The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Wadki, Pune, following a sharp rebuke from the Bombay High Court. The regulator told the court it would issue a fresh show-cause notice to the company and take a reasoned decision after considering its response.
The development came after a bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad criticised the FDA’s handling of the matter. The court accused the regulator of going “overboard” and behaving in a “high-handed” manner, observing that the procedure followed was contrary to the principles of natural justice.
The FDA had cancelled the drug sale licences of Cipla’s Pune facility with effect from August 27. The action followed inspections that allegedly found irregularities involving the packaging, storage and recall of Reactin Plus Tablets. According to the FDA, officials had also detected unauthorised promotional wording on the packaging of the prescription medicine, along with discrepancies between physical and computerised stock records and gaps in purchase and sale documentation.
Cipla challenged the cancellation before the High Court. During the hearing, the company’s senior counsel Aabad Ponda said the FDA had asked Cipla to appear for a hearing on August 26, which was a public holiday in Maharashtra. Cipla reportedly sought an adjournment because it did not have a representative available that day. Despite this, the FDA passed the cancellation order on the same day, according to the company’s submission.
The court questioned the fairness of the procedure, particularly why the regulator had called the company for a hearing on a government-declared holiday and then proceeded with the cancellation after the company requested more time. The bench stressed that regulatory authorities must follow due process before taking serious action against a company.
The FDA subsequently agreed to withdraw the cancellation order immediately. It will now issue a fresh show-cause notice to Cipla, provide an opportunity for the company to respond and then pass a fresh, reasoned order in accordance with the prescribed procedure.
The episode underlines the importance of balancing strict regulatory enforcement with procedural fairness. While the FDA’s concerns over alleged compliance lapses remain part of the matter, the Bombay High Court’s intervention has ensured that Cipla gets a proper opportunity to present its case before any fresh decision is taken.
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