Over 1 lakh drug samples tested in 2024-25, 3,000 fail quality standards: Centre

The minister also said that in order to assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organisation (CDSCO) along with State Drugs Controllers (SDCs) have conducted Risk-Based Inspections of more than 960 premises since December, 2022 and based on findings, more than 860 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses, warning letters have been taken by the State Licensing Authorities.The Drugs Rules, 1945 have been amended in year 2023 to mandate that manufacturers of the top 300 drug formulation brands listed in Schedule H2 shall print or affix a Barcode or QR Code on the primary packaging label, or on the secondary label where space is insufficient, to store data readable through software applications for authentication.Similarly, the Rules have also been amended to require that every Active Pharmaceutical Ingredient (bulk drug), whether manufactured or imported, shall bear a QR Code on each level of packaging containing data readable through software applications to facilitate tracking and tracing.The Central Government has amended the Drugs Rules 1945 on December 28, 2023 to revise the schedule M to the said rules related to Good Manufacturing Practices and requirements of premises, plant and equipment for pharmaceutical products.Revised Schedule M has become effective for the drug manufacturers with turnover of over Rs. 250 crores from June 29, 2024. However, for manufacturers having turnover of less than Rs. 250 Cr, conditional extension up to December 31, 2025 is currently operational for those who submitted their upgradation plan for the extended compliance period.In February 2024, CDSCO published regulatory guidelines for the sampling of drugs, cosmetics, and medical devices by Central and State Drugs Inspectors. These guidelines provide a structured approach to ensure the quality and efficacy of products available in the market through uniform drug sampling methodology.An online portal, SUGAM labs is in place since September 2023 for integrating the drug testing labs of the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specification and tracing the testing status in the laboratories.The Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.The central government is providing regular residential, regional training and workshops to officials of CDSCO and State Drug Regulatory Authorities on Good Manufacturing Practices.In 2023-24, CDSCO trained 22,854 persons while in 2024-25, 20,551 persons were trained.



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