18 Alert on theft of Lantus® SoloStar® (Insulin Glargine Injection IP, r‑DNA origin, 100 IU/mL Batch No. 5F0347B of M/s Sanofi India Limited during transit 2026-Mar-03 69 KB

F. No. Enforc-11021(11)/18/2026-eoffice Government of India

Directorate General of Health Services Central Drugs Standard Control Organization (Enforcement & intelligence Cell)

FDA Bhawan, Kotla Road New Delhi-110002

Subject: Alert on theft of Lantus® SoloStar® (Insulin Glargine Injection IP, r-DNA origin, 100 {U/mL Batch No. 5F0347B of M/s Sanofi India Limited during transit-reg

M/s Sanofi India Limited has informed about a theft ofLantus® SoloStar® (Insulin Glargine Injection IP, r-DNA origin, 100 [U/mL Batch No. 5F0347B, during transit fromJagmohanpur, Keonjhar Road, Odisha while the consignment was en route to the company’s Kolkata CFA. 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 above, the foliowing advisory is provided:

e Doctors and Healthcare professionals

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

• e Patients and consumers © To be careful and procure the above products from authorized sources only and with proper invoice.

• e Regulatory authorities (All state/UT Drugs Controllers and Zonal/SubZonal offices of CDSCO)

Copy to:

• 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 \RajeevSi Raghuvanshi)

• Drugs Controller General (I)

• (Dr.a

1. All State/UT Drugs Controllers 2. All Zonal/Sub-Zonal offices of CDSCO

2. AIOCD through email aiocd@aiocd.com

3. JS(R), Drugs Regulation Section, MoHFW, Nirman Bhawan, New Delhi 5. CDSCO-IT cell for publication on website for general public