For the mitigation of COVID-19 pandemic, R&D efforts are directed at the development of vaccines, diagnostics and therapeutics. The specimens collected from COVID-19 positive subjects can be a valuable resource for the R&D efforts. NITI Aayog has recently issued guidelines for sharing of bio specimens and data for research related to COVID-19. As per the directives of the Cabinet Secretary, the Indian Council of Medical Research (ICMR) has notified 16 bio-repositories for collecting, storing and maintaining clinical samples (oropharyngeal/ nasopharyngeal swabs, broncheoalveolar lavage, sputum, blood, urine and stool) of COVID-19 patients.
The enlistment of 16 Bio Repositories are as follows: ICMR – 9, DBT – 4 and CSIR – 3. The four Bio Repositories under the purview of the Department of Biotechnology are, NCR-Biotech Science Cluster (i) THSTI, Faridabad – Clinical samples (ii) RCB Faridabad –Viral samples, Institute of Life Sciences, Bhubaneswar, InStem, Bangalore and ILBS, New Delhi .Oropharyngeal / nasopharyngeal swabs, bronchoalveolar lavage, sputum, blood, urine and stool of COVID19 patients will be collected and archived for future use to develop validated diagnostics, therapeutics, vaccines etc.
These designated facilities will develop uniform Standard Operating Procedures (SoPs) for sample collection, transportation, aliquoting, storage, and sharing. The role of bio-banks for COVID-19 samples would be development of a vaccine and treatments; guidance regarding handling, including nasopharyngeal swabs; and conditions under which the higher BSL-3 practices should be followed for example, when working with cultures of the coronavirus specimens. The Department of Biotechnology would be supporting these COVID-19 designated Bio-bank facilities through a well strategized future plan so that novel technological interventions can be developed in due course of time. These designated bio repositories will use the clinical samples for R&D purpose in their respective Institutes.
In addition, they are also authorized to share the samples with academia, industry and commercial entities involved in development of diagnostics, therapeutics, vaccines etc., after scrutinising the purpose of the request and ensuring benefit to the country. Sharing of Biospecimens both Clinical and Viral is going to be key for new technology and product development by our researchers, start-ups and industry, a critical step in our journey towards becoming an Atmanirbhar Bharat.
A Rapid Response Regulatory enabling mechanism facilitated by Department of Biotechnology for COVID 19
The Department of Biotechnology has taken several proactive measures to streamline the biosafety regulation and to facilitate researchers and industries which are undertaking research and development in Recombinant DNA Technology and Hazardous Microorganisms.
1. Operationalization of Indian Biosafety Knowledge Portal. The Indian Knowledge Biosafety Portal launched in May, 2019 was made fully operationalized and now the Department is receiving all new applications through online portal only. This has made the whole process transparent and time bound.
2. Notification of Revised Simplified Guidelines on Import, Export and Exchange of GE Organisms and Product Thereof for R&D Purpose: The Department issued the Revised Guidelines in January, 2020 in which Institutional Biosafety Committee have been delegated authority to take decisions on applications of import export and exchange of GE organisms and product thereof for R&D purpose for RG1 and RG2 items.
3. Facilitation of Research and Development on COVID-19: Considering the emerging situations of spread of Coronavirus and with the understanding on requirement of rapid research and development for COVI-19, the Department has proactively taken several steps to facilitate researchers and industries involved in research on COVID19. DBT has issued following guidelines, orders and checklist on COVID 19:
- Rapid Response Regulatory Framework for COVID-19 to deal with application for development of vaccines, diagnostics, prophylactics and therapeutics has been notified on 20.03.2020
- DBT notified “Interim Guidance Document on Laboratory Biosafety to Handle COVID-19 Specimens” on 08.04.2020.
- IBSCs are allowed to conduct their meeting through video conferencing up to 30thJune, 2020.
- Rapid response regulatory framework for development of recombinant DNA COVID 19 vaccine was issued on 26.05.2020
Scaling up of COVID testing centres (Hub and spoke model) inNationalresearch laboratories and Universities
To scale up testing and enhance the reach across the countryCity /Regional clusters have been established in a Hub and Spoke Model to scale-up testing of COVID-19 samples in government institutions across the country. Institutes and Laboratories which have the capacity and expertise for both sample collection, handling/processing (BSL-2 facility) and testing (RT-PCR) serve as the hubs and they involve a number of laboratories which have RT PCR machines and the requisite manpower as their extended Testing facilities.
The Hubs are Government laboratories approved by respective Ministries /Departments (DBT, DST, CSIR, DAE, DRDO, ICAR etc) as per ICMR guidelines. So far 19 City /Regional clusters have been established in Bangalore, Delhi/NCR, Hyderabad, Thiruvananthapuram, Chandigarh/Mohali, Bhubaneshwar, Nagpur, Pune, Mumbai, Lucknow, Chennai, Kolkata, North Eastern Region, Jammu & Kashmir, Ahmedabad, Madhya Pradesh, Rajasthan, Banaras, Palampur and Delhi city.
About 100 institutions have been involved and over 1,60,000 samples tested. Seven DBT Autonomous institutes have been approved as hubs by ICMR and they are performing testing for diagnosis of COVID-19 (RGCB, THSTI, ILS, inStem, NCCS, CDFD, NIBMG).
They are also functioning as hubs in the respective Cities/Regions and coordinating the efforts with a number of other premier Central and State Government institutions. In addition, they are working closely with the respective State Governments in obtaining samples for testing and are reporting every day to ICMR on their testing results. Collectively in about 4 weeks, these clusters have done nearly 1,70,000 tests. These clusters will now be scaled to nearly 50 in next 4 weeks and reach remote corners of the country.