Maharashtra FDA Cancels Cipla Pune C&F License Over Reactin Plus Violations; Firm Challenges Order

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale license of Cipla Pharma & Life Sciences Ltd.’s Carrying and Forwarding (C&F) unit at Wadki in Pune, from August 27, 2026, stating regulatory lapses involving the packaging, storage, records and recall of Reactin Plus Tablets. Cipla has challenged the order, pointing out the matter is currently sub judice and clarifying that the action does not allege any concerns related to safety and quality.

According to India Today, the Maharashtra Food and Drug Administration (FDA) cancellation took effect on August 27 after the regulator reviewed inspection findings and the company’s response to a show-cause notice.

The action followed an inspection conducted around June this year, FDA officials found that the packaging of Reactin Plus, a Schedule H prescription medicine, carried an unauthorized claim describing it as an “analgesic and antipyretic,” according to the FDA statement cited by India Today.

The FDA said the claim lacked the required approval and was contrary to provisions of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

The FDA subsequently seized Reactin Plus stock valued at about ₹11.9 lakh and directed a recall of the affected medicines.

FDA later inspected the C&F unit’s drug sale and distribution system and found further storage deficiencies. These included differences between purchase and sales records, computerized stock and physical stock, as reported in The Telegraph.

They also found medicines stored directly on the floor, along with improper pallets and racks. It flagged shortcomings in records and procedures for handling expired medicines.

It further stated that the company had not fully complied with directions to recall the affected Reactin Plus Tablets. A show-cause notice issued, FDA concluded that the identified deficiencies and recall-related directions had not been rightly addressed.

Also see: Maharashtra Homeopathic Doctors Get MMC Registration to Prescribe Allopathic Medicines: Who Are the 3 Doctors?

Cipla has challenged the FDA order, stating, “Cipla Pharma & Life Sciences (CPLS) has contested the Pune FDA’s order pertaining to the operations of a C&F warehouse operated on behalf of CPLS and the matter is currently sub judice,” adding, “it would not be appropriate to comment further on the proceedings at this stage,” as reported in the Business Standard.

In addition to it, cipla also clarified that the FDA order does not allege concerns over the safety, quality, or efficacy of its products.

Meanwhile, FDA Commissioner Tukaram Mundhe said that the department would not show any ease on issues involving the advertising, sale, storage and distribution of Schedule H medicines.

The dispute will now be considered through the judicial process, while the FDA’s cancellation remains the regulator’s stated.

(Rh/TP)