Having established its leadership in the generics market, India is now looking at replicating the success in the complex generics and biosimilars market. However, despite being the first mover in this space, India hasn’t really been able to create a bigger position on the global map.

Speaking at BioAsia 2021, the flagship event of the Telangana government, industry leaders stressed identifying 4-5 moonshots and working towards strengthening them. There is a broader consensus on the need for access to venture capital funds, infrastructure, quality resources, industry-academia linkages, and industry orientation courses.  

Calling for an enabling ecosystem, Sriram Shrinivasan, India Life Sciences Leader, EY says, “Lot many of innovative drugs and technologies were discovered by startups and then later developed by bigger pharmaceutical companies. In the western world, Stanford University, Harvard University and others are working on innovative molecules and IP in collaboration with companies but here in India, we see most of the stakeholders working in silos. What is required is a single nodal agency for clearances, venture capital, startup ecosystem, regulatory support, and industry-academia collaboration.”

“We have to move from volume plate to value plate though the R&D. Government has provided seed funds yet a lot of IP is migrating from India to the US. Why can’t we increase our R& D spend from 6 to 16 percent?, asks Kiran Mazumdar Shaw, Executive Chairperson, Biocon who calls for R& D incentives to provide impetus to the sector. “If we identify 5 cutting edge technologies, we can see a lot of innovative products in the domestic market. Compared to the global scenario where there are innovative programs, access to capital, and regulatory support, India really needs to catch up. Look at the way Moderna and Pfizer were supported by public funds. We can have the same as well.” 

Shaw is bullish about the growth of the clinical research sector. “The good part of the pandemic is that it has reintroduced the clinical research ecosystem rapidly and it has potential to become a huge sector in itself. Only if we fast-track the idea from the lab to market, we will see a lot of investments. The next-generation technologies in the areas of anti-microbial resistance, synthetic drugs for cancer treatment, and gene therapies from startups can reach their final stage if they have financial support capital access and regulatory support.” 

Amitabh Kant, Chief Executive Officer, NITI Aayog, is optimistic about the production liked incentive (PLI) scheme’s success. He says, “215 applications have been received including 83 from manufacturers. PLI should lead towards drug development. The industry must come forward to avail it. We have identified 10 key sectors where we have to put them on the growth trajectory.”

Listing out the steps taken by the government, Kant points out that the timelines for approvals have been reduced. “The committees will meet every 15 days for consideration of applications that can be put through the online portal. I am happy to mention that there is no case pending for animal trials. The regulator should work as a developmental person than a mere regulator.”

Expressing her candid views, Dr Swati Piramal , Vice-Chairperson, Piramal Group opines, “We claim all the limelight for being a vaccine producing nation but price control has to be rethought. Vaccines are privately funded yet the control remains with the government. A big question is that why are we not receiving the jab despite being innovators. Despite the two major vaccine companies having the surplus products, why is the government not addressing it?” she asks. 

Piramal calls for streamlining the regulatory systems and investing in the infrastructure. “We need to increase the workforce in regulatory bodies and have enough experts in all domains.”  

Since we dominate oral solids, it is only natural that we should dominate complex generics, says Nilesh Gupta, Managing Director, Lupin Ltd. who believes that there is a significant opportunity to gain market share in complex generics. “Unlike oral solids, the expertise required in complex generics is much more. Biologics and biosimilar are an opportunity for volume, value, and job creation.  Key challenges need to be addressed in India, be it stringent regulations, insufficient funding ecosystem, and absence of cutting edge academic collaboration.” 

Gupta who bats for the creation of a robust funding ecosystem feels that innovation is heavily funded in most of the countries except India where a lot of promising startups are struggling for capital. 

A report by the Associated Chambers of Commerce of India (Assocham) predicts that by 2030 the global market for biosimilars will have reached $240 billion and the Indian market will be at a booming $35 billion. Unlike China where technical guidelines for the development and evaluation of biosimilars is in place since 2015, India is still implementing an already defined pathway. Despite this fact, more than 95 such products are marketed in India. As regulatory frameworks mature, the quality of these products is rapidly improving, making them more portable to other markets.