5 days ago
Bombay High Court Rebukes FDA, Cipla Licence Order Withdrawn
Maharashtra’s medicine regulator first cancelled the sales licences of a Cipla warehouse near Pune.
The regulator said the package of Reactin Plus, a prescription medicine, used words that were not authorised.
It also said some medicines were kept on the floor and that stock records did not match the medicines physically present.
The FDA seized tablets worth ₹11.19 lakh and ordered a recall.
It said Cipla did not fully follow the recall instructions.
Cipla challenged the decision in court.
The Bombay High Court said the regulator had used an improper process and had acted too strongly.
The FDA then withdrew its cancellation order.
The Maharashtra FDA initially cancelled Cipla Pharma & Life Sciences Ltd’s Pune C&F unit drug sale licences effective August 27, 2026.
The regulator cited unauthorised “analgesic and antipyretic” wording on Reactin Plus, a Schedule H prescription medicine.
FDA inspections also reported medicines stored on the floor, inadequate pallets and racks, record discrepancies and expired-medicine procedure gaps.
The FDA seized Reactin Plus stock worth ₹11.19 lakh and said Cipla had not fully complied with recall directions.
After Cipla challenged the order, the Bombay High Court criticised the FDA’s procedure and the regulator withdrew the cancellation.
- Who
- The Maharashtra Food and Drug Administration, Cipla Pharma & Life Sciences Ltd, and the Bombay High Court; FDA Commissioner Tukaram Mundhe was quoted defending strict enforcement.
- What
- The FDA cancelled, then withdrew, the drug sale licence cancellation for Cipla’s Pune Carry and Forwarding facility after Cipla challenged the order.
- Where
- At Cipla’s Carry and Forwarding facility and main warehouse in Wadki, Pune district, Maharashtra; the challenge was heard by the Bombay High Court.
- When
- The main inspection occurred around June 2026; the cancellation took effect on August 27, 2026, and was withdrawn the following day according to the court report.
- Why
- The FDA cited alleged packaging, storage, stock-record and recall violations, while the High Court said the regulator had followed an improper procedure and breached principles of natural justice.
FDA’s Allegations
Cipla and Court Response
Packaging and recall
FDA’s Allegations
The FDA said Reactin Plus packaging carried an unauthorised description as an “analgesic and antipyretic,” potentially encouraging self-medication, and that Cipla did not fully comply with the recall directions.
Cipla and Court Response
Cipla contested the order and said it was under judicial consideration; the company stated that the order did not allege product safety, quality, efficacy or patient-safety concerns.
Warehouse and recordkeeping
FDA’s Allegations
The regulator reported medicines stored directly on the floor, inadequate pallets and racks, discrepancies in purchase, sales, computerised and physical stock records, and gaps in expired-medicine procedures.
Cipla and Court Response
The available reports do not provide Cipla’s separate response to each operational allegation, but the company challenged the overall order.
Licence cancellation procedure
FDA’s Allegations
The FDA said it issued a show-cause notice, examined Cipla’s explanation and found the deficiencies and recall directions had not been adequately addressed.
Cipla and Court Response
The Bombay High Court said the FDA had followed an improper procedure, acted in a “high-handed” manner and breached principles of natural justice; the FDA withdrew its order.
Key facts
- Regulator
- Maharashtra Food and Drug Administration
- Affected facility
- Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding unit
- Location
- Wadki, Pune district, Maharashtra
- Initial licence action
- Drug sale licences cancelled with effect from August 27, 2026
- Subsequent development
- The FDA withdrew the cancellation order after Bombay High Court criticism
- Medicine involved
- Reactin Plus Tablets, described by the FDA as a Schedule H prescription medicine
- Seized stock
- ₹11.19 lakh
- Legal framework cited
- Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945
Quotes
Cipla Pharma & Life Sciences
Cipla subsidiary named in the FDA order
“As the issue is under judicial consideration, it would not be appropriate to comment further on the proceedings at this stage. We would, however, like to clarify that the order does not allege any concerns relating to the safety, quality or efficacy of our products, nor does it involve or indicate any patient safety issue”
thehindubusinessline.com
NDTV
“CPLS has contested the Pune FDA’s order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice”
thehindubusinessline.com
Bombay High Court bench
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad.
“You (FDA) 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.”
wionews.com
“Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law.”
freepressjournal.in
deccanchronicle.com
thestatesman.com
telegraphindia.com
NDTV
Sources
Maharashtra FDA cancels Cipla Pune unit’s sale licence; company contests order
Maharashtra FDA Cancels Drug Sale Licences Of Cipla Pharma & Life Sciences’ Pune C&F Unit Over Reactin Plus Irregularities
FDA Cancels Cipla Pharma & Life Sciences’ Pune Unit Drug Sale Licence
Here’s why Maharashtra FDA cancelled drug sale licence of Cipla’s Pune unit
'You are going overboard': HC raps FDA over Cipla Pune licence cancellation
Tukaram Mundhe-led Maharashtra FDA cancels Cipla unit's drug licence over Reactin Plus irregularities
FDA cancels drug sale licences of Cipla Pharma & Life Sciences's Pune Carry and Forwarding unit
Maharashtra FDA cancels Cipla facility drug licences over Reactin Plus irregularities
Cipla Pune Unit's Drug Sale Licence Cancelled Over 'Irregularities'
Maharashtra FDA cancels Cipla Pharma’s Pune drug licences, seizes ₹11.19 lakh stock
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