In February, a small team of 24 people in the R&D division of Pune-based Mylab Discovery Solutions started working 24×7 to develop a kit to test for Sars-Cov-2, the virus that causes coronavirus disease (Covid-19), when it became obvious that no country would escape unscathed.
“We started work six weeks ago and worked in two shifts, with a focus on creating a product that didn’t miss diagnosis even when the viral load was low,” said Hasmukh Rawal, managing director, Mylab Discovery Solutions, which was the first Indian company to get the nod for manufacturing testing kits to test for Sars-Cov-2.
As for the requisite government approval, it came in a matter of days, he added.
The Covid-19 research consortium, under the department of biotechnology, announced it would fast-track research in early March. Since then, approvals for research, manufacturing and marketing of everything related to Covid-19, including vaccine candidates, have been approved in days.
On Friday, Bharat Biotech announced its plans to develop a unique intranasal vaccine for coronavirus called ‘CoroFlu’ in partnership with the University of Wisconsin–Madison and the vaccine manufacturer, FluGen.
“Anything related to Covid-19 is getting approved very quickly, “ said Krishna Ella, the founder of Bharat Biotech.
“An approval that would usually take three to four months is getting approved in less than 48 hours”.
In addition, the newly established Centre for Augmenting WAR with Covid-19 health crisis (CAWACH) has been given ₹56 crore to scout, evaluate and support innovations and start-ups that address Covid-19 challenges.
The urgency has charged researchers and innovators, some of whom are attempting to use existing platforms to address the Covid-19 challenge . The use of a pre-approved platform can cut cost, and, most importantly, time. Even better, it will not need fresh approvals.
“Many of these innovations were in the pipeline much before the pandemic; however, Covid-19 has forced them out of the labs and into production. The government is looking for start-ups that can scale up the production of their products and with a good manufacturing partner we will be able to do it,” said Professor Renu John from the biomedical engineering department of IIT Hyderabad. John is the faculty in-charge of the Center for Healthcare Entrepreneurship, which offers lab-to-market solutions.
“All state drug regulators have been issued directions that approvals should be given within three days, if all requirements are met. Anything related to Covid-19 must be cleared on a priority basis,” said a senior health ministry official, requesting anonymity.
As a result, the ecosystem is abuzz with activity.
Pharmaceutical major Zydus Cadila has already begun pre-clinical animal trials for two vaccine candidates, which act completely differently. “We got approvals within days. In another four to six weeks, we should have the results of the animal trials. Depending on the results of the pre-clinical trials, we will decide which to take forward and apply for approvals accordingly,” said Pankaj Patel, chairman, Zydus Cadila.
Through the week, and even on weekends, DST officials review discoveries and innovations. “We have been having meetings every day and have come up with strategies to prioritise our research work. The focus has been on developing improved diagnostic kits, looking for novel molecules or repurposed drugs for the treatment of the disease, and also developing a vaccine,” said Dr Renu Swarup, secretary, department of biotechnology.
The research group works under the guidance of the Science and Technology core group set up by K VijayRaghavan, principal scientific advisor to the government. His office has created a “S&T Core-team on Covid-19”, composed of experts who help define problems that need urgent and immediate solutions. They also work with academia and industry to help connect teams to solve these problems swiftly.
“The focus of the consortium is on better prevention of the disease by looking at vaccine development, better diagnostics, and therapy – both in terms of ancillary treatment needed and new molecules for treatment. Basically, the health care sector is currently focusing on how to deal with Covid-19 with what we have, our job is to look at what we should have and make it happen,” says Dr Anurag Agarwal, director, Institute of Genomics and Integrative Biology (IGIB).
Collaborations have resulted in the Defence Research and Development Organisation (DRDO) developing a biosuit to keep medical, paramedical and other personnel on the frontlines of the war against Covid-19 safe. “It has a special sealant as an alternative to seam sealing tape based on the sealant used in submarine applications. Presently, biosuits prepared using this glue for seam sealing by an industry partner has cleared test at Southern India Textile Research Association (Sitra), Coimbatore. DRDO can mass produce this glue through industry to support the seam sealing activity by suit manufacturers,” DRDO said in a statement.
The implementing agency of CAWACH is the Society for Innovation and Entrepreneurship (SINE), a DST-supported technology business incubator at IIT Bombay, long considered India’s equivalent of Stanford for its ability to link academia with industry.
SINE is working on boosting innovations in novel ventilators, respiratory aids, protective gears, solutions for sanitisers and disinfectants, diagnostics, therapeutics, and informatics. It will offer up to 50 potential start-ups financial assistance for innovations that can be brought to market within the next six months.
Meanwhile, in the background, the Indian Council of Medical Research is providing technical support by validating diagnostic kits for accuracy and specificity, having validated five of 20 kits for Covid-19 testing in two weeks.
Its apex virology laboratory at National Institute of Virology in Pune has cultured 11 virus strains of SARS-COV-2. “We got lucky that we managed to grow all 11 specimens. It will have long-term implication in vaccine and drug development,” a senior ICMR official said on condition of anonymity.
ICMR is also conducting a demonstration study to know the effect of anti-malaria drug, hydroxychloroquin, as a prophylactic medicine against Covid-19. “The anti HIV/AIDS drugs that had earlier shown promise fizzled out, hydroxychloroquin is turning out to be a better option. The medicine has shown promise in bringing down the viral load, now we are analysing if it can also prevent infection in high-risk groups, like health workers,” the official said.
Essentially, no avenue is being left unexplored. But research, for all the haste these agencies are displaying now, has its own pace. “ Unfortunately, science can’t move that fast, and it will take us about at least two-and-half months to three months to move from animal trials to human trials [with the vaccine],” says Bharat Biotech’s Ella.
“The drug controller is personally monitoring the situation and our team faced no problems when we approached them with the request. I must say the government is really proactive in ensuring the work doesn’t get hampered at any level” said Rawal.
