The Central Government has amended the Drug Rules 1945 on 28 December 2023.
The number of batches of medicines recalled after failing quality tests increased from 950 in 2019-20 to 1,394 (provisional) in 2023-24. Minister of State for Health Anupriya Patel informed this to the Rajya Sabha on Tuesday. According to PTI news, Patel said in a written reply that as per information received from drugs controllers of different states and union territories, 1,171 batches were recalled in the financial year 2022-23. Data about drugs recalled after failing quality tests is not maintained centrally by the Central Drugs Standard Control Organization (CDSCO).
282 medicine samples found fake or adulterated
According to the news, the Union Minister said that during the year 2023-24 (April to March), 2,988 drug samples were declared not of standard quality, while 282 drug samples were found to be fake or adulterated. Based on the findings, 604 prosecutions were filed for manufacture, sale and distribution of counterfeit/adulterated drugs. A total of 1,06,150 drug samples were tested during this period. CDSCO and the Ministry of Health and Family Welfare have taken several measures to ensure that medicines produced in the country meet the required safety and efficacy standards.
Risk-based inspection of pharmaceutical manufacturing firms
To assess the regulatory compliance of drug manufacturing complexes in the country, CDSCO in collaboration with State Drug Controllers (SDCs) started risk-based inspection of drug manufacturing firms in December 2022. Risk-based inspection of more than 500 campuses has been conducted so far. Drug manufacturing firms have been identified on the basis of risk parameters, such as number of medicines declared as per quality standards, complaints, severity of products etc.
Amendment in Drug Rules 1945
Based on the findings of the inspections, more than 400 actions like issuance of show cause notices, stop production orders, suspension, cancellation of licenses/product licenses etc. have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945. The Central Government has amended the Drugs Rules, 1945, dated 28 December 2023, to amend Schedule M of the rules relating to premises, plant and equipment requirements and good manufacturing practices for pharmaceutical products. The amended Schedule M has become effective from June 29, 2024 for drug manufacturers with a turnover of more than Rs 250 crore.
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