Bombay HC Questions Maharashtra FDA's Enforcement Approach

The Bombay High Court has raised concerns over the way Maharashtra's Food and Drug Administration (FDA) has taken enforcement action against businesses. The court has examined whether the regulator followed due process and whether its actions were proportionate to the alleged violations.

The scrutiny has involved pharmaceutical companies, restaurants, hotels, dairies and sweet shops. However, the court has not challenged the FDA's authority to enforce food and drug safety regulations.

Cipla Licence Cancellation Comes Under Scrutiny

On 29 August, the Bombay High Court questioned the cancellation of wholesale drug-sale licences associated with Cipla Pharma & Life Sciences' distribution facility in Wadki, Pune.

The FDA had acted after inspections identified alleged irregularities concerning Reactin Plus tablets. These included packaging and artwork issues, differences between physical and computerised stock records, gaps in purchase and sales documentation, and concerns about the product recall.

Cipla challenged the cancellation, saying it had not been given a proper opportunity to present its case.

The FDA issued a show-cause notice on 13 August. Cipla submitted its response on 25 August. A personal hearing was then scheduled for 26 August, which was a public holiday.

After Cipla requested an adjournment, the FDA proceeded with the cancellation. The High Court criticised the approach as "high-handed".

The FDA subsequently agreed to withdraw the cancellation order and issue a fresh notice, giving Cipla an opportunity to respond before taking a fresh decision.

The bench also advised the regulator to avoid scheduling hearings on public holidays unless there was a genuine emergency.

Restaurants, Dairies And Hotels Also Receive Relief

The court has also intervened in a dispute involving five restaurants operating at the Mumbai Cricket Association (MCA) premises in the Bandra Kurla Complex (BKC).

The FDA had suspended their food licences over alleged hygiene violations and concerns about third-party operation. The licences were held in the MCA's name, while the regulator argued that the outlets were being operated by M/s Shirke Infrastructure.

The High Court set aside the suspension orders and permitted the restaurants to reopen. It criticised the FDA for adopting what it described as a "pedantic instead of pragmatic" approach.

In another case, Gurunanak Dairy and Sweets in Pune faced suspension following a food-poisoning incident. A later inspection found the business to be 98% compliant. The High Court quashed the suspension and ordered the FDA to pay ₹5 lakh in compensation.

The court also restored the licence of Park Inn by Radisson in Navi Mumbai while examining whether the deficiencies found during inspection justified continued suspension.

In July, the Aurangabad bench stayed FDA action against milk vendors and suppliers. The proceedings examined whether statutory requirements, including improvement notices and an opportunity for a hearing, had been followed.

The FDA's powers were also examined in a case involving Cadila Pharmaceuticals. The court considered whether the regulator had appropriately exercised its authority to stop the sale and distribution of certain medicines.

The outcomes have varied between cases. For example, the court declined urgent interim relief for Udupi Swaad in Thane after FDA officials found the restaurant serving analogue paneer.

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