Maharashtra FDA has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences' Pune warehouse over findings linked to Reactin Plus packaging, storage and record-keeping. Cipla called the decision disappointing and said the facility complies with required protocols.

October 2, 2026, 11:16:11 PM IST Maharashtra's Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's Warehouse No. A at Wadki in Pune following proceedings over alleged violations involving Reactin Plus Tablets and deficiencies found during inspections.

Cipla Pharma & Life Sciences, a unit of drugmaker Cipla Ltd, said it was disappointed with the decision and maintained that its Pune C&FA warehouse complies with distribution, storage and digital record-keeping standards. The company said it is reviewing the order and evaluating further options.

Cipla also reiterated its commitment to quality and patient safety and said it remains focused on ensuring uninterrupted access to safe, high-quality medicines. Why did Maharashtra FDA cancel the Cipla warehouse licences?

The action relates to Reactin Plus Tablets, a Schedule H prescription medicine. The FDA said the drug's packaging carried claims and illustrations that were not permitted under applicable provisions.

The Pune FDA issued the fresh order on October 1 after completing proceedings in accordance with directions from the Bombay High Court.

The regulator had withdrawn its earlier proceedings against the facility following the court's directions in Writ Petition No. 11376/2026. It then issued a revised show-cause notice to Cipla on September 4.

Cipla submitted its written response on September 11 and was given a personal hearing on September 21. The licensing authority said it considered the company's response, hearing submissions, inspection findings, records and applicable legal provisions before issuing the fresh order. What did the FDA find in Reactin Plus packaging?

According to the FDA, Reactin Plus packaging described the medicine as an analgesic and promoted its use for headache, muscular pain, backache, joint pain, sprain, body ache and toothache. The packaging also featured a human figure and showed the medicine as providing relief from muscular pain.

The regulator said these claims and illustrations did not comply with statutory provisions and constituted misbranding under the Drugs and Cosmetics Act, 1940. What deficiencies were found at the Pune warehouse?

The FDA also reported deficiencies in the storage, documentation and inventory management practices at the Wadki facility. Among its findings were: Medicines stored directly on the floor because of inadequate pallets or racks. Dust accumulation on stocks and shortcomings in cleanliness. Expired medicines not kept in a separately marked "Expiry-Not for Sale" area. Lack of records and standard operating procedures for disposal of expired medicines. Deficiencies in purchase invoices and sale-invoice records. Differences between computerised or SAP records and physical stock, including for antibiotics. What did Maharashtra FDA say?

FDA Commissioner Tukaram Mundhe said the department's objective was to ensure the safety and quality of medicines, proper storage and compliance with statutory requirements across the drug supply chain.

The latest order follows the FDA's earlier action on August 27 concerning Reactin Plus packaging, storage, documentation and recall. Those proceedings were later withdrawn following the Bombay High Court's directions, after which the regulator initiated the process afresh.