The Maharashtra Food and Drug Administration has withdrawn its order cancelling the drug sales licence of Cipla Pharma and Life Sciences’ Carry and Forwarding unit in Pune after the Bombay High Court questioned the procedure followed by the regulator. The court observed that the action appeared to have been taken without giving the company a proper opportunity to be heard and raised concerns over compliance with the principles of natural justice.
The cancellation order had been made effective from August 27. During the hearing, a bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the manner in which the FDA had proceeded against the company.
FDA agrees to withdraw cancellation order
The FDA told the court that it would immediately withdraw the order revoking the licence. It also said a fresh show-cause notice would be issued to the company and that a reasoned order would be passed thereafter.
Cipla Pharma and Life Sciences had challenged the regulatory action. The company also clarified that the FDA order did not raise any concerns regarding the safety, quality or efficacy of its products and did not indicate any issue related to patient safety.
Company says hearing was fixed on a public holiday
Senior advocate Abad Ponda, appearing for the company, told the court that the FDA had sent an email directing the company to appear for a hearing on August 26. The date was a public holiday.
According to the company’s submission, no representative was available on that day and an adjournment was sought. However, the FDA passed the order on the same day without giving the company another opportunity for a hearing.
Additional public prosecutor P.P. Kakade, appearing for the FDA, argued that the law did not give the company a right to be heard.
High Court questions procedure followed by regulator
The bench questioned why the department had called the company for a hearing on a state-declared holiday and then proceeded with the cancellation order.
The court said the FDA had adopted an arbitrary approach and followed an improper procedure while revoking the licence. It also questioned whether asking the company by email to send a representative for a hearing on the same day could be considered fair and transparent.
The court’s observations ultimately led to the FDA withdrawing the cancellation order and agreeing to restart the process through a fresh show-cause notice and a subsequent reasoned decision.
About the author — Suvedita Nath is a science student with a growing interest in cybercrime and digital safety. She writes on online activity, cyber threats, and technology-driven risks. Her work focuses on clarity, accuracy, and public awareness.
