02 October,2026 11:02 PM IST | Mumbai | mid-day online correspondent
Maharashtra FDA Commissioner Tukaram Mundhe (File pic)
Amid the statewide crackdown, the Maharashtra Food and Drug Administration (FDA) has cancelled the wholesale drug sale licences of Cipla Pharma & Life Sciences Ltd's C&F warehouse in Wadki, Pune. As per the official press note shared by FDA, an inspection revealed alleged misbranding of a prescription medicine and several irregularities in storage and record-keeping.
According to the FDA, the earlier proceedings against the establishment were withdrawn in compliance with the Bombay High Court's directions, following which a revised show-cause notice was issued on September 4, 2026.
Cipla submitted its written response on September 11 and was subsequently granted an opportunity for a personal hearing on September 21.
Furthermore, the licensing authority examined the company's explanations alongside the inspection findings and available records before passing the cancellation order.
FDA further clarified that the decision was an independent regulatory order issued after completing the entire procedure afresh, rather than a repetition of the earlier action.
FDA in the press note added, "The action was taken by the FDA's Pune office after completing the prescribed legal procedure in compliance with the directions of the Bombay High Court."
One of the key issues identified during the inspection concerned the packaging and advertising claims of Reactin Plus, a Schedule H prescription medicine.
Maharashtra FDA found that the medicine was advertised as an analgesic and anti-inflammatory drug, claiming quick relief from headaches, muscular pain, backache, joint pain, sprain-related pain, body aches and toothaches.
Furthermore, the medicine's carton also featured a human figure suggesting that its use could reduce muscular pain.
As per FDA, the claims, text and illustrations on the packaging did not comply with applicable statutory provisions, raising concerns of misbranding under the Drugs and Cosmetics Act, 1940.
FDA further highlighted that the responsibility of the marketer placing the medicine on the market was also examined.
The licensing authority observed that an establishment could not avoid its statutory obligations as a marketer merely by attributing responsibility to the manufacturer.
The inspection of the Wadki warehouse also revealed several deficiencies in the storage and management of medicines.
The FDA listed the following irregularities:
The FDA said, "Cipla submitted explanations in its written response and during the personal hearing, which were independently examined by the licensing authority."
However, the order clarified that maintaining records in SAP or other computerised systems does not exempt a licensed establishment from its statutory responsibilities concerning documentation, actual stock, safe storage, cleanliness and the availability of records required during inspections.
The department emphasised that every licensed establishment involved in the sale and distribution of medicines must ensure compliance with its legal obligations.
Issuing an official statement about the incident, Cipla said, "Cipla maintains an unwavering commitment to quality and patient safety, and we find the Maharashtra FDA's decision regarding our Wadki C&FA in Pune disappointing."
"We believe, our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards. We are reviewing the order and evaluating further options," they added.
The pharmaceutical further added, "Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers."
FDA Commissioner Tukaram Mundhe, while hailing the action taken by the FDA, said, "The objective of the Food and Drug Administration is not only to take action but also to ensure compliance with the legal provisions in the drug supply chain regarding the quality, safety, etc. of drugs."
Mundhe added, "In this case, the action has been taken by keeping in full respect the directions of the Hon'ble Bombay High Court and following all the aspects of natural justice, transparency, due process of law, etc. The Food and Drug Administration, Maharashtra State, strictly follows the legal provisions related to the quality and safety of drugs."
