Maharashtra FDA withdraws Cipla licence cancellation after Bombay HC rebuke
Synopsis
The Bombay High Court called out the Maharashtra FDA for scheduling a hearing on a public holiday and then cancelling Cipla's drug licence without granting the company any opportunity to be heard — a textbook natural justice violation. The regulator backed down in court, agreeing to withdraw the order and restart the process. The bench's pointed remark that 'this is not the first time' raises questions about systemic due-process failures at the FDA.
Key Takeaways
Maharashtra FDA withdrew its drug sale licence cancellation order against Cipla Pharma & Life Sciences Ltd 's Pune C&F facility on 29 August .
The Bombay High Court found the FDA had acted against principles of natural justice and followed the wrong procedure.
The FDA had scheduled a hearing for 26 August — a state public holiday — and passed the cancellation order the same day without granting Cipla a hearing.
The original cancellation was over alleged irregularities in packaging, storage, and recall of Reactin Plus Tablets , a Schedule H prescription drug.
Cipla clarified the order did not allege any patient safety, quality, or efficacy concerns.
A fresh show-cause notice will now be issued, followed by a reasoned order after due process.
The Maharashtra Food and Drug Administration (FDA) on Saturday, 29 August withdrew its order cancelling the drug sale licence of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) facility in Pune, after the Bombay High Court sharply criticised the regulator for acting in a 'high-handed manner' and going 'overboard'. The FDA told the court it would issue a fresh show-cause notice to the company, following which a reasoned order would be passed.
What the Bombay High Court Said
A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad found that the FDA had followed the wrong procedure and acted against the principles of natural justice. The court was hearing a petition filed by Cipla Pharma & Life Sciences challenging the cancellation of drug sale licences at its Wadki, Pune facility, effective 27 August.
'You 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 bench told the regulator.
The Holiday Hearing That Triggered the Crisis
Senior counsel Aabad Ponda, appearing for Cipla, told the bench that the FDA had directed the company via email to appear for a hearing on 26 August — a public holiday declared by the state government. When Cipla sought an adjournment citing the unavailability of a representative on a holiday, the FDA passed the cancellation order the same day without granting any hearing.
Additional Government Pleader P P Kakade, appearing for the FDA, argued that the law did not provide the company a right to a hearing — a position the court did not accept. The bench pointedly questioned why the regulator had scheduled a hearing on a public holiday and then proceeded to pass an adverse order without affording an opportunity to be heard.
The Underlying Allegations Against Cipla
The FDA had originally cancelled the licences over alleged irregularities related to the packaging, storage, and recall of Reactin Plus Tablets. Inspections reportedly found unauthorised promotional text on the packaging of the Schedule H prescription medicine, discrepancies between physical and computerised stock records, gaps in purchase and sale records, and non-compliance with recall directions.
Cipla, however, clarified that the FDA's order did not allege any concerns regarding the safety, quality, or efficacy of its products and did not involve or indicate any patient safety issue.
What Happens Next
With the cancellation order withdrawn, the FDA will now issue a fresh show-cause notice to Cipla, after which a reasoned order will be passed — this time following due process. The case underscores a recurring concern about procedural rigour within drug regulatory enforcement in Maharashtra. The High Court's observation that 'this is not the first time this is happening' signals that the judiciary is watching the FDA's conduct closely. Industry observers will track whether the fresh notice leads to a substantively different outcome once Cipla is given a proper hearing.
Point of View
The episode is a reminder that regulatory risk in India is not always about product quality — sometimes it is about the regulator's own conduct. Cipla's swift legal challenge and the court's equally swift rebuke may deter repeat behaviour, but only if the FDA internalises the lesson rather than simply reissuing the notice with the same outcome in mind.
NationPress
29 Aug 2026
Frequently Asked Questions
Why did the Bombay High Court intervene in the Cipla drug licence case?
The Bombay High Court intervened after Cipla Pharma & Life Sciences challenged the Maharashtra FDA's cancellation of its Pune facility's drug sale licence. The court found the FDA had violated principles of natural justice by scheduling a hearing on a public holiday and then passing an adverse order without giving Cipla any opportunity to be heard.
What were the FDA's original allegations against Cipla?
The Maharashtra FDA alleged irregularities in the packaging, storage, and recall of Reactin Plus Tablets at Cipla's Wadki, Pune facility. Inspections reportedly found unauthorised promotional text on the Schedule H medicine's packaging, stock record discrepancies, gaps in purchase and sale records, and non-compliance with recall directions.
Did the FDA's action raise any patient safety concerns?
No. Cipla clarified that the FDA's cancellation order did not allege any concerns about the safety, quality, or efficacy of its products and did not involve or indicate any patient safety issue.
What happens now that the FDA has withdrawn the cancellation order?
The Maharashtra FDA will issue a fresh show-cause notice to Cipla, following which a reasoned order will be passed after due process. This means Cipla will be given a proper opportunity to be heard before any further regulatory action is taken.
What is a C&F facility in the context of pharmaceutical licensing?
A Carry and Forwarding (C&F) facility is a distribution and warehousing hub through which a pharmaceutical company moves its products to distributors and retailers. A drug sale licence is required to operate such a facility legally; its cancellation would halt the company's distribution operations in that region.
