What are the steps that India needs to take for reaching the next level of maturity in the biotech/ biopharma space?
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Shakthi M Nagappan
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India biotech market has evolved steadily and significantly over the past two decades – thanks to the progressive biotech policy and incentive schemes of Government of India. The sector has been growing at an average rate of 20 per cent in the past decade and is estimated to grow at 30 per cent in the next decade. The steep raise in the growth estimates can be attributed to the tremendous potential offered by the sector in addressing major global challenges in healthcare, agriculture and energy. For India to move towards the next level of maturity, innovation in research and processes holds the key. With the increasing disease burden, growing need for more efficient and affordable healthcare solutions, innovation holds the key and will drive the global life sciences economy in the coming years.
Do you think India is likely to be a hub or a preferred destination for biobetters in the near future?
Both, biosimilars and biobetters offer tremendous growth prospects to the companies. Indian biosimilar sector has picked up momentum in the past few years and in 2012, India had about 20 companies developing biosimilars with about 50 products in the market. Pledging more efficacious healthcare solutions with potentially less development costs and multiple product opportunities through platform approach, Indian players are increasingly eyeing to capitalise on the opportunities in biobetters market. Further, the segment which demonstrates improved profile and significant modifications from the innovator drugs also offers reduced litigation risks and better patenting opportunities.
What are the other opportunities that lie in the biotech sector in India?
Areas like medical technologies and diagnostics, regenerative medicine, personalised medicine and gene therapy, agriculture and food biotechnology promises tremendous growth opportunities for India. India is one of the most lucrative markets for medical devices globally. With the market relying largely on imports currently, the country provides significant manufacturing opportunities for international and domestic players.
Do you think that India’s laws for the biotech sector are at par with the global standards? Are they being implemented as required?
Indian policy making agencies are investing significant efforts in enabling highly stringent but hassle free regulatory environment. Further, the Ministries have started to incentivise and fund early stage research, which will reduce the associated risks and encourage Indian players to focus on R&D. Decision on allowing 100 per cent FDI in pharma and biotech will also encourage more investment into the country and help create an ecosystem. There are indeed some areas that continue to remain a bottleneck, like delays in approvals, requirement for approvals from multiple agencies, etc. but they are being looked into by the Government. Establishment of proposed biotechnology regulatory authority of India could be a milestone in streamlining the regulations and regulatory framework in India.
From an IP point of view, what are the hurdles for biopharma players in India, for e.g. data exclusivity norms, etc.
The challenge is to focus on the ways to balance out innovation with affordability and availability. In the context of India and other emerging markets, where there is a mushrooming disease burden, it is extremely important to keep in mind the fact that large chunk of these patients cannot afford healthcare and hence, drug monopoly can be highly devastating. Having said that, the innovative research demanding significant investment and involves considerable risk needs to be incentivised. Though the current IP regime attempts to prevent ever-greening of patents, it creates a lot of room of ambiguity. There is an increasing need to relook at article 3D on Indian Patent Act for defining the lower limits of what constitutes a substantial modification, given the fact that even a slight modification in chemical structure of a drug is expected to have significant effect.