Maharashtra FDA Cancels Licences of 10 Ayurvedic Drug Manufacturers

The Maharashtra Food and Drugs Administration (FDA) has permanently cancelled the manufacturing licences of ten Ayurvedic drug-manufacturing companies across the state, including facilities in Pune, Baramati, and Nashik. The regulatory enforcement followed a comprehensive inspection drive of 434 licensed Ayurvedic establishments across Maharashtra, which uncovered serious violations of the Drugs and Cosmetics Act, 1940.

During the comprehensive inspections, state regulatory teams scrutinized multiple operational areas. The FDA evaluated the adequacy of factory premises, the availability of required technical manpower, the implementation of good manufacturing practices, and the proper functioning of quality control departments. Inspectors also examined batch manufacturing records, raw material and finished product testing logs, and standard operating procedures.

Following the state-wide drive, show-cause notices were issued to 135 non-compliant Ayurvedic manufacturing establishments. These non-compliant units have been directed to submit explanations regarding the specific deficiencies recorded by officials during their inspections.

According to an official press note from the FDA, manufacturing at the ten firms whose licences were revoked was being conducted without qualified and approved technical personnel. Quality control departments in these units were completely non-functional, and the facilities lacked the necessary machinery and equipment required for proper manufacturing and testing procedures.

Inspectors also reported that the premises of the ten defaulting companies were unhygienic and failed to meet prescribed standards. The FDA recorded a complete absence or discrepancy in batch manufacturing and raw material records, along with incorrect manufacturing dates listed on product labels. Medical examination and training records for technical staff were absent, and the facilities maintained no procedures to prevent the cross-contamination of medicines.

FDA Commissioner Tukaram Mundhe stated that Ayurvedic medicines are widely used by the public and must meet strict standard guidelines. He affirmed that classical medicines must be manufactured according to recognized authoritative reference texts, while patent and proprietary medicines must conform to prescribed standards under applicable rules. Mundhe warned that strict action will be enforced against any manufacturers failing to comply.