Public health, not popularity, drives Maharashtra FDA crackdown: Commissioner

Maharashtra Food and Drug Administration (FDA) Commissioner Tukaram Mundhe has said his recent high-profile enforcement drive is rooted in a commitment to public health, not a quest for personal fame. Responding to questions about his growing public profile, Mundhe said popularity was never his objective, and the focus must remain on broader health outcomes for the country.

"This is not about Tukaram Mundhe. This is about India and the goal to improve public health," he said, adding that he would be satisfied if his actions helped make health a public priority. Mundhe, a senior IAS officer, rejected suggestions that his approach is aggressive, describing it instead as diligent execution of his duties, consistent with his two decades in public service.

Since taking charge as FDA Commissioner in May, Mundhe said action has been taken against 12,083 entities, including suspension or cancellation of licenses and criminal cases. Improvement notices were issued to 5,269 entities, and suspension orders were served on 603. In the hospitality sector, 1,803 inspections of hotels and eateries led to 948 improvement notices and 199 license suspensions. Separately, 740 pharmacy licenses were cancelled or suspended for violations.

Mundhe identified hygiene and manufacturing protocols, poor raw material quality, and lack of trained staff as the most common violations found in restaurants. He also noted that online food delivery platforms are legally classified as food business operators and are subject to action, despite some not recognising this responsibility.

On the FDA's notice to actors Shah Rukh Khan, Ajay Devgn, and Tiger Shroff over an elaichi advertisement suspected of being a surrogate promotion for a banned paan ad, Mundhe said two of the three have responded so far, with time still remaining in the 30-day window.

Addressing the Bombay High Court's criticism in the Cipla case, Mundhe maintained there was no procedural mistake by the FDA, though he acknowledged a minor error where an officer was overly lenient in scheduling a hearing on a public holiday. A fresh notice has been issued, and a decision is pending. He ruled out changes to the FDA's standard operating procedures, saying the agency follows the law and takes cognisance of any errors.

On the issue of substandard medicines, Mundhe said the problem exists but is difficult to quantify. He has directed officers to focus on process audits rather than mechanical inspections, particularly regarding good distribution practices. Online pharmacies face the same scrutiny as physical ones and must comply with the Drugs and Cosmetics Act.

Regarding resources, Mundhe said existing labs are adequate but capacity is being enhanced with four new facilities under construction. While most sanctioned posts are filled, drug inspector recruitment has been delayed after the Maharashtra Public Service Commission cancelled an exam due to a question paper leak, in which seven people have been arrested.