The Maharashtra Food and Drug Administration (FDA) has initiated a comprehensive crackdown on Ayurvedic drug manufacturers following the discovery of significant violations during inspections. This statewide operation involved the examination of 434 licensed Ayurvedic drug manufacturing facilities, focusing on adherence to the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

The inspections were part of a larger drive aimed at ensuring compliance with Schedule T, which outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani medicines. The inspections resulted in 135 manufacturers receiving show-cause notices for diverse violations and non-compliance with the established regulations.

Manufacturers have been instructed to address the identified violations and adhere to the mandatory requirements to ensure public safety and the quality of Ayurvedic medicines. The FDA’s actions reflect a serious commitment to uphold health standards in the Ayurvedic sector.

Permanent Licence Revocation for Major Violations

The FDA permanently cancelled the manufacturing licences of 10 Ayurvedic manufacturers deemed to have committed serious infractions that may jeopardise the quality, safety, and efficacy of their products. These actions were taken after extensive scrutiny revealed alarming practices within these establishments.

Among the serious violations noted were the absence of qualified technical personnel, a lack of competent technical staff overseeing manufacturing activities, and the operation of non-functional quality control departments. Such deficiencies present a significant risk to public health, raising concerns over the integrity of the medicines produced.

Additional findings during inspections included unhygienic manufacturing conditions, incorrect or missing batch production and raw material records, and discrepancies in manufacturing dates on product labels. The shortage of testing and quality assurance processes for raw materials and finished products was also a notable area of concern.

Regulatory Emphasis on Compliance and Quality Standards

The actions taken follow an evaluation by the Ayurvedic Licensing Authority at the Maharashtra FDA, which highlighted that the violations posed an extreme risk to medicine quality and safety. FDA Commissioner Tukaram Mundhe emphasised the importance of adhering strictly to the established manufacturing standards for Ayurvedic medicines.

Commissioner Mundhe urged manufacturers to ensure that classical Ayurvedic products are produced in accordance with recognised reference texts, while patent and proprietary medicines must meet specific quality-control criteria. The inspections serve to reaffirm the FDA’s commitment to maintaining high standards in Ayurvedic medicine production in the state.

The FDA has issued a stern warning to Ayurvedic manufacturers regarding compliance with Schedule T Good Manufacturing Practices (GMP). This initiative aims to ensure that all Ayurvedic medicines produced in Maharashtra are aligned with established health standards and that any lapses endangering public health are addressed decisively.

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