Bombay HC Raps Maharashtra FDA For 'Displaying Its Powers', Says Drastic Action Must Be Exercised Judiciously

The Bombay High Court criticised the Maharashtra FDA for taking drastic action against Cadila Pharmaceuticals without first hearing the company. While questioning the regulator’s use of its powers, the court accepted the FDA’s statement that it would revoke the impugned orders, issue show-cause notices and pass a reasoned order after hearing Cadila’s response.

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Bombay HC Raps Maharashtra FDA For 'Displaying Its Powers', Says Drastic Action Must Be Exercised Judiciously
Urvi Mahajani Updated: Tuesday, August 11, 2026, 05:31 PM IST
Bombay HC Raps Maharashtra FDA For 'Displaying Its Powers', Says Drastic Action Must Be Exercised Judiciously

Bombay High Court questioned the Maharashtra FDA’s drastic action against Cadila medicines and stressed the need for judicious use of regulatory powers and due procedure | AI Generated Representational Image

Mumbai, August 11, 2026: The Bombay High Court on Tuesday warned the Maharashtra Food and Drug Administration (FDA) against “displaying its powers” through drastic action, saying its authority must be exercised “judiciously” and with due procedure.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad made the remarks while hearing a petition filed by Cadila Pharmaceuticals Ltd against the FDA’s orders stopping the sale and distribution of some of its medicines and seizing stock worth around Rs 2.45 crore.

Cadila Challenges FDA Action

Senior advocate Birendra Saraf, appearing for Cadila, said the company had not been given an opportunity to explain its case before the orders were passed. The action related to medicines including Aciloc 150, Aciloc 150 Plus, Aciloc 300 and Aciloc 300 Plus.

Government pleader Neha Bhide defended the FDA’s action, saying there was confusion between the medicines because of similarities in their branding despite differences in their active pharmaceutical ingredients (APIs). She said the action was a “preventive measure and not high-handed action”.

Court Questions Procedure

The bench, however, questioned the manner in which the FDA had exercised its powers.

“We are not worried about the loss faced by the company in the past two weeks since the order was passed. We are worried about those people who have not had access to these medicines,” the court said.

Referring to its earlier criticism of the regulator, the bench said, “We have no doubts about your powers… You only display your powers, but the problem is, as I said last week, you have the power to use the sword, but you use it to kill a mosquito. Power has to be judiciously exercised… How to use the powers with adequate propriety is the question.”

The court also criticised the FDA for acting before hearing the affected party. “Even in the cases of hotels and restaurants, you shoot first and then ask questions,” the bench observed.

FDA To Revoke Orders

The court said it had come across several cases involving drastic action by the FDA and warned that it may impose heavy costs on the regulator.

Following the court’s remarks, Bhide assured the bench that the FDA would revoke its orders against Cadila. The regulator would issue show-cause notices, allow the company to submit its response and then pass a reasoned order, she said.

The High Court accepted the statement and disposed of the petition.

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The same bench had last week used the “sword to kill a mosquito” analogy while hearing a plea concerning FDA action against Amazon Retail India’s warehouse.

The court had then said that while the regulator had the power to act against violations, it needed to exercise that power judiciously and follow due procedure. While lauding the FDA’s action, the bench had asked whether shutting down all commercial establishments was the way to deal with the situation.

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Published on: Tuesday, August 11, 2026, 05:31 PM IST

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