Domestic virus test kits await ICMR nod for mass use

It is expected that ICMR will ensure that India becomes a global hub for making low-cost test kits.

The prestigious Indian Council of Medical Research (ICMR) needs to ensure the removal of existing delays in the manufacturing of homegrown Wuhan virus testing kits, sources dealing with testing kits say.

Feedback from the country’s domestic pharma sector has caused the ICMR to be active and change its validation norms. Initially, many companies waited for several months to get the validation process done. The ICMR has now added four more validation centers besides the ICMRNIV (National Institute of

Virology) Pune, but industry sources say many more are needed.

“Knowing the harshness of the situation and the need for having a large number of Wuhan virus testing kits in the country, officials at the ICMR needed to take timely action to ensure fast production of indigenously manufactured Wuhan virus testing kits. This has left the field to companies selling imported test kits and they were not in a position to locally manufacture the test kits,” a source close to the ICMR told The Sunday Guardian. It is expected that ICMR will ensure that India becomes a global hub for the manufacture of low-cost test kits and medicines rather than remain dependent on imported drugs and kits.

The same source cited above said: “It is worth noticing that the previous norms for manufacturing home-grown testing kits were restrictive in nature, at least for domestic Indian companies, as according to the old provisions, having USFDA (U.S. Food and Drug Administration) and European CE (Conformitè Europëenne) was mandatory for the manufacturing of the kits.”

“Cosara—a joint venture of Co-diagnostics Inc of Utah, USA, and Ambalal Sarabhai Enterprises of India—was not in a position to begin commercial manufacture of the Wuhan virus testing kits anywhere despite becoming first to get the CDSCO (Central Drugs Standard Control Organisation) licence. In contrary, the lone Indian company, Mylab Discovery Solutions, which got the validation process done only a week ago after the new norms came into place, have already supplied the indigenously manufactured kits and this was possible because of having locally procured raw material,” the same source cited above said.

Mylab’s Wuhan virus testing kits will not only limit the country’s dependency on the imported kits from the US,