What data says about Tukaram Mundhe’s 100-day stint as FDA Commissioner

Regulatory crackdown on drug manufacturers and sellers by the Food and Drug Administration (FDA) has intensified drastically over the last three months, especially when compared to the last five years, data perused by The Hindu showed.

However, data also show that there has not been a huge spike in regulatory actions like cancellation and suspension of licences. The average number of regulatory actions per month has increased from approximately 258 over the five years to 293 during June-August 2026.

The number of inspections of Ayurvedic manufacturers stood at 203 for 2021-22; 279 in 2022-23; 371 in 2023-24. In the next financial year, the number of inspections rose to 427 in 12 months. But in the last quarter from June to August 2026 alone, the inspections of Ayurvedic manufacturers reached 301.

When compared with the data in the year 2025-26, the last three months have seen a 557% increase in the number of complaints received, 378% increase in investigation of complaints, and a 217% increase in the number of searches and seizures. The FDA on Monday (September 7, 2026) presented the data of crackdown against drug manufacturers and sellers in the last three months. IAS officer Tukaram Mundhe recently completed 100 days in office as the FDA Commissioner.

The five-year period saw an average of approximately 1,463 inspections per month (87,807 inspections in 60 months). The June-August 2026 period recorded an average of 967 inspections per month (2,902 inspections in three months). While the simple monthly average appears lower, the FDA emphasised large-scale inspections during the last three months.

FDA claimed that there was a dramatic increase in the enforcement metrics when the quarterly data was compared to the quarters of the last five years. The quarterly data for the last year, from 2025 to 2026, for example, reflected 212.5 complaints per quarter. But the same number jumped to 1,397 complaints from June to August 2026.

“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,” Mr. Mundhe said.

In the last year of 2025-2026, there were 193.25 investigations per quarter. That figure rose to 924 in the last quarter, from June to September 2026.

A press statement issued by the FDA gave a comparison with the data from the year 2025-26 with the quarter of 2026, from June to August. According to the statement, there is a 121% rise in FIRs from 66 in 2025-26 to 20 in June - August 2026. The searches and seizures increased by 234% from ₹13.64 Crore in 2025-26 to ₹11.41 Crore in June to August 2026.

There were 32.75 cases/quarter, as compared to 104 cases in the recent quarter. Similarly, goods worth ₹3.41 crore/quarter were seized in 2025-26. The seizures went up to ₹11.41 Crore from June to August, 2026.

FDA said that the common violations included discrepancies in Batch Manufacturing Records (BMR), testing without competent technical personnel, absence of Annual Product Quality Reviews (APQR), lack of sterilisation records, and production of Not of Standard Quality (NSQ) drugs. During the inspection of the blood centres, the FDA found irregularities such as unregistered blood transfusion officers, outdated records, improper storage of expired or contaminated blood bags, and critical deficiencies in traceability and Standard Operating Procedure (SOP) adherence.

Violations for sales establishments included selling without a registered pharmacist’s supervision, transactions without bills, missing batch numbers or expiry dates on bills, non-compliance with Schedule H1 register maintenance, keeping expired medicines for sale, and improper storage of temperature-sensitive drugs like insulin and vaccines.

“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,” Mr. Mundhe said.