New Delhi: Generic medicines form the bulk of pharmaceutical production in India, though separate production data for generics is not maintained, the government informed the Lok Sabha on Friday. Citing sales and export data, the Centre said the total sales value of medicines produced in the country rose by 26 per cent, from ₹3.22 lakh crore in 2022–23 to ₹4.06 lakh crore in 2024–25.
In a written reply, Union Minister of State for Chemicals and Fertilizers Anupriya Patel said the Department of Pharmaceuticals has not received any reports of manufacturers of generic medicines supplying empty or half-filled wrappers to bulk buyers. She added that all medicines manufactured in India—whether generic or branded—are required to meet the same quality standards prescribed under the Drugs and Cosmetics Act, 1940, and its rules.
Quality Standards and Regulatory Oversight
The Ministry of Health and Family Welfare informed Parliament that drugs found to be “not of standard quality” (NSQ) are detected from time to time through testing in government laboratories. Such cases are investigated by licensing authorities, with action taken under the law, including prosecution where required.
While no separate study on the quality of generic medicines has been conducted, a nationwide survey carried out between 2014 and 2016 found that 3 per cent of samples from retail outlets were NSQ, while spurious drugs accounted for 0.023 per cent.
To strengthen quality assurance, the government has introduced multiple regulatory measures in recent years. These include mandatory barcodes or QR codes on top-300 drug brands and bulk drugs for traceability, revised Good Manufacturing Practices under Schedule M, and stricter penalties for spurious and adulterated medicines. Compliance timelines under the revised Schedule M have been extended till December 31, 2025, for manufacturers with turnover up to ₹250 crore.
The Centre has also increased sanctioned posts in the Central Drugs Standard Control Organisation (CDSCO), mandated joint inspections by central and state drug inspectors before licensing, and strengthened coordination with state drug regulators to ensure uniform enforcement of the law.
Jan Aushadhi Scheme for Affordable Generics
Highlighting efforts to improve access to affordable medicines, the minister said the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) continues to expand across the country. As of November 30, 2025, a total of 17,610 Jan Aushadhi Kendras were operational, offering over 2,100 medicines across major therapeutic categories at prices 50 to 80 per cent lower than branded alternatives.
To ensure quality under the scheme, medicines are procured only from WHO-GMP-certified manufacturers, each batch is tested at NABL-accredited laboratories, and vendor facilities are subject to routine quality audits.
The minister said regulatory provisions under the Drugs and Cosmetics Act are reviewed periodically to further strengthen quality, safety and efficacy of medicines manufactured or imported into India.
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