Bombay High Court Pulls Up Maharashtra FDA Over Cipla Drug Licence Cancellation
核心洞察
The Bombay High Court questioned the Maharashtra FDA (搜索)'s cancellation of Cipla Pharma & Life Sciences (搜索)' wholesale drug-sale licences, describing the action as "high-handed."
The FDA withdrew the cancellation order and agreed to issue a fresh notice after Cipla argued it had not received an adequate opportunity to be heard.
The dispute stems from alleged irregularities involving Reactin Plus (搜索) tablets, including packaging claims, stock-record discrepancies, and non-compliance with recall directions.
The Bombay High Court has questioned the Maharashtra Food and Drug Administration's (FDA) cancellation of wholesale drug-sale licences linked to Cipla Pharma & Life Sciences (搜索)' primary distribution facility at Wadki in Pune, describing the regulator's action as "high-handed." The court's scrutiny, which came on August 29, focused on the procedure followed by the FDA and the circumstances surrounding the enforcement action, rather than questioning the regulator's authority to enforce drug safety standards.
The FDA had cancelled the drug sale licences of Cipla Pharma & Life Sciences (搜索) Ltd's Carry and Forwarding (C&F) unit in Pune over what it described as serious irregularities related to the packaging, storage and recall of Reactin Plus (搜索) Tablets. According to a statement issued by the regulator on Friday (August 28, 2026), the cancellation came into effect on August 27, following an inspection of its main warehouse at Wadki in Pune district.
Alleged Irregularities Involving Reactin Plus Tablets
During an inspection around June this year, FDA officials found that the packaging of Reactin Plus (搜索) tablets, a Schedule H prescription medicine, carried an unauthorised claim describing it as an "analgesic and antipyretic." The FDA seized stock worth ₹11.19 lakh, stating that such advertising was contrary to provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
The regulator subsequently directed the company to recall the misbranded Reactin Plus (搜索) Tablets from the market. However, the company did not fully comply with the directions and required measures, the regulator stated. 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 FDA also reported finding medicines stored directly on the floor, inadequate pallet and rack arrangements, and deficiencies in records and procedures for handling expired medicines. The department issued a show-cause notice to the licence holder, and after examining the company's explanation, found that the deficiencies and directions concerning the recall of Reactin Plus (搜索) Tablets had not been adequately complied with.
Due Process Concerns Raised in Court
Cipla challenged the cancellation, arguing that it had not received an adequate opportunity to be heard. According to proceedings reported by Bar & Bench, the FDA issued a show-cause notice on August 13, to which Cipla responded on August 25. A personal hearing was scheduled for August 26, which was a public holiday. After Cipla sought an adjournment, the authority proceeded with the cancellation order.
The High Court questioned the procedure and described the action as "high-handed." The FDA subsequently agreed to withdraw the cancellation order and issue a fresh notice, giving Cipla an opportunity to respond before taking a fresh decision. The bench also advised the FDA to avoid scheduling hearings on public holidays unless there was a genuine emergency.
Broader Pattern of Judicial Scrutiny
The Cipla case is the latest in a series of interventions by the Bombay High Court examining whether the Maharashtra FDA (搜索)'s actions against businesses were proportionate and followed due process. The court's scrutiny has covered restaurants, hotels, sweet shops, milk businesses and pharmaceutical companies, according to a CNBC-TV18 report.
In the case of Gurunanak Dairy and Sweets in Pune, the FDA had suspended the establishment's licence following a food-poisoning incident. A subsequent inspection found the business to be 98% compliant, but the suspension remained in place. The high court quashed the suspension and directed the FDA to pay Rs.5 lakh in compensation to the business.
In another case involving Park Inn by Radisson in Navi Mumbai, the hotel challenged an FDA licence suspension following an inspection that raised hygiene concerns. The high court subsequently restored the licence while examining whether the deficiencies justified continuing the suspension. The Aurangabad bench of the Bombay High Court in July also stayed FDA action against milk vendors and suppliers, raising questions about whether statutory procedure, including improvement notices and an opportunity for a hearing, had been followed before suspension.
The regulator's powers have also come under scrutiny in the Cadila Pharmaceuticals case, where the high court examined action stopping the sale and distribution of certain medicines and whether the FDA had exercised its powers appropriately.
A Nuanced Judicial Approach
The recent cases do not indicate that the Bombay High Court has taken a blanket position against FDA action. In the case involving Udupi Swaad, a Thane restaurant whose licence was suspended after FDA officials found it serving analogue paneer, the court declined to grant urgent interim relief against the regulatory action.
The differing outcomes show that the court's interventions have depended on the circumstances of each case, including the nature of the alleged violation and the procedure followed by the regulator. The proceedings have highlighted several issues that can become important when FDA action is challenged, including whether businesses were given an adequate opportunity to respond, whether the alleged violation justified immediate suspension or cancellation, whether subsequent corrective action was considered, and whether the regulator gave sufficient reasons for its decision.
FDA Commissioner Tukaram Mundhe said the department would not show any leniency on issues concerning drug safety and public health, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines. "Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," he said. The developments come as Maharashtra's FDA has intensified inspections and enforcement against restaurants, food companies, dairies and other establishments since Mundhe took charge as FDA Commissioner around three months ago.