Maharashtra FDA Cancels Cipla Pharma & Life Sciences’ Pune Warehouse Drug Licences Over Multiple Lapses

Mumbai: The Maharashtra Food and Drug Administration (FDA) has cancelled the wholesale drug licences of Cipla Pharma & Life Sciences Ltd’s warehouse at Wadki in Pune, citing misbranding of a medicine and multiple lapses in drug storage, record-keeping and inventory management.

Fresh Proceedings After HC Directions

The action was taken after the FDA completed fresh proceedings in compliance with directions of the Bombay High Court in Writ Petition No. 11376/2026. The department withdrew its earlier proceedings, issued a revised show-cause notice on September 4, considered the company’s reply submitted on September 11 and conducted a personal hearing on September 21 before passing a fresh, reasoned order on October 1.

One of the key findings concerned Reactin Plus, a Schedule H medicine found at the warehouse. According to the FDA, its packaging carried claims such as relief from headache, muscular pain, backache, joint pain, body ache and toothache, along with a human figure depicting relief from muscle pain. The FDA held that the claims, text and illustrations did not comply with applicable statutory provisions and raised an issue of misbranding under the Drugs and Cosmetics Act, 1940.

FDA Raises Misbranding Issue

The regulator also held that the establishment, in its role as a marketer, could not avoid its statutory responsibility by attributing the responsibility solely to the manufacturer.

The inspection further found that medicines were stored directly on the floor due to inadequate pallets or racks, while dust had accumulated on stocks. The warehouse also lacked a prescribed Form 35 inspection book and a clearly marked separate area for expired medicines carrying an “Expiry – Not for Sale” notice.

Storage Conditions Found Deficient

The FDA said the establishment could not produce the required SOP and records for disposal of expired medicines. Inspectors also found deficiencies in purchase and sales invoices and discrepancies between SAP/computerised records and the actual physical stock, including antibiotics.

The company’s explanations were considered during the proceedings. However, the licensing authority held that maintaining records in SAP or another computerised system does not absolve a licence holder of statutory obligations relating to physical stock, prescribed records, proper storage, cleanliness and inspection documentation.

Cipla statement:

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.

Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers.

An email was sent to Cipla seeking the company’s response to the FDA’s action, but no response was received until the time of going to press.

FDA Commissioner Tukaram Mundhe said the department’s objective was not merely enforcement but ensuring the safety and quality of medicines and compliance throughout the drug supply chain. He said the fresh proceedings were conducted in accordance with the High Court’s directions, natural justice, transparency, an opportunity of hearing and a reasoned decision.

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