Bombay High Court Asks Maharashtra FDA to Use Powers Judiciously in Cadila Pharmaceuticals Case

The Bombay High Court has asked the Maharashtra Food and Drug Administration (FDA) to use its powers judiciously after Cadila Pharmaceuticals Ltd challenged the regulator’s decision to stop the sale of some of its medicines. The court questioned the FDA’s approach and accepted its assurance that the orders against Cadila would be revoked, followed by show-cause notices and a hearing, a TOI report stated.

A bench of acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad heard Cadila’s plea against the FDA’s action.

Cadila senior advocate Birendra Saraf told the court that the dispute involved the wider pharmaceutical industry practice of using brand extensions. He said the Centre had begun a public consultation on July 6, 2026, on the issue.

According to Cadila, the consultation was still underway when the state FDA took coercive action against the company despite it having a valid manufacturing licence.

During the hearing, the FDA offered to revoke its orders against Cadila. It also agreed to issue show-cause notices and give the company an opportunity to be heard before passing a reasoned order.

Government pleader Neha Bhide made the submission for the FDA after the high court suggested that the company should be heard before any drastic action was taken.

The bench accepted the statement and disposed of Cadila’s plea.

Bhide told the court that the FDA “action was a preventive measure, not-high-handed action’’. She said the action followed confusion over the medicines.

The high court also commented on the wider enforcement drive launched by the FDA under its latest commissioner, Tukaram Mundhe, to address alleged non-compliance with safety standards.

“Be judicious,” the high court said while referring to the FDA’s actions.

Saraf argued that a valid manufacturing licence could not be followed by a prohibition on sale without following the required procedure.

“Once there is a valid licence, the prohibition of sale can be only by following the prescribed procedure of issuing show-cause and hearing the licence holder,’’ said Saraf, seeking a stay on the “arbitrary” stoppage order.

He further argued that stopping sales without a hearing effectively amounted to an illegal suspension or revocation of the licence.

Cadila told the court that it had suffered substantial losses after the sale ban remained in place for 20 days when the petition was filed.

The company also said stocks worth Rs 2.4 crore had been seized across the state over alleged branding issues.

The acting chief justice, however, said the bench was not focused on the company’s losses. Instead, the court was concerned about the availability of an important medicine to patients.

The medicines are used for stomach acid-related problems, including acid reflux, heartburn and stomach or intestinal ulcers.

The bench noted that the medicines had effectively been unavailable to patients for 32 days.

The acting chief justice repeated the analogy of “using a sword to swat a mosquito” while questioning the FDA’s approach.

The court said the regulator appeared to “shoot first” and make enquiries later. It also warned that costs could be imposed, noting that several cases involving the department’s “drastic action” had come before it.

“You (FDA) have the power to use a sword, but the problem is you are using it to kill a mosquito. The power has to be judiciously exercised. It has to be used properly. Even in the cases of hotels and restaurants, you shoot first and then ask questions,” the bench said.