Pune: The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding unit at Wadki in Pune. The decision came after the Bombay High Court criticised the regulator’s procedure and directed it to reconsider the matter.
The FDA told the court that it would issue a fresh show-cause notice to Cipla and take a fresh, reasoned decision after considering the company’s response. The court said the earlier action did not follow the principles of natural justice.
The FDA had cancelled the licence with effect from August 27 over alleged irregularities linked to the packaging, storage and recall of Reactin Plus Tablets. The action followed inspections of the Wadki facility.
Cipla challenged the order in court. The company’s lawyer, Aabad Ponda, said the FDA had called the company for a hearing on August 26, which was a public holiday in Maharashtra. Cipla had sought more time as no representative was available, but the cancellation order was issued the same day, he told the court.
The court questioned the decision to schedule a hearing on a public holiday and then cancel the licence after Cipla sought an adjournment. The bench described the FDA’s approach as “high-handed” and said the procedure followed was not fair and transparent.
The FDA had cited several irregularities during its inspections. These included promotional wording on the packaging of Reactin Plus, a Schedule H prescription medicine, along with differences between physical and computerised stock records, gaps in purchase and sale records and alleged non-compliance with recall directions.
Cipla had earlier clarified that the cancellation order did not raise concerns about the safety, quality or efficacy of its products and did not indicate any patient safety issue.
The licence cancellation will now be reconsidered by the FDA after Cipla is allowed to respond.
