SRINAGAR: The Government of India said it has taken multiple measures to ensure the quality and safety of medicines sold in the country, as clarified in a response by the Ministry of Health and Family Welfare in the Rajya Sabha on February 4, 2025. The response came in reply to an unstarred question raised by Sushmita Dev regarding concerns over the substandard quality of generic medicines.
The ministry stated that there is no specific definition of ‘generic medicines’ under the Drugs and Cosmetics Act. However, all medicines, whether branded or generic, are required to meet the same quality and safety standards as prescribed by the Act. Licensing authorities are responsible for investigating complaints and taking action against violations.
To strengthen drug quality assurance, the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Health and Family Welfare have implemented several key measures. Since December 2022, risk-based inspections of drug manufacturing units have been conducted in collaboration with State Drugs Controllers. More than 500 inspections have taken place, leading to over 400 actions such as show cause notices, production stoppages, and license suspensions or cancellations.
Further, the government has revised Good Manufacturing Practices (GMP) regulations under the Drugs Rules, 1945. The amended Schedule M, notified in December 2023, became effective for pharmaceutical manufacturers with a turnover exceeding Rs 250 crore from June 29, 2024. For smaller manufacturers, draft rules propose an extension until December 31, 2025, to comply with the revised GMP standards.
Other regulatory changes include the mandatory use of barcodes or QR codes on the packaging of the top 300 drug brands and active pharmaceutical ingredients (APIs) to enhance tracking and authentication. Additionally, since March 2021, marketers of drugs have been made accountable for quality, alongside manufacturers. The government has also imposed stricter penalties for the production of spurious and adulterated drugs, making certain offences cognizable and non-bailable. Special courts have been established for the speedy disposal of cases under the Drugs and Cosmetics Act.
To ensure efficacy, manufacturers must now submit bioequivalence study results for certain oral dosage drugs before obtaining manufacturing licenses. Stability and safety data for excipients must also be submitted for approval. The CDSCO has significantly increased its sanctioned workforce over the past decade, enhancing regulatory oversight.
To standardise drug quality across states, the central regulator has been coordinating with State Drug Control Organisations through the Drugs Consultative Committee (DCC). Regular training and workshops on Good Manufacturing Practices have been conducted, with 22,854 personnel trained in 2023-24 and 13,007 trained so far in 2024-25.
The Department of Pharmaceuticals is implementing the ‘Revamped Pharmaceuticals Technology Upgradation Scheme’ (RPTUAS) to help existing pharmaceutical units upgrade to Revised Schedule M and WHO-GMP standards. The scheme, running from 2021-22 to 2025-26, has a total outlay of Rs 300.10 crore.
Regarding the funding of drug testing facilities, the government clarified that there is no separate budget for the Seven National Laboratories. Instead, funds are allocated by the CDSCO based on requirements.
