The Indian Council of Medical Research has intensified its efforts to enhance availability of COVID-19 testing kits and newer innovative testing solutions amid the rising cases of coronavirus in India.
ICMR has proposed to exempt several reputed global agencies from validation criteria for RTPCR, RAT, home based testing solution, antigen, antibody ELISA and rapid antibody tests. It further proposed to accord marketing permission by Drugs Controller General of India on the basis of existing approvals.
Several global agencies of Europe, Japan, South Korea, Australia, Brazil and the agencies listed in the World Health Organization’s emergency use listing will benefit from this move.
At present, kits approved by the US Food and Drug Administration under regular or emergency use are exempted from validation in India. It qualifies for direct marketing permission from the Drug Controller General of India.