Indian Covid-19 test kit production scaled up to lower imports

India is currently testing 75,000-80,000 samples a day through the reverse transcriptase polymerase chain reaction (RT-PCR) test, the gold standard for confirming Covid-19 cases , and has set itself a target of testing at least 100000 samples per day by the end of May.

Pune-based Mylab Discovery Solutions has increased its manufacturing capacity from 20,000 coronavirus disease (Covid-19) tests a day in early April to 200,000 tests now, after tying up with Serum Institute of India (SII) Ltd, ensuring that just one domestic manufacturer can meet India’s current testing needs, which are projected to cross 100,000 by the end of the month.

A research scientist works on a testing kit for the coronavirus disease inside a laboratory of GCC Biotech during the outbreak of the disease on the outskirts of Kolkata.(Reuters Photo)

Mylab was one of the first local companies to receive an approval for its test from the Central Drugs Standard Control Organisation (CDSCO), which has now approved six more local companies to supply diagnostic kits that meet the Indian Council of Medical Research’s benchmark.

India is currently testing 75,000-80,000 samples a day through the reverse transcriptase polymerase chain reaction (RT-PCR) test, the gold standard for confirming Covid-19 cases , and has set itself a target of testing at least 100000 samples per day by the end of May.

Thus far, Mylab Discovery Solutions has supplied 650,000 tests to 140 labs and hospitals in close to 20 states.

“It overwhelms me to see our efforts with Mylab in making India self-reliant in combating COVID-19 fructified. As our production capacity increases from 20,000 tests per day to 2 lakh COVID-19 tests per day, we will now be able to meet India’s growing demand for testing completely,” said Adar Poonawalla, chief executive officer, Serum Institute of India, which partnered with Mylab to help scale up production of the tests early last month. SII has also started work on the manufacturing of a vaccine currently undergoing clinical trials in the UK -- so as to be ready in case the vaccine gets approved.

With six more indigenous RT-PCR kit manufacturers , India may now be in a position to even export kits, say experts.

Mumbai-based Meril Diagnostics Pvt Ltd, one of the six, has begun production, and has 200,000 RT-PCR tests in stock.

“We currently have a stock of around 2 lakh tests ready, and the capacity to produce about 5 million tests per month. Our first priority will be to manufacture for India; once domestic needs are taken care of then will think of exporting kits,” said Anil Grover, business head, Meril Diagnostics, adding that the company isn’t thinking of exports for the next two to three months.

Delhi based Medsource Ozone Biomedicals Pvt. Ltd , another of the seven, is also working on scaling up capacity.

“Earlier we would create about 30,000 kits in a month-and- half, but we are now looking at scaling up to at least 50,000 test kits a week in the next three weeks,” said Prateek Mittal, director, marketing, Medsource Ozone Biomedicals Pvt Ltd.

There’s also a demand from states for the kits, especially with rapid testing kits that test blood for antibodies, and which can be used to measure disease prevalence and previous infections (as opposed to diagnosing current cases), not meeting the bar -- not just in India but even in the US.

“Not just the centre, many states are also showing interest in procuring kits from domestic manufacturers like us. Several states are placing orders with us. We are now equipped to handle bulk orders at short notice, and ready to even export testing kits, but our first preference will always be to fulfil domestic requirements,” said Hasmukh Rawal, managing director, Mylab.

While ICMR was directly procuring test kits previously, the sourcing has been assigned to HLL Infra Tech Services Limited (HITES), a fully owned subsidiary of the state-owned HLL Lifecare Ltd. (HLL).

Experts say it is high time India starts encouraging domestic manufacturers.

“We should encourage Indian manufacturers by protecting their investments and creating a market for them. India has the capability all we need is help in scaling up our capacity. This is the time to consolidate our resources and work like a single unit. It should be a consortium approach and not a competitive approach then we might even be able to export stuff,” says Dr T Jacob John, former head, department of virology, CMC Vellore.