FDA Cancels Cipla’s Pune Licence
The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences’ Carry and Forwarding facility at Wadki in Pune, after the Bombay High Court criticised the regulator’s approach.
The FDA had cancelled the licences with effect from August 27, citing several regulatory irregularities linked to the packaging, storage and recall of Reactin Plus tablets, a Schedule H prescription medicine.
The decision was challenged by Cipla before the Bombay High Court.
Court Questions FDA’s Procedure
During the hearing, a bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad strongly questioned the manner in which the FDA had proceeded against the company.
The court observed that the regulator appeared to have acted against the principles of natural justice and questioned whether Cipla had been given a proper opportunity to present its case before such a significant action was taken.
The judges also criticised the FDA for going “overboard” and behaving in a “high-handed” manner.
Hearing Was Scheduled on a Public Holiday
A major issue raised before the court was the timing of the hearing offered to Cipla.
According to the company’s legal counsel, the FDA had emailed Cipla asking a representative to appear before the department on August 26, which was a public holiday.
Cipla sought an adjournment because it could not arrange for a representative to appear that day. However, the FDA proceeded to issue the cancellation order on the same day.
The court questioned why the regulator had scheduled the hearing on a holiday and then proceeded with the cancellation without granting the company an effective opportunity to respond.
FDA Agrees to Withdraw the Order
Following the court’s criticism, the Maharashtra FDA agreed to withdraw the licence cancellation order forthwith.
The regulator will instead issue Cipla a fresh show-cause notice and reconsider the matter after giving the company an opportunity to respond.
A fresh, reasoned order will subsequently be passed based on the proceedings.
This means the withdrawal does not necessarily end the regulatory dispute. The FDA retains the ability to take further action after following the required procedure.
What Led to the Original Cancellation?
The FDA’s initial action followed an inspection of Cipla’s main warehouse at Wadki in June.
Officials had flagged several issues involving Reactin Plus tablets, including unauthorised promotional text on the packaging.
The drug is classified as a Schedule H prescription medicine, for which advertising and promotional claims are subject to regulatory restrictions.
The FDA had also seized Reactin Plus stock worth around ₹11.19 lakh and directed the company to recall the affected medicine from the market.
Stock and Storage Irregularities Also Flagged
The regulator’s inspection identified additional issues concerning the warehouse and inventory records.
These included discrepancies between physical and computerised stock records, gaps in purchase and sale records and concerns regarding compliance with directions related to the recall of medicines.
Inspectors also reportedly found medicines stored directly on the floor, along with inadequate arrangements involving pallets and racks.
The FDA further raised concerns about procedures and records relating to expired medicines.
Cipla Says There Is No Patient Safety Issue
Cipla had maintained that the regulatory action did not allege any concerns about the safety, quality or efficacy of its products.
The company also said that the matter was under judicial consideration and therefore declined to comment extensively on the proceedings.
This distinction is important because the dispute centres on regulatory compliance, packaging, storage and recall procedures rather than an allegation that the medicine itself was unsafe for patients.
Why the Court’s Intervention Matters
The case highlights the importance of following due process even when regulatory authorities identify potential violations.
Drug regulators have significant powers to inspect pharmaceutical facilities and take action when companies allegedly breach rules. However, companies must also be given a meaningful opportunity to respond before major punitive measures are imposed.
The High Court’s intervention has therefore shifted the immediate focus from the alleged violations to the procedure followed by the FDA while cancelling Cipla’s licences.
Fresh Proceedings Likely
With the cancellation order withdrawn, the FDA is expected to begin the process again by issuing a fresh show-cause notice.
Cipla will then have an opportunity to respond to the allegations before the regulator decides what action, if any, should follow.
The outcome could determine whether the FDA ultimately imposes restrictions on the Pune facility or concludes the matter after considering the company’s response.
A Regulatory Dispute, Not a Product Safety Recall
For consumers, the most important distinction is that the licence dispute does not establish that Reactin Plus was unsafe or ineffective.
The FDA’s concerns relate to regulatory compliance involving packaging, storage, stock records and recall procedures.
The Bombay High Court’s intervention has now ensured that the next stage of the dispute will take place through a fresh regulatory process, with Cipla given another opportunity to defend its position.
Summary
The Maharashtra FDA has withdrawn its order cancelling Cipla Pharma & Life Sciences’ Pune drug sale licences after the Bombay High Court criticised the regulator for going “overboard” and violating principles of natural justice. The FDA had cited packaging, storage, stock-record and recall-related violations involving Reactin Plus. A fresh show-cause notice will now be issued before any further decision.
