The guidelines issued on Saturday by the health ministry for Covid-19 testing in private laboratories has left Indian manufacturers of test

bewildered as they stipulate that only USFDA or European CE certified kits can be used by the labs. Going by this stipulation, none of the Indian test kits currently being validated by the

Institute (NIV) in Pune can be used.

W ith export of kits shut down by most countries and a global shortage of testing kits, it was expected that once Indian companies got their test kits validated by the NIV, they could get manufacturing licences from the drug controller general of India (DCGI) and start supplying the kits.

"W here will labs get FDA- or CE-approved kits overnight when most countries are not allowing exports? This would mean that even Chinese and

Korean kits, if imported, cannot be used," said a lab owner.

T he testing guidelines for private labs laid down by

and put out by the health ministry stated that "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 under emergency use". The DCGI's office confirmed that only kits with USFDA or CE would be allowed for sale in India. " Why did DCGI issue test licences to Indian companies so that they can get their test kits validated, if they were going to allow only USFDA-approved or CE-certified tests? It's a totally crazy move. Why is NIV working to validate the tests if they cannot be sold in India?" asked the owner of one of the companies trying to get its test kits validated. TOI has learnt that NIV has finished validating the test kits submitted to it and handed over the results to ICMR .

C urrently, there seems to be only one Indian manufacturer with USFDA approval, Cosara diagnostics, an Ahmedabad-based company, which has a tie up with a US firm. "One firm will not be able to meet the demands of all private sector labs. This will make it very difficult to expand testing facilities," said an Indian test kit manufacturer .

"W e are writing to the government against these guidelines. A lot of effort and R&D has gone into developing these kits in record time and our companies must be given a chance to prove the quality and reliability of their test kits," Veena Kohli of the

of India said.

"It is disheartening that the health ministry endorses overseas regulatory approvals as a means of qualification while keeping out Indian manufacturers instead of respecting India's own regulatory processes," said Rajv Nath of AiMed.

Full report on www.toi.in