MUMBAI, India — The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of a Carrying and Forwarding (C&F) unit operated by Cipla Pharma & Life Sciences Ltd in Pune after regulators identified serious deficiencies involving the packaging, storage, inventory control and recall of Reactin Plus Tablets.
The cancellation took effect on August 27, 2026, following regulatory inspections of the company’s warehouse at Wadki in Pune district, according to a statement from the Maharashtra FDA cited by Indian media.
Regulators said an inspection conducted around June found that packaging for Reactin Plus Tablets, a Schedule H prescription medicine, carried an unauthorised claim describing the product as an “analgesic and antipyretic.”
The FDA said the labelling claim did not comply with provisions of India’s Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Authorities subsequently seized Reactin Plus stock valued at approximately Rs 11.19 lakh and instructed the company to recall the affected product from the market.
Further inspection of the Pune C&F unit reportedly identified additional weaknesses in the company’s drug storage and distribution system. These included discrepancies between physical inventory and computerised stock records, inconsistencies involving purchase and sales records, medicines stored directly on the floor, insufficient pallet and rack arrangements, and inadequate procedures for handling expired pharmaceutical products.
The Maharashtra FDA issued a show-cause notice to the licence holder and reviewed the company’s response. Regulators later concluded that the deficiencies had not been adequately addressed and that required actions relating to the Reactin Plus recall remained incomplete.
Following the review, the authority ordered the cancellation of the unit’s drug sale licences.
Maharashtra FDA Commissioner Tukaram Mundhe said the regulator would continue taking strict action against violations that could affect medicine quality, patient safety and public health, particularly in relation to the advertising, storage, sale and distribution of prescription medicines.
He said entities involved in pharmaceutical manufacturing and distribution must comply fully with applicable drug regulations or face enforcement action.
The case highlights the growing regulatory focus on pharmaceutical supply-chain compliance, including accurate labelling, effective product recalls, warehouse standards and reliable inventory records.
For regulators and pharmaceutical distributors across Africa, the incident also underscores the importance of strong post-market surveillance and traceability systems to ensure that mislabelled, expired or otherwise non-compliant medicines can be rapidly identified and removed from circulation.
Source: Maharashtra Food and Drug Administration statement, as reported by PTI and The Times of India.
