NIV Pune to approve Covid-19 testing kits made by Indian companies

New Delhi: The government has established a fast-track mechanism to boost domestic manufacturing of testing kits for novel coronavirus infection, allowing validation by Pune-based National Institute of Virology, even as it looks to pre-empt a surge of Covid-19 cases in the country.

Indian Council of Medical Research (ICMR) on Monday said Indian manufacturers can produce testing kits and supply to private and government laboratories with NIV validation, even if they don’t have approval from the USFDA and European CE.

“We have fast tracked approval system,” ICMR director general Balram Bhargava told reporters here. “Now kits manufactured in India need NIV validation and then apply to Drug Controller General of India (DCGI) for manufacturing licence.”


Two manufacturers — Altona Diagnostics and MY LAB — have already got their kits approved.

The move comes as the number of Covid-19 cases rose to 467 on Monday.

Till last week, Covid-19 confirmatory tests were being conducted by only 50 government laboratories. The number has increased to 111 with ICMR on Friday allowing some private laboratories to start testing for the pandemic.

The guideline issued by the council on Saturday, however, said “commercial kits for real-time PCR based diagnosis of Covid-19 should be USFDA approved or European CE certified or both for in-vitro diagnosis of Covid-19 emergency use”. It has now clarified that NIV-validated kits would be allowed.

The government said 12 private laboratory chains have registered for conducting tests.

“These chains have 15,000 collection centres,” Bhargava said.

The government also brushed aside suggestions that there is a shortage of personal protective equipment (PPEs).

India was exporting PPEs till March 19 although guidelines issued by the World Health Organisation (WHO) on February 27 had said that global stockpile of PPEs was insufficient. “Surging global demand − driven not only by the number of Covid-19 cases but also by misinformation, panic buying and stockpiling − will result in further shortages of PPE globally,” it had said.

When asked about this, joint health secretary Lav Agarwal said, “What guidelines? Show us the guidelines you are talking about. We have taken adequate measures from time to time to ensure availability of PPEs.”