Indian Women Develops Covid 19 Testing Kit in Pune, Maharashtra

India has a population of 1.3 billion, with only 118 Government Laboratories and estimated 50 private labs, which are not adequate during this pandemic. And this is why the Health Ministry will be identifying many more labs for testing of coronavirus.

In the meantime, the first made-in-India coronavirus testing kits reached the market, raising hopes of an increase in screening of patients with flu symptoms to confirm or rule out the Covid-19 infection. 

The Pune based My Lab became the first Indian firm to get full approval to make and sell testing kits. It shipped the first batch of 150 to diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru (Bangalore) this week. The molecular diagnostic company, which also makes testing kits for HIV and Hepatitis B and C, and other diseases, says it can supply up to 100,000 Covid-19 testing kits a week and can produce up ,to 200,000 if needed. 

Each My Lab kit can test 100 samples and costs 1,200 rupees that's about a quarter of the 4,500 rupees that India pays to import Covid-19 testing kits from abroad. 

"Our kit gives the diagnosis in two and a half hours while the imported testing kits take six-seven hours," says virologist Minal Dakhave Bhosale, My Lab's research and development chief. 

Ms Bhosale, who headed the team that designed the coronavirus testing kit called Patho Detect, said it was done "in record time" - six weeks instead of three or four months. 

And the scientist was battling with her own deadline too. Last week she gave birth to a baby girl - and only began work on the programme in February, just days after leaving hospital with a pregnancy complication. 

"It was an emergency, so I took this on as a challenge. I have to serve my nation," she says, adding that her team of 10 worked "very hard" to make the project a success. 

In the end, she submitted the kit for evaluation by the National Institute of Virology (NIV) in just mid of March, just a day before delivering her daughter. 

Dr Gautam Wankhede, Mylab's Director for Medical Affairs informed that "Our manufacturing unit... is working through the weekend and the next batch will be sent out on Monday”.

That same evening, just an hour before she was taken to hospital ahead of her Caesarean, she submitted the proposal to the Indian FDA and the drugs control authority CDSCO for commercial approval. 

"We were running against time," says Dr Wankhede. "Our reputation was at stake, we had to get everything right on the first go, and Minal was leading our efforts from the front." 

Before submitting the kits for evaluation, the team had to check and re-check all the parameters to ensure its results that were precise, and accurate. 

"If you carry out 10 tests on the same sample, all 10 results should be same," said Ms Bhosale. "And we achieved that. Our kit was perfect." 

The government-run Indian Council for Medical Research (ICMR), under which NIV operates, agreed. It said Mylab was the only Indian company to achieve 100 percent  results.