**Summary:**
This communication, reference number F. No. 120122DC Pt142, issued on July 7, 2022, by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), New Drugs Division, addresses challenges faced by sponsors importing non-drug lab kits and ancillary items for clinical trials and clinical research. To streamline the import process and encourage research and clinical development, the Drugs Controller General of India, Dr. V.G. Somani, has authorized that sponsors/importers may submit an undertaking to the concerned CDSCO Port Office. This undertaking, accompanied by a copy of the clinical trial/research approval, must state that the imported items will be used solely for approved clinical trial/research purposes and will not be diverted. Upon submission of this documentation, import consignments may be cleared at the port of import. This clarification is directed to all Zonal/Sub-Zonal/Port Offices of CDSCO.
Key Entities Referenced
Directorate General of Health Services: A department of the Government of India related to health services.
Central Drugs Standard Control Organization (CDSCO): The national regulatory authority for pharmaceuticals and medical devices in India.
New Drugs Division: A division within the CDSCO responsible for new drugs.
New Delhi: City in India where the FDA Bhawan, CDSCO office is located.
ZonalSubZonalPort Offices of CDSCO: Regional offices of the CDSCO responsible for import and export regulation.
clinical trial clinical research: Refers to the clinical trials and clinical research activities mentioned in the context of importing lab kits.
Port Office of CDSCO: The office at the port of entry/exit where CDSCO regulations are enforced.
Dr. V.G. Somani: The Drugs Controller General of India at the time of the notification.
F. No. 12-01/22-DC (Pt-142)
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(New Drugs Division)
FDA Bhawan, Kotla Road
New Delhi- 110002
Dated: 7/7) 2022.
To
All Zonal/Sub-Zonal/Port Offices of CDSCO
Subject: Clarification regarding import of non-drug / lab kits shipments related to
clinical trial / clinical research purposes
Sir,
This office has received representation regarding challenges being faced by
sponsors conducting clinical trial / clinical research in importing of ancillary items
including non-drug items / lab kits / equipment / accessories etc. which are necessitated
for conducting clinical research / clinical trial as per approved protocol.
In this regard, for encouraging research and clinical development and for
streamlining the import of such items, the sponsor / importer may submit an undertaking
along with the copy of clinical trial / clinical research approval obtained by sponsor /
importer, at the concerned Port Office of CDSCO stating that such imported items are
being imported and will be used for clinical trial / clinical research purpose only and will
not be diverted for any other purposes, as per applicable rules, based on which such
import consignments may be cleared at the port of import.
Yours Faithfully,
\ ase
a
(Dr. V.G. Somani)
Drugs Controller General (India)