The three-month drive was aimed at ensuring the quality and safety of medicines and checking compliance with regulations governing their manufacturing, storage and sale.
Of the 2,902 inspections, 607 were conducted at manufacturing establishments, while 2,295 involved drug sales establishments. The FDA took regulatory action against 880 licence holders, including 140 manufacturing establishments and 740 sales establishments.
Following inspections and regulatory proceedings, 677 licences were suspended and 203 licences were cancelled.
The department also conducted 104 search and seizure operations during the three-month period, seizing illegal medicines and cosmetics worth Rs 11.41 crore. The operations resulted in 20 FIRs being registered and 21 people being arrested, the Maharashtra FDA said.
Officials said action was taken against establishments found violating safety and regulatory requirements. Serious or repeated violations resulted in show-cause notices, hearings and, where applicable, suspension or cancellation of licences.
During inspections of allopathic, Ayurvedic and cosmetics manufacturers, officials found several violations, including the absence of qualified technical staff, discrepancies between batch manufacturing records and actual production, incomplete production and testing records, and failures in quality-control procedures.
The FDA also found instances involving the manufacture of medicines that did not meet required quality standards and products that were not covered by the establishment's licence.
Drug sales establishments were also found violating several rules. The FDA reported cases of medicines being sold without the direct supervision of registered pharmacists and transactions being conducted without proper bills. Some establishments had incomplete Schedule H1 records or sold scheduled medicines without prescriptions.
Officials also found expired medicines being kept in areas meant for sale, discrepancies between physical stocks and records, and improper storage of temperature-sensitive medicines such as insulin and vaccines.
The FDA also inspected blood banks and blood storage centres, where officials found inadequate record-keeping, the absence of registered blood transfusion officers in some cases and problems with the traceability of blood components.
Other violations included improper storage of expired or contaminated blood bags, inadequate emergency kits, non-compliance with biomedical waste procedures and missing calibration records for equipment.
The department said its enforcement activity increased significantly compared with the quarterly average of 2025-26. According to the FDA's figures, the number of complaints received rose by 557, while complaint investigations increased by 378. Search and seizure operations increased by 217, and the value of seized goods increased by 234 per cent. The department also reported a 21 per cent increase in FIR registrations.
FDA Commissioner Tukaram Mundhe said ensuring access to safe, quality and compliant medicines remains the department's top priority.
Mundhe said inspections were being accelerated to strengthen regulatory oversight at every stage, from medicine production to final sale.
He added that the FDA would continue to support establishments that follow the rules while taking strict action against those found violating them.
The enforcement drive, covering manufacturing, sales and blood-related establishments, has resulted in licence suspensions and cancellations, seizures, FIRs and arrests as the Maharashtra FDA steps up regulatory action to ensure compliance with medicine safety and quality requirements.
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