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Gireesh Babu, New Delhi November 23 , 2021
NITI Aayog, the public policy think tank of the Government of India, is working on a research-linked incentive scheme, which would incentivise the risk-taking for discovery and translation of drug research in the country, said Dr Vinod K Paul, member, NITI Aayog. It is also keen to create capacity in the area of clinical research, clinical trials in particular, among the experts from the Ayush background to create high quality studies in the sector.

It may be noted that the research oriented medicine industry in the country has been seeking the government to bring in a research-linked incentive scheme, in line with the production linked incentive (PLI) Scheme the government has launched for the manufacturing industry.

“At NITI Aayog, we are working on a research-linked incentive scheme, which would incentivise risk-taking for discovery and translation of new drugs, biologics, vaccines and other moonshot area,” said Dr Paul speaking to the industry in the two-day first Global Innovation Summit - 2021, organised by Indian Pharmaceutical Alliance.

“In the moonshot areas, where risk is very important, we would like to propose to support by the way of weighted tax deductions, using the production linked incentive paradigm. We are going to look at multiple pathways to support research and development and of course, manufacturing by way of the PLI scheme, mega parks etc.”

Kiran Mazumdar-Shaw, executive chairperson, Biocon Limited, has recently requested that the government should provide R&D support in the form of research linked incentive scheme in areas such as biosimilars and biologics

“The research and development in this field requires huge investments and such a scheme would help the industry to grow stronger,” she said. It could help the industry in increasing its investments into innovation and R&D.

Paul, in the IP Alliance event, said that efforts have to be made to prepare high quality clinical researchers in the domain of Ayurveda and Ayush systems. The clinical, epidemiological and biomedical studies have rules that need to be followed to gain global acceptance and the challenge in attaining this in the Ayush systems is building the capacity to conduct high quality studies, to design such studies, ample sample sizes, measurement, high quality analysis, high quality avoidance of a plethora of biases which colours the results of these studies.

“NITI Aayog would be very keen to create capacity in the area of clinical research, clinical trials in particular, among the experts from the Ayush background. We can work together, that when they conduct studies, the studies should be fully funded, they should be of the sample sizes that make the difference that are decisive, and there is a rigour of the highest kind and level for these studies, as also for every other R&D work that industry would do,” he added.

The Indian pharma industry has been too cozy as an industry in not taking risks. The future requires industry to turn in the right direction by way of being discoverers of solutions, drugs and medicines and biotechnologies. Indian industry shall be ready to take risks.

“I have been told that the failure rate is 90 per cent in such journeys, particularly pharmaceuticals. Therefore, that level of failure has to be accepted truly as a success in a larger context. That is the first very important imperative.  The second imperative is that as we move in the direction of discovery, research and early development pathways, we will have to be methodologically very rigorous. Not only in the laboratory and early clinical stage developments, which is one area, but also beyond that, in the clinical studies,” he added.

Some of the drugs that were trailed during the Covid-19 phase, were so poorly supported by sample size. They were sub-sized files. Whether they worked or not is not important, but some of these drugs we had in the country undergoing trials were so poorly conducted. The results and the pathologies were really below par.

At the same time, India has seen vaccine trials of the highest order encompassing 28,000 subjects in the phase III and a few thousand in the earlier phases. But some of the drug trials were as sub-sized as 150, less than 100, or 200 and obviously there could be a hype, but they would not have scientific acceptance.

“We also thought that perhaps we will find a drug against Corona earlier than the vaccine, it happened the other way around. I think partly it is due to the fact that the methodologies we’re invested in and I hope that going forward industry will resolve how high quality efforts have to be made. If we make sub-standard products, it won't lead anywhere and it is a waste of time and energy eventually,” he added. The real future and the leapfrogging that this nation can achieve is in the areas of, what at NITI experts like to call, as the moonshot ideas and priorities, the complex generics, the gene-based therapy, the biosimilar, regenerative medicine solutions, orphan drugs and drugs that will offset the antimicrobial resistance, he added.

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