From pharmacy to innovation hub: Why India needs a regulatory revolution in biotech

Last week, the PM stated in his Independence Day speech: 'We are known as the 'pharmacy of the world'. But isn't it the need of the hour to invest more in R&D? Shouldn't we be the ones providing the best and most affordable medicines for the welfare of humanity?'

This wasn't merely a rhetorical question. It was a call to act. For decades, India has been the backbone of global healthcare, supplying affordable generics and vaccines to billions. But the future of medicine won't be decided by volume manufacturing alone. It will be defined by who leads in innovation, who brings new therapies, new biologics and new techs 'from clone to clinic', 'from lab to market' in record time.

And here lies the challenge: India's regulatory frameworks, while robust in ensuring safety, remain slow, fragmented and unpredictable. Without reform, we risk being outpaced by competitors who have already married regulatory agility with scientific ambition.

In less than a decade, China has rebranded itself from a producer of low- cost generics to a genuine drug innovator. Its regulatory agency, National Medical Products Administration (NMPA), harmonised with global standards, embraced real-world evidence, and introduced priority review mechanisms that shortened approval cycles dramatically. These reforms unlocked billions in VC, created thriving biotech hubs in Shanghai and Shenzhen, and propelled Chinese-origin drugs onto global markets.

If India is to transform from 'pharmacy of the world' to 'innovation lab of the world', regulatory reform on the following lines must lead the way.

AI-powered approvals Accept AI- driven predictive toxicology, in silico modelling, and ML-based safety analytics as part of dossiers.

Adaptive trials & real-world evidence (RWE) Embrace trial designs that adjust mid-course and leverage India's digital health backbone - ABHA IDs, eSanjeevani, wearable health data.

Fast-track pathways Introduce 'priority review' and 'breakthrough designation' categories for drugs targeting oncology, rare diseases and pandemic preparedness.

Single-window digital approvals Merge Central Drugs Standard Control Organisation (CDSCO), ethics committees and state regulators into an integrated platform with statutory deadlines.

Regulatory sandboxes Pilot novel therapies - gene editing, mRNA vaccines, SiRNA, and cell and gene therapies - in controlled regulatory environments.

Public market access for biotech startups Create a special listing framework on Indian stock exchanges for R&D-heavy biotech startups, modelled on Nasdaq's biotech index. Allowing pre-revenue companies to raise funds publicly would provide critical capital inflows and, importantly, give VC investors a clear exit pathway - unlocking a cycle of reinvestment into new startups.

Investors chase predictability and exit visibility. China's biotech boom was not just about science - it was also about regulatory clarity and capital markets designed for innovation. If India delivers the same, VC will flow, IPOs will thrive, and biotech entrepreneurs will no longer need to move overseas to scale.

Tax breaks and patent-box regimes can reward IP creation.

Sovereign-backed innovation funds can crowd-in private capital.

Public listings can provide exits, liquidity and global visibility.

India has the scientists. It has the manufacturing base. It has global credibility. What it lacks is a regulatory revolution - one that accelerates approvals, integrates AI and opens capital markets for innovation. If we seize this moment, India can not only catch up with China in this sector but surpass it.

The writer is chairperson, Biocon Group.