The Bombay High Court has issued a stern warning to the Maharashtra Food and Drug Administration (FDA), led by Commissioner Tukaram Mundhe, over its aggressive and non-compliant actions against commercial and pharmaceutical entities. While the court acknowledged the FDA’s vigilance in regulatory matters, it emphasized the necessity for the agency to wield its powers judiciously and in accordance with legal procedures.
High Court’s Critique in Amazon Retail Case
During a hearing on August 7, the court addressed a case filed by Amazon Retail India, challenging the FDA’s abrupt cancellation of its food business license at its Bhiwandi facility. Senior advocate Venkatesh Dhond, representing Amazon, highlighted that FDA officials had visited the warehouse on June 24 and suspended its license the following day without first issuing an improvement notice.
The court questioned the legality of revoking a license while an appeal against the suspension was still pending. Acting Chief Justice Ravindra Ghuge remarked, “In the vigorous implementation of your policies, you are attempting to kill a mosquito with a sword. Procedure must be followed.” The court expressed concern over the disproportionate effects of such regulatory actions on commerce.
On August 10, an understanding was reached between Amazon and the FDA, wherein Amazon agreed to prepare an inventory of expired goods for disposal by the FDA at its expense. The court has directed the FDA to submit an affidavit-in-reply by August 22, with a hearing on the matter scheduled for August 27.
Relief for Cadila Pharmaceuticals
In another significant ruling on August 10, the High Court compared the FDA’s methods to “the rule of the wild west.” This case involved Cadila Pharmaceuticals, which petitioned the court after the FDA issued a ‘stop-sale’ order and seized its drug stock over branding issues. Senior Advocate Birendra Saraf, representing Cadila, argued against the arbitrary orders that halted distribution and led to significant losses.
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The bench acknowledged the public impact of such regulatory bans. “The drug was unavailable for 20 days, and now for 32 days in total,” the court noted. Criticizing the FDA’s approach, the bench stated, “Shooting first and asking questions later is not applicable in the realm of law.”
Despite the FDA’s defense citing irregularities and statutory powers, the court advised the regulator to exercise its powers judiciously, warning of potential costs if procedural lapses persist. “We may impose heavy costs to underscore the seriousness of the problem,” the court cautioned.
Following the court’s rebuke, the FDA agreed to lift the stop-sale orders against Cadila and pledged to adhere to procedural norms by issuing show-cause notices and considering written responses before finalizing decisions.
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Advocates Suhaan Mukerji, Prashant Gupta, Shubhank Patel, Pragati Mishra, and Harsh Hiroo Gursahani represented Amazon Retail India, while Advocates Alankar Kirpekar, Shekhar Bhagat, Ashutosh Kumar, Kunal Vats, Anmol Saxena, and Ayush Tiwari appeared for Cadila Pharmaceuticals. Government Pleaders Neha S Bhide, OA Chandurkar, PJ Gavhane, and Pooja Patil represented the State of Maharashtra/FDA.
The court has consistently objected to the FDA’s disproportionate actions following complaints from multiple private food establishments. During a hearing on August 1, the court criticized the FDA’s biased enforcement of rules, noting partiality towards canteens and eateries in government establishments like Mantralaya and Vidhan Bhavan. The court emphasized the need for equal enforcement and cautioned against selectively targeting private establishments while overlooking government-affiliated ones.
