Maharashtra FDA Intensifies Pharma Inspections, Takes Action Against 880 Licence Holders

The Maharashtra Food and Drug Administration (FDA) has intensified regulatory surveillance of pharmaceutical manufacturing and sales establishments, taking action against 880 licence holders following an extensive inspection drive conducted between June and August 2026.

During the three-month period, the regulator carried out 2,902 inspections across the state. Of these, 607 involved manufacturing establishments, while 2,295 covered pharmaceutical sales establishments. Regulatory action was initiated against 140 manufacturers and 740 sales establishments.

The enforcement drive resulted in 677 licence suspensions and 203 cancellations. Authorities also conducted 104 search-and-seizure operations involving illegal medicines and cosmetics valued at approximately ₹11.41 crore.

Importantly for pharmaceutical manufacturing professionals, inspections revealed several deficiencies directly related to GMP and quality management. These included incomplete Batch Manufacturing Records, absence of Annual Product Quality Reviews, inadequate vendor qualification documentation and quality-control testing conducted without competent technical personnel. Inspectors also identified discrepancies between documented manufacturing records and actual production activities.

Other shortcomings involved sterilisation documentation, autoclave records, employee medical examination reports and incomplete production and testing records. Cases involving Not of Standard Quality medicines and products manufactured without appropriate authorisation were also identified.

The findings highlight why accurate documentation, trained personnel, validated procedures and effective quality systems remain fundamental to pharmaceutical GMP compliance.

Maharashtra FDA Commissioner Tukaram Mundhe has emphasised that regulatory oversight is intended to ensure the availability of safe, compliant and good-quality medicines throughout the supply chain. The enforcement drive sends a strong message to manufacturers that GMP compliance must remain an ongoing operational responsibility rather than an exercise undertaken only in preparation for inspections.

10-09-2026