The Bombay High Court has cautioned the Maharashtra Food and Drug Administration (FDA) against taking drastic action without following the procedure prescribed by law. A Division Bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad made the observations while dealing with petitions arising from FDA action against Amazon Retail India and Cadila Pharmaceuticals.
The Bench said regulatory vigilance was necessary, but statutory powers could not be exercised disproportionately or without adequate procedural safeguards.
Amazon Retail Licence Dispute
The Court made the first set of observations while hearing Amazon Retail India's challenge to FDA action concerning its Bhiwandi warehouse. The company argued that its food business licence was suspended shortly after an inspection and was later cancelled while its appeal against the suspension was still pending.
Acting Chief Justice Ghuge questioned the manner in which the action had been taken.
“It is a settled law that during the appeal period, no such action can be taken,” the Bench observed, adding that the authorities appeared to be trying to “kill a mosquito with a sword.”
The Court clarified that it appreciated the FDA's objective of ensuring food safety but stressed that enforcement had to proceed systematically. “Procedure has to be followed,” the Bench remarked.
On August 10, the Court recorded an understanding between Amazon and the FDA under which Amazon agreed to prepare an inventory of expired goods at the warehouse for scientific disposal by the FDA. The FDA was directed to file its reply by August 22, with the matter posted for hearing on merits on August 27.
FDA's Action Against Cadila Pharmaceuticals
The Court also expressed strong reservations over FDA action against Cadila Pharmaceuticals after a stop-sale order was issued and drug stock was seized over branding-related concerns.
The Bench noted that the affected medicine remained unavailable to patients for several weeks and said the consequences of regulatory action could extend beyond the concerned company.
“Shooting first and asking questions later is a rule of the Wild West which does not apply in the arena of law,” the Bench said.
The Court further clarified that it did not doubt the FDA's statutory powers. The concern, it said, was how those powers were exercised.
“You have the power to use the sword, but you use it to kill a mosquito,” the Bench remarked, stressing that regulatory powers must be exercised with “adequate propriety.”
Court Warns Against Repeated Procedural Lapses
The Bench also indicated that repeated procedural failures could invite substantial costs. It observed that the Court was repeatedly being approached against similar orders and said the authorities needed to understand the seriousness of its directions.
Following the Court's observations, the FDA assured the Bench that the stop-sale orders against Cadila would be revoked and that the department would follow the prescribed procedure, including issuing show-cause notices and considering written responses before passing final orders.
Decision
The Bombay High Court directed the FDA to place its response on record in the Amazon matter by August 22 and fixed August 27 for hearing on merits.
In the Cadila matter, the FDA undertook to revoke the stop-sale orders and comply with procedural requirements before taking further final action.
 chief. Eknath Shinde – Shiv Sena leader-300x169.webp)
