The Drugs Controller General of India (DCGI) has issued an alert regarding the theft of a specific batch of Sanofi India’s insulin product, Lantus SoloStar (Insulin Glargine Injection IP, r-DNA origin, 100 IU/mL). The affected batch, numbered 5F0347B, was stolen from Jagmohanpur in Odisha while it was being transported to a forwarding agent in Kolkata.

In a public notice released by DCGI’s Dr. Rajeev Raghuvanshi, it was highlighted that the products in question, being rDNA origin injectables, necessitate precise temperature control during storage, specifically between 2 to 8 degrees Celsius. These temperature conditions are crucial for maintaining the integrity of the formulations. Any deviation from these requirements could compromise the product’s quality and subsequently affect patient safety. The theft is currently under investigation by local law enforcement.

DCGI asks doctors to exercise caution in prescribing this insulin formulation

Following this advisory, the DCGI has called on doctors and healthcare professionals to exercise caution in prescribing this insulin formulation. The notice emphasized the importance of patient education regarding the reporting of any adverse drug reactions (ADRs). Patients are urged to obtain these products exclusively from authorized suppliers and always ensure they have proper invoices for their purchases.

The DCGI has also directed all state and union territory Drugs Controllers, as well as zonal and sub-zonal offices of the Central Drugs Standard Control Organization (CDSCO), to monitor the distribution of the aforementioned products rigorously. Authorities are expected to take requisite action as stipulate under the Drugs and Cosmetics Act of 1940, along with the relevant rules. This proactive measure aims to ensure that such incidents do not compromise public health and safety.

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