Mumbai: The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Pune facility after the Bombay High Court criticised the regulator’s procedure and said it had acted “overboard” and in a “high-handed” manner.
The FDA had cancelled the licences of Cipla’s carrying and forwarding facility at Wadki in Pune with effect from August 27. The action followed inspections in June, during which officials reported several irregularities involving the packaging, storage, stock records and recall of Reactin Plus tablets, a Schedule H prescription medicine.
According to the FDA, inspectors found unauthorised promotional wording on the packaging of Reactin Plus, including the terms “analgesic and antipyretic”. The regulator said such wording on a prescription medicine could encourage self-medication. Officials also reported discrepancies between physical and computerised stock records, gaps in purchase and sales documentation and alleged non-compliance with recall directions. The FDA had also seized Reactin Plus stock valued at around ₹11.19 lakh and ordered its recall.
Cipla challenged the licence cancellation before the Bombay High Court. During the hearing, the company’s senior counsel Aabad Ponda argued that the FDA had asked the company to appear for a hearing on August 26, which was a public holiday. Cipla sought an adjournment because no representative was available, but the regulator allegedly passed the cancellation order on the same day without providing the company an effective opportunity to be heard.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the FDA’s approach. The court observed that the regulator had followed an incorrect procedure and that the cancellation order appeared to violate the principles of natural justice.
The bench also questioned the fairness of asking a company to appear for a hearing on a government-declared holiday and then proceeding with an order when the company requested more time.
Following the court’s intervention, the Maharashtra FDA agreed to withdraw the cancellation order immediately. The department said it would issue a fresh show-cause notice to Cipla and, after considering the company’s response, pass a fresh and reasoned order.
The development does not mean the allegations against Cipla have been finally cleared. The FDA is expected to reconsider the matter through the fresh proceedings. Cipla had also clarified that the original FDA order did not allege any concern regarding the safety, quality or efficacy of its products and did not indicate any patient-safety issue.
The case highlights the importance of both strict regulatory oversight of prescription medicines and adherence to due process when action is taken against pharmaceutical companies.
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