The Maharashtra Food and Drug Administration (FDA) on Saturday withdrew its order cancelling the drug sales licence of Cipla Pharma & Life Sciences Limited’s Pune facility, hours after the Bombay High Court criticised the regulator for allegedly going “overboard” and following a “high-handed” procedure.
The FDA said the cancellation order would be withdrawn with immediate effect and that a fresh show-cause notice would be issued to the company. A reasoned order will be passed after the prescribed process is completed.
The dispute concerns Cipla’s carrying and forwarding facility at Wadki in Pune, where the FDA had cancelled drug sales licences effective August 27 over alleged irregularities involving the packaging, storage and recall of Reactin Plus Tablets.
Bombay High Court questions FDA procedure
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad questioned the manner in which the FDA had proceeded against Cipla.
Senior counsel Aabad Ponda, representing Cipla, told the court that the company had been asked by email to appear for a hearing on August 26, which was a public holiday. Cipla sought an adjournment as it did not have a representative available, but the FDA passed the cancellation order the same day, Ponda said.
The FDA argued that the law did not provide Cipla with a right to a hearing. The court, however, questioned why the regulator had called the company for a hearing if it intended to proceed without allowing the requested adjournment.
“You are going overboard,” the bench observed, while questioning the fairness and transparency of the procedure.
The court also described the FDA’s approach as “high-handed” and said the cancellation order was contrary to the principles of natural justice.
Why was Cipla’s licence cancelled?
The FDA’s action followed inspections of Cipla’s Pune facility. During an inspection in June, officials allegedly found unauthorised promotional wording on the packaging of Reactin Plus Tablets, a Schedule H prescription medicine.
The packaging reportedly carried the words “analgesic and antipyretic”. According to the FDA, such wording could promote the use of prescription medicines without medical advice and potentially encourage self-medication.
The regulator also cited discrepancies between physical and computerised stock records, gaps in purchase and sales documentation, and alleged non-compliance with recall directions.
Cipla, however, had said the FDA’s order did not raise concerns about the safety, quality or efficacy of its products and did not involve any identified patient-safety issue.
Fresh proceedings likely
With the cancellation order now withdrawn, the FDA will issue a fresh show-cause notice to Cipla. The company will subsequently have an opportunity to respond before a fresh, reasoned decision is taken.
The development puts the focus not only on the alleged regulatory violations but also on the importance of following due process when authorities take action against pharmaceutical companies.
The Bombay High Court’s observations underline the principle that regulatory enforcement must be carried out through a fair and transparent procedure, even when authorities are acting on alleged violations involving prescription medicines.
