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

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 warehouse at Wadki in Pune over alleged violations related to drug packaging, storage, documentation and inventory management. Cipla called the decision "disappointing" and said it is reviewing the order.

The action was ordered on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, after fresh proceedings conducted in compliance with directions from the Bombay High Court.

The FDA said Cipla was issued a revised show-cause notice on September 4. The company submitted its written response on September 11 and was given a personal hearing on September 21. The regulator said it considered the company's submissions, inspection findings, records and applicable legal provisions before passing the fresh order.

Why did Maharashtra FDA cancel Cipla's Pune licence?

The latest action follows an earlier FDA order on August 27 concerning alleged irregularities at the Wadki facility.

One of the key issues involved Reactin Plus Tablets, a Schedule H prescription medicine. During its inspection, the FDA found packaging describing the drug as an analgesic and promoting 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 an illustration showing the medicine as providing relief from muscular pain. It said the claims, wording and illustrations did not comply with applicable statutory provisions and constituted misbranding under the Drugs and Cosmetics Act, 1940.

The FDA also said the establishment's statutory responsibilities as a marketer of the drug could not be avoided by pointing to the manufacturer's role.

FDA flags storage, inventory and documentation lapses

The regulator also listed several deficiencies at the Pune warehouse.

These included the absence of the prescribed Form 35 inspection book, medicines being stored directly on the floor because of inadequate pallets or racks, dust accumulation on drug stocks and shortcomings in cleanliness.

The FDA said expired medicines did not have a separate area clearly marked "Expiry-Not for Sale". It also found that the required standard operating procedure and records relating to the disposal of expired medicines were unavailable.

Officials further identified issues with purchase invoices, signatures on duplicate sale invoices and discrepancies between computerised or SAP records and physical stock, including antibiotics.

The FDA said maintaining records in SAP or another computer system did not exempt a licensed establishment from its statutory responsibilities relating to records, physical stock, storage, cleanliness and inspection documents.

What did Tukaram Mundhe say?

FDA Commissioner Tukaram Mundhe said the regulator's objective was not simply enforcement but ensuring compliance across the drug supply chain.

"The objective of the Food and Drug Administration is not merely to take action but to ensure the safety and quality of medicines and statutory compliance in the drug supply chain."

Mundhe said the latest proceedings were completed while respecting the Bombay High Court's directions and following principles of natural justice, transparency, an opportunity of hearing and a reasoned decision.

The FDA said the October 1 order was not merely a repetition of its August action but an independent decision after the proceedings were completed afresh.

What did Cipla say?

Cipla said it remains committed to quality and patient safety but disagreed with the FDA's decision.

"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," it said.

The company added that it was 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," the pharmaceutical major's statement added.

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