2,988 drugs not of standard quality, 282 adulterated in tests conducted in 2023-24: Govt
New Delhi: A total of 2,988 drug samples tested between April 2023 and March 2024 were declared not of standard quality while 282 were found to be spurious or adulterated, the Rajya Sabha was informed on Tuesday.
In a written reply, Minister of State for Health Anupriya Patel said 1,06,150 drug samples were tested during the period and 604 prosecutions were launched for manufacturing, sale and distribution of spurious or adulterated drugs.
To assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organisation, along with the State Drugs Controllers, had initiated risk-based inspections of drug manufacturing firms from December 2022, she said.
“Risk-based inspections of more than 500 premises have been conducted so far. Drug manufacturing firms have been identified based on risk criteria like number of drugs declared as not of standard quality, complaints, criticality of the products,” she said.
Based on the findings of the inspections, more than 400 actions like issuance of show cause notices, stop production orders, suspension, cancellation of licenses or product licenses have been taken by the State Licensing Authorities according to the provisions of the Drugs Rules 1945, Patel said.
The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of the central government and the state government, she said.
Further, the drug inspector under the Act randomly draws drug samples from the supply chain for quality checks.
The list of drugs of various companies, which are declared not of standard quality or spurious, misbranded or adulterated by the Central Drugs Testing Laboratories is regularly uploaded and available on the website of Central Drugs Standard Control Organisation — cdsco.gov.in, she said.
In the cases concerning the quality or safety of drugs as and when reported, actions are taken by the licensing authorities concerned under the provisions of the Drugs and Cosmetics Act 1940 and its rules, including prosecution in the appropriate Court of law, Patel said.
