Lok Sabha Question No. 778 (UNSTARRED), answered on 2024-11-29
Subject: Production of Quality Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri K C Venugopal

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 778 TO BE ANSWERED ON THE 29 TH  NOVEMBER 2024

## Production of Quality Medicines

## 778. Shri K C Venugopal:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) the measures being taken by the Government to produce quality medicines for all the people across the country;
- (b) whether pharmaceutical industry in the country is working to address the challenges posed by climate change, biodiversity and environmental impact;
- (c) if so, the details thereof; and
- (d)  the  measures  being  taken  by  Government  to  ensure  new  and  innovative  means  of drugs/treatment are made available in rural and tribal areas of Kerala?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

- (a): Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare  have  taken  various  measures  to  ensure  quality,  efficacy  and  safety  of  medicines manufactured in the country. The key measures are as stated below:
- i. In  order  to  assess  the  regulatory  compliance of  drug manufacturing premises in the country, the Central Drugs Standard Control Organization (CDSCO) along with State Drugs Controllers  (SDCs) have conducted  risk-based  inspections  of  more  than  400 premises. The firms have been identified based on risk criteria like number of drugs declared as Not of Standard Quality. complaints, criticality of the products etc. Based on findings of inspections, more than 300 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.
- ii. Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices  and  requirements  of  premises,  plant  and  equipment  for  pharmaceutical products.  As  per  the  amendment,  the  revised  Good  Manufacturing  Practices  and Requirements shall come into force for manufacturers for implementation as under:

| Category of manufacturers [Based on turnover (INR)]                                | Time line for implementation                            |
|------------------------------------------------------------------------------------|---------------------------------------------------------|
| Large Six months manufacturers from the date (Turnover> of publication 250 crores) | Six months from the date of publication of these rules. |

Small and Medium manufacturers (Turnover of these rules. 250 crores)

Twelve  months  from  the  date  of publication of these rules.

- iii. On 17.11.2022, the Drugs Rules, 1945 were amended vide G.S.R. 823(E) which has come into force from 1st of August. 2023 providing that the manufacturers of top 300 brands of drug formulation products, as specified in Schedule H2, shall print Or affix Bar  Code  or  Quick  Response  Code  on  its  primary  packaging  label  or,  in  case  of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication.
- iv. On 18.01.2022. the Drugs Rules, 1945 were amended vide G.S.R. 20 (E) providing that every Active Pharmaceutical Ingredient (bulk drug) manufactured or imported in India shall bear Quick Response Code on its label at each level of packaging that store data or information readable with software application to facilitate tracking and tracing. The stored  data  or  information  shall  include  the  minimum  particulars  including  unique product identification code, Batch Number, Manufacturing date, Expiry Date etc.
- v. On 11.02.2020, the Drugs Rules, 1945 were amended vide G.S.R, 101 (E), providing that with effect from 01.03.2021 any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these Rules.
- vi. The  Drugs  and  Cosmetics  Act,  1940  was  amended  under  Drugs  &  Cosmetics (Amendment) Act 2008 to provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable.
- vii. States/  UTs  have  set  up  special  Courts  for  trial  of  offences  under  the  Drugs  and Cosmetics Act for speedy disposal.
- viii. To ensure efficacy of drugs, the Drugs and Cosmetics Rules, 1945 have been amended providing that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of some drugs.
- ix. The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the  grant  of  manufacturing  license,  the  manufacturing  establishment  is  to  be inspected jointly by the Drugs Inspectors of Central Government  and State Government.
- x. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.
- xi. Central  regulator  coordinates  activities  of  State  Drug  Control  Organisations  and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.
- xii. Central government is providing regular Residential, regional training and workshops to CDSCO, State Drug Regulatory Authorities on Good Manufacturing Practices. In the training Financial Year 2023-24 CDSCO has trained 22854 persons while in F.Y 2024-25 so far 13007 persons have been trained.
- xiii. Further, for strengthening the drug regulatory system in the country both at the Central and State level, the Government had approved Rs.1750 Crore. Out of this, Rs. 900 Crore was for strengthening the central drug regulatory structures and Rs. 850 Crore is for the Centrally  Sponsored  Scheme  Strengthening  of  States'  Drug  Regulatory  System (SSDRS) which envisages to strengthen the laboratory infrastructure and upgradation of existing State Drug Controller offices in States. So far under the SSDRS scheme, 17

New Drug Testing Labs have been constructed and 24 existing labs have been upgraded.

(b) to (c): Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products. Manufacturers are required to comply with Good Manufacturing Practices as prescribed under Schedule M to the Drugs Rules, 1945. As per the GMP requirement, the disposal of sewage and effluents (solid, liquid and gas) from the manufacturing area shall be in conformity with the requirements of the guidelines issued by the Environmental Pollution Control Board and all  bio-medical  waste  shall  be  destroyed  as  per  the  provisions  of  the  Bio-Medical  Waste (Management and Handling) Rules, 2016

(d): As  per  the  information  provided  by  the  State  Government  of  Kerala,  state  has implemented several initiatives to ensure that tribal and rural population have access to new and innovative treatments as follows:

## (1)   Healthcare Infrastructure:

## (i) Primary Health Centers (PHCs) and Community Health Centers (CHCs):

The state has established a network of PHCs and CHCs in rural and tribal areas to provide basic healthcare services.

(ii) Sub-Centers:  These  smaller  health  facilities  are  located  in  remote  areas  to improve accessibility.

(iii) Mobile Medical Units: These units travel to remote areas to provide healthcare services, including vaccinations, check-ups, and treatment for common ailments.

## (2)   Specialized Healthcare:

(i) Telemedicine:  The  government  has  implemented  telemedicine  services  to connect  remote  areas  with  specialists  in  urban  centers.  This  allows  for  remote consultations and diagnosis.

(ii) Referral Systems: Patients in rural areas can be referred to specialized hospitals in cities for advanced treatment.

(iii) Ayurveda and Traditional Medicine: Kerala has a strong tradition of Ayurveda and other traditional medicine systems. The  government supports the integration of these systems with modern medicine to provide holistic healthcare.

## (3)   Financial Assistance

(i) Health Insurance Schemes: The government provides health insurance schemes to  cover  the  cost  of  medical  treatment  for  low-income  and  vulnerable  populations, including tribal communities.

(ii) Subsidized Medications: The government subsidizes essential medications to make them affordable for the poor.

## (4) Awareness and Education:

(i) Health  Education  Campaigns:  The  government  conducts  health  education campaigns to raise awareness about preventive healthcare, hygiene, and the importance of seeking timely medical attention.

(ii) Community Health Workers: Community health workers are trained to provide health education and promote preventive healthcare practices in rural areas.

## (v)  Specific Initiatives for Tribal Populations:

(i) Tribal Health  Clinics: These  clinics  provide specialized care for tribal communities, addressing their unique health needs.

(ii) Nutrition Programs: The government implements nutrition programs to address malnutrition and other nutritional deficiencies among tribal populations.

(iii) Mental Health Services: Mental health services are provided in tribal areas to address issues like depression, anxiety, and substance abuse. By implementing these measures, the Kerala government aims to bridge the healthcare gap between urban and rural  areas  and  ensure  that  all  citizens,  including  tribal  and  rural  populations,  have access to quality healthcare services.

The  role  of  Non-Governmental  Organizations  (NGOs)  and  the  private  sector  in improving  healthcare  in  tribal  areas  is  also  significant.  They  focus  on  providing  free  or subsidized healthcare, including mental health, disability support, and maternal health. These organizations work to improve healthcare access in rural and tribal areas, often complementing government efforts. Providing primary healthcare camps, nutrition kits, medical aid, and safe drinking water in rural areas.

Apart from the above, Government of India launched 'Jan Aushadhi' Scheme in 2008 with  an  objective  of  making  quality  generic  medicines  available  at  affordable  prices  to  all citizens, especially the poor and the deprived ones.  The Scheme was revamped and named as 'Pradhan  Mantri  Jan  Aushadhi  Yojana'  (PMJAY)  in  Sept.2015  and  further  renamed as 'Pradhan Mantri Bhartiya Janaushadhi Pariyojana' (PMBJP) in December 2016. Under the Scheme, dedicated outlets known as Pradhan Mantri Bhartiya Janaushadhi Kendras (PMBJKs) are opened to provide quality generic medicines at affordable prices.  Objectives of the Scheme are as follows:

(a) To make available quality medicines consumables and surgical items at affordable prices for all and thereby reduce out of pocket expenditure of consumers/patients.

(b) To popularize generic medicines among the masses and dispel the prevalent notion that low priced generic medicines are of inferior quality or are less effective.

(c)  Generate  employment  by  engaging  individual  entrepreneurs  in  the  opening  of PMBJP Kendras.

Under the scheme, district-wise list of Jan Aushadhi Kendras opened in the State of Kerala is enclosed as Annexure-I.

Annexure-I

| District wise list of Jan Aushadhi Kendras opened in Kerala   | District wise list of Jan Aushadhi Kendras opened in Kerala   | District wise list of Jan Aushadhi Kendras opened in Kerala   |
|---------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Sl. No.                                                       | Name of the District                                          | No. of Jan Aushadhi Kendras                                   |
| 1                                                             | Alappuzha                                                     | 118                                                           |
| 2                                                             | Ernakulam                                                     | 171                                                           |
| 3                                                             | Idukki                                                        | 40                                                            |
| 4                                                             | Kannur                                                        | 79                                                            |
| 5                                                             | Kasaragod                                                     | 37                                                            |
| 6                                                             | Kollam                                                        | 87                                                            |
| 7                                                             | Kottayam                                                      | 96                                                            |
| 8                                                             | Kozhikode                                                     | 127                                                           |
| 9                                                             | Malappuram                                                    | 156                                                           |
| 10                                                            | Palakkad                                                      | 140                                                           |
| 11                                                            | Pathanamthitta                                                | 50                                                            |
| 12                                                            | Thiruvananthapuram                                            | 130                                                           |
| 13                                                            | Thrissur                                                      | 185                                                           |
| 14                                                            | Wayanad                                                       | 27                                                            |
| Total                                                         | Total                                                         | 1443                                                          |

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