The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Pune after the Bombay High Court criticised the regulator’s approach.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA appeared to have acted in violation of the principles of natural justice.
Following the court’s intervention, the regulator agreed to withdraw the cancellation order and issue a fresh show-cause notice to the company before passing a reasoned decision.
Bombay HC Questions FDA Procedure
The FDA had cancelled the licences of Cipla’s Wadki facility with effect from August 27 over alleged irregularities involving the packaging, storage and recall of Reactin Plus Tablets.
Cipla challenged the decision, stating that the FDA action did not raise concerns about the safety, quality or efficacy of its products and did not involve any patient safety issue.
During Saturday’s hearing, Cipla’s senior counsel Aabad Ponda said the regulator had asked the company to appear for a hearing on August 26, which was a state-declared public holiday. After Cipla sought an adjournment because no representative was available, the FDA proceeded to issue the cancellation order that same day.
The court questioned the fairness of requiring the company to attend a hearing on a holiday and then passing an order without granting the requested adjournment.
FDA to Issue Fresh Show-Cause Notice
The FDA maintained that the law did not specifically provide Cipla with a right to a hearing. However, the court criticised the department for adopting what it described as a “high-handed” approach and following an improper procedure.
The FDA subsequently agreed to withdraw the licence cancellation immediately and conduct fresh proceedings through a new show-cause notice.
The underlying inspection had identified several alleged compliance issues, including promotional wording on Reactin Plus packaging despite it being a Schedule H prescription medicine. Officials also reported discrepancies between physical and digital stock records, gaps in purchase and sales documentation, and alleged non-compliance with recall instructions.
