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How red tape, government delays have left biotech start-ups struggling to ramp up their war against COVID-19

Azmia Riaz

Perhaps science is the only thing that has not slowed down due to the Coronavirus lockdown. Research institutes and labs across the country have been working relentlessly to try and help contain the spread of the COVID-19 virus. However, a number of private start-ups, some of whom have been incubated at India's top institutes - at crucial points in finding solutions have hit massive roadblocks due to a number of issues.

SciDogma Research, a start-up based in Bengaluru received a rejected permit from the government just a day ago. The institute has attempting to develop a molecular COVID-19 diagnosis machine. CEO of the organisation Dr Satya Tapas says, “It will be necessary to have affordable, indigenous machines for quick diagnosis if we are headed towards community spread. And need more centres to do them."

The start-ups are well-connected and in most cases, able to help each other out. While the central government has paid a lot of attention to such centres, a full fledged action plan for their operations is yet to be formulated. Dr Satya says, “During the time of a crisis, the startup community also needs a lot of freedom to operate. One major challenge that we are facing is that we have some ideas and research already underway but we are struggling with permits. It would greatly help if the government could set up a special fast track process at this time to support startups to foster innovation. For example, all the labs at IISc have been closed. If the government can take the effort to involve such premium institutes where they have resources, it could help many of us.” 

Access to reliable information is another issue. Azooka Lifesciences is a start-up incubated under the IISc. Currently they are working to develop a PCR-based diagnostic kit. The development process has slowed down because they were unable to validate their test since they are in need of samples from patients who tested positive for the Coronavirus. Currently, licenses are issued only to accredited laboratories. Diagnostic kits have to be approved by the Indian Council of Medical Research or Central Drugs Standard Control Organisation.

“Right now, there is no proper source from where we can get samples and we don’t know whom to contact,” says Dr Alex Paul, co-founder of Azooka. “Currently, the information has been passed on only to government agencies. We could have started our work two weeks back. Institutions were not given access to the main positive controls based on which we can develop the diagnostic kits. We have the kits ready to detect any disease. You only need to add the positive controls for this particular disease and it will become specific for COVID-19.”

A number of start-ups have been struggling as they are unable to open their labs and their staff don't seem to be able to make it to work. Although they fall under the critical biotechnological services category, most scientists and researchers are chained to their home offices. Dr Alex explains, “We all want to open the labs but the protocol says that you cannot. So all of us are stuck in different places. Although we have a product, we are unable to go to a lab and continuously work on it. The curfew passes are working in a manner that we cannot figure out.”

In addition to this, they are also under a severe threat of running out of supplies. While suppliers the are running on 20 per cent staff, they have to give hazard pay to the employees which increases cost further. Azooka got in touch with Agni, the national initiative guided by the Principal Scientific Advisor to the Indian government. When Agni enquired how the cost of testing kits can be cut the start-up pointed out that the best solution would be to knock off GST for all chemical components that are used in creating the diagnostic kits. In this way, the actual value can be passed on to the people. However, all this falls under policy planning and will take a long time to be implemented. 

Utpal Tatu, a molecular biologist and a professor at the department of biochemistry at IISc has been working on this for the past 4 years and is capable of producing the kits in good quality and time. He agrees that the greatest challenge facing India’s COVID-19 fight are the prices of the tests. The professor says, “Private organisations have been working with the government to make diagnostic kits. The question is, can’t we make it more affordable? With the way things are going currently,  we are going to have to ramp up the screening. And at that juncture, it will need to be more affordable.”

He continues, “The lockdown has slowed things down. Science is trying to do what it can to help the govt and I hope they will consider taking help from the startups also. The key is going to be the most affordable solution so a large number of people can be screened. We are already working on this and think we can offer something that is not only accurate but also affordable so the government can do this on a large scale.”

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