Maharashtra FDA cancels licence of Cipla’s Pune unit

By Sohail Khan 28 August 2026, 7:13 pm

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Business News›Industry›Healthcare/Biotech›Pharmaceuticals›Tukaram Mundhe cracks down: Maharashtra FDA cancels licence of Cipla's Pune unit over regulatory violations

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Tukaram Mundhe cracks down: Maharashtra FDA cancels licence of Cipla's Pune unit over regulatory violations
Synopsis

Maharashtra FDA cancelled Cipla's Pune unit drug sale licences. Serious irregularities in storage and recall procedures were cited by the regulator. The company failed to fully comply with market recall directions for Reactin Plus Tablets. Further non-compliance was discovered in the unit's distribution and sales system.

The Maharashtra Food and Drug Administration has revoked Cipla's licenses to sell Reactin Plus Tablets — FDA Commissioner Tukaram Mundhe said there would be no leniency on drug safety and public health violations, particularly in the advertising, sale, storage and distribution of Schedule H prescription medicines.

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd's Carry and Forwarding (C&F) unit in Pune, citing serious irregularities regarding the storage, packaging, and recall procedures for Reactin Plus Tablets, the regulatory body announced.

The licence cancellation took effect on August 27 following an inspection at the company's primary warehouse located in Wadki, Pune district, according to a statement released by the regulator on Friday.

During an initial inspection around June this year, FDA officials discovered that the packaging for Reactin Plus tablets, a Schedule H prescription drug, carried an unauthorised claim describing the medication as an "analgesic and antipyretic." Acting on these findings, the FDA seized stock valued at Rs 11.19 lakh, noting that such promotional statements violate provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

FDA Commissioner Tukaram Mundhe emphasized that the department maintains a zero-tolerance policy regarding public health and drug safety, particularly concerning Schedule H prescription drugs and their storage, sale, advertising, and distribution.

Also read: Demand for vaccines surges as H1N1, other influenza cases see a sharp rise

"Any violation of rules by any entity involved in the manufacture and distribution of medicines will invite strict action as per law," Mundhe said.

(With inputs from PTI)

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