The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences’ carrying and forwarding facility in Wadki, Pune, after the Bombay High Court criticised the regulator for acting “high-handedly” and “going overboard”.
The court questioned the FDA’s decision to schedule a hearing on August 26, a state holiday, and proceed with cancellation after Cipla sought an adjournment. The FDA has now agreed to issue a fresh show-cause notice before September 4, consider Cipla’s response and pass a reasoned decision.
While Cipla has said the action does not concern the safety, quality or efficacy of its medicines, the FDA’s underlying concerns over Reactin Plus packaging, storage, records and recall compliance remain open.
Court Questions FDA Procedure
The dispute reached the Bombay High Court after the FDA cancelled the wholesale drug sale licences covering Cipla’s Wadki facility, which reportedly serves around 180 customers and distributes more than 4.3 lakh medicine units every month across Maharashtra.
The cancellation followed inspections that raised concerns over Reactin Plus Tablets, a Schedule H prescription medicine, including packaging that carried the words “Analgesic and Antipyretic” and promotional material. The FDA subsequently cited concerns relating to storage, stock records and recall procedures.
The turning point came when Cipla challenged the cancellation and questioned whether it had been given a fair opportunity to respond. The company had submitted a detailed reply to the FDA’s August 13 show-cause notice on August 25.
However, it was called for a personal hearing on August 26, which was a state holiday. According to the company’s submissions, when an administrative employee arrived to request an adjournment, the cancellation order was handed over instead.
Acting Chief Justice Ravindra V Ghuge questioned the fairness of the process, asking, “How is it appropriate, fair and transparent?” The bench also said the FDA was doing “a laudable job” but had gone “overboard”, while Justice Gautam A Ankhad questioned how the order could be sustained in view of a possible violation of natural justice. The court advised the department to avoid hearings on public holidays unless there was a dire emergency.
Reactin Plus Triggered Action
The regulatory action originated with an FDA inspection of Cipla’s Wadki facility in June. Officials reportedly flagged packaging and promotional material associated with Reactin Plus. The FDA considered the wording and promotional content inconsistent with provisions of the Drugs and Cosmetics Act and Rules governing prescription medicines. Around ₹11.19 lakh worth of Reactin Plus stock was reportedly seized and ordered to be withdrawn from the market.
The FDA’s subsequent scrutiny reportedly identified additional concerns, including differences between physical and computerised stock records, shortcomings in purchase and sales documentation, inadequate storage arrangements and alleged gaps in recall and expired-medicine procedures.
Medicines were reportedly found stored directly on the floor, with concerns also raised about racks and pallets. These findings ultimately preceded the cancellation of the licences, which had taken effect from August 27.
The regulator’s position has been that the action followed alleged violations and shortcomings identified during inspections. Reports on the initial cancellation also quoted Maharashtra FDA Commissioner Tukaram Mundhe as taking a strict position on compliance and public-health safeguards. However, the later High Court proceedings shifted the immediate focus from the substantive allegations to whether the FDA had followed a fair procedure before imposing the severe regulatory measure.
Cipla, meanwhile, has contested the cancellation. The company has clarified that the FDA order does not allege concerns regarding the safety, quality or efficacy of its products and does not indicate a patient-safety issue. The company’s challenge was centred on the regulatory action and the process through which the licence was cancelled.
Fresh Notice, Fresh Decision
Following the High Court’s intervention, the FDA agreed to withdraw the cancellation order with immediate effect. Government pleader P P Kakade told the court that the order would be withdrawn, while the regulator committed to serving a fresh notice on Cipla before September 4. Cipla was represented by senior advocate Aabad Ponda and advocate Ranjeet Sangle.
The development should therefore not be interpreted as a final clearance for Cipla. The FDA has not been prevented from examining the alleged violations again. Instead, it must restart the process, give Cipla a meaningful opportunity to respond and then pass a reasoned decision.
For consumers, the distinction matters. Regulatory authorities must act firmly when there are genuine concerns involving medicines and their distribution, but such enforcement must also be transparent, proportionate and procedurally fair. The Bombay High Court’s intervention underlines that both public-health protection and due process are essential to maintaining trust in regulatory institutions.
The Logical Indian’s Perspective
Regulators have an important responsibility to protect public health, particularly when prescription medicines, storage standards and recall systems are involved. At the same time, strong enforcement should never come at the cost of fairness or an individual or company’s right to be heard. The Cipla case shows why transparent procedures, clear communication and reasoned decisions matter as much as decisive action.
The FDA now has an opportunity to address the concerns raised by the court while continuing to examine the substantive regulatory issues. For citizens, the larger question is how India can build regulatory systems that are both firm enough to protect public health and fair enough to command public trust.
