Maharashtra FDA Cracks Down on Ayurvedic Drug Makers, Cancels 10 Licenses Over Major Violations

Mumbai: In a major regulatory crackdown aimed at safeguarding public health, the Maharashtra Food and Drug Administration (FDA) has permanently cancelled the manufacturing licenses of 10 Ayurvedic drug manufacturers following a comprehensive, statewide inspection drive.

The rigorous campaign examined 434 licensed Ayurvedic drug manufacturing establishments across the state to enforce compliance with safety, quality, and efficacy standards.

Alongside the permanent license cancellations, the state authority issued show-cause notices to 135 other Ayurvedic manufacturers after discovering widespread operational and quality-control lapses.

Non-compliant facilities have been ordered to submit formal explanations addressing the deficiencies recorded during the inspections.

The regulatory action was executed under the provisions of the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Schedule T requirements governing Good Manufacturing Practices (GMP) for traditional medicines.

Inspectors uncovered a series of severe violations during the statewide drive. Several facilities were found operating without qualified or approved technical personnel overseeing production processes.

In multiple instances, quality-control departments were non-functional or entirely lacking the essential machinery and testing equipment required to evaluate raw materials and finished products.

Sanitation and documentation standards were also breached across several units. FDA officials reported unhygienic manufacturing premises, widespread discrepancies in batch production and raw-material records, and inaccurate manufacturing dates printed on product packaging.

Furthermore, non-compliant establishments failed to maintain proper testing logs, control samples, and master formula records. Authorities also flagged significant gaps in operational protocols, citing inadequate safeguards to prevent cross-contamination during medicine manufacturing.

FDA Commissioner Tukaram Mundhe issued a stern warning to manufacturers, emphasising that public safety remains paramount. He noted that Ayurvedic medicines are widely consumed across the country, requiring strict adherence to regulatory standards.

Mundhe clarified that classical Ayurvedic formulations must strictly follow recognised authoritative reference texts, while patent and proprietary medicines must rigorously meet prescribed quality-control standards.

Reaffirming the state’s uncompromising stance on pharmaceutical quality, Mundhe warned that stringent enforcement and legal action will continue against any Ayurvedic establishment that fails to meet the mandated Schedule T Good Manufacturing Practices.

The ongoing FDA initiative underscores Maharashtra's commitment to ensuring that traditional medicines distributed to consumers meet uncompromising standards of safety and efficacy.

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