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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
To,
Dated:-23-02-2026
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:
Sample
taken
Premises
Name of the|ltem Name/ RC
Batch No.
Firm (M/s)
Brand
No/
DOM/DOE
Name
Item
No/
/Name of
Laboratory/
Report No. &
Date
the Reason
NSQ
of
Page
No
ESIC
Marc
Inj.
160
Medical
Laboratories
College
& Limited
Hospital
Tranexamic
Acid 500mg
TRAXAGE
Batch No.-
TG-156
522
DOM:08/25
Sanath
DOE:07/27
Nagar,
The
Government
Analyst,
Central Drug
Testing
Laboratory,
Hyderabad
Hyderabad
HYD/LS/2025-to the test
26/1201
Dated -
23/01/2026
The sample
received
does not
conform to
IP 2022
Specification
with respect
for Bacterial
Endotoxins
only (coру
enclosed).
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 Medical Store to immediately withdrawn stock from respective sub-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.
1
File No. U-25/12/NSQ/2021-MedV(e-file) (Computer No. 1119)
Generated from eOffice by Arun Kumar, PHARMACIST-RC-AK, PHARMACIST(MEDS), Employees State Insurance Corporation (ESIC) on 24/02/2026 12:04 pm
1/3620132/2026
U-25/12/NSQ/2021-MedV(e-file)
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
Copy to:
Yours Sincerely,
Digitally signed by
Sanjiv Kochhar
Date: 24-02-2026
11:42:59
Dy. Medical Commissioner
(Rate Contract)
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, Č.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
2
File No. U-25/12/NSQ/2021-MedV(e-file) (Computer No. 1119)
Generated from eOffice by Arun Kumar, PHARMACIST-RC-AK, PHARMACIST(MED5), Employees State Insurance Corporation (ESIC) on 24/02/2026 12:04 pm
1/3620132/2026
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
2. Serial No. and date of Inspector's memorandum
3. Number of Sample
4. Date of receipt
: 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)
: 6-2(1)HZ/2025/1393, 28-NOV-2025
: LS/SKK/HZ/2025-11/008
: 28-NOV-2025
5. Names of drugs purporting to be contained in the sample : Tranexamic Acid Injection I.P, (TRAXAGE)
Lab. Sample No.
Report No.
Batch No.
Date of Mfg. &
Exp
Marketed By
LSD/HYD/2025-
26/1036
HYD/LS/2025-
26/1201
TG-156
D
Aug-2025
Jul-2027
NA
GANISAT
Mfg. By
Marc Laboratories Ltd. Unit-
III, Plot No. 107 & 112, H.P.S.
I.D.C., Baddi, Distt. Solan (H.
P.)
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
Sr No.
Test Name
Result
Limits
Description
Clear, colourless, sterile solution, packed in sealed
transparent glass ampoules arranged in plastic tray,
enclosed in paper carton box.
2
Identification
Positive for Tranaxemic Acid
3
pH
7.37
4
Bacterial Endotoxins
Does not complies
5
Sterility
Complies
Page 1 of 2
6.5 to 8
NMT 0.5 EU/mg
of Tranexamic
Acid
6
7
Assay
Particulate Matter (Visual
Inspection)
Extractable Volume
Complies
5.01 ml
NLT Nominal
Volume (5.0)
Sr.No
Ingredient Name
Found
Claim
% of claim
Limits
Procedure / Method
1
Tranexamic Acid
94.602 mg
100 mg
94.602
90 to 110%
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
CENTRAL
DRUGS TESTING LABORATO
DRUGS
DARD CONTROL
ORGA के. नितिन कुमार / K. NITIN KUMAR
GOVERNMENT OF INDIA
*MOME
ebad Telange
Kitruf
GOVERNMENT ANALYST
सरकारी विश्लेषक / Government Analyst
केंद्रीय औप परीक्षण प्रयोगशाला / Central Drugs Testing Laboratory
के पधि मानक नियंत्रण संगठन
Central Drugs Standard Control Organization
arahe
स्वासस्थ्य सेवा मte Generai of Health Services
Report in the red colored paper indicates the sample is nototstandard qualityneary of Heath & Faly Wetn
भारत सरकार / Government of India
END OF REPORT साा ा
MINISTRY OF HEALTH,
सत्यमेव जयते
GOVERNMENT OF INDIA
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