Sat. Oct 24th, 2020

India didn’t have a single IVD kit for Covid detection till 19 March: DCGI


Over 250 IVD kits are available today and half of which are from indigenous sources

While India did not have even a single in vitro diagnostic (IVD) kit available till 19 March for detection of Covid-19, today there are over 250 kits available in all the categories and half of them are from indigenous sources, said Dr V.G. Somani, Drugs Controller General of India (DCGI) in an ASSOCHAM World Health e-Expo.


“The Indian Council of Medical Research (ICMR) took the challenge to assess and validate these kits and ancillaries while the Department of Biotechnology (DBT) took the challenge to promote them and we took the challenge of assessing, regulating, inspecting and also licensing these kits so that not only in India but it gets recognised in the entire world,” said Dr Somani sharing his views on the theme ‘Aatmnirbharta: Will it be the panacea of the pandemic?’.


He informed that even in case of therapeutics, small molecule drugs, biologicals, vaccines the DCGI office worked day and night to see that it is made available to the public through indigenisation while not compromising on safety and quality of product and system.


He also informed that 163 clinical trials have been approved with the subject experts coming thrice to evaluate in these three months’ times which is equivalent to one year’s work. These included – phytopharmaceuticals, diagnostics, convalescent plasma, monoclonal antibodies, antibodies, vaccines, stem therapeutics products, cell or cell-based products all such things are being assessed and people are being encouraged.


“These three months have given us more confidence that we can really become aatmnirbhar, we have so much of capability and capacity to work through our IT systems, interactions, awareness programs and many organisations,” added Dr Somani.


He said that it was very rare that academic institutions like IITs (Indian Institute of Technology) develop the products and those see the market but with help of DBT, ICMR and regulatory interventions, the products from IITs are seeing the market, something very heartening.


“This is the beginning and if it extends then probably the industry-academia, as well as the regulatory-academia, market-academia dynamics and interactions will lead us to aatmnirbharta and we are committed to doing that,” further said the DCGI.


He also informed, “We have started e-PRO offices all over the country, we have given special training to our people on how to become more proactive during pandemic, hand-holding, going to stakeholders from places to places so that they become encouraged and they work together with you as a partner in the growth story as a facilitator and not just as a regulator.”


Noting that there is a long way to go, he said that lessons from the pandemic should become a new normal. “All the meetings, evaluations, pre-consultations should and they are already happening on the online platform and they have given a very good flavour to the entire working and public confidence has also increased.”


He also lamented that India imports even small raw materials like calibrators, standards, panels worth thousands of dollars as such industry should work in coordination with all stakeholders to help the country become self-reliant in a mission mode in the diagnostics sector.

The DCGI also stated, “We are certain the solutions for this problem (Covid-19) will come from India and all the dynamics will change.

Amid others who addressed the ASSOCHAM e-Expo included: Dr Alka Sharma, scientist ‘G’ and advisor, DBT; Dr Jitendra Sharma, CEO, AMTZ; Dr Reba Chhabra, director in-charge, National Institute of Biologicals; Sonia Gandhi, chief manager-investments, Biotechnology Industry Research Assistance Council; Hasmukh Rawal, MD, My Lab Discovery Solution; D.G. Tripathi, founder-director, Tulip Diagnostics and Mr Abhinav Thakur, secretary, ADMI.

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