Lok Sabha Question No. 2108 (UNSTARRED), answered on 2025-12-12
Subject: Production of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Anup Sanjay Dhotre

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

LOK SABHA UNSTARRED QUESTION No. 2108 TO BE ANSWERED ON THE 12 th  DECEMBER 2025

## Production of Generic Medicines

## 2108. Shri Anup Sanjay Dhotre:

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

- (a) the percentage increase in the production of generic medicines in the country during the last three years;
- (b)  whether  the  Government  is  aware  that  manufacturers  of  generic  medicines  have  been supplying empty or half-filled wrappers to bulk buyers, if so, the details thereof and the action taken or proposed to be taken by the Government in this regard;
- (c) whether the Government has received complaints about the quality of generic medicines, if so, the details thereof;
- (d) whether the Government has conducted any study on the quality of generic medicines in the country, if so, the details and the findings thereof and if not, the reasons therefor; and (e) the steps being taken/proposed to be taken by the Government to maintain public confidence in generic medicines?

## ANSWER

## THE MINISTER OF STATE IN THE  MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

- (a): While generic medicines constitute the predominant proportion of medicines produced in India,  separate  data  on  its  production  is  unavailable.  Based  on  the  sales  turnover  data  of Pharmarack, a company that provides commercial intelligence on medicines sold in the country and the data of exports maintained by the Directorate General of Commercial Intelligence and Statistics, the total sales value of medicines produced in the country increased by 26%, from ₹3,22,116 crore in the financial year (FY) 2022-23 to ₹4,06,047 crore in FY2024-25.
- (b): The Department of Pharmaceuticals is not in receipt of any report regarding such supply.
- (c):  The Ministry of Health and Family Welfare has informed that drugs manufactured in the country, irrespective of whether they are generic or branded, are required to comply with the same standards for quality that have been provided under the Drugs and Cosmetics Act, 1940 and the rules made thereunder. Based on quality testing of drugs in government drug testing laboratories, cases of not of standard quality (NSQ) drugs are reported from time to time and as  and  when  reports  regarding  such  cases  are  received,  the  same  are  investigated  by  the licensing authorities concerned for taking action under the provisions of the said Act and rules, including prosecution in a court of law.

(d) and (e): The Ministry of Health and Family Welfare has informed that Government has not conducted any specific study on quality of generic medicines. However, a nation-wide survey (2014-16) was conducted to assess the extent of NSQ/spurious drugs, in which a total of 47,012 drug samples were drawn from various sources and the percentage of NSQ and spurious drugs from retail outlets was 3% and 0.023% respectively.

Further, the Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and  Family  Welfare  have  taken  the  following  measures  to  ensure  production  of  quality medicines across the country:

- (i) The Drugs Rules, 1945 as amended on 17.11.2022 require with effect from 1.8.2023 that manufacturers of top-300 brands of drug formulation products, as specified in Schedule H2 to the said rules, 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  stores  data  or  information  legible  with  software application  to  facilitate  authentication.  Such  stored  data  shall  include  particulars regarding unique product identification code, proper and generic name of the drug, brand  name,  name  and  address  of  the  manufacturer,  batch  number,  date  of manufacturing, date of expiry and manufacturing licence number.
- (ii) The said rules were amended on 18.1.2022 to provide 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 no., manufacturing date, expiry date etc.
- (iii) The  said  rules  were  amended  on  28.12.2023  to  revise  the  good  manufacturing practices  and  requirements  of  premises,  plant  and  equipment  for  pharmaceutical products  under  Schedule  M  to  the  said  rules.  The  revised  Schedule  M  specifies pharmaceutical  quality system,  quality  risk  management,  good  manufacturing practices for pharmaceutical products, qualification and validation etc. The revised Schedule M is already in effect in respect of manufacturers having turnover of over ₹250 crore. For manufacturers with turnover of up to ₹250 crore, the timeframe for compliance has been extended up to 31.12.2025 vide notification dated 11.2.2025.
- (iv) The  Drugs  and  Cosmetics Act,  1940  was  amended  in  2008  to  provide  stringent penalties for manufacture of spurious and adulterated drugs, and certain offences were made cognizable and non-bailable.
- (v) States and Union territories have set up special courts for trial of offences under the said Act, with a view to facilitate speedy disposal.
- (vi) The number of sanctioned posts in CDSCO has been increased significantly over the last 10 years.
- (vii) To ensure efficacy of drugs, the Drugs Rules, 1945 have been amended to provide 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.
- (viii) The  said  rules  have  been  amended  to  make  it  mandatory  that  before  grant  of manufacturing license, the manufacturing establishment is inspected jointly by the drugs inspectors of the Central Government and the State Government concerned.
- (ix) The said rules have been amended to make it mandatory that applicant shall submit evidence  of  stability,  safety  of  excipients,  etc.  to  the  State  Licensing  Authority concerned before manufacturing license is granted by such authority.
- (x) CDSCO coordinates activities of State drugs control organisations and provides expert advice through meeting of the Drugs Consultative Committee, held with the State

Drugs Controllers, with a view to ensure uniformity in the administration of the Drugs and Cosmetics Act, 1940.

Further, regulatory provisions under the said Act and the rules made thereunder are considered from time to time for appropriate amendment, with a view to ensure quality, safety and the efficacy of drugs manufactured in or imported into the country.

Government  has  also  launched  Pradhan  Mantri  Bhartiya  Janaushadhi  Pariyojana  to  make quality generic medicines available at affordable prices to all. Under this scheme, dedicated outlets  known  as  Jan  Aushadhi  Kendras  (JAKs)  are  opened  across  the  country  to  provide medicines at 50%-80% cheaper rates than branded medicines. A total of 17,610 JAKs have been opened across the country till 30.11.2025. Under PMBJP, 2,110 types of medicines are part  of  product  basket  covering  all  major  therapeutic  groups  such  as  cardiovascular,  anticancers, anti-diabetics, anti-infectives, anti-allergic, gastro-intestinal medicines, nutraceuticals, etc. With a view to ensure supply of quality medicines sold from JAKs, the following measures are in place:

- (i) Medicines are procured only from suppliers certified for World Health Organization - Good Manufacturing Practices (WHO-GMP).
- (ii) Each batch of drugs supplied under the scheme is tested at laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and  only  after  passing  quality  tests,  medicines  are  dispatched  to  Jan  Aushadhi Kendras.
- (iii) Quality audit of the facilities of vendors is routinely done by the Pharmaceuticals and Medical Devices Bureau of India.

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