Rising Drug Recalls: A Health Sector Challenge

The number of drug batches recalled due to quality failures increased from 950 in 2019-20 to 1,394 in 2023-24. The CDSCO, partnering with State Drugs Controllers, initiated inspections leading to significant actions against non-compliant firms. Revised standards aim to enhance drug quality and safety.

The number of drug batches recalled after failing quality tests has surged from 950 in the financial year 2019-20 to a provisional figure of 1,394 for 2023-24, Minister of State for Health Anupriya Patel revealed in a session of the Rajya Sabha. This data, sourced from state drug controllers, indicates a growing concern over drug quality in India.

During the 2023-24 period, 2,988 samples were found subpar, with 282 deemed spurious or adulterated, prompting 604 prosecutions related to the manufacture and distribution of such drugs. The Central Drugs Standard Control Organization (CDSCO), alongside the Ministry of Health, has ramped up efforts to maintain safety and efficacy in drug production.

Risk-based inspections initiated in December 2022 have examined over 500 manufacturing premises, leading to over 400 regulatory actions. Concurrently, the government's amendment of the Drugs Rules 1945 modernizes manufacturing practices for high-turnover firms, effective from June 2024.

(With inputs from agencies.)