Archive · 3 Oct 2026
Maharashtra FDA Cancels Cipla Pune Warehouse Licences After Fresh Probe
Maharashtra’s drug regulator cancelled the licences for a Cipla warehouse in Pune.
The warehouse stores and distributes medicines.
The regulator said packaging for Reactin Plus, a prescription medicine, made claims and used pictures that were not allowed.
Inspectors also reported problems with how medicines were stored and how warehouse records were kept.
They said expired medicines were not clearly separated and some computer stock records did not match the physical stock.
The FDA restarted its proceedings after directions from the Bombay High Court.
Cipla replied to the notice and took part in a hearing before the new order was made.
Cipla disagreed with the decision and said it was reviewing what to do next.
Maharashtra FDA cancelled the wholesale drug sale and distribution licences of Cipla Pharma & Life Sciences’ warehouse at Wadki, Pune.
The fresh order was passed on October 1 after proceedings were restarted in line with Bombay High Court directions.
The FDA said Reactin Plus packaging made unauthorised promotional claims and illustrations, raising a misbranding issue under the Drugs and Cosmetics Act, 1940.
Inspectors also reported storage, cleanliness, expired-medicine handling, invoice, inspection-record and physical-inventory discrepancies.
Cipla called the decision disappointing, said its warehouse follows applicable protocols and said it was reviewing the order and considering further options.
- Who
- Maharashtra FDA and Cipla Pharma & Life Sciences Ltd.; FDA Commissioner Tukaram Mundhe commented on the action.
- What
- The FDA cancelled the wholesale drug sale and distribution licences of Cipla’s Wadki warehouse.
- When
- The fresh order was passed on October 1; the FDA said it announced the action on Friday. Cipla replied on September 11 and attended a hearing on September 21.
- Where
- Cipla’s carrying and forwarding warehouse at Wadki, Pune, Maharashtra.
- Why
- The FDA cited alleged Reactin Plus misbranding and deficiencies in storage, cleanliness, expired-medicine handling, documentation and inventory management.
FDA’s findings and rationale
Cipla’s response
Reactin Plus packaging
FDA’s findings and rationale
The FDA said the product’s packaging described it as an analgesic, promoted uses for several types of pain and included illustrations it considered non-compliant and an issue of misbranding.
Cipla’s response
Cipla disagreed with the FDA’s decision; the company’s stated response focused on the warehouse’s compliance and its review of the order, rather than detailing its position on each packaging claim.
Warehouse compliance
FDA’s findings and rationale
The regulator reported shortcomings in storage, cleanliness, expired-medicine procedures, records, invoices and alignment between computerised records and physical stock.
Cipla’s response
Cipla said its Pune warehouse operates in compliance with distribution, storage and digital record-keeping standards.
Regulatory decision
FDA’s findings and rationale
The FDA said it considered the company’s reply, hearing submissions and inspection records, and that the fresh order was an independent decision made after proceedings were conducted anew under court directions.
Cipla’s response
Cipla called the outcome disappointing, said it was reviewing the order and evaluating further options.
- Facility
- Cipla Pharma & Life Sciences Ltd.’s carrying and forwarding warehouse at Wadki, Pune
- Regulator
- Maharashtra Food and Drug Administration
- Fresh order
- Passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune
- Court-related process
- Fresh proceedings followed directions from the Bombay High Court; the articles identify Writ Petition No. 11376/2026
- Notice and hearing
- Revised show-cause notice issued September 4; Cipla replied September 11 and received a personal hearing September 21
- Medicine at issue
- Reactin Plus Tablets, described in the articles as a Schedule H prescription medicine
- Reported warehouse issues
- Findings included medicines on the floor, dust, lack of a marked expired-medicine area and disposal records, invoice deficiencies, missing Form 35 inspection book and stock discrepancies
- Cipla response
- Cipla called the decision disappointing, said its warehouse follows distribution, storage and digital record-keeping protocols, and said it was reviewing the order
Sources
FDA cancels drug sale licence of Cipla in Pune
FDA cancels wholesale drug sales license of Cipla Pharma & Life sciences Ltd
Maharashtra FDA Cancels Cipla Pharma & Life Sciences’ Pune Warehouse Drug Licences Over Multiple Lapses
Tukaram Mundhe in action! Maharashtra FDA cancels Cipla's Pune drug sale licence
FDA cancels drug sale licence of Cipla facility in Pune
Cipla on Maharashtra FDA action: ‘Disappointing’, says Pune warehouse follows protocols
