Role of CSIR
CSIR vigorously and strategically pursued COVID-19 on multiple fronts. Be it testing, diagnostic development, designing personal protection equipment, innovating hospital assistive devices, repurposing drugs and so on, CSIR lead from the front and also joined forces with other organizations including industries, PSUs and MSMEs with the singular overall objective of mitigating the impact of COVID-19.
CSIR is perhaps the only scientific organization to mount multi-pronged scientific, technological and innovative approaches for developing COVID-19 specific processes, tools and technologies. So much so, CSIR developed over 100 COVID-19 technologies in nearly as many days. Many of the technologies have been transferred to industry partners. CSIR has also been involved in SARS-CoV-2 genome sequencing, carrying out research on SARS-CoV-2 and also conducting large scale cohort studies.
Till date, there is no medicine for COVID-19. There is no vaccine available, as well. Drug and vaccine developments are long drawn systematic and time-consuming process, many times, even taking close to a decade or more to develop an active curative molecule.
Hence, efforts are on globally to fast track and test the drugs approved or tested for non-coronavirus diseases such as HIV or Ebola (called as repurposing).
CSIR has also been actively engaged in enabling quick access to drugs against coronavirus for Indian patients as soon as they are developed in India or globally. CSIR is exploring all possible options ranging from repurposed drugs to new drugs to phyto-pharmaceuticals and AYUSH products and biological therapeutics including vaccines.
Of the drugs/drug candidates shortlisted, CSIR has prioritized drugs for establishing optimal synthetic processes for those drugs for which there is a higher potential of them getting approved and which are not commercially available in India. Developing the synthetic process of these top drugs/drug candidates will enhance the chances of the drugs getting introduced in India by an Industry, once favorable outcomes are obtained in clinical trials. Many CSIR labs across India such as CSIR-IICT, CSIR-CDRI, CSIR-NCL, CSIR-IICB, CSIR-IIIM, CSIR-NIIST, CSIR-NEIST, and others are involved in this strategy.
Key Drugs Repurposed for Covid-19
- Remdesivir: The drug developed by Gilead for Ebola received FDA approval for emergency use for COVID-19 patients. Subsequently, Indian regulator gave approval for emergency use. Gilead has given voluntary licenses to many Indian Pharma companies and cost effective synthetic process has been developed by CSIR. Lab scale synthesis has been achieved and intermediates on Kg scale has also been accomplished. CSIR has transferred the technology to many pharma companies who have launched the drug in the market.
- Favipiravir: Favipiravir a generic drugs originally used in Japan to treat new strains of influenza has received emergency use authorization by FDA and in India for the mild to moderate Covid19 patients. CSIR-IICT has developed a synthetic process using locally available ingredients and transferred the technology to Cipla. The technology provided by CSIR-IICT is very efficient and makes it affordable and allows Cipla to make large quantities of the product within a short period. Cipla has scaled up the process in their manufacturing facility and launched the drug as Ciplenza, which was about 30% cheaper than the drugs available in the market at the time of launch.
Clinical Trial Pipeline:
Biological Therapeutics and Vaccines:
Antibodies and Serology Approach: CSIR through its NMITLI program has approved a project for the development of human monoclonal antibodies (hmAbs) that can neutralize SARS-CoV-2 in patients. A multi-institutional and multi-disciplinary team comprising NCCS, IIT-Indore, PredOmix Technologies, and Bharat Biotech International would implement the project. The project aims to generate hmAbs to SARS-CoV-2 from the convalescent phase of COVID-19 patients and select high affinity and neutralizing antibodies. The project also aims to anticipate future adaptation of the virus and generate hmAbs clones that can neutralize the mutated virus and could be readily available for combating future SARS-CoV infections.
- CSIR-CCMB has entered into MoU with the University of Hyderabad and VinsBioproducts Ltd to enable the development of antisera against SARS-CoV-using inactivated virus in horses, which is amenable for large-scale production.
- CSIR-CCMB has begun an industry collaboration under CSIR NMITLI program to produce COVID-19 vaccine using inactivated virus with Bharat Biotech
- Further, CSIR-CCMB, CSIR-IMTECH and CSIR-IICB are working with Aurbindo Pharma for developing vaccines using different platforms.
In silico screening of FDA approved drugs against validated targets:
New Drug Discovery and Development:
Further, CSIR labs have set up Corona Viral Cultures and Cell lines for Screening Assays and Testing at CSIR-CCMB and CSIR-IMTECH as to take forward new drug discovery, a critical step is the establishment of viral cultures and assays for testing. Various drug target based assays for screening of in-silico predicted compounds are being set up at CSIR-CDRI and other CSIR labs.
CSIR is also co-organizing the Drug Discovery Hackathaon DDH2020 which is a joint initiative of AICTE, CSIR and supported by Office of Principal Scientific Advisor, Govt. of India, NIC and MyGov. DDH2020 vision and mission is to establish ‘Open innovation Model’ for in silico drug discovery against Covid-19 virus and will cover the various processes in drug discovery, including but not limited to, in silico screening of molecules, lead optimization and identification of drug-able non-toxic targets. The targets/tools/lead molecules identified through the process of DDH2020 will be further taken forward for synthesis followed by subsequent steps in routine drug discovery program.