In a major breakthrough, India has developed its first Wuhan Coronavirus testing kit that delivers result in just two and a half hours as compared to the imported testing kits which take six-seven hours to deliver the results. And moreover, the made-in-India kit will cost Rs 1,200, about a quarter of the Rs 4500 that India pays to import testing kits from abroad.
On Thursday, the first made-in-India coronavirus testing kits reached the markets. Mylab Discovery, in the western city of Pune, is the first Indian firm to get approval to make and sell testing kits for Wuhan Coronavirus. The first batch of 150 kits were shipped by the Mylab to other diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru (Bangalore) this week.
All this was made possible because of the relentless efforts of one virologist Minal Dakhave Bhosale, Mylab’s research and development chief, who delivered on a working test kit, just hours before delivering her baby girl.
Minal boasts 10 years of experience in the diagnostic field, primarily in the area of molecular diagnostics of infectious diseases, diagnostic product development and R&D management functions. Bhosale has the experience of working on the swine flu disease at NIV, Pune, during the 2009 outbreak.
Under Minal Dakhave Bhosale, the coronavirus testing kit called Patho Detect was developed in a record time of six weeks.
Bhosale began work on the programme in February, just days after leaving the hospital with pregnancy complications. “It was an emergency, so I took this on as a challenge. I had to serve my nation,” she said, adding that her team of 10 members worked very hard to make the project a success.
“We started the development process for Covid-19 six weeks ago on an emergency basis looking at the national crisis and need for an indigenous accurate solution for improved management. We have developed a unique formulation for test reagents that increases the catalytic activities of the enzymes, reducing the enzyme unit requirement, resulting in reduced cost”, said the Virologist.
“Our test aims to detect nucleic acid of the virus, based on RT PCR technology, which is very specific for virus detection. The developed test is based on WHO/CDC guidelines and covers specific targets of Covid-19/Sars-CoV-2 where we didn’t observe any mutations during the development process”, she said.
The kit was submitted for evaluation by the National Institute of Virology (NIV) on 18 March. In the evening, Bhosale submitted the proposal to the Indian FDA and the drugs control authority CDSCO for commercial approval. Within an hour of submitting the proposal for FDA approval, she got admitted to a hospital for a c-section and the very next day, Minal delivered her daughter.
The government-run Indian Council for Medical Research (ICMR), under which NIV operates, approved the testing kit, confirming that Mylab was the only Indian company to achieve 100 per cent results at that time.
Bhosale had to deal with many challenges during the development of the kit like the accurate design of the product, product validation for 100 per cent sensitivity and specificity in a short-time protocol run, but with her and the team’s dedication and perseverance, all of those were overcome.
“If you carry out 10 tests on the same sample, all 10 results should be the same, and we achieved that. Our kit was perfect,” said Bhosale.
In the times to come, Minal Dakhave Bhosale will be remembered for her dedication and contribution to the nation.
First made-in India Covid-19 testing kit:
The first made-in-India test kits hit the Indian markets on Thursday. Minal Bhosale confirmed in an interview with Hindustan Times: “Our kit gives the diagnosis in two and a half hours while the imported testing kits take six-seven hours.”
Mylab Discovery Solutions, the molecular diagnostic company, had received statutory approvals late on Monday from authorities. The firm can manufacture over 15,000 testing kits per day from its facility at Lonavala in Pune district and the same will be boosted to 25,000 kits per day.
Mylab shipped the first batch of 150 to diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru (Bangalore) this week. “Our manufacturing unit is working through the weekend and the next batch will be sent out on Monday,” said Dr Gautam Wankhede, the Mylab’s director for medical affairs.
The firm, 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.
In the past few days, India has scaled up testing. Initially, only the state labs were allowed to test for coronavirus, but permission has now been extended to several private labs too.