India's Regulatory Revolution in Biotech: The Path to Innovation Leadership

India's regulatory frameworks need to be reformed to keep pace with competitors and enable the development of new therapies and biologics. The country should adopt AI-powered approvals, adaptive trials, fast-track pathways, single-window digital approvals, regulatory sandboxes, and public market access for biotech startups to drive innovation and become a global leader in biotechnology.

India, long known as the 'pharmacy of the world' for its affordable generics and vaccines, is now aiming to transform into an 'innovation hub' by overhauling its regulatory landscape [1]. The goal is to keep pace with global competitors, particularly China, which has rapidly advanced in drug innovation through regulatory reforms.

The current regulatory frameworks in India, while robust in ensuring safety, are slow, fragmented, and unpredictable. This has hindered the country's ability to lead in innovation and bring new therapies, biologics, and technologies to market quickly. To address this, India needs to adopt several key regulatory reforms:

1. AI-Powered Approvals: Integrating AI-driven predictive toxicology, in silico modeling, and ML-based safety analytics into the approval process can expedite drug evaluation and increase efficiency.

2. Adaptive Trials & Real-World Evidence (RWE): Embracing trial designs that adjust mid-course and leveraging India's digital health infrastructure, such as ABHA IDs and eSanjeevani, can accelerate clinical research and provide real-world data.

3. Fast-Track Pathways: Introducing 'priority review' and 'breakthrough designation' categories for drugs targeting oncology, rare diseases, and pandemic preparedness can significantly reduce approval times.

4. Single-Window Digital Approvals: Merging the Central Drugs Standard Control Organisation (CDSCO), ethics committees, and state regulators into an integrated platform with statutory deadlines can streamline the approval process.

5. Regulatory Sandboxes: Pilot novel therapies, such as gene editing, mRNA vaccines, SiRNA, and cell and gene therapies, in controlled regulatory environments to test and refine their safety and efficacy.

6. Public Market Access for Biotech Startups: Creating a special listing framework on Indian stock exchanges for R&D-heavy biotech startups can provide critical capital inflows and create a clear exit pathway for VC investors.

7. Investment Incentives: Offering tax breaks, patent-box regimes, and sovereign-backed innovation funds can reward IP creation and crowd-in private capital.

These reforms, if implemented, can not only help India catch up with China in the biotech sector but also surpass it. India has the scientific talent, manufacturing base, and global credibility needed to become a global leader in biotechnology. A regulatory revolution is the key to unlocking this potential.

References:
[1] https://economictimes.indiatimes.com/opinion/et-commentary/from-pharmacy-to-innovation-hub-why-india-needs-a-regulatory-revolution-in-biotech/articleshow/123370652.cms