Sword to kill mosquito: Bombay High Court again raps Tukaram Mundhe-led FDA over procedural violations

The Bombay High Court has reprimanded the Maharashtra Food and Drug Administration (FDA) led by its Commissioner Tukaram Mundhe for taking high-handed and procedure-defying actions against commercial and pharmaceutical entities. 

While a division bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad commended the regulatory vigilance by FDA in several instances, it also warned authorities to exercise its powers judiciously. 

It cautioned the food safety regulator that shooting first and asking questions later is unacceptable in law.

The remarks were made in several matters heard over multiple days.

"Kill a Mosquito with a Sword": High Court rescues Amazon Retail

The Court made these observations on August 7 while hearing a plea filed by Amazon Retail India against the FDA’s decision to cancel its food business licence at its Bhiwandi warehouse.

Senior advocate Venkatesh Dhond, appearing for Amazon, informed the Bench that FDA officials visited the warehouse on June 24 and suspended its licence the next day without issuing an improvement notice. 

While Amazon's appeal against the suspension was pending, the regulator issued a show-cause notice on July 1 and cancelled the licence altogether.

ACJ Ghuge questioned the legality of cancelling a licence while an appeal against suspension was still pending.

"It is a settled law that during the appeal period, no such action can be taken. Therefore, we need to tell you that in order to implement your policies vigorously, you are trying to kill a mosquito with a sword. Procedure has to be followed," he said. 

The Court questioned the disproportionate impact of such regulatory overreach on broader commerce. 

"As we have said, we appreciate your action. This is a laudable object and you deserve a compliment. But go systematically. To deal with the situation, will you shut down all commercial establishments in Mumbai, Thane, Pune and Palghar? Unless that is the rule that everything should be stopped and you want foreign entities to come in," the judge said. 

On August 10, the Court noted that an understanding was reached between Amazon and FDA. Amazon said it will prepare an inventory of expired goods at the warehouse within three days for scientific disposal by the FDA at their own expense. 

The High Court directed the FDA to file its affidavit-in-reply by August 22 and posted the matter for hearing on merits on August 27.

"Rule of the Wild West": Relief to Cadila Pharmaceuticals

In another case heard on August 10, the Court likened the approach of FDA to "rule of the wild west".

The Court was hearing a plea by Cadila Pharmaceuticals which approached the Court after the FDA issued ‘stop-sale’ order and seized its drug stock over branding concerns. 

Senior Advocate Birendra Saraf, representing Cadila, urged the Court to quash the arbitrary orders that halted distribution and caused massive losses.

The bench took note of the public impact of such hasty regulatory bans.

"The drug was not sold for 20 days. We are not concerned with the loss of Saraf’s clients. We are concerned that the drug was not available to the patients for 20 days, effectively 32 days till today."

It criticized FDA's enforcement approach.

"Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law. Even when it comes to hotels, you shoot first, then ask questions. At least, undertake the task of shooting all the insects. The same is happening in this case,” the bench said. 

When the regulator countered with irregularities and its statutory powers, the Court warned the regulator to exercise said powers judiciously. 

"We have no doubts about your powers. You only display your powers, but the problem is, as I said last week (in Amazon), you have the power to use the sword, but you use it to kill a mosquito. That is the problem. Power has to be judiciously exercised. How to use the powers with adequate propriety is the question," the bench said. 

The bench also warned the department of costs if there are repeated procedural lapses. 

"We are finding that we hear a petitioner, allow the petition, give relief, matter closed. Tomorrow one more matter, same order, day after tomorrow same matter, same order. We are finding that your clients are not realising the seriousness of the order. In order to impress upon them the seriousness of the problem, we will now be imposing heavy costs," the judge said.

Following the High Court’s rebuke, the FDA assured the Court that it would revoke the stop-sale orders against Cadila and adhere strictly to procedural requirements by issuing show-cause notice and considering written responses prior to passing final orders.

Dhond with Advocates Suhaan Mukerji, Prashant Gupta, Shubhank Patel, Pragati Mishra, and Harsh Hiroo Gursahani appeared for Amazon Retail India. 

Saraf with Advocates Alankar Kirpekar, Shekhar Bhagat, Ashutosh Kumar, Kunal Vats, Anmol Saxena, and Ayush Sharma appeared for Cadila Pharmaceuticals

Government Pleaders Neha S Bhide, OA Chandurkar, PJ Gavhane, and Pooja Patil appeared for State of Maharashtra / FDA

The same bench has been taking objection to FDA’s disproportionate action since multiple private food establishments approached the court challenging said actions. 

During the hearing of one such petition on August 1, the bench flagged the biased enforcement of rules by the regulator which it found was showing partiality towards canteens/ eateries in government establishments like Mantralaya (State secretariat) and Vidhan Bhavan (State legislature) 

It underscored the need for parity in enforcement and said that statutory authorities should not selectively target private establishments while overlooking government or government aided establishments.