'You are going overboard': HC raps FDA over Cipla Pune licence cancellation

A day after the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) facility at Wadki in Pune was cancelled, citing serious irregularities linked to Reactin Plus tablets, the Maharashtra Food and Drug Administration (FDA) withdrew its order after the Bombay High Court rapped the regulator for going “overboard” and acting in a “high-handed” manner.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad while hearing the case in which Cipla challenged FDA's action said the regulator had followed an improper procedure and acted against the “principles of natural justice”.

"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.

Why had FDA cancelled Cipla's sales licence?

According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines.

The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine.

The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication.

Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations.