Maha FDA cracks down on Ayurvedic drug makers

Mumbai: The Maharashtra Food and Drug Administration (FDA) has intensified a crackdown on Ayurvedic drug manufacturers after uncovering significant breaches of manufacturing and quality-control standards during inspections. Inspecting 434 licensed Ayurvedic drug production facilities across the state, the FDA evaluated compliance with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Schedule T, which outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha and Unani medicines.

Out of the 434 inspected establishments, 135 were issued show-cause notices for various infractions and instances of non-compliance, with a directive to explain the detected violations and adhere to the required standards. In the most egregious cases, 10 manufacturers had their manufacturing licenses permanently revoked following the discovery of major violations that jeopardize the quality, safety, and efficacy of medicines, potentially posing a public health hazard.

Detected violations included the absence of qualified or approved technical personnel, manufacturing conducted without competent technical staff, non-functional quality-control departments, and a lack of essential machinery and equipment for production and testing. The FDA also uncovered unhygienic manufacturing premises, missing or inconsistent batch and raw-material records, incorrect manufacturing dates on product labels, and absent or inadequate testing records for raw materials and finished products.

Other violations included the lack of proper raw material records, manufacturing premises without an approved layout, failure to maintain technical staff medical examination records, and inadequate procedures to prevent cross-contamination during manufacturing. The FDA's action was directed by the Ayurvedic Licensing Authority of the Maharashtra FDA, emphasizing the critical importance of adhering to prescribed standards for quality, safety, and efficacy in Ayurvedic medicine production.

FDA Commissioner Tukaram Mundhe underscored that Ayurvedic medicines, both classical and proprietary, must be manufactured strictly in accordance with established standards, utilizing recognized reference texts for classical medicines and meeting specified quality-control requirements for patent and proprietary medicines. The FDA has warned that strict action will be taken against establishments failing to comply with Schedule T Good Manufacturing Practices (GMP) requirements, signaling a firm stance against lapses that could jeopardize public health.