Sanofi's Diabetes Drug Lantus SoloStar Insulin Batch Stolen, CDSCO Issues Alert

New Delhi: India's apex drug regulator, the Central Drugs Standard Control Organization (CDSCO), has issued a public advisory following the reported theft of a batch of the insulin product Lantus SoloStar (Insulin Glargine Injection IP, r-DNA origin, 100 IU/mL) manufactured by Sanofi India Limited during transportation.

The alert was issued by the Enforcement & Intelligence Cell of CDSCO under the Directorate General of Health Services (DGHS), Ministry of Health and Family Welfare.

According to the official notice, the stolen consignment belongs to Batch No. 5F0347B and was reportedly stolen while in transit from Jagmohanpur, Keonjhar Road in Odisha. The shipment was being transported to the company’s Kolkata Carrying and Forwarding Agent (CFA) when the incident occurred. The matter is currently under investigation by the police.

Lantus SoloStar is an injectable insulin formulation of recombinant DNA origin used for the management of diabetes mellitus. As per the regulator, the product must be stored strictly under refrigerated conditions between 2°C and 8°C to maintain its stability and therapeutic efficacy.

Authorities warned that since the stolen products may not have been maintained under the required storage conditions after the theft, their quality and safety could be compromised. Improper temperature handling can degrade insulin formulations, potentially reducing their effectiveness or posing safety risks to patients.

The alert stated, "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."

Based on the above, the following advisory is provided:

For Doctors and Healthcare professionals :

Carefully prescribe and educate the patients for reporting of any ADRs.

For Patients and consumers:

To be careful and procure the above products from authorized sources only and with a proper invoice.

For Regulatory authorities (All state/UT Drugs Controllers and Zonal/Sub- Zonal offices of CDSCO)

Instruct your 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.

The communication has also been shared with the All India Organisation of Chemists and Druggists (AIOCD) and other regulatory stakeholders to ensure wider dissemination of the alert.

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/2026/03/05/sanofi-public-advisory-331209.pdf