Maharashtra FDA cancels Cipla's Pune warehouse licences over Reactin Plus packaging claims

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 Vadki in Pune, following fresh proceedings over violations involving the prescription drug Reactin Plus Tablets and irregularities found during inspections.

Cipla Pharma & Life Sciences Ltd, a unit of drugmaker Cipla Ltd, operates the warehouse.

The action was taken by the FDA's Pune office after completing the required legal process in accordance with directions from the Bombay High Court, the regulator said in a statement on Friday.


The case centres on Reactin Plus Tablets, a Schedule H prescription drug. The FDA said its packaging carried advertisements and claims that were not permitted under applicable provisions.

Subsequent inspections of the warehouse also found deficiencies relating to storage, documentation, inventory management and the handling of expired medicines.

The FDA said it had withdrawn its earlier proceedings against the facility in compliance with directions issued by the Bombay High Court in Writ Petition No. 11376/2026.

It then issued a revised show-cause notice to the company on September 4.

Cipla submitted its written reply on September 11 and was given an opportunity for a personal hearing on September 21.

After considering the company's response, hearing submissions, inspection findings, records and applicable legal provisions, the licensing authority issued a fresh, reasoned order on October 1 cancelling the licences.

What the FDA found

During inspection of the Vadki warehouse, the regulator found Reactin Plus packaging carrying claims describing the medicine as an analgesic and promoting its use for headache, muscular pain, backache, joint pain, sprain, body ache and toothache.

The packaging also carried a human figure and depicted the medicine as providing relief from muscular pain. The FDA said the claims and illustrations did not comply with statutory provisions and constituted an issue of misbranding under the Drugs and Cosmetics Act, 1940.

The regulator also found medicines being stored directly on the floor due to inadequate pallets or racks, dust accumulation on stocks and shortcomings in cleanliness. Expired medicines were not kept in a separately marked "Expiry-Not for Sale" area, while records and standard operating procedures for their disposal were unavailable.

The FDA further flagged deficiencies in purchase invoices and sale-invoice records, along with discrepancies between computerised or SAP records and physical stock, including antibiotics.

The latest order follows an earlier FDA action on August 27 over Reactin Plus packaging, storage, documentation and recall. The FDA subsequently withdrew those proceedings following the court's directions and conducted the process afresh.

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