This marks initiation of efforts at the government level to search for a coronavirus vaccine. In a letter to secretaries who have been asked to inform the concerned research institutes, the office of the Principal Scientific Advisor, K VijayRaghavan, has asked research institutions which have received clearances from ICMR as Covid-19 testing sites and wish to use samples for R&D, to inform the VTF, delineating the specific research intended to be undertaken.
“The joint committee (of VTF and an Empowered Technology Group set up by PMO) will examine each request where the R&D objectives and protocols are clearly presented and defined. Field applications and deployment of R&D results will need necessary subsequent approvals following due process,” the letter dated April 22, which ET accessed, has mentioned.
The Empowered Group (EWG) No.1 on ‘Medical Emergency Management Plan’, headed by NITI Aayog member VK Paul has framed guidelines which have been circulated with the letter. “The guidelines for sharing of bio-specimen and data for research related to Covid-19 framed by the EWG should be followed and the stipulated timelines for sharing or providing bio-specimen should be adhered to. This will allow those who host specimen/samples to speedily and correctly share bio-specimen for research collaboration,” the letter has added.
The VTF set up earlier in April is co-chaired by Paul and VijayRaghavan and met on April 16 and April 20 to approve the decisions.
The framework would enable sharing of such material among all national and public research institutions, healthcare facilities and those private entities collaborating with the government on Covid-19.
“Scientists and researchers across the globe are working towards the development of rapid diagnostic methods, prophylactics, therapeutics and for detection, prevention, treatment and management of Covid-19 infections. It is imperative to ensure that biological samples and data are appropriately managed. The government is committed to providing an enabling research ecosystem in the country to develop tests, diagnostics, drugs, therapeutics and vaccines for Covid-19. To address this, there is an urgent need for having a sharing mechanism for bio-specimen and data between researchers and different institutions during an unprecedented public health emergency of Covid-19,” the guidelines have mentioned.
The guidelines have been aligned with the existing international framework of Biological Weapons Convention to which India is a signatory and are consistent with frameworks related to conduct of scientific research, clinical trials, medical practice and data privacy.
“It will be obligatory upon every custodian of bio-specimens (the bio-repositories and hospital) to share the bio-specimen as per the procedure and timeline prescribed in these guidelines. Delays, if any, will be liable for appropriate action and necessary accountability will have to be fixed for the same,” the guidelines say. They stipulate that the transit of bio-specimen samples including labelling, packaging, shipment or transport shall be as prescribed by ICMR.
“Sharing of collected bio-specimens and associated data can be vital for addressing the pandemic of Covid-19, as progress in science & technology and subsequent medical research for development of products is driven by such biological samples. Therefore, rapid and timely dissemination of biospecimen and sharing of associated data must be simple and transparent, without compromising the research interests of the sample providers and confidentiality of the study participants,” the guidelines say.
