F.No. IC/36/2024 (E-office)

Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services, Central Drugs Standard Control Organization (HQ), (International cell)

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CIRCULAR

Subject: Shipment of Drug samples sent by foreign National Regulatory Authorities into India for test, examination, or analysis-regarding

This office has received communications from foreign National Regulatory Authorities (NRAs) requesting to facilitate the clearance of shipments of drug samples sent to India for testing at the authorized drug testing laboratories, to ascertain that only safe, efficacious, and quality drugs are released for their population. It is further informed that any delays in clearing such shipments by Indian port offices will affect the testing & release, and may lead to delayed access of such lifesaving drugs.

In this regard, all port offices of CDSCO are hereby directed that such drug shipments sent by any NRAs of foreign nations are required to be released on a fast-track basis, subject to the fulfilment of the following conditions.

1. The Drug samples shall be sent only by the concerned National Regulatory Authority —

2. Drug Samples shall be accompanied by an undertaking stating that the samples have NIL commercial values, and are exclusively used for test, examination, or analysis only

3. The analysis shall be carried out at a testing laboratory possessing valid permission in Form-37

4. The residual samples shall not be returned and shall be disposed of by the testing laboratory as per applicable procedures

Yours faithfully,

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Dr. Rajeev Singh Raghuvanshi Drugs Controller General (India)

To:

1. All zonal and sub-zonal offices of CDSCO 2. All port offices (Air/Sea) of CDSCO : 3. All stakeholders through CDSCO website (for information)

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