Maharashtra FDA Cracks Down on Ayurvedic Manufacturers for Violations

The Maharashtra FDA has initiated a statewide inspection revealing serious manufacturing violations at several Ayurvedic drug establishments. Show-cause notices were issued to 135 manufacturers, with 10 licenses permanently cancelled due to major breaches impacting medicine safety and quality. The FDA emphasizes strict adherence to standards to safeguard public health.

The Maharashtra Food and Drug Administration (FDA) has embarked on a major enforcement action against Ayurvedic drug manufacturers across the state after uncovering worrying violations of mandatory manufacturing and quality-control standards. Inspections of 434 licensed establishments were conducted under a comprehensive drive to ensure compliance with prevailing laws, including the Drugs and Cosmetics Act, 1940, and Schedule T.

In the wake of these inspections, which exposed numerous compliance gaps, 135 manufacturers were served with show-cause notices. The FDA has demanded explanations for infractions detected and adherence to established guidelines. Notably, licenses for 10 manufacturers were revoked permanently due to severe violations posing risks to the safety, quality, and effectiveness of Ayurvedic medicines.

The discrepancies included unqualified personnel, non-functional quality departments, and unhygienic premises. Alarming lapses like no records for raw materials and inadequate cross-contamination prevention were found. This action, led by FDA Commissioner Tukaram Mundhe, underscores the critical importance of adhering to Good Manufacturing Practices to protect public health.