New Delhi: Generic medicines continue to make up the bulk of pharmaceutical production in India, though separate data on their exact production volumes is not maintained, the government told the Lok Sabha on Friday. Overall sales of medicines produced in the country grew by 26 per cent over the past two years, underscoring the sector’s steady expansion.
According to sales turnover data from Pharmarack and export figures compiled by the Directorate General of Commercial Intelligence and Statistics, the total sales value of medicines increased from ₹3,22,116 crore in FY 2022–23 to ₹4,06,047 crore in FY 2024–25.
Quality Standards and Compliance
The Department of Pharmaceuticals said it has not received any reports of manufacturers of generic medicines supplying empty or half-filled wrappers to bulk buyers. The Ministry of Health and Family Welfare clarified that all drugs manufactured in India—whether generic or branded—are subject to the same quality standards under the Drugs and Cosmetics Act, 1940, and the rules framed under it.
Based on routine testing in government drug laboratories, instances of medicines being “not of standard quality” (NSQ) are detected from time to time. Such cases are investigated by the concerned licensing authorities, with action taken under the law, including prosecution where warranted.
While the government has not conducted a dedicated study on the quality of generic medicines, a nationwide survey carried out between 2014 and 2016 assessed the prevalence of NSQ and spurious drugs. Of the 47,012 samples collected from retail outlets, 3 per cent were found to be NSQ and 0.023 per cent spurious.
Regulatory Measures to Ensure Quality
The Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare have rolled out a series of regulatory reforms to strengthen drug quality assurance. These include mandatory barcodes or QR codes on packaging of the top 300 drug brands, QR codes on active pharmaceutical ingredients for tracking and tracing, and revised Good Manufacturing Practices under Schedule M of the Drugs Rules, 1945.
The revised Schedule M norms are already in force for manufacturers with an annual turnover exceeding ₹250 crore, while smaller units have been given time until December 31, 2025, to comply. The Drugs and Cosmetics Act was amended in 2008 to introduce stricter penalties for spurious and adulterated drugs, with certain offences made cognisable and non-bailable. States and Union territories have also set up special courts to expedite trials under the Act.
Additional safeguards include mandatory joint inspections by central and state drug inspectors before granting manufacturing licences, submission of bioequivalence study results for certain oral medicines, and closer coordination between CDSCO and state drug control organisations to ensure uniform enforcement.
Affordable Access Through Jan Aushadhi Scheme
To promote access to affordable medicines, the government highlighted the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), under which generic medicines are sold at 50–80 per cent lower prices through Jan Aushadhi Kendras. As of November 30, 2025, 17,610 such outlets were operational across the country, offering 2,110 types of medicines covering all major therapeutic categories.
Medicines supplied under the scheme are procured only from manufacturers certified under World Health Organization–Good Manufacturing Practices. Each batch is tested in laboratories accredited by the National Accreditation Board for Testing and Calibration Laboratories before distribution, and regular quality audits of vendors are conducted.
The information was provided by Union Minister of State for Chemicals and Fertilizers Anupriya Patel in a written reply to the Lok Sabha.
