Eyeing a growth pill: Pharma Inc calls for easier regulatory prescription

Industry says approval delays, weak clinical trial infra holding back sector

India’s leading pharmaceutical industry veterans have made a strong case for faster, simpler and more predictable regulation.

 

They warned that delays in approvals, weak clinical trial infrastructure and poor domestic acceptance of Indian innovation are holding the sector back. This comes at a time when global peers — particularly China — are moving rapidly up the value chain.

 

Speaking at a panel discussion on the past and future of Indian pharma at the launch of the book ‘Made in India — The Story of Desh Bandhu Gupta, Lupin and Indian Pharma’, industry stalwarts, including Dilip Shanghvi, managing director of Sun Pharma, Yusuf Hamied, chairman of Cipla, GV Prasad, managing director of Dr Reddy’s Laboratories and Vinita Gupta, chief executive officer (CEO) of Lupin, said India must urgently reform its regulatory ecosystem. This would help it transition from a generics-led model to higher-value innovation.

 

The industry veterans highlighted how regulatory delays, especially in clinical trial approvals, are forcing Indian companies to conduct early-stage studies overseas.

 

Shanghvi noted that Phase-I trials often get completed in countries such as Belgium or Australia before approvals come through in India, underscoring the need for smoother processes if the country wants to become an innovation hub.

 

He said the government’s recent steps, including the production linked incentive–style PRIP scheme and plans to certify 1,000 clinical trial centres, signal intent, but execution will be key.

 

China emerged repeatedly as a point of comparison. Prasad said India had underestimated China for years, seeing it mainly as a low-cost manufacturing base, while it quietly built a powerful innovation ecosystem.

 

He pointed to China’s large reimbursed domestic market, faster regulatory clearances, rapid clinical development timelines and its success in attracting globally-trained biopharma leadership as critical advantages.

 

These factors, he said, have enabled Chinese firms to move beyond generics into fast-follower and best-in-class innovation, a space that requires millions of dollars of investment per molecule and far higher risk tolerance.

 

The panel stressed that “fast follower” drugs should not be trivialised as incremental work.

 

Prasad described them as best-in-class innovations that demand expensive clinical trials, advanced medicinal chemistry and strong regulatory capabilities.

 

“This is a very different game from generics,” he said, adding that innovation involves fewer but much larger bets compared with the multiple small bets, typical of generics.

 

Hamied traced India’s pharma roots to policy choices that prioritised access over monopoly, recalling the 1972 patent law changes that enabled domestic manufacturing of essential drugs.

 

While reiterating his support for science being rewarded through royalties, he argued against monopolistic pricing and said innovation in India continues to face a major hurdle: acceptability.

 

Indian doctors, he said, often remain sceptical of domestically-developed new drugs, asking why multinational companies have not launched them first.

 

Academia-industry collaboration also came under focus.

 

Sharma said India has a cultural resistance to being “first in the world” and a reluctance to accept failure, both of which stifle innovation.

 

He stressed that applied research must ultimately find its way into industry and markets, and called for greater focus on areas such as biotransformation, formulation engineering and sustainable manufacturing. Here, India remains overly dependent on imports, particularly from China.

 

Gupta argued that India does not need to replicate the multi-billion-dollar research and development (R&D) spending of global pharma giants to innovate.

 

Instead, she said, companies can leverage India’s large patient pool, improving regulatory pathways and government incentives to conduct faster development locally, establish proof of concept and then scale products globally.

 

She also highlighted opportunities in off-patent brands, specialty generics, biosimilars and novel formulations as lower-risk pathways to value creation.

 

While acknowledging that innovation requires significant capital and tolerance for failure, Shanghvi said Indian companies need a few visible success stories to build confidence across the industry.

 

Recent out-licensing deals, he said, show that Indian innovation can attract global interest if supported by the right ecosystem.

 

The overarching message from the panel was clear: without regulatory agility, better clinical infrastructure, stronger industry–academia links and a shift in mindset towards risk-taking and acceptance of failure, India risks ceding ground to faster-moving peers.

 

As Prasad put it, India may need to become a “fast follower” not just in drugs, but in adopting policies that enable innovation.