Tukaram Mundhe in action! Maharashtra FDA cancels Cipla's Pune drug sale licence

The Maharashtra Food and Drug Administration (FDA) has revoked the wholesale drug licences of Cipla Pharma & Life Sciences Ltd’s warehouse in Pune's Wadki area. The decision stemmed from the FDA's findings of numerous lapses in drug storage, record-keeping, and inventory management at the facility. This action followed a series of proceedings the FDA conducted in compliance with the Bombay High Court's orders in Writ Petition No. 11376/2026.

The key issue highlighted by the FDA was the misbranding of Reactin Plus, a Schedule H medicine present at the warehouse. The regulator pointed out that the product's packaging contained misleading claims regarding relief from various pains, which did not align with the legal requirements under the Drugs and Cosmetics Act, 1940. Furthermore, the inspection revealed that medicines were stored on the floor because of a lack of sufficient pallets or racks, leading to dust accumulation on stockpiles.

Another significant deficiency identified was the absence of a required Form 35 inspection book and a clearly marked area for expired medicines, which were accompanied by a "Expiry – Not for Sale" notice. Additionally, the FDA found that the establishment did not possess the necessary Standard Operating Procedures (SOP) and records for handling expired medicines, as well as discrepancies in purchase and sales invoices, and inconsistencies between computerized records and actual physical stock, including antibiotics.

Despite the company's explanations during the proceedings, the licensing authority maintained that merely using a computerized system (SAP) does not exempt a license holder from obligations related to physical stock, prescribed records, proper storage, cleanliness, and inspection documentation. Cipla expressed disappointment with the FDA's decision, asserting that their Pune C&FA warehouse complies with distribution and storage protocols and digital record-keeping standards. The company is currently reviewing the order and exploring further options.

Cipla reaffirmed its commitment to quality and patient safety, stating that they operate according to distribution and storage protocols and digital record-keeping standards. They are reviewing the order and considering additional steps. However, as of the time of this report, Cipla had not responded to the FDA's action. The FDA Commissioner, Tukaram Mundhe, emphasized that the department's goal extends beyond enforcement to ensuring the safety and quality of medicines and compliance throughout the entire drug supply chain.

The fresh proceedings were carried out following the High Court's directions, adhering to principles of natural justice, transparency, an opportunity for a hearing, and providing a reasoned decision.