The Maharashtra Food and Drug Administration has cancelled the wholesale drug sale licences of Cipla Pharma & Life Sciences Ltd’s clearing and forwarding warehouse in Wadki, Pune, after an inspection found alleged misbranding of a prescription medicine and multiple deficiencies in storage, cleanliness and record-keeping.
The FDA said the action followed a fresh process conducted in compliance with directions of the Bombay High Court. Earlier proceedings against the establishment had been withdrawn, after which the department issued a revised show-cause notice on September 4, 2026. Cipla submitted its written response on September 11 and was given an opportunity for a personal hearing on September 21.
According to the FDA’s press note, the licensing authority examined Cipla’s explanations along with the inspection findings and available records before issuing the cancellation order. The department said the decision was an independent regulatory order passed after completing the prescribed procedure afresh, rather than a repetition of the earlier action.
One of the central findings concerned Reactin Plus, identified by the FDA as a Schedule H prescription medicine. The regulator said the product’s packaging and advertising described it as an analgesic and anti-inflammatory drug offering quick relief from headaches, muscular pain, backache, joint pain, sprain-related pain, body aches and toothaches. The carton also carried a human figure suggesting that the medicine could reduce muscular pain.
The FDA said the claims and illustrations did not comply with applicable statutory provisions, raising concerns of misbranding under the Drugs and Cosmetics Act, 1940. The authority also examined the responsibility of the marketer placing the medicine on the market, stating that a licensed establishment could not avoid its statutory obligations by attributing responsibility to the manufacturer.
The inspection of the Wadki facility recorded several other deficiencies. The prescribed Form 35 inspection book was unavailable, while medicine boxes had been stored directly on the floor because of inadequate pallets and racks. Dust had accumulated on medicine stocks, indicating shortcomings in cleanliness, the FDA said.
The department also found no separately marked area for expired medicines designated as “Expiry – Not for Sale”. Standard operating procedures and records required for the disposal of expired medicines were unavailable. Purchase invoices lacked required serial numbers, and copies of sales invoices had deficiencies relating to the signatures of authorised personnel.
The FDA further reported discrepancies between computerised SAP records and the physical stock of medicines, including antibiotics. It clarified that maintaining records in SAP or another computerised system does not exempt a licensed establishment from statutory requirements relating to documentation, actual stock, safe storage, cleanliness and the availability of inspection records.
Cipla said it was disappointed by the Maharashtra FDA’s decision and maintained that its Pune clearing and forwarding warehouse operated in compliance with distribution, storage and digital record-keeping protocols. The company said it was reviewing the order and evaluating further options. It also said it remained committed to quality, patient safety and uninterrupted access to medicines.
FDA Commissioner Tukaram Mundhe said the department’s objective was not only to take action but also to ensure compliance with legal provisions governing the quality and safety of medicines across the drug supply chain. He said the order had been issued while respecting the Bombay High Court’s directions and following due process, natural justice and transparency.