The Government of Maharashtra, on September 29, 2026 issued a public alert regarding a suspected falsified product labelled “Rabies Vaccine, Human I.P. (Freeze-Dried)” bearing the name and particulars of Serum Institute of India Pvt. Ltd. (SIIPL), Pune. The alert follows a communication from SIIPL dated September 24, 2026, after a vial was reportedly received without its accompanying diluent at the 4033 Field Hospital, Sukna, Darjeeling, West Bengal.
The suspected product bears Batch No. 1630T092, with a stated manufacturing date of February 2026 and expiry date of January 2029. SIIPL has confirmed that this batch number does not correspond to any rabies vaccine batch manufactured or released by the company. Healthcare institutions, medical practitioners, pharmacists, distributors, wholesalers and vaccination centres have been directed not to use the product, to segregate and quarantine any available stock, and to prevent its sale, distribution or administration. The product must be retained securely for inspection and investigation, rather than destroyed, discarded or returned through an unauthorised channel. Any suspected availability, sale, distribution or use must be reported to the FDA.
The alert has been issued under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Regulatory examination and investigation are ongoing, and appropriate enforcement action will be taken as warranted. Reports may be sent to [email protected], along with supplier or distributor details and the quantity available.
[Drug Alert-716-2026/10]
