Bombay High Court pulls up FDA over revocation of Pune drug firm’s licence

The Bombay High Court criticized the FDA for revoking a Pune-based drug firm's license without following proper legal procedures, including failing to hold a hearing. The FDA agreed to withdraw the order and issue a fresh notice.
Why it matters
It underscores the importance of due process and natural justice in administrative actions taken by government regulatory bodies.
The Bombay High Court on Saturday (August 29, 2026) took exception to the procedure followed by the Food and Drug Administration (FDA) in revoking the drug sale licence of a Pune-based company.
The court observed that the authority had acted against the principles of natural justice. Following the court’s remarks, the FDA informed the Bench that it would withdraw the revocation order and issue a fresh show-cause notice to the company.
The bench, comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad, was hearing a petition filed by Cipla Pharma and Life Sciences Limited against the FDA’s order dated August 27, which cancelled the licences for its carry and forwarding unit at Vadki, Pune.
The FDA had initiated action against the company for publishing unauthorised text on the packaging of its drug ‘Rectin Plus’ and for deficiencies in purchase-sale records and storage of drugs.
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