate thebids and select the lowest responsive bidder
and makes its recommendation to theProcurement Committee to make an award.

Pre-Shipment /Post Delivery Sample testing• Based on the nature of the product, products
from first time suppliers and depending on theavailability, TECs / Procurement Committees
decide on the testing of pre-shipment
samples.
• SPC Quality Assurance Laboratory carries out
testing samples for SPC Open Market
Supplies.
• National Drug Quality Assurance Laboratory(NDQAL) testing for State Sector supplies

92Quality Failures detected by NDQAL
Quality Testing by NDQAL

Single Batch
failureOnly the particular batch
to be withdrawn from themarketMultiple
Batch failure

Product failure (In case ofwithdrawal of 05 batches)

All batches
mentioned to bewithdrawn

Total product to bewithdrawn

Then suppliers license will
be withdrawn by the Drug
Regulatory Authority

Drug Regulation• The Health Ministry of Sri Lanka has taken steps
to increase the number of Pharmacists andInspectors at Cosmetic Devices and Drugs
Authority ( CDDA )• The data base of the Drug Regulatory Authority
has been updated with the assistance of WHO• The fourth amendment to the CDDA Act has beenenacted• Drug Evaluation Sub Committee DESC evaluate
and strengthen Drug Registration at CDDA

93

Recent Achievements in Regulatory
Services• Compiling the 05th Revision of National List of
Essential Medicines 2013-2014• Pre-Qualification of suppliers of multisource
products by SPC and inviting bids from prequalified sources.
• Preparation of Guidelines on Re-call procedure
for medicinal drugs.
• Preparation of Draft bill of the National Drug
Policy making the Drug Regulatory Authority amore independent body.

Suspected Defective
Medicinal Drugs

Pass

Adverse Drug Events

Through CDDA

Yes

NDQAL

Analysis
NeededInform to
the SourceNo
Failrecommendations

Recommendations

CDDA

Defective Medicines Review Committee

Regulatory Action / Recall

94

Safety of Medicine
and Risk Evaluation
Sub Committee(SAFRESC)Experiences about Bad Practices• Even with comprehensive regulations Eg. CDD Act andBidding Conditions, still the problem of inflow ofsubstandard drugs persist.
• No. of complains received for year 2013 with regards topharmaceuticals is 205• During the year 2013, all products of 02 Indian drug
manufacturers were withdrawn and SPC had to face anurgent procurement situation.
• Some of the examples of bad practices SPC experienced
during the year 2013

– Adrenaline injection supplied by M/S Poonam Pharmaceuticals
India contained 02 vials without labels which later revealed to
be Atropine injection. This was a severe mishap.

Experiences about Bad Practices Contd.
– 03 batches out of a consignment of Rabies Vaccine (for human use)
were less in potency when the summary protocol was inspected by the
Medical Supplies Division (MSD)– 123 Cartons of Rabies Vaccine were exposed to normal temperature
conditions (Whereas the temperature should be maintained at 2 °C - 8°C) at Air Port due to the negligence of the Air Cargo Handling Staff .

95

Current Problems• CDDA registration granted mainly on documentation.
Hence, paves the way for the submission of forge
documents by errant suppliers.
• Even though the regulations prevail, due to various issues
no regular inspections are carried out by CDDA.
• No routine GMP inspections are carried out by CDDA.
• No routine post market surveillance due to lack of facilities
at NDQAL.
• Non availability of proper storage conditions in drugs storesof Hospitals Etc.,• Non availability of proper transport facilities required for
drug transport.
• Bad Handling of cargo at the Airport leading to cold chain
breakage

Current problems Contd.
• Pre-Qualification by SPC carried out only on
documentation.
• Pre-Qualification applied only for multisource
products.
• No regular system of testing due to inadequate
laboratory facilities.
• In Sri Lanka, the Local Manufacturers base is very
poor. Therefore, imported drugs constitute morethan 75% of the current requirement and quality
failures amounts to 82 suppliers from a supplierbase of (Imports) 236. 34.7% for the year 2013.

96

Recent Achievements in the Health Sector withregards to Quality Assurance of medicines.
Consideration to be given to the creation and legislation of a new
statutory body in the health infrastructure, the "National Medicinal Drug
Regulatory Authority (NMDRA)“
Progress• Achieved 100% political commitment• A new Drug Act / policy have been formulated• The Cabinet of Ministers approval was granted for same.
• Currently in the process of getting the public opinion on the Draft Bill
• It will be finalized with stakeholder suggestions and will be
submitted to the parliament for the formal legislation• Under this act the proposed NMDRA will be established.
• It will be an independent body
Parties Responsible – Sec/MOH, Legal Draftsman

Topics of interest• Counter measures against the supply of
quality failed sub standard drugs.
• Best Practices in drug regulation adopted inother countries.
• Monitoring and surveillance procedures ofother countries

97Good Governance of Medicines for National
Pharmaceutical Regulatory Authorities

TANZANIA

98

Good Governance of Medicines for
National Pharmaceutical Regulatory Authorities （JFY 2014）

Format for Inception ReportCountry: TANZANIA
Organization/Department/Division:

MoHSW/PSUPart I: ＩＮＦＯＲＭＡＴＩＯＮ ＳＨＡＲＩＮＧ
Why?
→ To share the basic information related to pharmaceutical administration in each country.
What? → Information that overviews each-other situations in regard to pharmaceutical laws, regulations, and etc.
When? → Before or at the arrival to Japan→ Collected information will be summarized; then it will be sent to each participant. Participants will read carefully & understand it.
How?
1) Organizational Chart−Please attach the organizational chart at national/state & local levels about pharmaceutical administration in your country.
−Please briefly describe each role and responsibility on pharmaceutical administration.
※ Please see the attached sample A as a reference.

The quality, safety and efficacy of pharmaceutical products (medicines, medical devices and related products) are regulated by Tanzania
Food and Drugs Authority (TFDA), a goverment regulatory body under the Ministry of Health and Social Welfare (MOHSW). The Director
General of TFDA is responsible for daily operations of the organization. S/he reports to the Permanent Secretary of the MOHSW and the
Chairperson of the Ministerial Advisory Board (MAB) which advices the responsbile Minister for policy and strategic issues of TFDA.
2) Legislation on pharmaceutical administration−Please briefly bulletined major laws/acts◆National Level
Oversight of regulatory issues administered by
Medicines policy issues
administered by◆Local Level
Inspections at regional levels
Inspections at Council levels

administered byadministered by

TFDA
Pharmaceutical Services Unit (PSU) in the Ministry of Health and Social Welfare (MoHSW)
Regional Health Management Teams (RHMTs)
Council Health Management Teams (CHMTs)◆PIC/SNo3) Regulatory Services−Please describe pharmaceutical regulatory services of your country in response to each item provided below.
−Please add anything (systems, regulations, etc) related to the following services & briefly describe who administers it.
−Please prepare to explain your answer in case that you are asked about pharmaceutical regulatory services of your country.
◆ Drug Import/Export
・ Systems, Regulations, etc
There is a designated department under the National Drug Regulatory Body which isadministered bylooking after import and export control of medicines and related products. There areadministered by
Medicines Import and Export Control Guidelines and specific Standard Operating
Procedures (SOPs) which are used at Headquarters as well as Zone offices and Ports
of Entry (POE). respective Regulations under the Tanzania Food, Drugs and Cosmetics
Act, cap 219 are in the final stages of been approved, as to strengthern legal frameworkin the control systems. Inpectors have been allocated in all POEs whereby they use
stationed Minilab kits for preliminary screening of imported and/or exported medicines
before approval. All applications are received and processed, the necesary fees paid
and approval grated through established Management Information System (MIS).
through implemtation of Quality Management System (QMS), TFDA is also compliant to◆ Pharmaceutical Manufacturing
・ Systems, Regulations, etc
GMP Guidelines as well as Inspection Manual have been developed and are under use administered by
There is a designated GMP desk and responsible desk officer/custodian who reports to
the Manager, Medicines Inspection and Enforcement at TFDA. Inspectors checklists
and SOPs are used purposefully to ensure compliance to minimum GMP and GLP
requirements during pharmaceutical manufacturing sites inspection including the sites'
QC labs.

TFDA

TFDA
administered by※Example: Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice

99

TFDA
TFDA

◆ Marketing Authorization
・ Systems, Regulations, etc
Medicine information/dossiers are evaluated by well trained and experienced
administered byevaluators. Respective samples are analysed in the WHO pre-qualified TFDA Medicine
Laboratory to ascetain their quality, safety and efficacious standards before marketing
authorization. There are Application Guidelines for Evaluation and Registration ofhuman medicines which guide the evaluators during asssesment of dossiers. Moreover,the laboratory reports (of analysed medicine samples) form part of decicion criteria formarketing authorization by comparing with Evaluation report and respective
manufacturing site GMP status. All applications are received and processed, thenecesary fees paid and approval grated through established Management Information
administered by
System (MIS). QMS implemetation is also observed.

TFDA

TFDA

※Example: Good Quality Practice◆ Drug Distribution (including drug selection, procurement, sale)・ Systems, Regulations, etc
administered by
MSD
Its administered by National Medicines Procurement Agency named Medical Stores
Department (MSD) which is again under the Ministry of Health and Social Welfare.
TFDA has established Medicine Good Disribution Practice (GDP) Guidelines which are
to be adhered to by MSD and other private firms resposible for medicines distribution
and supply management. Responsible Regulations for Premises Registration, Import &Export Control of medicines are in final/good stages of development.
Essential Medicines List and Standard Treatment Guidelines is administered by the Pharmaceutical Services Unit in the Ministry of Health※Example: Good Distribution Practice◆ Medicine Safety (post-marketing)・ Systems, Regulations, etc
administered by
There is developed 3 years PMS programme whereby selected medicines are being
administered byfollowed up to the market and samples taken to TFDA Laboratory for checking their
quality, safety and efficasions standards before proposing way forward to Management
team.

TFDA

※Example: Good Pharmacovigilance Practice◆ Relief System for Adverse Drug Reactions
・ Systems, Regulations, etc
A passive way using YELLOW, prepaid forms to collect ADRs has proved low reporting administered byrate by HCWs (around 60 ADRs/year). A designated Cohort Event Monitoring (CEM)
which is an active strategy has been introduced to complement the passive initiative
whereby around 9,700 cohorts were reported in the first year of implemetation(2008/09).
4) Drug Pricing−Please describe about price control and drug price mechanism at public sector in your country.

TFDA

Pharmaceutical Services Unit conducts price survey frequently in collaboration with WHO. National Health Insurance Fund also sets prices5) Statistic Data
−Please answer the following questions (if the number is not applicable, please give an answer to the best of your knowledge).
−Put the year of the presented data as well if it's available
by considering that all TFDA Pharmacists are GMP inspectors
1: Number of pharmacists
1080
-2014
2: Number of GMP inspector (National & Loc
46-2014
3: Number of pharmaceutical manufacturers / manufacturing sites
11-2014
4: Number of traditional medicine manufacturers / manufacturing sites
1-2014
5: Number of pharmaceutical importers
80 + 24-2014
80 are those paying 2% FOB whereas remaing 24 are exempted ones including
FBOs, International NGOs such as CHAI, hospitals like KCMC, and Rawmaterials importation etc
6: Number of pharmaceutical wholesalers273-2014 After enactement of the Pharmacy Act, 2011 all wholesalers who are notimporters are regulated by the PC whereas TFDA remain with Importers of

100

101

DIAGNOSTIC AND HEALTH CARETECHNICAL SERVICES SECTION

TRADITIONAL AND ALTERNATIVEMEDICINE SECTIONORAL HEALTH SERVICES SECTIONNON-COMMUNICABLE DISEASES,MENTAL HEALTH AND
SUBSTANCE ABUSE SECTIONENVIRONMENTAL HEALTH,HYIGENE AND SANITATIONSECTION

HEALTH EDUCATION AND
PROMOTION SECTION

NUTRITIONAL SERVICESSECTION

PUBLIC AND PRIVATE HEALTHSERVICES SECTIONCURATIVE SERVICES DIVISIONREPRODUCTIVE AND CHILDHEALTH SECTIONEPIDEMIOLOGY AND DISEASECONTROL SECTIONPREVENTIVE SERVICESDIVISION



SOCIAL WELFARE STAFF
DEVELOPMENT SECTIONCONTINUING EDUCATIOTION AND
POSTGRADUATE TRAINING SECTIONNURSES SERVICES TRAINING SECTION

ALLIED HEALTH SCIENCES TRAINING
SECTIONNURSING SERVICESSECTION

HEALTH EMERGENCE
PREPAREDNESS ANDRESPONSE SECTIONHEALTH SERVICESINSPECTORATE AND QUALITYASSURANCEPHARMACEUTICALSERVICES UNIT

HEALTH QUALITYASSUARANCE DIVISION

GOVERNMENT CHEMIST LABORATORYTANZANIA FOOD AND DRUGS AUTHORITYLEGAL SERVICES UNITPROCUREMENT MANAGEMENT UNIT

GOVERNMENT COMMUNICATION UNIT

SOCIAL WELFARE DIVISIONPEOPLE WITH DISABILITY AND
ELDERLY PERSONS SECTIONJUVENILE JUSTICE SERVICESSECTION

FAMILY, CHILD WELFARE SERVICES
AND EARLY CHILDHOOD
DEVELOPMENT SECTIONADMINSTRATION AND HUMAN RESOURCES MANAGEMENT DIVISIONHEALTH HUMAN RESOURCESPLANNING SECTION

HUMAN RESOURCEDEVELOPMENT DIVISIONCHIEF MEDICAL OFFICERINFORMATION AND COMMUNICATIONTECHNOLOGY UNIT

INTERNAL AUDIT UNITFINANCE AND ACCOUNTS UNIT

POLICY AND PLANNING DIVISIONPERMANENT SECRETARYMINISTER(Approved by the President on 3rd June, 2011)

THE ORGANISATION STRUCTURE OF THE MINISTRY OF HEALTH AND SOCIAL WELFARE-TANZANIA.

102

103

PHARMACEUTICAL
MANAGEMENT IN TANZANIAMINISTRY OF HEALTHAND SOCIAL WELFARE, TANZANIA
1PRESENTATION LAYOUT
 Introduction
 Local production of pharmaceuticals in Tanzania
 Pharmaceutical Policies and Guidelines

 Key

Players in the Provision of Pharmaceutical
Services Medicine
Supply System in Public HealthFacilities
 Challenges in the Pharmaceutical Sector
 Initiatives to Improve Availability of Medicines Conclusion
2

104

INTRODUCTION I’m heading PSU since November 2012, major dutiesare: Provide stewardship of the pharmaceutical sector in the country Formulate and review
medicines policies, regulations &guidelines.
 Forecast national requirements and plan for medicines andhealth supplies.
 Promote the development of domestic pharmaceuticalmanufacturing.
 Develop, oversee and support the pharmaceutical management,
logistics systems.
 Develop and review mechanism to control and monitor pricesof 3essential medicines.


Local Production of Medicines About 80% of medicines are imported from outside There are about 10 local producers of medicines and one

producer of Traditional Medicines.
 GMP compliance is still a challenge to most local
industries
 Promotion of local producers is currently a high agendaof the Ministry of Health A ten years Strategy to Promote Local Industries has
been developed

4105

PHARMACEUTICAL POLICIES ANDGUIDELINES
 To

ensure citizens have access toaffordable quality, safe and efficacious
has
medicines,
thegovernment
developed
pharmaceuticalpolicies,
strategies and guidelines.
 Medicines
Policy ensures that all
stakeholders know their roles, rights andobligations in relation to management of
medicines
andrelatedsupplies,
particularly provision and availability
5

PHARMACEUTICAL POLICIES ANDGUIDELINES Cabinet

approved the first National
Medicines Policy in 1991
 The achievement of the 1991 Policy includes
establishment of Pharmaceutical Services Unit (PSU-MoHSW) Medical Store Department (MSD) under
MSD Act 13 of 1993
 Tanzania Food and Drug Authority TFDA,
under the Food and Drug Act No 1 of 2003
 Pharmacy Council under the Pharmacy Act,
No. 7 of 2002
Note: The revised Policy is waiting Cabinet
approval
6106PHARMACEUTICAL POLICIES ANDGUIDELINES
 Standard

Treatment Guidelines make decisions
about appropriate treatment for specific clinicalconditions
 The essential drug concept stresses the selectionof medicines to meet the real public needs
National STGs and NEMLIT in Tanzania First edition in 1991
 Second edition in 2003
 Third edition in 2007 Fourth edition 2013
7

KEY PLAYERS IN THE
PHARMACEUTICAL SECTOR
TFDA(Regulate
Pharmaceuticals)

MoHSW

PSU
(Overseeprovision of
medicines&
supplies

8

MSD(Procurement&Distribution)

PC(RegulationofPersonnel)

Regional, Hospital & District Pharmacists, RHMT, CHMT,HMT,TC,HFGC,
Village Committee, HF
107

Medicine Supply System in Public HealthFacilities

Supply Driven
System (EDP
Kit)
From
1984 - 2008

DemandDriven System(Indent)
From 19992009

DemandDriven System(ILS)
From 2005- To
date

9Challenges in Medicines Management Regardlessof the Government efforts toensure availability of essential medicines,
public health facilities still face shortage ofthese crucial commodities.
 The government budget is limited
 There is a disproportion between the funds
available for the purchase of medicinescompared to the real requirement
 Irrational use of medicines Human resources for the pharmaceuticalsector is a crisis
 Access of quality data for decision making
 Pile up of expired medicines
10108

Initiatives to Improve Availability of Medicines Direct Deliver to Health Facilities
 Health facilities have been experiencing stockouts of essential medicines and medical supplies
attributed by delayed delivery, non-delivery ofright quantities, and delivery of expired products Currently, MSD is delivering medicines andrelated supplies direct to all public healthfacilities in the country

11

Initiatives to Improve ….
 New Medicine Allocation Formulae The

PSU allocates the funds ‘vertically’
between several levels of hospitals, healthcentres and dispensaries
 The vertical resource allocation formula results
in a share of about 50% for PHC, 40% for
hospital levels and 10% other hospital supplies

12

109

eLMIS (eLMIS) was developed through a partnership between

the Ministry of Health and Social Welfare (MOHSW) in
Tanzania and the Ministry of Health (MOH) in Zambia.
 eLMIS is a web-based application which computerizes

existing paper-based logistics management information
systems (eLMIS) and is in line with National e- Healthstrategy that was launched in 2013.
 Currently the system is live operating in 162 district
councils and some reports are now being received at
MSD
13

eLMIS vision
An effective and sustainable electronic logistics management
information system (eLMIS) should be user friendly andfacilitate adequate quality and quantities of healthcommodities* that are always available at the point ofservice to meet patient demand. The eLMIS must provide
integrated access to:
Accurate, timely and routine consumption data Real-time logistics management capabilities covering point oforigin to point of consumption
 Demand forecasting, capacity planning & modeling based on
consumption
(* vaccines, medicines, medical & diagnostic supplies, etc.)
14

110

LMU
This is a Logistic Management Unit establishedin 2013 tocoordinate with all supply chain stakeholders with the following
objectives;
1.Coordinate logistics management activities of all commodity

categories under one unit through harmonizing national healthcommodities supply chains throughout all Programs ( HIV &AIDS commodities, PMTCT, RCHS etc.)

15

Supply Chain Actors in Tanzania

111

Medicines supply systems in TANZANIA. 2007
ESSENTIAL
MEDICINES

ARVs

MALARIA

TB

REAGENT
Blood safety(+ HIV test)

ARVs
Ped

OI

United Republic of Tanzania

VACCINES CONDOMS CONTRACEPTIVESMEDICAL
SUPPLIES

GOVERNMENT
BILATERALDONOR
MULTILATERAL
DONOR
NGO/PRIVATE

C
S
S
C

SourceOf Funds

Procurement
Agent/Body

W
H
O

TEC
&
CCT

S
I
D
A

N
O
R
A
D

C
L
I
N
T
O
N

U
N
I
T
A
I
D

C
I
D
A

H
A
V
A
R
D

H
A
V
A
R
D

MEDICALSTORE

Point of 1st
warehousing

TEC
&CC
T

Point of 2nd
warehousing

TEC
&CC
T

REGIONAL/DISTRICT
VACCINE STORE

Point ofDistribution

TEC
&CC
T

ZONAL BLOOD
SAFETY CENTRE

HOSPITAL

CRS

P
E
P
F
A
R

IMA

GLOBAL
FUND

C
R
S

C
L
I
N
T
O
N

S
C
M
S

A
X
I
O
S

E
G
P
A
F

MEDICAL STOREZONAL MEDICAL STORE

DISTRICT STORE

P
F
I
Z
E
R

MOH
&
SW

GOVERNMENT

A
X
I
O
S

AXIOS

U
N
I
C
E
F

J
I
C
A

C
D
C

J
I
C
A

C
D
C

C
O
L
U
M
B
I
A

A
B
B
O
T
T

C
O
L
U
M
B
I
A

A
B
B
O
T
T

HEALTH FACILITY COLUMBIAHEALTH FACILITY

G
A
V
I

G
A
V
I

C
U
A
M
M

U
N
I
C
E
F

C
U
A
M
M

HOSPITALCROWN
AGENTS

U
S
A
I
D

W
B

U
S
A
I
D

T
M
A
P

CUAMM

HOSPITALHEALTH FACILITY

PRIMARY HEALTH CARE FACILITYHOSPITALPATIENTLMU
2.

Strengthen logistics data management and visibility

3.

Link different organization levels and partners within
supply chain to improve health commodities

availability at the national level
4.

Identify supply chain bottlenecks, brainstorm

mitigation strategies and collaborate with key players
involved to implement those interventions.

18

112

LMU
-

Currently the LMU staff are located in all MSD zones

to ensure timely data availability and implement
MOHSW vision and Mission to ensure uninterrupted

supply of Health commodities.

19

LMU functions
 Logistics Data Management

 Quantification Coordination to all vertical

Programs and MSD
 Monitoring & Evaluation
 Coordination and Collaboration
 Supply Chain Intervention Planning ( Review and
Advice) Training & Capacity Building Supervision
20

113

LMU Benefits to All SC stakeholder
 Improved data quality and visibility for all programs Improved inventory management system
 Strengthened supply chain management at lower

levels Improved coordination and collaboration
 Improved commodity availability

21

Topics of my interests in the course Promoting GMP standards for local industries andmeasure to improve local productions of pharmaceuticals

 Improving Pharmaceutical Supply Chain Systems
 Measures to curb Substandard/Spurious/ Falsely-labelled/falsified /Counterfeit Medical Products

22

114

CONCLUSION
Drug management strengthening is
an important and sensitive healthsystems
entitythatrequiressystematic interventions to avoid stockouts that cause negative effects on the
population.

23

115