Strengthening of Drug Testing Mechanism in ESI Institutions

[Image omitted. See the official document.]

U-25/12/RC/Testing_of_Drugs/2025-Med._V (E-1211687) / 402 Website Upload

To

• Director (Medical) Delhi/Director (Medical) Noida.
• Dean, All ESIC PGIMSR's Medical Colleges.
• Medical Superintendents- All ESIC Hospitals.
• Director, Insurance Medical Services- All States/UTs
• Regional Director-All States/UTs

Sub: Strengthening of Drug Testing Mechanism in ESI Institutions-reg. Ref: MoU signed between ESIC Hqrs and PMBI approved Testing Laboratories.

Sir/Madam

Reference captioned subject, it has been observed that sufficient numbers of testing of supplied drugs are not being carried out by some Hospitals/Institutions, which may adversely affect quality assurance and regulatory compliance.

A- In an endeavour to ensure the quality of drugs procured by ESI Institutions, a Memorandum of Understanding (MoU) for Testing of drugs has been executed by ESIC Hqrs with approved Testing Laboratories of Pharmaceuticals & Medical Devices Bureau of India (PMBI) (copy enclosed) which will remain in force for a period of 01 year or validity of contract of Testing Laboratory with PMBI or till finalization of Empanelment of Testing Laboratories by ESI Institutions whichever is earlier.

In context to above, following instructions are being issued for compliance: -

1. ESI Institutions to ensure that approved Pharmaceutical Firms in Central Rate Contracts have submitted mandatorily a Test Report for that particular batch of medicines tested by the Government/ Government approved Laboratories along with each supply, failing which supply received may be rejected at the inspection stage and clauses of late supply/non supply should be enforced as per provisions.
2. Regular testing of 10% of supplies of drugs received in a month

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should be under taken by ESI Institutions from approved Testing Laboratories of Pharmaceuticals & Medical Devices Bureau of India (PMBI) (list enclosed). Additional quality testing may also be undertaken by ESI Institutions at any time during the shelf life or whenever any defect is noticed. 3. The List of Testing laboratories, the Terms & Conditions of MoU, the list of items along with approved Rates of Testing of each laboratory have been attached with this letter for your information. 4. The payment of Testing is to be done by ESI Institutes as per Terms & Conditions of MoU and approved rate list for each Item. 5. All ESIC Institutions are requested to send the list of samples (Name of the Item, RC Item No., RC No. and Batch No.) sent for testing for uploading on ESIC Hqrs website on email ID of website content manager at website@esic.nic.in .The subsequent test report of sample tested will also be uploaded on ESIC Hqrs website immediately by ESI Institutions.

B- ESI Institutions are also requested to do empanelment of Testing Laboratories at their level at the earliest and compliance in this regard to be submitted to ESIC Hqrs.

1. A reference document for selection of Testing Laboratories is being shared for ready reference (copy enclosed).
2. These reference documents are only for the purpose of facilitating locations and are not compulsory to be adopted. The Terms & Conditions of the Tender is to be finalized at your own level in consultation with local Finance & Accounts as per GFR/CVC/GeM and other instructions issued from Govt. of India.
3. Copy of Drug Schedule of ESIC is also attached for reference.

This is for your information and necessary action.

This issues with the approval of Competent Authority.

Yours sincerely,

Digitally signed by Sanjiv Kochhar Date: 26-07-2025 Dy. Medical Commissioner (RC&PC) 10:26:09