By Raju Vernekar
New Delhi, Sept. 3:
The Indian Institute of Technology (IIT), New Delhi joined the pool of domestic manufacturers engaged in manufacture of low-cost kits, even as India’s COVID-29 cases surged up to two million on Wednesday.
The IIT kit titled “Corosure”, announced in July by Union Human Resource Development Minister Ramesh Pokhriyal, is an RT-PCR test kit, priced at Rs. 399 and is considered the cheapest so far in India. The kit is currently being manufactured by Delhi based “Newtech Medical Devices”. Other companies have also received a license from IIT.
The launch of “Corosure” follows approval by the Indian Council of Medical Research (ICMR) of other home-made diagnostic kits in June and July. Pune, based “Mylab Discovery Solutions Pvt. Ltd” had reported in July that its ‘Pathocatch’, COVID-19 antigen rapid testing kit had received commercial approval, making it the first Indian firm to get the nod for the rapid antigen-based test kits costing around Rs.450. The turnaround time for Mylab’s test kits are two and half hours, compared to seven hours by most current protocols. The tests are priced at Rs.1000/-.
There are 18 RT-PCR test kits developed in India including those from Mylab and Bhopal-based 3B Blackbio Biotech Ltd.(a subsidiary of Kilpest India Ltd), compared to 104 international kits approved for use in confirmatory tests. “Looking at the current situation and what we know from our industry, there is a huge challenge on availability and cost of foreign products to the Government of India to screen so many suspected individuals,” Blackbio’s commercial head Prateek Goel said.
The imported kits include: two imported rapid antigen assays from South Korea’s “SD Biosensor Inc”. and Belgium’s “Coris Bioconcept”.
Since India went into a lockdown at the end of March, domestic med-tech companies have been scrambling to develop indigenous test kits. The push to develop test kits domestically is part of a national effort to shake off a heavy dependence on imports of medical devices, including diagnostic kits.
The bulk of COVID-19 testing in India – perhaps more than three quarters of all tests – is done using a laboratory method called reverse transcription polymerase chain reaction (RT-PCR) to make thousands of copies of a genetic sequence for testing. About a quarter of tests are rapid antigen-based tests, according to ICMR director general Balram Bhargava.
The Indian medical devices market, which accounted for more than 13% of the Asia-Pacific medical devices market in 2019, is expected to grow at a compound annual growth rate (CAGR) of 7.5% through 2025.
The Association of Indian Medical Device Industry (AIMED) has been calling on the Indian government to overhaul the country’s structure of regulations and tariffs, both of which heavily favour importers and may unintentionally discourage domestic manufacture.
The Indian industry has growing rapidly over the last decade, at between 15% to 20% per year. However that growth rate has now dropped to 10%-15% and the share of the domestic industry is declining. This does not sit well with AIMED, which expects the growth of 20 to 25 per cent, AIMED Forum Coordinator Rajiv Nath said.
