The number of drug batches recalled due to quality issues has increased from 950 in 2019-20 to a provisional 1,394 in 2023-24, according to Minister of State for Health Anupriya Patel, who addressed the Rajya Sabha on December 17, 2024. For 2022-23, 1,171 batches were recalled, as reported by state and union territory drug controllers. Patel also mentioned that the Central Drugs Standard Control Organization (CDSCO) does not centrally maintain data on such recalls.
Between April 2023 and March 2024, 2,988 drug samples were found to be substandard, while 282 were identified as spurious or adulterated. These findings led to 604 prosecutions related to the manufacturing, sale, and distribution of such drugs. During this period, a total of 1,06,150 drug samples were tested.
To enhance drug quality and safety, the cdsco and the Ministry of Health and Family Welfare have implemented measures to ensure compliance with regulatory standards. Starting in December 2022, the CDSCO, in collaboration with State Drugs Controllers (SDCs), began risk-based inspections of over 500 drug manufacturing facilities. These inspections prioritized premises based on factors such as the frequency of substandard drug reports, complaints, and product criticality. Following the inspections, more than 400 regulatory actions were taken, including show-cause notices, production halts, and license suspensions or cancellations, as per the provisions of the Drugs Rules, 1945.
Additionally, the government has revised the Drugs Rules, 1945, with amendments notified on December 28, 2023. These updates to Schedule M introduce enhanced Good Manufacturing Practices (GMP) and updated requirements for premises, plants, and equipment used in pharmaceutical production. The revised guidelines will apply to manufacturers with an annual turnover exceeding ₹250 crore starting June 29, 2024.
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