New Delhi, August 29, 2026 (Yes Punjab News)
The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Pune after the Bombay High Court questioned the regulator’s procedure and observed that it had acted beyond the proper limits.
The FDA told the court that it would withdraw the cancellation order immediately and issue a fresh show-cause notice to Cipla. The company will be given an opportunity to respond, following which the regulator said it would pass a reasoned order.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad observed that the FDA had adopted an incorrect procedure and failed to adhere to principles of natural justice.
The court was hearing Cipla Pharma & Life Sciences’ challenge to the cancellation of the drug sale licences of its C&F facility at Wadki in Pune, which had been made effective from August 27.
Senior counsel Aabad Ponda, appearing for Cipla, told the court that the FDA had asked the company by email to appear for a hearing on August 26, a public holiday declared by the Maharashtra government. He said Cipla sought an adjournment because it could not arrange for a representative to appear on the holiday, but the FDA proceeded to cancel the licences the same day without providing an effective opportunity of hearing.
Additional Government Pleader P.P. Kakade, representing the FDA, argued that the applicable law did not provide the company with a right to a hearing.
The bench questioned the regulator over scheduling the hearing on a public holiday and subsequently issuing the cancellation order without hearing the company.
“You are doing a laudable and appreciative job but now you are going overboard,” the court observed, adding that the regulator had “wronged” the company and needed to resolve the issue.
The FDA had cancelled the licences over alleged irregularities related to the packaging, storage and recall of Reactin Plus Tablets. The regulator had previously said inspections detected unauthorised promotional text on the packaging of the Schedule H prescription medicine, discrepancies between physical and computerised stock records, deficiencies in purchase and sale records, and non-compliance with recall directions.
Cipla, however, clarified that the FDA order did not raise concerns regarding the safety, quality or efficacy of its products and did not involve or indicate any patient safety issue.
FOLLOW NOW
