Pune: Bombay High Court Pulls Up Maharashtra FDA Over Cipla Licence Cancellation, Directs Fresh Proceedings

Mumbai/Pune, 29th August 2026: The Maharashtra Food and Drug Administration (FDA) on Saturday agreed to withdraw its order cancelling the drug sale licence of Cipla Pharma and Life Sciences Limited’s carrying and forwarding (C&F) unit in Pune after the Bombay High Court criticised the authority for acting in an “over-enthusiastic” and “authoritarian” manner.

The court also observed that the FDA’s action was contrary to the principles of natural justice.
The FDA informed a division bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad that it would immediately withdraw the licence cancellation order, issue a fresh show-cause notice to the company and pass a fresh order after following due procedure.

The matter concerns action taken by the FDA against Cipla Pharma and Life Sciences Limited’s drug distribution facility at Vadki in Pune. The authority had cited alleged irregularities, including unauthorised content on the packaging of the drug Rectin Plus, as well as discrepancies in records relating to the storage, purchase and sale of medicines.

Based on these findings, the FDA had cancelled the drug sale licences of the company’s transportation and distribution centre with immediate effect from August 27. Cipla subsequently challenged the decision before the Bombay High Court.

Senior advocate Abad Ponda, appearing for Cipla, argued that the FDA’s order did not raise concerns regarding the safety, quality or efficacy of the products and did not indicate any risk to patient safety.

Ponda further submitted that the FDA had sent an email directing the company to appear for a hearing on August 26, which was a public holiday. Since no company representative was available, Cipla requested that the hearing be postponed.

However, according to the company, the FDA proceeded to cancel the licence without providing it with an effective opportunity of being heard.

Representing the FDA, Additional Government Pleader Priyabhushan Kakade argued that the company was not entitled to a hearing under the relevant provisions of law.

The High Court, however, questioned the FDA’s decision to schedule the hearing on a state-declared public holiday.

“You are doing commendable and appreciable work, but now you are becoming over-enthusiastic and crossing your limits,” the bench remarked, adding that such instances were not occurring for the first time.

The court further observed that the FDA had acted arbitrarily and failed to follow the prescribed procedure before cancelling the licence.

Questioning the authority’s conduct, the bench asked whether it was fair and transparent to email the company asking it to send a representative for a hearing on the same day, particularly when it was a public holiday.

The judges also pointed out that government departments themselves frequently cite public holidays while seeking adjournments or postponements, and questioned how a government authority could insist on conducting such proceedings on a declared holiday.

Following the court’s observations, the FDA agreed to withdraw its earlier order and initiate fresh proceedings by issuing a new show-cause notice to Cipla.

The High Court’s intervention provides temporary relief to the company. However, the FDA can reconsider the matter and pass a fresh order after following the prescribed procedure and giving Cipla an effective opportunity to respond.