Maharashtra FDA Complaints Rise 557% in 3 Months

The Maharashtra Food and Drug Administration (FDA) has seen a significant surge in complaints, with 1,397 complaints received in just three months from June to August 2026. This represents a 557% increase over the quarterly average of 2025-26. The sharp rise in complaints came after Tukaram Mundhe took charge as FDA Commissioner.

The FDA has investigated 924 of the complaints, marking a 378% increase over the quarterly average of around 193 investigations recorded in 2025-26. The department received 850 complaints during the entire 2025-26 financial year, which translates to a quarterly average of around 213 complaints. The latest three-month figure is 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.

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. These violations included the absence of competent technical staff, unauthorised personnel making entries in batch records, and testing without qualified QC staff.

Between June and August 2026, the FDA conducted 2,902 inspections across drug manufacturing and sales establishments and took action in 880 cases. This included 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.

The increased enforcement by the FDA is a significant step towards ensuring the quality and safety of drugs and cosmetics in Maharashtra. The surge in complaints and inspections suggests that the FDA is taking a more proactive approach to regulating the industry. This is likely to have a positive impact on public health, as it will help to prevent the sale of substandard or counterfeit products.

The FDA's efforts to crack down on violators are also likely to have a deterrent effect on other manufacturers and sellers. The registration of 20 FIRs and the seizure of material worth Rs 11.41 crore demonstrate the FDA's commitment to taking strong action against those who flout the rules. Overall, the increased enforcement by the FDA is a welcome development, and it is likely to contribute to a safer and more regulated pharmaceutical industry in Maharashtra.

The FDA's actions are also a reminder of the importance of vigilance and regulation in the pharmaceutical industry. The sale of substandard or counterfeit products can have serious consequences for public health, and it is essential that regulatory bodies like the FDA take strong action to prevent such practices. By increasing enforcement and inspections, the FDA is helping to protect the public and ensure that drugs and cosmetics meet the required standards of quality and safety.

In conclusion, the surge in FDA complaints and enforcement in Maharashtra is a significant development that is likely to have a positive impact on public health. The FDA's efforts to regulate the industry and prevent the sale of substandard products are welcome, and it is essential that the department continues to take strong action against violators. By doing so, the FDA can help to ensure that the pharmaceutical industry in Maharashtra is safe, regulated, and effective in providing quality products to the public.