Maharashtra FDA Cancels Licences of 10 Ayurvedic Drug Units

The Food and Drug Administration (FDA) of Maharashtra has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturing units and issued show-cause notices to 135 others following a statewide inspection drive across Maharashtra. The regulatory enforcement was initiated after inspections revealed serious violations of prescribed safety norms and quality standards.

The statewide inspection drive targeted the Ayurvedic manufacturing sector, covering all 434 licensed Ayurvedic manufacturing units currently operating across Maharashtra. FDA officials conducted thorough examinations at each facility to evaluate operational adherence to statutory regulatory frameworks.

During the drive, officials checked compliance with the Drugs and Cosmetics Act, 1940, along with the Drugs and Cosmetics Rules, 1945. Inspections specifically focused on adherence to the Good Manufacturing Practices (GMP) prescribed under Schedule T for Ayurvedic medicines. The drive uncovered serious non-compliance with these prescribed safety and manufacturing norms, leading to the permanent cancellation of manufacturing licences for 10 establishments and the issuance of show-cause notices to 135 other non-compliant units.

FDA Commissioner Tukaram Mundhe stated that strict action will be taken against Ayurvedic manufacturers who fail to comply with the prescribed norms.