Maharashtra FDA Cancels 10 Ayurvedic Licences After Statewide Inspection Drive

The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturers following a statewide inspection drive that uncovered serious violations of prescribed manufacturing and quality-control standards. The regulator also issued show-cause notices to 135 manufacturers found to be non-compliant.

The FDA inspected 434 licensed Ayurvedic drug manufacturing establishments across Maharashtra to assess compliance with the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Schedule T Good Manufacturing Practices (GMP) requirements for Ayurvedic, Siddha, and Unani medicines.

FDA Commissioner Stresses Strict Adherence to Manufacturing Standards

The licence cancellations were ordered by the Ayurvedic Licensing Authority of the Maharashtra FDA after the violations were assessed as extremely serious from the standpoint of medicine quality, safety, and efficacy.

FDA Commissioner Tukaram Mundhe emphasised that Ayurvedic medicines must be manufactured strictly according to prescribed standards, with classical medicines following recognised reference texts and patent and proprietary medicines meeting specified quality-control requirements.

Part of a Broader Push for Regulatory Compliance

The regulatory action highlights the importance of compliance with Schedule T GMP requirements across India’s Ayurvedic medicine manufacturing sector. The Maharashtra FDA has warned manufacturers that strict action will be taken against establishments that fail to meet prescribed standards, as the state seeks to strengthen oversight and protect public health.

The latest crackdown comes amid wider efforts by drug regulators to strengthen quality control across India’s pharmaceutical and traditional medicine manufacturing ecosystem, with increased emphasis on manufacturing standards, documentation, testing, and regulatory compliance.