Imported IVDs Should Be Used By Institutions For Research Purposes Only: DCGI

Mumbai, 23 June 2020:

The Drugs Controller General of India (DCGI) has clarified that imported in vitro diagnostics (IVDs) 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.

Following quality issues with imported rapid antibody kits, the Indian Council of Medical Research (ICMR) had earlier mandated states to stop using it for COVID-19 for some time to review complaints related to it. India had taken delivery of 500,000 rapid antibody test kits from China in April 2020 which were reportedly facing quality issues.

In an advisory to all states, ICMR had stated that the national task force at ICMR has carefully reviewed the data evolving from various countries on use of such kits. Based on available evidence, the testing strategy for COVID- 19 has been revised further.

As per protocol for using rapid antibody test for epidemiological studies and surveillance, gold standard frontline test for COVID-19 diagnosis is real time PCR based molecular test, which is aimed at early virus detection. The rapid antibody test cannot replace the frontline test. “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 and medical device rule thereunder,” stated DCGI Dr V G Somani.

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 labeled as "for research use only."

ICMR and DCGI had recently jointly come out with guidelines for validation and batch testing of COVID-19 diagnostic kits.

As per the guidelines, US FDA approved RT-PCR kits, RNA extraction kits and viral transport medium (VTM), rapid antibody test, ELISA and CLIA kits will not require ICMR validation. The manufacturer and supplier of such kits can directly apply for DCGI approval. The first batch of CE-IVD approved, non US FDA approved and indigenous RT PCR kits will require validation from any of 24 ICMR identified validation centres prior to DCGI approval, thereafter for post marketing, additional two batches should be tested as per Medical Devices Rules in four months’ time, it stated.

One batch of CE-IVD approved, non US FDA approved, indigenous RNA extraction kits and VTM will require validation from any of ICMR identified validation centres prior to DCGI approval.

The testing of three batches of CE-IVD approved, non US FDA approved, indigenous rapid antibody test, ELISA and CLIA kits will be required for validation from any of ICMR identified validation centres prior to DCGI approval, the guidelines stipulated.

The firm will be required to provide batch testing certificate while delivering the consignment. ICMR identified validation centre will undertake random samples testing of batches of kits for quality assurance.

The requests for validation of kits for RT-PCR, RNA extraction, VTM, rapid antibody test, ELISA and CLIA will be sent by the manufacturer, supplier through e-mail (gstoteja@gmail.com) to Dr GS Toteja, additional director general, ICMR and national nodal officer for validation.

The request from manufacturer and supplier should mandatorily be accompanied with information like name of manufacturer, supplier, name of the kit and batch number, first time validation by ICMR, details of last validation along with validation report (if it is not first time validation), difference in kit composition as compared to first validation etc. Pharmabiz