Lok Sabha Question No. 719 (UNSTARRED), answered on 2024-11-29
Subject: Substandard Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Anto Antony, Smt. D K Aruna, Shri Suresh Kumar Shetkar, Shri Eatala Rajender, Adv. Adoor Prakash, Shri Kuldeep Indora

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

LOK SABHA UNSTARRED QUESTION No. 719 TO BE ANSWERED ON THE 29 TH  NOVEMBER 2024

## Substandard Drugs

719. Shri Anto Antony:

Smt. D K Aruna:

Shri Suresh Kumar Shetkar:

Shri Eatala Rajender:

Adv. Adoor Prakash:

Shri Kuldeep Indora:

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

- (a) whether the Central Drugs Standard Control Organisation has found more than 50 drugs, including some batches of widely used antacids and paracetamol, to be substandard or fake, if so, the details thereof and the corrective steps taken in this regard, State-wise;
- (b) whether the Government has taken any actions against the concerned companies, if so, the details thereof;
- (c) the details of the steps taken by the Government to ensure the quality of medicines including medicines available in Jan Aushadhi centres;
- (d) whether the Government noted that the circulation of counterfeit drugs is increasing in the country;
- (e) if so, the details of measures taken by the Government for prevention of counterfeit drugs;
- (f) whether the Government is planning to mandate QR code authentication for more drugs, if so, the details thereof; and
- (g) the measures taken by the Government to ensure that it does not tarnish the reputation of the country as a reliable supplier of medicines on a global stage?

## ANSWER

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

(a)  to  (b):  List  of  drugs  of  various  companies,  which  are  declared  Not  of  Standard  Quality/ Spurious  Misbranded/  Adulterated  by  the  Central  Drugs  Testing  Laboratories  is  regularly uploaded and available on the website of Central Drugs Standard Control Organization (CDSCO) under the heading of Drug Alert (www.cdsco.gov.in). In the cases concerning quality or safety of drugs as and when reported, actions are taken by the concerned licensing authorities under the provisions of Drugs and Cosmetics Act 1940 and its Rules including prosecution in appropriate Court of law.

(c) to (g): 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 manufacturers (Turnover> 250 crores)            | Six months from the date of publication of these rules.    |
| Small and Medium manufacturers (Turnover 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 1 st 8 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 nonbailable.

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 up-graded.

Apart from the above, Pharmaceutical and Medical Devices Bureau of India (PMBI) is the Implementing Agency of the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP). To ensure drug quality, PMBI procures medicines only from World Health Organization-Good Manufacturing  Practices  (WHO-GMP)  certified  suppliers.  Each  batch  of  drug  is  tested  at laboratories accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL).  Only  after  passing  the  quality  tests  the  medicines  are  dispatched  to Janaushadhi Kendras. PMBI also routinely audits vendors' facilities.

To ensure the supply and adequate availability of medicines at Janaushadhi Kendras, PMBI  has  set  up  a  strong  network  of  five  warehouses  located  at  Gurugram,  Bengaluru, Chennai, Guwahati, and Surat and 36 distributors across the country. PMBI has implemented an  Information  Technology  (IT)  enabled  end-to-end  supply  chain  system  and  SAP-based inventory management system.

Further,  Minimum  Stocking  mandate  has  been  implemented  for  Pradhan  Mantri Bhartiya  Janaushadhi  Kendras.  Stocking  mandate  requires  availability  of  200  medicines  at theses Kendras, which covers top 100 selling medicines of PMBJP product basket and 100 fast selling medicines in the market.

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