Pune, Maharashtra — The Maharashtra Food and Drug Administration (FDA) has cancelled the drug-sale licence of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) unit at Wadki in Pune after inspectors found multiple violations related to the packaging, storage and recall of medicines, the regulator said on Friday.
Inspection found unauthorised claims on Schedule H medicine
The FDA said an inspection in June showed that the packaging of Reactin Plus tablets — classified as a Schedule H prescription medicine — carried an unauthorised claim describing it as an "analgesic and antipyretic", a description the department said is not permitted for prescription drugs. Acting under provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945, officials seized stock of the product worth ₹11.19 lakh and directed the company to recall the affected batch as "misbranded".
According to the FDA statement, the company did not fully comply with the recall directions. A subsequent follow-up inspection of the Wadki C&F unit’s drug-sale and distribution system identified further deficiencies that the regulator said warranted cancellation of the licence with effect from 27 August.
- Unauthorised promotional text on Reactin Plus packaging (Schedule H drug).
- Medicines stored directly on the floor; inadequate pallet and rack arrangements.
- Discrepancies between physical stock and computerised inventory records.
- Gaps in purchase and sale records and deficient procedures for handling expired medicines.
- Incomplete compliance with recall directions issued by the FDA.
Regulator stresses public-health priority
"Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," FDA Commissioner Tukaram Mundhe said in the department statement, adding that the FDA would not show leniency on issues concerning drug safety and public health. The statement framed the promotional claim as a risk that could encourage consumers to self-medicate without consulting a doctor.
"Strict compliance with legal provisions is essential, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines," the FDA said.
Cipla Pharma & Life Sciences Ltd issued a statement saying it has contested the FDA order and that the issue is under judicial consideration. The company clarified that the order does not allege any concerns regarding the safety, quality or efficacy of its products, nor does it indicate any patient-safety issue.
Local consequences and context
The cancellation affects the C&F unit at Wadki, a significant logistics and distribution node for pharmaceutical products in Pune. While Cipla’s statement seeks to limit public concern about product safety, the FDA’s move highlights regulatory scrutiny of how prescription medicines are labelled, stored and tracked before they reach pharmacies and hospitals.
| Issue found | Regulatory action |
|---|---|
| Unauthorised advertising on Schedule H packaging | Stock seizure (₹11.19 lakh); recall directed |
| Storage deficiencies (floor storage, inadequate racking) | Licence cancellation (effective 27 Aug) |
| Inventory discrepancies; non-compliance with recall | Further inspection and regulatory action |
For Pune residents the immediate impact will depend on how widely the seized or recalled stock had been distributed and on the company’s compliance with recall orders. The FDA statement noted that non-compliance with recall instructions and record discrepancies were central to the department’s decision to cancel the licence.
The matter is now before the courts, the company said. The FDA’s action underlines continuing regulatory vigilance in Maharashtra’s pharmaceutical supply chain, particularly where prescription medicines are involved.
