‘Do You Feel You Are A Lord?’ Bombay HC Questions Tukaram Mundhe's FDA Over ‘Hasty’ Orders

The Bombay High Court on Saturday pulled up the Maharashtra Food and Drugs Administration (FDA) for what it termed “undue haste” and a “pedantic instead of pragmatic” approach, prompting the regulator to withdraw two major enforcement orders involving a Cipla facility in Pune and five eateries at the Mumbai Cricket Association (MCA) premises.

The court questioned the FDA’s approach while hearing separate matters concerning the cancellation of Cipla Pharma and Life Sciences Ltd’s drug sale licence and the suspension of food licences of five restaurants at the MCA complex in Bandra-Kurla Complex (BKC).

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam A Ankhad criticised the regulator for failing to follow due process and warned officials of possible contempt proceedings in the MCA matter.

“Do you feel you are a Lord and you can do anything?” the court asked the FDA during the hearing.

FDA Withdraws Cipla Licence Cancellation

In the Cipla case, the FDA agreed to withdraw its order cancelling the drug sale licence of the company’s carrying and forwarding facility at Wadki in Pune.

The action followed a June inspection in which the FDA had allegedly detected irregularities concerning the packaging and promotional material of Reactin Plus tablets, besides other compliance-related issues.

Cipla challenged the cancellation before the High Court, arguing that it had not been given a proper opportunity to present its case.

The court also questioned the FDA over an email calling the company’s representative for a hearing on August 26, which was a state government-declared public holiday.

“You are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue,” the bench observed.

The court held that the procedure followed by the FDA was contrary to the principles of natural justice. The regulator informed the court that the impugned order would be withdrawn and that fresh notices would be issued to Cipla before September 4.

Five MCA Eateries Allowed To Reopen

In the second matter, the FDA agreed to withdraw its suspension order against five restaurants operating at the MCA premises in BKC.

The eateries had earlier faced regulatory action over alleged food safety and hygiene violations. Following the High Court’s directions, a fresh inspection found the establishments to be 88 per cent compliant with food safety requirements.

The FDA had initially maintained that the restaurants were being operated by M/s Shirke Infrastructure even though their food licences were issued in the name of the MCA.

However, the High Court questioned whether the law actually prohibited such an arrangement and had earlier directed the regulator to take a pragmatic view after examining the contractual arrangement between the MCA and Shirke Infrastructure.

The court expressed strong displeasure after finding that the FDA had continued to take what it described as a rigid approach.

“Don't kill a mosquito with a sword,” the court observed, while warning that contempt proceedings could be initiated against the officials concerned.

The FDA then agreed to issue a fresh notice to the MCA, provide it an opportunity to explain the arrangement with Shirke Infrastructure and pass a fresh, reasoned order.

With the eateries found substantially compliant during the fresh inspection, the High Court treated the suspension as vacated, allowing the establishments to resume operations.

Court Questions FDA's Enforcement Approach

The High Court repeatedly questioned why the regulator was acting in haste without adequately analysing the applicable law and following proper procedures.

The bench said it was “tired of scolding” the department and warned that it would be compelled to issue “stinging orders” if officials failed to comply with judicial directions.

The court stressed that regulatory authorities must balance enforcement with due process and cannot take action mechanically when legal or contractual issues require examination.

The two cases have resulted in the FDA withdrawing or vacating its immediate enforcement actions, while leaving the regulator free to follow the prescribed procedure and take fresh decisions after giving the affected parties an opportunity to be heard.