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Mumbai News: The crackdown by Maharashtra’s Food and Drug Administration (FDA) on drug manufacturers and sellers has intensified sharply over the past three months, with enforcement activity rising significantly compared with the trends seen over the last five years, data presented by the department showed.
The FDA presented the figures on Monday, September 7, 2026, highlighting a sharp rise in complaints, investigations, searches and seizures between June and August this year. The intensified enforcement comes as IAS officer Tukaram Mundhe recently completed 100 days as FDA Commissioner.
However, the data does not show a similarly dramatic rise in regulatory actions such as the cancellation or suspension of licences. The average number of such regulatory actions has
increased from around 258 per month over the last five years to 293 per month during June-August 2026.
Ayurvedic Manufacturer Inspections Rise Sharply
According to a report in The Hindu, inspections of Ayurvedic manufacturers have also increased substantially. The FDA conducted 203 inspections in 2021-22, followed by 279 in 2022-23 and 371 in 2023-24. The number rose further to 427 inspections during 2024-25. In just three months between June and August 2026, the department carried out 301 inspections of Ayurvedic manufacturers, indicating a much more concentrated enforcement drive.
Overall, the five-year period recorded around 87,807 inspections in 60 months, averaging approximately 1,463 inspections a month. The June-August 2026 period saw 2,902 inspections, or an average of about 967 per month.
While this three-month monthly average is lower than the five-year average, the FDA stressed that the latest drive involved large-scale and focused inspections.
Complaints And Investigations See Major Jump
The sharpest increase was recorded in complaints received by the FDA. According to the department, the quarterly average during 2025-26 was around 212.5 complaints, while the number jumped to 1,397 between June and August 2026.
Investigations into complaints also increased significantly. The average stood at around 193.25 investigations per quarter in 2025-26, compared with 924 investigations during the latest quarter.
The FDA said the rise was part of an effort to make the regulatory system more transparent and accountable through technology. “We have made the entire system automatic. You can track your complaint once you register it on our portal. The system is such that the officials have to resolve the complaint and have to give an update about it on the portal,” Mundhe said.
The department also reported a substantial rise in searches and seizures during the three-month enforcement drive. Goods worth around Rs 11.41 crore were seized between June and August 2026, compared with an average of Rs 3.41 crore per quarter during 2025-26.
The FDA said the number of cases also increased from an average of 32.75 cases per quarter in 2025-26 to 104 cases during the latest quarter.
What Violations Did FDA Find?
The inspections uncovered several violations among drug manufacturing establishments. These included discrepancies in Batch Manufacturing Records, testing being carried out without competent technical personnel, the absence of Annual Product Quality Reviews, inadequate sterilisation records and the manufacture of drugs classified as Not of Standard Quality.
Inspections of blood centres also revealed several irregularities. These included unregistered blood transfusion officers, outdated records, improper storage of expired or contaminated blood bags and serious deficiencies in traceability and adherence to Standard Operating Procedures.
The FDA also found violations at establishments selling medicines. These included selling drugs without supervision by a registered pharmacist, conducting transactions without bills, bills missing batch numbers or expiry dates, failure to maintain the Schedule H1 register and keeping expired medicines for sale.
Improper storage of temperature-sensitive medicines, including insulin and vaccines, was another violation identified during the inspections.
FDA Steps Up Action Against Non-Compliant Drug Sellers
The latest enforcement drive has already resulted in action against individual establishments, including cancellation of drug sale licences. The FDA has said that its priority is to ensure that medicines available to consumers are safe, of good quality and properly regulated. “FDA’s highest priority is to ensure safe, quality, and regulated medicines. We are committed to continuous, rigorous action against non-compliant establishments while supporting compliant ones,” Mundhe said.
The latest figures suggest that while the overall number of licence-related regulatory actions has not risen dramatically, the FDA has significantly intensified inspections, complaint investigations, searches and seizures over the past three months.
