The Maharashtra Food and Drug Administration (FDA) has withdrawn its decision to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Pune, following sharp observations from the Bombay High Court. The regulator’s move came after the high court criticised the manner in which the FDA had proceeded against the company, describing its conduct as “high-handed” and saying the department had gone “overboard”.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad also held that the FDA’s action was contrary to the “principles of natural justice”.
The FDA has now said it will withdraw the licence cancellation order with immediate effect and issue a fresh show-cause notice to Cipla Pharma & Life Sciences. A fresh, reasoned decision will subsequently be taken after the company gets an opportunity to respond.
Why Maharashtra FDA Cancelled Cipla Facility’s Licence
The FDA had earlier cancelled the drug sale licences of Cipla Pharma & Life Sciences’ carrying and forwarding facility at Wadki in Pune, effective August 27. The action followed inspections that allegedly uncovered several irregularities involving the packaging, storage and recall of Reactin Plus Tablets.
The dispute escalated after the company challenged the regulator’s order before the Bombay High Court.
Cipla Pharma & Life Sciences had also clarified that the FDA’s action did not raise any concerns regarding the safety, quality or efficacy of its products. The company further stated that the regulatory action did not involve or suggest any patient safety issue, according to a PTI report.
Cipla Challenges FDA Action Over Hearing
During Saturday’s hearing, senior counsel Aabad Ponda, representing the company, highlighted the circumstances surrounding the hearing offered by the FDA. Ponda told the court that the regulator had emailed the company asking it to send a representative for a hearing on August 26. However, August 26 was a public holiday declared by the state government.
“The company had no representative available that day and had sought an adjournment. However, the FDA passed the order the same day without granting a hearing,” Ponda said.
The FDA, represented by Additional Government Pleader P P Kakade, argued that the applicable law did not give the company a right to a hearing.
That argument prompted questions from the bench over why the department had asked the company to appear for a hearing in the first place, particularly when the scheduled date was a public holiday.
Bombay HC Questions FDA’s Procedure
The court expressed strong reservations about the regulator’s approach and questioned whether the process followed by the FDA could be considered fair and transparent.
“You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue,” the high court said.
The bench further criticised the manner in which the licence cancellation was carried out, observing that the regulator had adopted an incorrect procedure.
The court said the FDA had behaved in a “high-handed” manner and stressed that the licence cancellation order was contrary to the “principles of natural justice”.
The judges also questioned the fairness of requiring the company to appear for a hearing on a state-declared holiday.
“If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday,” the bench questioned.
FDA To Issue Fresh Show-Cause Notice
Following the court’s observations, the Maharashtra FDA agreed to withdraw the earlier licence cancellation order.
The regulator said the cancellation would be withdrawn forthwith and that a new show-cause notice would be issued to the company. The matter will then be reconsidered, with the FDA expected to pass a reasoned order after following the fresh process.
This means the latest development does not amount to a final clearance of the regulatory concerns raised during the inspections. Instead, the FDA will have to restart the process and give the company an opportunity to respond before taking another decision.
What Did FDA Find During Inspection?
The regulatory action originated from an inspection conducted in June. According to the FDA, officials discovered promotional wording on the packaging of Reactin Plus Tablets, which is classified as a Schedule H prescription medicine.
The packaging reportedly carried the words “analgesic and antipyretic”.
The FDA had argued that promotional content on prescription medicines could encourage consumers to use such drugs without medical supervision, potentially increasing the risk of self-medication.
The inspection also identified several other alleged compliance issues. These included differences between the physical inventory and computerised stock records, deficiencies in purchase and sales documentation and alleged non-compliance with directions relating to the recall of the medicine.
(With PTI Inputs)