For the Indian pharmaceutical industry to scale the innovation challenge, it would require a strong research-push from the government, backed by regulatory reform, says Dr Reddy’s Laboratories Chairman Satish Reddy, outlining the challenges for domestic drugmakers in 2023.

“If India has to be at the cutting edge of innovation, our regulatory system also needs to undergo reforms. It needs to be reflecting the new kinds of work that goes on in this industry,” said Satish Reddy, who was also President, Indian Pharmaceutical Alliance (IPA 2019-2021 and 2013-2015). IPA is a platform for large domestic drugmakers.

Companies are growing because there is a market in India and outside, but for the pharma industry to remain competitive and move into the next level, the government’s support and intervention is critical, Reddy told businessline.

He hoped that Budget 2023 outlines research incentives for the sector.

It could be by way of funding support through allocations in the Budget or infrastructure by way of research-oriented clusters and innovation hubs, he said on interventions needed to incentivise industry to invest in research.

The support can be through tax incentives, by creating a funding ecosystem that allows venture capital (VC) funds to participate, or a catalytic joint fund, where the government also invests and so can a VC, he points out.

There is also the industry-academic collaboration, he says, adding that some of it is already happening, though much more could be done on that front.

Incidentally, a draft policy to give the pharmaceuticals and medical technology sector a research-edge is already in place.

Seeking a comprehensive approach towards supporting innovation efforts of the estimated ₹4 lakh crore Indian pharma industry, Reddy explained that going through multiple agencies for an approval, especially for a biotech product, required reform because “the whole process takes enormous time.”

On the clinical development side, “Phase 1 trials are being carried out for new molecules by most of the companies outside of India, and the single reason for that is the amount of time it takes for approval. These are things that can’t wait and can easily be done in India,” he said, giving a snapshot of the challenges faced by the pharma industry.