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Nearly 3,000 Drug Samples Substandard, 282 Found Spurious: Rajya Sabha Report
In a written response, Minister of State for Health Anupriya Patel shared that 1,06,150 drug samples were tested during the period, leading to 604 prosecutions for the production, sale, and distribution of spurious or adulterated medicines.
- By Newsdesk
- New Delhi
- Dec 05, 2024
The Rajya Sabha was informed on Tuesday that between April 2023 and March 2024, a total of 2,988 drug samples were deemed substandard, while 282 were identified as spurious or adulterated.
In a written response, Minister of State for Health Anupriya Patel shared that 1,06,150 drug samples were tested during the period, leading to 604 prosecutions for the production, sale, and distribution of spurious or adulterated medicines.
To enhance regulatory compliance, the Central Drugs Standard Control Organisation (CDSCO) and State Drugs Controllers initiated risk-based inspections of drug manufacturing facilities in December 2022. Patel revealed that over 500 manufacturing sites had been inspected so far, focusing on premises flagged due to risk factors such as complaints, the criticality of products, or repeated instances of substandard drug quality.
As a result of these inspections, state licensing authorities took over 400 actions, including issuing show-cause notices, halting production, and suspending or canceling licenses in line with the Drugs Rules of 1945.
Additionally, recent amendments to the Drugs and Cosmetics Rules, 1945, mandate joint inspections by central and state drug inspectors before granting manufacturing licenses. Drug inspectors also routinely collect random samples from the supply chain to ensure quality.
Patel further noted that the Central Drugs Testing Laboratories regularly publish lists of substandard, spurious, or misbranded drugs on the CDSCO website (cdsco.gov.in). In cases where drug quality or safety concerns arise, licensing authorities take necessary legal actions, including initiating court prosecutions, under the Drugs and Cosmetics Act, 1940.