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To urgently develop safe and effective Biomedical solutions against SARS CoV-2, Department of Biotechnology and Biotechnology Industry Research Assistance Council (BIRAC) had invited applications for COVID-19 Research Consortium. In addition, BIRAC has also created a provision to fund COVID-19 solutions that are ready for immediate deployment under a ‘Fast Track Review Process’.

Under the research consortium, DBT and BIRAC have continuously been evaluating applications with an intent to support Industry/ Academia and Jointly Academia & Industry for developing Diagnostics, Vaccines, Novel Therapeutics, Repurposing of Drugs or any other intervention for control of COVID-19. Through a rolling multitiered review mechanism, 70 proposals of devices, diagnostics, vaccine candidates, therapeutics and other interventions have been recommended for receiving financial support. The shortlisted proposals includes 10 Vaccines candidates, 34 Diagnostics products or scale-up facilities, 10 Therapeutics options, 02 proposals on Drug Repurposing and 14 projects which are categorised as preventive interventions.

To be able to provide an accelerator approach for vaccine development, DBT has identified institutes which will provide animal models for testing pre-clinical efficacy and also make available neutralization assays. IIT Indore will produce Pseudovirus SARS CoV-2 which can be used for development of in-vitro assays. Enzene biosciences limited will make available Spike protein and Receptor Binding Domain protein in large quantities to vaccine and diagnostic companies as a reagent. The portfolio of vaccine candidates has further been enhanced by providing support for development of Next-generation mRNA vaccine candidate by Gennova and also separately to CMC, Vellore for a lipid encapsulated mRNA based vaccine.

Early development work for developing an Intranasal vaccine candidate for COVID-19 has also been awarded to Indian Institute of Chemical Technology.

University Delhi South Campus has initiated work towards discovering neutralizing antibodies from an existing phage display based library and are being supported under National Biopharma Mission of DBT.

To ensure complete indigenization of COVID diagnostics, support has already been provided to AMTZ and other companies to scale-up production of RT PCR kits. In addition anticipating long term need for diagnostics, DBT/ BIRAC have also committed support for different types of diagnostics platforms like: Fluorescence and Electrochemistry Mediated Rapid Detection of SARS-Cov-2 Nucleic Acid from Bennett University, Greater Noida;  portable microfluidics embedded on chip rRT-PCR and microelectrode array coupled point-of care optoelectronic device for large scale screening: JNU, Delhi; Development and evaluation of aptamer based lateral flow assay kit for detection of SARS-CoV2 detection to IIT Delhi and CRISPER based diagnosis of Covid-19 using paper microfluidics form  IIT Guwahati.  Other companies to get funding support are Denovo, Biolabs, ShineBiotech, Prantae, Proma Therapeutics, Achira. In total, 34 companies and academic institutes will receive financial support for ensuring there is no shortage of indigenous diagnostic kits in the near future.

Department of Biotechnology has also  launched a National Biomedical Resource Indigenization Consortium (NBRIC) in a Public Private Partnership model to foster indigenous innovation focused on developing reagents and resources for  diagnostics, vaccines and therapeutics for COVID19 which is in partnership with ABLE and CII and is being hosted by C-CAMP.

Under its ‘Fast Track Review Process’ Process BIRAC has created a provision to fund COVID solutions that are ready for immediate deployment. Through this initiative Startups with PPE solutions have been approved for supporting manufacturing of “Full body coverage suits”  to Aarna Biomedical Products and for “Face Shields” to Alpha Corpusles Pvt Ltd. Automoted Sanitizer  to  MicroGO, Remote patient monitoring Stasis Health Pvt Ltd. Turtle Shell for DOZEE a sleep monitoring device, Monitra for remote monitoring of patients, Perisodhana for N-95 Mask’s and Remidio for Ambu bags.

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Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test “COVID KAVACH ELISA” for antibody detection for COVID-19.

COVID19 pandemic has spread across 214 countries with a total of 38,55,788 confirmed cases and 2,65,862 deaths. Most countries in the world are struggling to contain the pandemic using possible interventions. There is an augmented demand of various types of diagnostic tests by countries all across the globe. Most of the diagnostic material for COVID19 is imported into India from other countries. Therefore, Indian scientists are tirelessly engaged in developing indigenous diagnostics for SARS-CoV-2, the causative agent of COVID19.

ICMR-National Institute of Virology (NIV), Pune is the apex laboratory of the country with state-of-art infrastructure and expertise for research in virology. NIV’s competent scientific team successfully isolated the SARS-CoV-2 virus from laboratory confirmed patients in India. This in turn has paved the way for development of indigenous diagnostics for SARS-CoV-2.

While real time RT-PCR is the frontline test for clinical diagnosis of SARS-CoV-2, robust antibody tests are critical for surveillance to understand the proportion of population exposed to infection.

The scientists at ICMR-NIV, Pune have enthusiastically worked to develop and validate the completely indigenous IgG ELISA test for antibody detection for SARS-CoV-2. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, the test will have the advantage of testing 90 samples together in a single run of 2.5 hours. Moreover, ELISA based testing is easily possible even at district level as the ELISA kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market.

Speaking on the occasion, Dr. Harsh Vardhan said, “The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of population exposed to SARS-CoV-2 Coronavirus infection.”

ICMR has partnered with Zydus Cadila for mass scale production of the ELISA test kits. After development at ICMR-NIV, Pune, technology has been transferred for mass scale production to Zydus Cadila, which is an innovation driven global healthcare company. Zydus has proactively taken up the challenge to expedite the approvals and commercial production of the ELISA test kits so that they can be made available for use at the earliest. The test is named as “COVID KAVACH ELISA”. This is a perfect example of “Make in India” in record time.

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Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL) have partnered to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR’s National Institute of Virology (NIV), Pune.

The strain has been successfully transferred from NIV to BBIL to work on vaccine development. ICMR-NIV will provide continuous support to BBIL for vaccine development.

ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine.

The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. ICMR’s research agenda align with the National health priorities.

These efforts are undertaken with a view to reduce the total burden of disease and to promote health and well-being of the population. ICMR promotes biomedical research in the country through intramural as well as extramural research.

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Zydus Cadila, a global innovation driven healthcare company, announced that it is launching Enzalutamide, a highly effective drug for the treatment of Prostate Cancer, under the brand name ‘Obnyx’ in India. In a step that can significantly reduce treatment cost by almost 70%, the drug is priced at Rs 5995 (weekly therapy) reducing the monthly treatment cost to less than Rs. 27000. The current MRP of Enzalutamide drug ranges from Rs. 70000 to Rs 80000 for a monthly therapy and can be a huge financial burden for the elderly patients as they need to continue the therapy for a long period of time. This price reduction will benefit many prostate cancer patients to adhere to the treatment.

One of the important aspects of prostate cancer treatment is reducing the effect of androgens (a male reproductive hormone) on prostate gland. Many patients require Androgen Receptor Targeted Therapies like Enzalutamide which works by blocking the effects of androgen to stop the growth and spread of prostate cancer cells. More importantly, it is a preferred option in patients with significant liver, heart and kidney diseases which is very common in the elderly men. Enzalutamide has an advantage of being taken through oral route. Zydus’ Obnyx scores over other formulations in the market as it is a soft gel capsule filled with liquid, similar to the innovator drug. This has been specially developed through in-house efforts. The other formulations available in the market are hard gelatin capsules.

Prostate cancer is one of the leading cancer in males in India and the risk increases with age. About 1 out of 9 men have risk of developing prostate cancer in lifetime. The incidence is nearly 60% in men over the age of 65 years. Other risk factors such as obesity, family history and improper diet have been identified as the main contributing factors towards an increased incidence of prostate cancer.

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