“The government is working on a new R&D policy where it will be addressing  most of the pain points of the life sciences industry. The government notification will be issued soon,” said Dr Vinod Kotwal, Member Secretary, National Pharmaceutical Pricing Authority (NPPA), while speaking at a panel discussion on the topic “Search for a New Molecule: Shift from Generics to Novel Drugs” organised at the BioSpectrum Excellence Awards 2023 ceremony in New Delhi on June 30. 

She further said “We request all the industry members to participate in the discussion and share their concerns and suggest ways to overcome gaps and improve the current situations. The new R&D policy is expected to reduce the burden of the industry as it will shorten the time for getting approvals.”  

Dr Vinod Kotwal also stated that the government has been doing its bit in supporting R&D activities.  “We need a collaborative approach involving government, venture funds, entrepreneurs to move from developing generics to novel drugs.”

Talking about the issues before the regulators, Dr Vinod Kotwal said “In fact there are still many issues before the regulators. The government on the other side is making its sincere efforts by reaching out to industry leaders indirectly to take their views and opinions, before introducing any regulations. The industry has to come forward with suggestions, feedbacks to improve and overcome the issues that are hindering the growth of the industry.”

Speaking about the ecosystem Dr Anandkumar, Co-Founder & CEO, Bugworks Research, said “The ecosystem for innovation has been much better as compared to a few years back. Now we have 5,000 startups in the biosciences space as compared to 50 eight years ago. But still, we lack the ecosystem which we find in places like Boston, Basel, Silicon Valley, Israel that have appropriate infrastructure for working on novel ideas.”  

Making his views on the pain points of the industry Dr Anandkumar said “The key pain point is the unavailability of a skilled talent pool to work on novel drug discovery areas. We have huge talent in the country in areas such as generics, chemistry, biology, developing novel vaccines like mRNA, mDNA among others, but not in novel drug discovery. Meanwhile we are now witnessing  a reverse brain drain with India emerging as the pharma and vaccine hub of the world. Experts from the bioclusters of the world are looking at India. Hopefully in the coming few years we can compete with global giants in the drug discovery space.” 

Talking about the industry expectations he said, “The government should double the public health spending to 3 per cent of the gross domestic product (GDP) to support the healthcare transformation from the current spending of 1.5 per cent of the GDP. India has been spending nearly 0.6 per cent on research and development (R&D). It should be increased to 2 per cent as countries such as the United States of America spend 2.8 per cent, while Korea spends 4.2 per cent of their GDP on R&D.”

Sharing his thoughts further on innovation, Dr Anandkumar said “Innovation is happening in the country where risk appetite is low. More research is needed for which the industry has to look at global models. Innovation comes at a cost. India has to look for a differential pricing model so as to invest in innovation and R&D.”  

Echoing similar views, Sai Prasad, Executive Director, Bharat Biotech said – “Innovation comes at different costs. It is difficult to follow the single pricing model. We should have a differential pricing model so that companies can reinvest returns on R&D.”  

Referring to the hurdles before the industry, Sai Prasad said “We are still facing too many regulations. 100 per cent presentations with involvement of so many departments and ministries. Getting approvals is becoming delayed.” 

“In the vaccine and small molecules space we have launched innovative products by developing novel platforms and technology which have benefited the whole nation. However, we are still far behind in the novel and new drug molecules as innovation is not an easy thing,” said Sai Prasad while making his points on the gaps in the industry.  

Sharing his views on issues that need the attention, Saurabh Singal, Founder, KnowDis/ Molecule AI said “Deeptech is yet to take a shape in the country. VC funding for novel drug discovery is still a long way to go.”

On expectations from the government, Singal said “We expect some non-fiscal support to be provided in addition to already available support-measures, to make best of the growth opportunity. The industry is keen on getting more support for R&D spends through fiscal (for example, Higher tax deduction on R&D spend) and non-fiscal support.”

Elaborating her views on the pain points, Dr Parul Ganju, Co-founder and CEO, Ahammune Biosciences, said “The risk appetite is a key issue in Indian life sciences industry. The companies are comfortable with the routine works/jobs and unable to take challenges in doing new things. Venture funding is another issue for innovation.” 

She further said “We feel it will take another 5-6 years for venture capitalists (VC) to understand the industry. Besides, we need a few success stories like Pfizer and Novo Nordisk in India. That will bring and garner more confidence among VC to invest in the area of innovation in life sciences.” 

Referring to the expectations Dr Parul said “The government has increased the outlay for healthcare. We want more tax rebates /reduction for innovation as well.” 

Dr Satya Dash, Founding Head Strategy, BIRAC and Founding CEO, BITS BioCyTiH Foundation who moderated the panel discussion said that Dr   Varaprasad Reddy of Shantha Biotechnics, BioSpectrum Lifetime Achievement Award Winner 2023 is a role model for many entrepreneurs who are in the business of life sciences area. Dr Varaprasad Reddy brought a complex novel biotechnology platform and launched vaccines at an affordable price. With no industry background, he overcame all the hurdles like finance, risk involved, skilled workforce and regulatory issues as his aim to offer or launch affordable products was very much loud and clear that brought him laurels later.  

The Indian pharmaceutical industry has long been recognised as a global leader in the production of generic drugs, which has helped to bring affordable healthcare to millions of people around the world. However, with the increasing demand for more effective and personalised therapies, Dr Satya Dash concluded that there is a need for the industry to shift its focus from generics to novel drugs. 

The panel discussion was sponsored by Lonza and CPC. 

Photo caption - Dr Satya Dash, Founding Head Strategy, BIRAC and Founding CEO, BITS BioCyTiH Foundation was the moderator of the panel discussion (left), along with the panelists (L-R) Dr Anand Anandkumar, Co-Founder & CEO, Bugworks Research, Dr Parul Ganju, Co-founder and CEO, Ahammune Biosciences, Dr Vinod Kotwal, Member Secretary, National Pharmaceutical Pricing Authority (NPPA), Saurabh Singal, Founder, KnowDis/ Molecule AI and Sai Prasad, Executive Director, Bharat Biotech