The Employees’ State Insurance Corporation (ESIC) on December 20, 2025, issued the notification regarding the "Not of Standard Quality" on Testing.
The following has been stated namely: -
• A batch of Vildagliptin 50 mg + Metformin HCl 500 mg Tablets IP manufactured by M/s Unicure India Ltd has been reported as Not of Standard Quality (NSQ) by the Central Drug Testing Laboratory, CDSCO, Mumbai.
• The NSQ finding is based on failure to comply with I.P. 2022 standards for Dissolution (Vildagliptin & Metformin) and Assay of Vildagliptin, as per the test report dated 18 December 2025.
• The affected batch details include Batch No. VMHT1315, DOM: 05.2025, DOE: 04.2027, sample tested under Sample No. LS/WZ/MG/2025/999 dated 26 August 2025.
• All user units that have procured the said batch are directed to immediately stop its use and withhold payments for the concerned supplies.
• User units must ensure replacement or recovery of cost along with testing charges from the firm and initiate action as per relevant clauses of DG-ESIC Tender/Rate Contract terms and conditions.
[Notification No. U-25/12/NSQ/2023-MedV(E-178406) – 753]
