The Maharashtra Food and Drug Administration (FDA) conducted 2,902 inspections across pharmaceutical manufacturing and sales establishments between June and August 2026, resulting in regulatory action against 880 licence holders for violations related to drug quality, manufacturing practices, storage and sale.
The inspections covered 607 manufacturing establishments and 2,295 pharmaceutical sales establishments. Regulatory action was initiated against 140 manufacturing and 740 sales establishments, including licence suspensions and cancellations for serious or repeated violations. Overall, the FDA recorded 677 licence suspensions and 203 cancellations.
During the three-month enforcement drive, the FDA also carried out 104 search and seizure operations, confiscating illegal medicines and cosmetics valued at INR 11.41 crore. The operations resulted in 20 FIRs and 21 arrests.
Inspections identified deficiencies including inadequate technical personnel, incomplete batch manufacturing and testing records, gaps in quality-control documentation, discrepancies between production records and actual output, and manufacture of drugs not authorised under applicable licences.
At blood centres and storage facilities, inspectors found issues involving documentation, blood-component traceability, storage temperatures, registered transfusion personnel and equipment calibration. At pharmaceutical sales establishments, violations included sale of medicines without registered pharmacist supervision, inadequate billing and record-keeping, sale of scheduled medicines without valid prescriptions, improper segregation of expired medicines and non-compliant storage of temperature-sensitive products.
The FDA said establishments found with serious or repeated violations were issued show-cause notices and given an opportunity for a hearing before regulatory action, including suspension or cancellation of licences, was taken.
Maharashtra FDA Commissioner Tukaram Mundhe said the enforcement programme is intended to strengthen regulatory oversight across the pharmaceutical supply chain, from manufacturing to the final point of sale.
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