As India grapples with the COVID-19 outbreak, the health system is grappling with a shortage of testing kits. One of the most important ways to flatten the curve—an effort to slow down the rate at which people will contract the virus over a period of time, to help reduce the load on hospitals—is to expand and speed up the testing process and provide kits as soon as possible. The Indian government has been facing strong criticism for its low testing rates, despite the scale of its population and the alarming speed at which the virus is spreading. The medical establishment, led by the Indian Council of Medical Research and the ministry of health and family welfare, has finally given the nod to private companies to manufacture testing kits. While the decision has been welcomed by public-health experts, it is not clear why the government waited until now to allow this. The process itself has been slow and marred by confusion, owing particularly to two notifications issued by the ICMR.
On 23 March, the ICMR issued a notification approving the kits of two companies for indigenous production, Altona Diagnostics, a German company and MyLab Discovery Solutions, a Pune-based company. Their kits—RealStar SARS-CoV-2- RT-PCR and Patho Detect MyLab, respectively—were found to have 100 percent concordance among true positives and true negatives, that is, the tests accurately represented whether the condition it was trying to detect was present or not. Kits from seven other companies were rejected because they did not generate 100 percent concordance.
The ICMR notification said that it had established a fast-track mechanism for validation of testing kits that were not certified by the United States’ Food and Drug Administration or the European Union’s CE—a certification mark indicating that a product meets the health standards in practice within the European Economic Area. In other words, kits manufactured by Indian companies now need only the certification of the National Institute of Virology, an ICMR institute in Pune.
This cleared some of the confusion created by an earlier notification issued by the health ministry on 21 March detailing guidelines for private labs and testing kits, which said that commercial kits should have FDA approval or have the European CE certification. This came when large parts of the country started going into lockdown. The chairman and managing director of a medical-technology company that has also developed a COVID-19 testing kit, which is awaiting approval, told me that the FDA-CE clause was discriminatory to Indian firms. The managing director agreed to speak to me on the condition that I do not identify him or the company. “Why would the US FDA certify Indian kits?” he asked. “It is stupid. The whole classification of private testing is discriminatory and the [medical] associations are reaching out to the Prime Minister’s office.”
The process until the second ICMR notification was that real time PCR testing kits—a polymerase chain-reaction test, which analyses small quantities of genetic material to enable detection—for COVID 19 were being procured by the NIV from the United States and distributed to testing laboratories around the country. As the guidelines for testing have now been relaxed by the ICMR, the country will need to ramp up production of testing kits.