The Maharashtra Food and Drug Administration (FDA) has withdrawn its order to cancel the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding unit in Pune after the Bombay High Court pulled up the regulator for going "overboard" and behaving in a "high-handed" manner. A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad said the FDA has acted against the "principles of natural justice" and has behaved in a "high-handed" manner. The FDA said it would withdraw the license cancellation order forthwith and issue a fresh show cause notice to the company, pursuant to which a reasoned order would be passed. The court questioned why the department sent an email to the drug company, asking it to send a representative for a hearing on August 26, which was a public holiday, and noted that the company had no representative available that day and had sought an adjournment. As per CNBC TV18, the FDA had cancelled the drug sale licenses of Cipla Pharma & Life Sciences Ltd's carrying and forwarding facility at Wadki in Pune for serious irregularities related to the packaging, storage and recall of Reactin Plus Tablets, with effect from August 27.
The inspection at the company's Pune facility revealed significant storage deficiencies, with drug stocks found stored directly on the floor instead of following prescribed storage practices. As reported by the Maharashtra FDA, the storage arrangement raised compliance concerns and contributed to the regulatory action. Additionally, the inspection identified discrepancies in purchase and sale records, computerised records and physical stock maintained at the warehouse. Officials also found differences between physical stock and computerised records, along with inadequate arrangements of pallets and racks required for proper medicine storage. The FDA also identified deficiencies in records and procedures for managing expired medicines. A subsequent inspection of the C&F unit's drug sale and distribution system found deficiencies in storage arrangements, discrepancies between purchase and sale records and actual computerised stock, and non-compliance with recall directions.
The regulatory action stemmed from an investigation into Reactin Plus Tablets, a Schedule H prescription drug, where the FDA found unauthorised claims describing it as an 'analgesic and antipyretic' on the packaging. According to the Maharashtra FDA, this promotional claim was not authorised and violated provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. The FDA seized Reactin Plus Tablets worth ₹11.19 lakh during the inspection. The regulator warned that advertising prescription medicines in such a manner could encourage consumers to take the drug without consulting a doctor, potentially increasing the possibility of self-medication and posing a potential risk to public health. The FDA subsequently directed the company to recall the misbranded Reactin Plus Tablets from the market. As per CNBC TV18, in the first round of inspection carried out in June, the FDA officials found unauthorised promotional text on the packaging of the tablets, a Schedule H prescription medicine.
Despite being directed to recall Reactin Plus stock from the market, the company failed to fully comply with recall directions, contributing to the regulatory action against its drug sales licences. Following the inspection, the company was issued a show-cause notice and asked to explain the violations. However, the FDA's findings, along with the company's explanation, indicated that required directions regarding the recall of Reactin Plus Tablets from the market and other statutory requirements had not been fully complied with. This incomplete compliance with recall directions was a significant factor in the decision to cancel the company's licences in Pune. The FDA found that the company didn't fully comply with the directions and required measures, with subsequent inspections confirming non-compliance with recall directions.
Cipla has contested the FDA's order and stated that the matter is currently sub judice under judicial consideration. As reported by CNBC TV18, on Friday evening, Cipla Pharma & Life Sciences said it had challenged the action while clarifying that the FDA order didn't allege any concerns about the safety, quality or efficacy of its products, nor does it involve or indicate any patient safety issue. Senior counsel Aabad Ponda, appearing for the company, on Saturday told the bench that the FDA had sent an email to the company directing them to appear before the department for a hearing on August 26, which was a public holiday. "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. Additional government pleader P P Kakade, appearing for the FDA, said the law does not provide the company the right to a hearing. The bench questioned whether it was "fair and transparent" on the part of the FDA to send an email to the company and direct them to send a representative for a hearing on the same day, noting that "if the court does the same thing, will it be fair?"
