New Delhi: There has been a continuous increase in the number of people testing positive for COVID-19 in India due to which a 21-day nationwide lockdown has been imposed. However, health experts hold that the number being cited is quite low on account of India’s insufficient rate of testing in comparison with other countries, whereas the World Health Organisation (WHO) has stated that the only way of getting to know the actual spread of the pandemic is by conducting as many tests as possible.
In light of this fact, the Indian Council of Medical Research (ICMR) has set up a fast track mechanism for validating non-US FDA EUA/CE IVD approved test kits as well as the private labs that will be allowed to conduct those diagnostic tests.
At present the ICMR has validated three test kits, all by private entities, including one by an Indian company, Mylab Discovery Solutions Pvt Ltd. The other two companies are Altona Diagnostics (Germany) and Seegene (South Korea). While Mylab has already started producing and supplying its kit, Altona Diagnostics has indicated that it will take some time to do so. As for Seegene, its kit was okayed only on March 24.
On March 26, Mylab, a Pune based molecular diagnostic company, became the first Indian company to dispatch its very first batch of COVID-19 diagnostic test kits. Speaking to The Wire, its public relations officer, Deepak Kumar, said the company has a production and supply capacity of 15,000 kits a day.
Kumar emphasised one thing: “We will not keep any stock with us. We will supply as much as we produce daily. We sent off our first batch of COVID-19 test kit today. We are making the kit available for a very reasonable price.” He disclosed that the price was much lower than what the ICMR had set: “Our kits range from about one-third to one-fourth of the threshold amount of Rs 4,500 finalised by the ICMR.”
As to the all-important question of how the company will supply the kits in the time of lockdown, Kumar stated, “Under the circumstances it is a big challenge. Much will depend on the regularity of the air services the courier company DTDC is able to provide.” He explained that a total of a hundred tests can be done by one COVID-19 test kit. As to exactly how many labs have put in an order for the supply of the kits, he was not able to give a clear answer.
The German company, Altona Diagnostics has stated that as their kits are not being produced in India – they have to be brought from Germany – it could take them a little more time to start their supply schedule. The general manager of its Indian subsidiary, Tarun Jain, told The Wire, “We have secured a licence from the Drug Controller General of India (DCGI) to import the kits from Germany. We are all set to commence now.”
Providing a background of the company Jain said, “Ours is a 26-year-old enterprise. During the SARS outbreak in 2002 we were the first company to have made a diagnostic kit to test the disease. Similarly, we were the first to come up with a test kit for Ebola, in 2014, and the Zika virus (2016). The COVID-19 test kit is ready for use in Germany. Because of the scale of the pandemic, we are not able to keep up with the requirements.”
While Jain was unable to give a clear answer as to how many kits the company would be able to provide and at what price, he mentioned that they had managed to import some kits which were sent on to the National Institute of Virology (NIV). Pointing out that importing the test kits at a time of lockdown in countries across the world could pose some problems, he said his company was exploring all possible ways to ensure a prompt supply of the much-needed kits: “We hope to commence our supply by the end of next week.”
Further, Jain added that his company had not only informed the ICMR about the difficulties they were facing in their attempt to procure supplies of the kit but also kept their distribution partners abreast of the issues they were facing – “even labs are facing the same problem for they are unable to send samples across.” He said the ICMR had stated it would find a way out.
In matters of regulation, coordination and promotion of biomedical research, ICMR is the highest body in the country. Until now only US FDA EUA/CE IVD approved kits had been validated for commercial use. Now the apex body has started according recognition to COVID-19 diagnostic test kits validated by one of its institutes, the National Institute of Virology, as well.
ICMR scientist, Dr. Lokesh Sharma, explained the process to The Wire: “It is the NIV which initially validates kits produced by companies. Then the company has to seek the approval of the Central Drugs Standard Control Organisation (CDSCO) for their commercial use by diagnostic labs.
So far 14 applicants have submitted their COVID-19 diagnostic test kits to the ICMR for evaluation. One of them happens to be IIT DELHI.
Translated from the Hindi original by Chitra Padmanabhan.