NEW DELHI: While the US

gave clearance for diagnostic tests for Covid-19 within 24 hours of application by two companies, in India a handful of companies looking to get their tests validated have been waiting for a month, or more in some cases.

Several companies have been approaching every

government

institution, from the

, the

Mission of the

(BIRAC), ICMR, NIV, health ministry and the

Control Organisation (CDSCO) from the first week of February onwards with proposals to get their test kits for Covid-19 validated.

“NIV expressed helplessness saying they do not have enough positive samples to do the validation. It is quite impractical to have a single centre for test validation. There seems to be no urgency on the part of the government in helping the development of indigenous capabilities. There are no guidelines regarding what processes need to be completed to have a test validated. So all of us are running from one office to another and trying to meet many government officials hoping to speed things up,” said an executive of one of the companies looking to get its test validated.

According to sources in NIV, nine companies have applied for validation of their tests and the institute has finished validating tests from four of these. What is delaying validation is the fact that NIV is currently the sole agency for validation. The government is learnt to be in the process of identifying more of them.

With a global shortage of reagents and testing kits, India could find it difficult to expand testing as and when demand ramps up. As the US looks to expand testing, it is expected to buy up millions of test kits being produced by the two companies that got US FDA approval -- Thermo Fischer and Roche. The ICMR has stated that it has a stockpile of reagents for one million tests and has already placed orders for more.

Labsystems Diagnostics had set up a joint venture with

. This JV has used Yinsheng’s experience in developing a real-time test kit in January now being sold widely in China. “Gaining from that expertise and knowledge, our India scientists are indigenously developing a Covid-19 kit and this will be sent to NIV Pune for approval next week. While the imported kits costs Rs 2,000-4,000 per test, we are planning to launch the Make in India kit at Rs 500 to 700 per kit depending on volumes. The commercial kit will be launched in about three weeks’ time depending on clinical validation,” said Dr Velu of Trivitron, Labsystems’s parent firm.

Dr Velu said they were working with the Institute of Genomics and Integrative Biology in Delhi to do lab-based validation of the test. He added that though NIV was the main centre for validation, it was inundated with work.

“We are already using our reagents for other kits like dengue, chicken guinea, HBV, TB etc. So these reagents are well tested and of proven quality. All are manufactured in house and so scale up may not be an issue,” said Dr Shesheer Kumar of Huwel LifeSciences, another company awaiting validation of its test kit.

USFDA commissioner Stephen Hahn was reported as saying that the agency had been in touch with 80 test developers that planned to bring their tests through the emergency process. The FDA approved the Thermo Fischer and Roche tests through the Emergency Use Authorisations issued when the US declares a public emergency.