The regulatory agency advised doctors and healthcare professionals to carefully prescribe the affected product.
India’s drug regulator issued an alert after a consignment of insulin manufactured by French drugmaker Sanofi India was reported stolen, raising concerns about possible improper storage and patient safety, News18 learnt.
In an official communication dated March 2, seen by News18, the Central Drugs Standard Control Organization (CDSCO) said it had been informed by Sanofi India Limited about the theft of Lantus SoloStar – insulin Glargine injection, especially its batch number 5F0347B.
Insulin glargine is a long-acting basal insulin used in the management of Type 1 and Type 2 diabetes and is prescribed to thousands of patients daily to maintain stable blood glucose levels. In a country known as the diabetes capital of the world, where millions depend on uninterrupted insulin access, the integrity of such temperature-sensitive products becomes especially critical.
The regulator, in the alert notice, mentioned that these r-DNA origin injectables are required to be stored between 2°C and 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 advisory stated.
According to a Sanofi spokesperson, “patient safety is of paramount importance” to the company.
“An FIR has already been lodged in this matter. In the interest of transparency, we are working closely with CDSCO and other stakeholders to address this issue. We uphold the highest ethical standards in all our operations and endeavours,” the spokesperson said.
The regulatory agency advised doctors and healthcare professionals to carefully prescribe the affected product and educate patients to report any “adverse drug reactions”. Patients and consumers have been asked to procure the product only from authorized sources and ensure proper invoices are available at the time of purchase.
