Cipla Pune Warehouse Licence Cancelled: FDA Flags Misbranded Reactin Plus, Drugs Stored on Floor

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse at Wadki in Pune, citing alleged irregularities involving the packaging of Reactin Plus tablets, medicine storage, documentation and inventory management. The fresh order was issued after the regulator completed proceedings in accordance with directions from the Bombay High Court.

The latest cancellation order was passed on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune. The action follows an earlier order issued in August, which was subsequently withdrawn after the Bombay High Court raised concerns over the procedure followed by the regulator. Why Was Mumbai’s Kyani & Co Irani Cafe Shut Down by Maharashtra FDA?.

Fresh proceedings after Bombay High Court directions

According to the FDA, the earlier proceedings were withdrawn following the High Court's directions, after which a revised show-cause notice was issued to Cipla on September 4. Cipla submitted its written response on September 11 and was given an opportunity for a personal hearing on September 21. The licensing authority said it considered the company's submissions, inspection findings, available records and applicable legal provisions before issuing the fresh order. The FDA said the latest decision was an independent regulatory order following completion of the proceedings afresh, rather than simply a repetition of its earlier cancellation.

Reactin Plus Packaging Flagged by FDA

A key issue concerned Reactin Plus, a Schedule H prescription medicine. During an inspection of the Wadki warehouse, the FDA found packaging that described the medicine as an analgesic and promoted its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache.

The regulator also objected to a human figure and illustration on the packaging depicting relief from muscular pain. The FDA said the claims, wording and illustrations did not comply with applicable statutory requirements and raised issues of misbranding under the Drugs and Cosmetics Act, 1940. The FDA also examined the responsibilities of the establishment as a marketer of the medicine and said those obligations could not be avoided solely by attributing responsibility to the manufacturer. Maharashtra FDA Mandates Breastfeeding Notices on Infant Food Packages and Prohibits Commercial Sale of Human Milk.

Storage, Expired Medicines and Record-Keeping Lapses

The regulator also cited several deficiencies at the warehouse. These included medicines being kept directly on the floor because of inadequate pallets or racks and dust accumulation on drug stocks. The FDA said the facility did not have a separately marked area for expired medicines carrying an “Expiry-Not for Sale” designation. It also flagged the absence of required standard operating procedures and records for disposal of expired medicines.

Other issues cited included deficiencies in purchase invoices, missing signatures on duplicate sales invoices and discrepancies between computerised or SAP records and physical stock, including antibiotics.

Earlier Action and Cipla's Response

The latest action follows the FDA's August 27 cancellation over alleged irregularities involving Reactin Plus packaging, storage, documentation and recall procedures. The Bombay High Court subsequently intervened in the matter, following which the earlier proceedings were withdrawn and the case was reconsidered.

In its earlier response, Cipla Pharma & Life Sciences said it had contested the FDA's order and that the matter was sub judice. The company also said the order did not allege concerns regarding the safety, quality or efficacy of its products or indicate a patient-safety issue.

FDA Commissioner Tukaram Mundhe said the department's objective was to ensure compliance with legal requirements governing the quality, safety, storage and distribution of medicines. He said the latest proceedings were completed in accordance with the High Court's directions and after providing the company an opportunity to be heard.

(The above story first appeared on LatestLY on Oct 02, 2026 09:07 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).