Pune-based molecular diagnostics company Mylab Discovery Solutions on Monday became the first Indian firm to receive commercial approval from the Central Drugs Standard Control Organisation (CDSCO) for its non US FDA EUA/CE COVID-19 test kit.
The six-year-old company is also India’s first FDA-approved molecular diagnostics company for RT-PCR-based kits for testing HIV, Hepatitis B and C.
Speaking to HuffPost India, Dr Gautam Wankhede, Director of Medical Affairs at Mylab, spoke about thhe company’s plan to manufacture over 15,000 test kits per day and also the tough challenge of providing the test kits at nearly one -third of the current price cap of Rs 4,500 per test.
You are the only Indian company to have got approval to manufacture non USFDA EUA/CE COVID-19 test kits in India. How will you meet the high rising demands of test kits in India?
Earlier, we could not manufacture the COVID test kits in India as we did not have the licence. After getting the approval on Monday, we are aiming to manufacture over 15000 kits a day so that over 1 lakh people can be tested in a week.
In a time when global demand for the COVID 19 test kits is high and is rising further, how long can you sustain the demand for the test kits? Do you have enough stock of the raw material in case the virus spread at the community level?
Due to the delay in getting the approval, we could not manufacture test kits in advance. But we did have a stock to last for at least two months and are hopeful that the government will surely take measures to maintain the supply of test kits components from the market. While most of the components are made in India, two of the components have to be procured from the international market.
Have you fixed the price of the test kits? Do you think you will be able to provide it under the current price cap of Rs 4,500 per test?
So far, we are aiming to provide the test kits at nearly one third of the current price cap but again a lot of challenges will come to the fore once we begin to supply the test kits. Like, in case of supplying test kits in remote or far flung areas at a time when there is a suspension of the transportation system in the country and also the quantity of order placed by the respective testing labs.
There was a lot of controversy over the U-turn taken by the government to initially allow the non USFDA approved test kits but later restricting the supply to only the USFDA approved test kits. Now again, it has changed its policy over night and included the non-USFDA companies like yours. What can be the reason behind this flip flop?
Initially, the government granted evaluation licence to some Indian companies already into the field of molecular diagnosis to manufacture COVID -19 testing kits and getting them approved from the Central Drugs Standard Control Organisation (CDSO).
However, taking precautionary measures during the Corona pandemic, the government changed the eligibility criteria and asked the companies having USFDA approval kits to supply directly to the ICMR approved labs.
The government however asked companies like us to undergo the evaluation process. Since it was quite cumbersome and may have taken months,the government finally allowed the use of non-US FDA approved kits as well after passing it through stringent checks.
We as an Indian company welcomes this step as with our expertise in the field of molecular diagnostics, we will be able to bring down the testing cost by almost one third without compromising on the quality.
Tell us more about ‘Patho Detect’ COVID-19 developed by your company and also how efficient it is in detecting the coronavirus?
The kits will eliminate the requirement of two tests — screening and confirmatory testing as both the processes are happening at the same time. Due to this, it delivers results within two-and-a-half hours of loading the samples on the machine. Our product has the unique capability of detecting the infection at an early stage since the test is based on the sensitive Polymerase Chain Reaction (PCR) technology. We are expecting to touch our production to test 15000 people on a single day and is expected to scale up the production according to the demand in the market.