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Following a communication from Sanofi India that a certain batch of its insulin injection formulation Lantus Solostar, the Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to its zonal offices and the State drug regulators to keep strict vigil on the movement of the product in the market.
The CDSCO, in an alert to the stakeholders including the State drug regulators, doctors and healthcare professionals, and patients and consumers, said that Sanofi India has informed about a theft of Lantus Solostar (insulin glargine injection IP, r-DNA origin, 100 IU/mL, Batch No. 5F0347B), during transit from Jagmohanpur, Keonjhar Road, Odisha while the consignment was on its way to the company's Carrying and Forwarding Agent (CFA).
The products under consideration are rDNA origin injectables, which are required to be stored at 2-8 degree celicius.
"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," said an alert issued by Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi.
The DCGI also issued an advisory to the regulatory authorities including all State and Union Territory drug controllers and zonal and sub-zonal offices of CDSCO to instruct their offices "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".
He also advised the doctors and the healthcare professionals that they should carefully prescribe and educate the patients for reporting of any adverse drug reactions.
Besides, the patients and consumers should be careful and procure the products from authorised sources only and with proper invoice, added the central drug regulator.
It may be noted that the latest information on theft follows another alert issued almost seven months back, regarding certain batches of r-DNA origin diabetes injection brands from Novo Nordisk, for fear of its quality being compromised following the company informed it about a theft of the batches.
The products which were under the alert include one batch each of Insulin degludec/insulin aspart (r-DNA origin) solution for injection, under the brand Ryzodeg FlexTouch, Insulin aspart (r-DNA origin) solution for injection under the brand Fiasp Penfill, and Insulin aspart (r-DNA Origin) solution for injection under the brand Fiasp FlexTouch.
Besides, one batch each of semaglutide Injection 0.5 mg (r-DNA origin) solution for injection, semaglutide injection 0.25 mg (r-DNA origin) solution for injection, and semaglutide injection 1 mg (r-DNA origin) solution or injection, under the brand Wegovy Flex Touch, were also stolen during the transit.
Novo Nordisk informed the drug regulator about the theft of its products during the transit from its Bhiwandi hub to the milk route, which is through Nagpur, Raipur, Cuttak, and Kolkata. The products are rDNA origin injectables which are required to be stored at 2°C to 8°C.
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