Maharashtra FDA cracks down on Ayurvedic manufacturers, cancels licences of 10 firms over serious violations

MUMBAI: The Maharashtra Food and Drug Administration (FDA) has launched a statewide crackdown on Ayurvedic drug manufacturers after inspections found serious violations of prescribed manufacturing and quality-control standards at several establishments.

The FDA inspected 434 licensed Ayurvedic drug manufacturing establishments across Maharashtra as part of a statewide inspection drive to assess 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.

Following the inspections, 135 manufacturers were issued show-cause notices for various violations and instances of non-compliance. The establishments have been directed to explain the violations detected during inspections and comply with the prescribed requirements.

In the most serious cases, the FDA has permanently cancelled the manufacturing licences of 10 Ayurvedic drug manufacturers after finding major violations that could affect the quality, safety and efficacy of medicines and pose a public health concern.

The violations found during inspections included the absence of qualified or approved technical personnel and instances of manufacturing being carried out without competent technical staff. Several establishments were also found to have non-functional quality-control departments and lacked the machinery and equipment required for manufacturing and testing.

The FDA also found cases involving unhygienic manufacturing premises, missing or discrepant batch production records and raw-material records, incorrect manufacturing dates on product labels and the absence of testing records or proper arrangements for testing raw materials and finished products.

Other violations included the absence of proper records of raw materials, manufacturing premises that either lacked an approved layout or did not conform to the approved layout, and failure to maintain medical examination records of technical staff and workers.

The inspections further revealed that some establishments had no records of training provided to technical employees and lacked Control Samples and Master Formula Records, which are important components of pharmaceutical quality control. The FDA also found inadequate procedures to prevent cross-contamination during the manufacturing process.

The action was 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 said Ayurvedic medicines must be manufactured strictly according to prescribed standards. He stressed that manufacturers of classical Ayurvedic medicines must follow recognised reference texts, while patent and proprietary medicines must meet specified quality-control standards.

The FDA has warned Ayurvedic manufacturers that strict action will be taken against establishments that fail to comply with Schedule T Good Manufacturing Practices (GMP) requirements. The statewide inspection drive is aimed at ensuring that Ayurvedic medicines manufactured in Maharashtra meet the required standards and that lapses affecting public health are dealt with firmly. (ANI)