Declaration of Drug Not of Standard Quality

U-25/12/NSQ/2021-MedV(e-file) कर्मचारी राज्य बीमा निगम (श्रम एवं रोजगार मंत्रालय, भारत सरकार) EMPLOYEES' STATE INSURANCE CORPORATION (Ministry of Labour & Employment, Govt. of India) मुख्यालय/ HEADQUARTERS पंचदीप भवन, सी.आई. जी मार्ग, नई दिल्ली -110 002 Panchdeep Bhawan, C.I.G. Marg, New Dethi-110002 www.esic.gov.in, -011-23604773,dmc-rc@esic.nic.in File No.: U-25/12/NSQ/2021-MedV (E-1119)-1119)/53 Dated:-23-02-2026

To, Director (Medical) Delhi / Director (Medical) Noida, Dean, All ESIC PGIMSR's, Medical & Dental Colleges Medical Superintendents - All ESIC Hospitals, Directors, ESI Scheme, All States

NSQ-03/2026

Subject: Declaration of Drug "Not of Standard Quality" on Testing - reg Sir/Madam

It is hereby informed that the Drug/item has been reported as "Not of Standard Quality". The details of the drug reported NSQ is given below:

In context to above, it is directed to:

1. Medical Store to immediately withdrawn stock from respective sub-stores/Dispensaries/patient care area.
2. Medical Store to immediately write a letter to vendor for replacement of stock with another batch, within 15 days or to pick up stock and return the payment made other process of risk purchase to be initiated and recover cost of testing (if any) from the vendor.
3. Stop use of the batch of the above-mentioned item immediately which has been reported as "Not of Standard Quality".
4. Initiate action as per relevant clause of Terms & Conditions of respective DG-ESIC Tender Enquiry/RC.
5. Stop accepting said NSQ drug of this batch in future orders.
6. Maintain record of action taken at in respective user units.

This issues with the approval of Medical Commissioner (Procurement).

Enclosures: As above

Yours Sincerely, Digitally signed by Sanjiv Kochhar Date: 24-02-2026 11:42:59 Dy. Medical Commissioner (Rate Contract)

Copy to:

1. The Drug Controller General of India, CDSCO, CIG Road, New Delhi- 110002 (Email: dci@nic.in).
2. Office of Deputy Drug Controller (I), Central Drug Standard Control Organization, North Zone, C.G.O. Building-I, Kamla Nehru Nagar, Hapur Chungi, Ghaziabad- 201 002 (U.P.) (Email: nzghaziabad@cdsco.nic.in)-
3. Office of Deputy Drug Controller (I), Central Drugs Standard Control Organisation Baddi, (Container Corporation of India Ltd. Complex) Village-Sheetalpur, Tehsil-Baddi, District- Solan, Himachal Pradesh-173205 (Email: chandigarh@cdsco.nic.in)
4. Marc Laboratories Limited, Avanbai Mansion, 3, Vidhan Sabha Marg, Lucknow 226001(UP) (Email: institution.marclabs@gmail.com, Amit.kishore@marclabs.in)
5. Marc Laboratories Limited, Plot No. 107 & 112, HPSIDC, Baddi, Distt. Solan Himachal Pradesh 173205.
6. Website Content Manager with request for uploading on ESIC website.
7. Guard file

सत्यमेव जयते Central Drugs Testing Laboratory CDSCO Bhavan, S.R. Nagar, Hyderabad-500038 Phone No.040-23811327 Email: cdtlhyd@cdsco.nic.in

FORM 13 (See rule 46)

CERTIFICATE OF TEST OR ANALYSIS BY GOVERNMENT ANALYST UNDER SECTION 25(1) OF THE DRUGS AND COSMETICS ACT, 1940

1. Name of Inspector from whom received: Mr. Salem Kalpana Kumari, Drugs Inspector Mr. Salem Kalpana Kumari Hyderabad Zone CDSCO, Zonal office, Hyderabad, CDSCO BHAVAN, Beside T.B. & Demonstration Centre, S.R. Nagar, Hyderabad - 500038, AP (India)
2. Serial No. and date of Inspector's memorandum: 6-2(1)HZ/2025/1393, 28-NOV-2025
3. Number of Sample: LS/SKK/HZ/2025-11/008
4. Date of receipt: 28-NOV-2025
5. Names of drugs purporting to be contained in the sample: Tranexamic Acid Injection I.P, (TRAXAGE)

6. Condition of seals on [the packet or on portion of sample or container]: Seals were intact & identical to the specimen impression of the seal received from Drugs Inspector
7. Result of test or analysis with protocols or test or analysis applied:

Date of Testing: From 19-Dec-2025 To 05-Jan-2026

COMPOSITION Please see below Each ml contains: Tranexamic Acid I.P 100mg Water for Injection I.P q.s. Protocol Applied: I.P. 2022

In the opinion of the undersigned the sample referred to above is not of standard quality as defined in the Drugs and Cosmetics Act, 1940, and Rules there under for the reasons given below:-

THE SAMPLE RECEIVED DOES NOT CONFORM TO I.P. 2022 SPECIFICATION WITH RESPECT TO THE TEST FOR BACTERIAL ENDOTOXINS ONLY.

Note: Related Substances performed without placebo. Requested placebo is not received from the Manufacturer. While performing related substances test observed extra unknown peaks in test solution, Hence we are unable to conclude that test results for related substances Standard Quality or Not of Standard Quality.

CDTLH REPORT NO.: CDTLH/1534/F-1115/2025-26 Date: 23-JAN-2026

[Image omitted. See the official document.]

के. नितिन कुमार / K. NITIN KUMAR GOVERNMENT ANALYST सरकारी विश्लेषक / Government Analyst केंद्रीय औप परीक्षण प्रयोगशाला / Central Drugs Testing Laboratory केन्द्रीय औषधि मानक नियंत्रण संगठन Central Drugs Standard Control Organization स्वास्थ्य एवं परिवार कल्याण मंत्रालय / Ministry of Health & Family Welfare स्वास्थ्य सेवा महानिदेशालय / Directorate General of Health Services भारत सरकार / Government of India Report in the red colored paper indicates the sample is not of standard quality.

MINISTRY OF HEALTH, सत्यमेव जयते GOVERNMENT OF INDIA