India’s drug regulator has issued a public advisory after a consignment of insulin pens manufactured by Sanofi India Limited was reported stolen during transportation, raising concerns about potential risks if the products enter the market through unauthorized channels.
According to the advisory issued by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, the incident involves a batch of Lantus SoloStar (Insulin Glargine Injection IP, r-DNA origin, 100 IU/mL). The stolen stock belongs to Batch No. 5F0347B and was being transported from Jagmohanpur in Odisha to the company’s Kolkata carrying and forwarding agent when the theft occurred.
Regulators warned that insulin products require strict cold-chain storage between 2°C and 8°C. If the stolen consignment has not been maintained under proper temperature conditions, the quality and effectiveness of the medicine could be compromised. Authorities cautioned that using such improperly stored injectables may pose safety risks to patients.
The CDSCO stated that the matter is currently under investigation by local police. Meanwhile, drug regulators have alerted healthcare professionals, patients, and state drug control authorities to remain vigilant and prevent circulation of the stolen products in the market.
Doctors and healthcare professionals have been advised to carefully prescribe insulin and encourage patients to report any adverse drug reactions if suspected. Patients and consumers have been urged to purchase insulin products only from authorized pharmacies and always obtain proper invoices to ensure authenticity.
State and Union Territory drug controllers have also been directed to keep strict surveillance on the movement and sale of the affected batch in the market. Authorities may initiate action under the Drugs and Cosmetics Act, 1940 if the stolen medicines are detected in circulation.
Officials emphasized that vigilance from healthcare providers, pharmacists, and patients will be critical in preventing the potentially compromised insulin pens from reaching consumers.
