Declaration of Drug “Not of Standard Quality” on Testing - reg

[Image omitted. See the official document.] कर्मचारी राज्य बीमा निगम (श्रम एवं रोजगार मंत्रालय, भारत सरकार) EMPLOYEES' STATE INSURANCE CORPORATION (Ministry of Labour & Employment, Govt. of India)

[Image omitted. See the official document.]

मुख्यालय/HEADQUARTERS पंचदीप भवन, सी.आई.जी मार्ग, नई दिल्ली-110002 Panchdeep Bhawan, C.I.G. Marg, New Delhi-110002 www.esic.gov.in, ☎ 011-23604773, ✉ dmc-rc@esic.nic.in

File No. U-25/12/NSQ/2021-MedV(e-file)(E-1119)/333 दिनांक:

सेवा में, 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-13/2026

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 Medical Store to immediately withdrawn stock from respective sub-stores/Dispensaries/patient care area.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. Maintained record of action taken at in respective user units.

यह चिकित्सा आयुक्त (प्रोक्योरमेंट) के अनुमोदन से जारी किया जाता है।

संलग्नकः उपरोक्त

भवदीय,

Digitally signed by Sanjiv Kochhar Date: 29-10-2026 11:19:44

उप चिकित्सा आयुक्त (दर अनुबंध)

प्रतिलिपिः

1. The Drug Controller General of India, CDSCO, CIG Road, New Delhi-110002 (dci@nic.in).
2. Office of Assistant Drug Controller (I), Central Drug Standard Control Organization, Sub-Zonal Office, Regional Drugs Testing Laboratory Campus, Six Mile, Panjabari Road, Guwahati-781022, AP, (E-mail: subzone.guwahati@cdsco.nic.in)
3. Signature Phytochemical Industries, A-301 Peninsula Business Park Ganpatrao Kadam Marg Lower Parel Mumbai 400013 (Email: marketing@signaturepi.in)
4. Signature Phytochemical Industries, 122, MI, LELAQUI INDUSTRIAL AREA, DEHRADUN-248001
5. Website Content Manager with request for uploading on ESIC website.
6. Guard file

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[Image omitted. See the official document.] GOVERNMENT OF ASSAM OFFICE OF THE INSPECTOR OF DRUGS:: TINSUKIA C/O THE OFFICE OF JOINT DIRECTOR OF HEALTH SERVICES, TINSUKIA-786125 Email: idtinsukia@gmail.com

NO. ID /TSK/ 576 / Dated Tinsukia the 15th day of October -2026

From : The Inspector of Drugs, Tinsukia

To : The Medical Superintendent E.S.I.C Hospital, Bordoloi Nagar, Tinsukia

Sub: NSQ report of "TELMISARTAN & AMLODIPINE TABLETS IP" (TELMISIGN AM), Batch No. 1156-003, Mfg. Date: 06/2026, Exp. Date: 05/2028, Manufactured by M/S SIGNATURE PHYTOCHEMICAL INDUSTRIES, 122, MI, SELAQUI INDUSTRIAL AREA, DEHRADUN-248001-reg.

Sir/Madam,

With reference to the subject cited above, I am forwarding herewith one Test Report in Form-13 (Report No. SDTL/L/AK/2026/1582) received from the Government Analyst, State Drugs Testing Laboratory, Jalukbari, Guwahati-14. The report declares "TELMISARTAN & AMLODIPINE TABLETS IP(TELMISIGN AM), Batch No. 1156-003, Mfg. Date: 06/2026, Exp. Date: 05/2028, Manufactured by M/S SIGNATURE PHYTOCHEMICAL INDUSTRIES, 122, MI, SELAQUI INDUSTRIAL AREA, DEHRADUN-248001, as Not of Standard Quality (NSQ).

You are therefore requested to immediately stop all distribution of the aforementioned batch and arrange to withdraw and recall the distributed stock of the said batch from all sources without delay.

Further, you are requested to furnish the following information within 7(seven) days from the date of receipt of this letter:

1. Total quantity of the drug received, along with invoice details and dates of receipt.
2. Name and full address of the supplier/manufacturer from whom the drug was procured.
3. Present stock position of the aforesaid batch currently held in your premises.
4. Any other withdrawal protocols (if any).

This is for your kind information and immediate necessary action.

Inspector of Drugs, Tinsukia

Memo. NO. ID /TSK/ 576-A / Dated Tinsukia the 15th day of October -2026

Copy for information to-

1. The District Commisioner, Tinsukia
2. The Drugs Controller (i/c) LA, Hengrababi, Guwahati-36

Inspector of Drugs, Tinsukia

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[Image omitted. See the official document.] STATE DRUGS TESTING LABORATORY IN-CHARGE, GOVERNMENT ANALYST, JALUKBARI, GUWAHATI - 781014 Phone No: 0361-2208010 Email: sdtlguwahati@gmail.com

No. SDTL/Report/L/2026-2027/97/1700 Date: 19/10/2026

To : Dipu konwar Inspector of Drugs, Tinsukia, Assam

[Image omitted. See the official document.]

Sub : Test report in Form 13 of sample received as per Drugs and Cosmetics Act, 1940 and Rules, 1945 thereunder regarding.

Ref. No.: ID/TSK/DK//Sample/76/26, 17/09/2026

Sir/Madam,

With reference to the subject cited above, please find herewith the enclosed test report in Form 13 (in triplicate) of the sample received vide letter No. ID/TSK/DK//Sample/76/26, 17/09/2026

This is for your kind information and necessary action please.

Yours faithfully,

(Dhrubajyoti Sarma) Government Analyst SDTL, Guwahati

Copy for kind information to: i) The Drugs Controller General (I), CDSCO, FDA, Bhawan, Kotla Road, New Delhi-110002 ii) The Drugs Controller, Hengrabari, Ghy-36

(Dhrubajyoti Sarma) Government Analyst SDTL, Guwahati

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[Image omitted. See the official document.] STATE DRUGS TESTING LABORATORY IN-CHARGE, GOVERNMENT ANALYST, JALUKBARI, GUWAHATI - 781014 Email: sdtlguwahati@gmail.com

[Image omitted. See the official document.]

FORM 13 (See Rule 46)

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

1. Name of Inspector from whom received : DIPU KONWAR INSPECTOR OF DRUGS TINSUKIA, ASSAM

2. Serial No. and date of Inspector's memorandum : ID/TSK/DK//Sample/76/26, 17/09/2026

3. Number of Sample : 60 TABLETS

4. Date of receipt : 22/09/2026

5. Names of drugs purporting to be contained in the sample: TELMISARTAN & AMLODIPINE TABLETS IP

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 analysis applied: Please see below Date of Testing: From: 07/10/2026 to 14/10/2026

COMPOSITION: Each uncoated tablet contains: TELMISARTAN IP 40 MG & AMLODIPINE BESYLATE IP Eq to AMLODIPINE 5 MG