Maharashtra FDA Cancels 10 Ayurvedic Drug Licences in Statewide Drive
The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturers and issued show-cause notices to 135 others after a statewide crackdown revealed major quality and safety violations across Maharashtra.
The regulatory action followed a comprehensive inspection drive covering 434 licensed Ayurvedic drug manufacturing establishments in the state. Inspectors evaluated compliance with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Schedule T, which lays down Good Manufacturing Practices (GMP) requirements for Ayurvedic, Siddha, and Unani medicines.
According to the FDA, the severe step of permanently revoking 10 licences was taken due to critical violations that directly threatened the quality, safety, and efficacy of medicines, posing serious public health concerns. Meanwhile, the 135 establishments issued show-cause notices have been directed to explain the non-compliance instances detected during the visits and rectify them to meet statutory standards.
The inspections exposed severe lapses in operational and quality standards. Establishments were found operating without qualified or approved technical personnel and carrying out production without competent staff. Many units lacked functional quality-control departments and missed essential machinery and equipment required for manufacturing and testing products.
Inspectors also found unhygienic manufacturing premises, layout discrepancies, and incorrect manufacturing dates printed on product labels. Several units failed to maintain proper records for batch production, raw materials, staff medical examinations, employee training, Control Samples, or Master Formula Records. Inadequate procedures to prevent cross-contamination during production and a lack of proper testing arrangements for raw materials and finished goods were also noted.
The enforcement orders were issued by the Ayurvedic Licensing Authority of the Maharashtra FDA. FDA Commissioner Tukaram Mundhe stressed that Ayurvedic medicines must be produced strictly under prescribed guidelines, highlighting that classical formulations must adhere to recognised reference texts and patent or proprietary medicines must meet designated quality-control standards.
The FDA cautioned all Ayurvedic manufacturers in Maharashtra that firm action will continue against establishments failing to follow Schedule T requirements as part of its ongoing efforts to protect public health.
