Diagnostic Reagents for research purposes not under the ambit of D&C Act: DCGI

The applicant needs to submit an undertaking in this regard at the concerned port office of CDSCO

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CDSCO
2 min. read

The Drugs Controller General of India (DCGI) has clarified that the imported  Diagnostic Reagents imported under “RUO” Category shall be used by Indian research institutions for academic research purpose only and not for any diagnosis or therapeutic purpose in diagnostic labs and hospitals.

VG Somani DCGI
Dr. VG Somani, DCGI

In this regard, it is to clarify that the products meant for research use only (RUO) to be used in academic research institutions are not meant for any diagnostic or therapeutic purpose. They are not being regulated under provisions for Drugs and Cosmetic Act 1940 and Medical Device Rules 2017 made thereunder, as stated by DCGI Dr V G Somani as per the office order issued on 19th June 2020.

He further stated, “However, the applicant needs to submit an undertaking in this regard at the concerned port office of Central Drugs Standard Control Organisation (CDSCO) stating that the imported products shall be used by the research institutions for academic research purpose only and shall not be used for any diagnosis or therapeutic purposes in diagnostic labs and hospitals”. Such products shall be labelled as “for research use only” Or “RUO”.

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The request from importer should mandatorily be accompanied with an undertaking and other information like name of manufacturer, supplier, name of the kit, batch number, manufacturing & expiry date, certificate of analysis, validation reports and ADC Sheet in the prescribed format.

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