Employees’ State Insurance Corporation (ESIC) has issued a notice of Not of Standard Quality (NSQ) for the drug Vildagliptin Tablet lP 50mg having batch number VLD09H22. This notice was issued on 17th February, 2023.
The details of the drugs are as follows:
- Name of the Firm: Bajaj Healthcare Limited, wagle lndustrial Area Thane (w)-400604
- Item Name: Vildagliptin Tablet lP 50mg
- Brand Name: Vindajaj-50 (As per report of the Drug Inspector)
- Dale of sample receipt: 21.12.22
- RC No: 145G
- Item No: 1690
- Page No: 13
- Batch No: VLD09H22
- Date of Manufacture: 03/2020
- Date of Expiry: 02/2023
- Name ot the Laboratory: Govt. Analyst Drug Testing Laboratory Thiruvananthapuram
- Report No.: Sw/5741/2O22/DTL
- Date of Report: 09.02.2023
- Reason of NSQ: The sample does not comply with IP standards. It fails the test Dissolution Category”8″
Hence all concerned stakeholders are directed to stop use of the batch of the above item immediately. Further action as per clause for “Testing of Drugs-Quality Control” of Terms & Conditions of DG ESIC RC should be initiated. Replacement of supplies or cost of the material is to be recovered along with the testing charges (if any) from the firm. Additionally, any action taken is to be maintained in respective user unit.