Maharashtra FDA has cancelled the drug-sale licence of Cipla Pharma and Life Sciences’ C&F centre in Vadki, Pune, after an inspection linked to Reactin Plus tablets found multiple compliance failures. The order took effect on 27 August 2026 and ends the centre’s permission to sell and distribute medicines.
The regulatory action followed findings concerning inventory control, documentation, storage conditions and the handling of expired medicines. Inspectors reported a mismatch between the physical stock and computer records, along with deficiencies in purchase and sales documentation.
Medicines were also found stored directly on the floor. The facility did not have adequate racks and pallets for keeping the products, according to the findings. Records and procedures relating to expired medicines were also incomplete, with the required management process not being properly followed.
Reactin Plus packaging under scrutiny
The inspection separately examined the packaging of Reactin Plus tablets. The medicine falls under Schedule-H, meaning it is supplied on prescription. Maharashtra FDA said the packaging carried wording referring to pain relief and reduction of fever without the necessary permission.
Officials treated that packaging issue as a breach of drug-related rules. The department seized drug stock valued at about ₹11.91 lakh during the proceedings and stressed that prescription medicines must be sold, stored and distributed in accordance with prescribed requirements.
FDA had also directed the company to withdraw from the market the Reactin Plus stock carrying the disputed information. During the inspection, the department found that the withdrawal instruction had not been fully followed.
Licence cancelled after company response
The department issued a show-cause notice after recording the inspection findings and sought the company’s explanation. FDA reviewed Cipla’s response alongside the facts identified during the investigation before deciding to cancel the licence.
The cancelled authorisation belonged to Cipla Pharma and Life Sciences Limited, Vadki, Pune, and covered medicine sales and distribution through the C&F centre. Maharashtra FDA said the decision reflected the need to maintain proper drug storage and records and to enforce rules intended to protect medicine quality and patients.
The department further said that violations involving Schedule-H medicines, including their advertising, sale, storage and distribution, must comply with legal provisions. It added that action would be taken under the law if breaches were found at any stage of the drug trade.
Cipla challenges order in court
Cipla Pharma and Life Sciences said it has challenged the Pune FDA order and that the matter is currently before the court. The company said it would not be appropriate to comment further while the proceedings are pending.
Cipla also said the order contains no concern about the safety, quality or efficacy of its medicines and does not involve a patient-safety issue. The company said it has been a trusted healthcare institution for the past 90 years and remains committed to quality, regulatory compliance and high standards of patient safety.
