Maharashtra FDA Complaints Surge 557 Per Cent To 1,397 In 3 Months As Drug Enforcement Intensifies

Mumbai, September 12, 2026: For consumers buying medicines in Maharashtra, the risk of encountering drugs being sold without prescriptions, medicines making unauthorised claims or products that do not meet quality standards appears to be under increased scrutiny, with the Food and Drug Administration (FDA) receiving 1,397 complaints in just three months from June to August 2026—a 557% rise over the quarterly average of 2025-26.

The sharp increase came after Tukaram Mundhe took charge as FDA Commissioner. Of the 1,397 complaints received during the three-month period, 924 were investigated, marking a 378% increase over the quarterly average of around 193 investigations recorded in 2025-26.

Complaint Numbers Surge

According to FDA data, the department received 850 complaints during the entire 2025-26 financial year, translating into a quarterly average of around 213 complaints. The latest three-month figure is therefore more than six times the previous quarterly average.

The FDA has also stepped up enforcement beyond complaint investigations. Seizure action increased by 217% during the three-month period compared with the quarterly average of 2025-26, while the value of seized material stood at Rs 11.41 crore, a 234% increase over the corresponding quarterly average. The department also registered 20 FIRs, around 21% higher than the quarterly average.

Key Violations Identified

Officials said the highest number of complaints related to allopathic medicines being sold without prescriptions, followed by complaints against Ayurvedic medicines being sold with claims.

Routine inspections also uncovered several violations at allopathic and Ayurvedic drug and cosmetic manufacturing units, including the absence of competent technical staff, unauthorised personnel making entries in batch records, testing without qualified QC staff, failure to prepare Annual Product Quality Reviews, discrepancies in sterilisation and autoclave records, lack of employee medical and vendor audit records, mismatches between batch records and actual production or material weights, incomplete production and testing records, and the manufacture of Not of Standard Quality (NSQ) drugs or products not covered under approved licences.

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Inspections Lead To Action

Between June and August 2026, the FDA conducted 2,902 inspections across drug manufacturing and sales establishments and took action in 880 cases, including 677 licence suspensions and 203 cancellations. In the manufacturing sector, 123 allopathy units were inspected, with action against 58 units, including 13 suspensions and 45 cancellations. Among 301 Ayurvedic units inspected, 31 faced action, including 26 suspensions and five cancellations.

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