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A COVID-19 diagnostic test kit developed by the Indian Institute of Technology (IIT) in New Delhi is the latest to join a growing pool of low-cost kits domestically developed in a country where the number of cases topped 2 million in August and continues to rise.

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 IIT kit called Corosure, announced in July by India’s human resource development minister Ramesh Pokhriyal, is an RT-PCR test kit. At a cost of ₹399 (US$5.30), it is the cheapest so far in India. The kit is currently being manufactured by Delhi, India-based Newtech Medical Devices but other companies have received a license from IIT.

According to the analytics firm Global Data, the IIIT kit could expand the testing criteria.

“Corosure proves that India can produce quality devices at an affordable price,” said Global Data analyst Rohit Anand. “This also indicates academic institutes such as IITs are capable of producing affordable and reliable devices through innovative research.”

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, India-based Mylab Discovery Solutions Pvt. Ltd. reported in July that its ‘Pathocatch’ COVID-19 antigen rapid testing kit has received commercial approval, making it the first Indian firm to get the nod for the rapid antigen-based test kits. The kits cost around ₹450.

India has so far approved only three antigen-based test kits, which include the Mylab kit, and 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.

Mylab was the first Indian company to receive the nod for its RT-PCR test kit at the end of March. 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 ₹1000.

Following approval of a second kit from his company, Mylab managing director Hasmukh Rawal said in July that “with the approval for an antigen testing kit, we will cover whole spectrum of COVID-19 testing and leave no stone unturned to fight this pandemic.”

In early April, ICMR approved a RT-PCR test kit developed by Bhopal-based 3B Blackbio Biotech Ltd., a subsidiary of Kilpest India Ltd.

“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.

As of the end of July, there were 18 RT-PCR test kits developed in India including those from Mylab and Kilpest compared to 104 international kits approved for use in confirmatory tests.

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, according to Global Data.

“The Indian government should incentivize domestic manufacturers to produce low cost indigenously developed test kits,” said Anand. “This will help manufacturers to clear unsold inventory and will inspire them to continue to produce COVID-19 care devices. However, the government may likely impose quantitative restrictions on exports to keep a control over the stocks.”

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 favor importers and may unintentionally discourage domestic manufacture.

The Indian industry has growing rapidly over the last decade, at between 15% to 20% per year. That growth rate has now dropped to between 10%-15% and the share of the domestic industry is declining. This does not sit well with Aimed’s Forum Coordinator Rajiv Nath.

“The domestic industry growth should exceed 20% to 25%,” Nath said. – Bioworld

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