Generic Medicine Production Rises 26% to Rs 4.06 Lakh Cr in Three Years, Parliament Informed

He also questioned whether complaints had been received regarding the quality of generic medicines, whether any studies had been conducted to assess their quality, and what steps were being taken to maintain public confidence in generics.

Responding to the queries, Minister of State for Chemicals and Fertilizers Anupriya Patel stated that while generic medicines form the predominant share of India’s pharmaceutical output, separate production data for generics is not maintained.

She clarified, "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."

On allegations related to empty or half-filled wrappers, the Minister informed the House that the Department of Pharmaceuticals (DoP) has not received any such reports.

Further, addressing concerns over quality, she stated that all drugs manufactured in India—whether generic or branded—are required to meet the same quality standards under the Drugs and Cosmetics Act, 1940 and its associated rules.

"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," she added.

On studies assessing drug quality, the Minister said, "Government has not conducted any specific study on the quality of generic medicines."

"However, a nationwide 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." the Minister noted.

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

(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 the 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 the manufacture of spurious and adulterated drugs, and certain offenses were made cognizable and non-bailable.

(v) States and Union territories have set up special courts for the trial of offenses 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 the applicant shall submit the result of a bioequivalence study along with the application for grant of a manufacturing license of an oral dosage form of some drugs.

(viii) The said rules have been amended to make it mandatory that before the grant of a manufacturing license, the manufacturing establishment be inspected jointly by the drug inspectors of the Central Government and the State Government concerned.

(ix) The said rules have been amended to make it mandatory that the applicant shall submit evidence of stability, safety of excipients, etc. to the State Licensing Authority concerned before a 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", the Minister added.

Highlighting access and affordability, the Minister also pointed to the Pradhan Mantri Bhartiya Janaushadhi Pariyojana, under which 17,610 Jan Aushadhi Kendras are operational nationwide as of November 30, 2025.

Government has 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.

The Minister further added that 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 the 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 are medicines dispatched to Jan Aushadhi Kendras.

(iii) Quality audits of the facilities of vendors is routinely done by the Pharmaceuticals and Medical Devices Bureau of India.