Captains of India’s pharmaceutical industry believe that the current Production Linked Incentive (PLI) scheme for the pharmaceutical industry can be extended to link it to research, and more specifically to research on biologics and biosimilars.
Speaking at BioAsia 2022, Kiran Mazumdar Shaw, Executive Chairman of Biocon Group, said there must be a different PLI program which must focus on emerging opportunities for the Indian pharmaceutical industry. “As a nation, we need to start moving towards large molecule biologics. There is huge growing interest in combination immunotherapies. Can we take the leap? The PLI regime was way too generically oriented. There should have been a much larger allocation for biologics, biosimilars, cell and gene therapies, etc., which didn’t happen,” Shaw explained.
In fact, she cited the example of Biocon to say, “We couldn’t qualify for Category A companies because we didn’t have that many ANDAs. So we received a very small amount.
The Rs 15,000 crore PLI scheme announced by the Center comprises three categories of companies – Category A (global pharmaceutical manufacturing revenue for FY 2020 above Rs 5,000 crore), Category B (between Rs 500 crore and Rs 5,000 crore) and Category C (income below Rs 500 crore). The amount of incentives varies for the three groups – Rs 11,000 crore (Group A), Rs 2,250 crore (Group B) and Rs 1,750 crore (Group C).
So far, 55 drug manufacturers have been selected under the PLI program.
Sanjiv Navangul, MD and CEO, Bharat Serums and Vaccines also agreed with Shaw.
“If we look at our own PLI program, a lot of emphasis has been placed on abbreviated new drug applications (ANDAs). This is not innovation. We talk about atmanirbhar in terms of what we don’t produce in terms of chemical and generic drugs. It is not enough. There is not enough venture capital to encourage innovation,” Navangul stressed.
An ANDA contains data that is submitted to the USFDA for review and potential approval of a generic drug. In comparison, for biologics, companies file a Biologics License Application (BLA), which is an application for permission to introduce a biologic to the US market.
Shaw said: “I tried to point out that one BLA equals almost 20 ANDAs in terms of investments. But, the PLI regime had not adopted this as a criterion. We can extend the PLI scheme. PLI schemes need to evolve over time. We can have a research-PLI program, where you include research in the PLI program.
Overall, pharma captains seemed to agree that the way forward lies in biologics innovation if India’s pharma industry were to achieve $120-130 billion in revenue over the of the next few decades.
Sharvil Patel, MD, Zydus Lifesciences said, “If 8 of the top 10 molecules in the world are biological, we need to find money to invest in them. No one can invest unless there is a significant financial benefit associated with it. So unless the ecosystem is restored and the financial incentive and benefits are in place, whether for an individual scientist, a start-up, a company or an institution, we will never succeed.
He added that incremental innovation would not help India’s pharma industry grow and take us from a 3-4% value share in the global pharma industry to a 10% value share. at 20%.
Satish Reddy, Chairman of Dr Reddy Laboratories, pointed out that “Indian companies are not risk averse, but there needs to be some government involvement – funding, regulatory support, etc.”