Maharashtra FDA Cancels Wholesale Drug Sales License of Cipla Unit in Pune — October 2, 2026

The Maharashtra Food and Drug Administration (FDA) has cancelled the wholesale drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd's carrying and forwarding (C&F) warehouse located at Wadki in Pune. The fresh cancellation order was issued on October 1 by the Assistant Commissioner (Drugs), Division 3, FDA Pune, following an extensive regulatory review.

The regulatory action was undertaken after completing legal procedures stipulated by the Bombay High Court. State FDA Commissioner Tukaram Mundhe stated that the decision followed the identification of serious operational and regulatory violations during inspections of the facility.

Key Regulatory Violations Cited

According to regulatory authorities, the primary infractions involved:

• Misbranding and Packaging Claims: The facility held inventory of Reactin Plus Tablets, a Schedule H prescription drug. The packaging promoted the medicine as an "Analgesic and Anti-inflammatory" offering relief from headaches, muscular pain, backaches, and toothaches, alongside an illustration of a human figure indicating pain reduction. Under the Drugs and Cosmetics Act, 1940, such promotional claims and visuals on prescription medicines are classified as misbranding.
• Storage and Expired Medicines: Deficiencies were noted in the warehouse's physical storage conditions and protocols for handling and segregating expired medicines.
• Inventory and Record-Keeping Mismatches: Regulators identified discrepancies between computer records (SAP systems) and physical stock, alongside missing authorised signatures on duplicate copies of sales invoices.

Girish Hukare, Joint Commissioner (Drug), Pune, noted that statutory non-compliance regarding packaging texts and illustrations formed a significant basis for regulatory intervention under drug advertising regulations.

Legal Background and Court Directives

The dispute traces back to an inspection conducted earlier this year, which initially led the state regulator to cancel the warehouse's licence on August 27. Cipla Pharma & Life Sciences Ltd challenged that order before the Bombay High Court via a writ petition, contesting procedural aspects including natural justice standards after a hearing was scheduled on a state holiday.

Following observations by the High Court, the FDA withdrew the initial order and initiated fresh proceedings. The department issued a revised show-cause notice on September 4. Cipla filed its written reply on September 11 and attended a personal hearing on September 21. After reviewing the submissions, inspection records, and statutory mandates, the licensing authority determined that the violations warranted a full revocation of the wholesale licences.

Impact and Industry Context

In earlier statements regarding the dispute, Cipla had asserted that the FDA's regulatory notices did not allege deficiencies regarding the safety, quality, or clinical efficacy of the underlying pharmaceutical formulations, maintaining that patient safety remained uncompromised.

While the order targets a regional carrying and forwarding warehouse rather than primary active pharmaceutical ingredient (API) or formulation manufacturing lines, it emphasizes the growing administrative vigilance by state authorities over domestic distribution channels, labelling compliance, and inventory accountability across India's pharmaceutical supply chain.

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