New Delhi [India], March 4 : The DCGI (Drugs Controller General of India) on Wednesday issued an alert regarding a stolen batch of Sanofi India's insulin formulation, Lantus SoloStar (Insulin Glargine Injection IP, r-DNA origin, 100 IU/mL), with batch number 5F0347B.
The consignment was stolen from Jagmohanpur, Odisha, while being transported to a Kolkata clearing and forwarding agent.
According to the public notice issued by the DCGI Dr Rajeev Raghuvanshi, "The products under consideration are rDNA origin injectables which are required to be stored at 2-8°C. The quality of the products may be compromised if the products are not handled in proper storage conditions, since the formulations are supposed to be maintained at 2°C to 8°C, failing which would impact the quality of the product and, in turn, impact the safety of the patients. The matter is currently under investigation by the Police."
Based on the DCGI alert on advisory has been issued to doctors and Healthcare professionals. "Doctors and healthcare professionals carefully prescribe and educate patients on reporting any ADRs. Patients and consumers are to be careful and procure the above products from authorised sources only and with proper invoices," the notice read.
Regulatory authorities (All stateUT Drugs Controllers and Zonal/Sub- Zonal offices of CDSCO) have been asked to instruct officers to keep a strict vigil on the movement of the said products in the market and initiate necessary action under the provisions of Drugs & Cosmetics Act, 1940, and Rules made thereunder.
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