The Union health ministry’s guidelines for COVID-19 testing in private laboratories has complicated matters for Indian manufacturers as only the United States Food and Drug Administration or European Conformitè Europëenne (CE) certified kits was mandated for use, The Times of India reported on Monday. These guidelines, released by the ministry on Saturday, excluded all the Indian National Virology Institute-validated test kits.
At least 80 districts across the country, with confirmed coronavirus cases or deaths, went into lockdown as three more people in the country died on Sunday, taking the toll to seven. The Indian Council of Medical Research’s last update said a total of 396 people have been infected as of Sunday evening.
“Where will labs get FDA or CE approved kits overnight when most countries are not allowing exports?” said an unidentified owner of a laboratory. “This would mean that even Chinese and South Korean kits, if imported cannot be used.”
The testing guidelines for private facilities specified 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 Drug Controller General of India’s office confirmed this mandate.
However, companies trying to get test kits validated have questioned the move, asking why the DCGI issued test licences to Indian firms if they were only going to allow those with certain certification. “It is a totally crazy move,” an unidentified owner of a company, attempting to get its test kits validated, told the newspaper. “Why is NIV working to validate the tests if they cannot be sold in India?” The report added that NIV Pune has validated all the test kits submitted, and has handed over results to Indian Council of Medical Research.
As of now, only one Ahmedabad-based company has collaborated with a firm in the United States. However, manufacturers said that will not be enough to meet demands. Veena Kohli from the Association of Diagnostic Manufacturers of India said she will be writing to the Centre against the guidelines. “A lot of effort and R&D [resource and development] 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.”
The Centre has allowed six private labs to undertake coronavirus testing – four in Maharashtra, and one each in Gujarat and Karnataka while a few more await approval.