Daijiworld Media Network - Pune
Pune, Oct 3: 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 over alleged violations involving drug packaging, storage, record-keeping and inventory management.
The fresh cancellation order was issued on October 1 after the FDA completed proceedings in accordance with directions from the Bombay High Court. The regulator had withdrawn its earlier proceedings and subsequently issued a revised show-cause notice to Cipla on September 4. The company submitted its response on September 11 and was given a personal hearing on September 21 before the fresh order was passed.
The case centres on Reactin Plus Tablets, a Schedule H prescription medicine. During an inspection, the FDA found packaging carrying claims describing the medicine as an analgesic and promoting its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache. The packaging also contained an illustration of a human figure intended to indicate relief from muscular pain.
The regulator 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 had also seized Reactin Plus stock valued at around Rs 11.19 lakh during its earlier inspection.
The inspection also identified deficiencies in the warehouse's storage and management practices. According to the FDA, medicine boxes were stored directly on the floor because of inadequate pallets or racks, while dust accumulation and shortcomings in cleanliness were observed. Expired medicines were allegedly not kept in a separately designated area marked “Expiry-Not for Sale”, and prescribed records and procedures relating to their disposal were also found lacking.
The regulator further cited deficiencies in purchase and sales records and discrepancies between computerised or SAP records and physical stock, including antibiotics. It said maintaining digital records did not exempt the licensed establishment from statutory requirements relating to physical inventory, storage conditions and documentation.
Maharashtra FDA Commissioner Tukaram Mundhe said the department's objective was not merely to take regulatory action but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain. He said the latest proceedings followed the Bombay High Court's directions and principles of natural justice, transparency and an opportunity for a hearing.
Cipla described the FDA's decision as “disappointing” and said its Wadki C&F warehouse follows prescribed protocols for drug storage and distribution as well as applicable standards for digital record-keeping. The company said it was reviewing the order and evaluating its available options. Cipla also reiterated its commitment to quality, patient safety and uninterrupted access to medicines.
The FDA action concerns the licences of the Pune C&F warehouse and the alleged violations identified during inspections. Cipla has contested the regulator's findings and is reviewing the latest order.