India’s Biopharma Industry Needs to Become More Ambitious: The Case for Deeper Industry-Regulator Engagement

India's biopharmaceutical sector has long been celebrated as the "pharmacy of the world," supplying affordable generics and vaccines to millions across the globe. Yet, as the global life sciences landscape rapidly evolves, it is increasingly clear that the next frontier for India is not just scale, but innovation. To fully realize this potential, India’s biopharma industry must become more ambitious, and one of the most crucial levers for that transformation is deeper and more strategic engagement between industry players and regulators, both domestic and international.

**From Generics Giant to Innovation Hub**

India's dominance in the generics market is a remarkable achievement, underpinned by world-class manufacturing capabilities, cost efficiencies, and a robust talent pipeline. However, the innovation ecosystem remains underdeveloped in comparison. While Indian firms have made progress in areas like biosimilars and vaccine innovation, the pipeline of novel biologics, gene therapies, and cutting-edge biotech platforms remains thin.

A key challenge lies in the high-risk, capital-intensive nature of biopharma innovation, which requires long gestation periods and regulatory clarity. This is where meaningful collaboration between industry and regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO) and international agencies like the US Food and Drug Administration (FDA) becomes critical.

**The Role of Regulatory Engagement in Driving Innovation**

Engagement between industry and regulators is not just about compliance. It is a strategic tool that can drive growth, enhance competitiveness, and foster innovation in a sector that is heavily governed by safety, efficacy, and quality standards.

1. **Regulatory Clarity Fuels Confidence**

Early and ongoing communication with regulators can help companies navigate complex regulatory pathways, reduce uncertainty, and make more informed R&D investments. For example, if Indian startups working on novel biologics or gene therapies have access to clear guidelines and responsive feedback mechanisms from CDSCO and the US FDA, they are more likely to commit to bold, high-value projects.

2. **Accelerated Approvals and Innovation Pathways**

Regulators in advanced markets have pioneered mechanisms like the FDA's Breakthrough Therapy Designation or the EMA’s PRIME scheme to accelerate the approval of promising therapies. India could develop its own versions of these frameworks, co-designed with industry, to fast-track products addressing critical public health needs. Such initiatives would be a game-changer for startups and established firms alike.

3. **Mutual Capacity Building**

Engagement should be a two-way street. While industry gains clarity and speed, regulators benefit from exposure to emerging technologies and real-world challenges in drug development. Regular workshops, joint task forces, and advisory panels can create a feedback loop where policy and innovation evolve in tandem.

4. **Global Harmonization and Market Access**

A transparent and predictable regulatory environment aligned with global standards enhances India’s credibility as a source of high-quality, innovative products. Regular interaction with global regulators like the US FDA also enables Indian firms to better understand expectations for international market entry, thus improving approval rates and reducing costly rejections or delays.

**The CDSCO's Evolving Role**

India’s CDSCO has shown encouraging signs of reform and modernization in recent years. Initiatives such as digitization of submissions, capacity-building programs, and updates to clinical trial rules are steps in the right direction. However, more can be done to make the CDSCO a proactive partner in innovation.

Creating specialized regulatory tracks for novel therapies, increasing staffing of expert reviewers, and fostering regular pre-submission meetings with industry would significantly improve the regulatory experience. Furthermore, increased transparency in review timelines and decision-making processes would instill greater confidence in both domestic and international stakeholders.

**Public-Private Partnerships: A Model for the Future**

India has successfully leveraged public-private partnerships in sectors like space and digital infrastructure. The biopharma sector could benefit from a similar approach. A formalized platform for continuous dialogue between regulators, academia, startups, and established firms would help co-create policy and regulatory frameworks that are both rigorous and innovation-friendly.

For example, a national Biopharma Innovation Council comprising CDSCO representatives, industry leaders, researchers, and international advisors could guide strategic priorities, resolve bottlenecks, and coordinate pilot initiatives like adaptive trial designs or real-world evidence frameworks.

**Investing in Regulatory Science and Talent**

Ambition must also be backed by expertise. India needs a new generation of regulatory scientists who understand both the science of biopharma and the nuances of policy-making. Investing in specialized training programs, university partnerships, and global exchanges can build a workforce that strengthens both industry and regulatory institutions.

Moreover, CDSCO and other health authorities must be equipped with adequate resources, skilled evaluators, and digital infrastructure to handle the increasing complexity of new therapies.

**Looking Ahead: A Call to Action**

India stands at a critical inflection point. The opportunity to lead in global biopharma innovation is real, but it requires a mindset shift from "make for the world" to "discover for the world." This ambition can only be realized if the regulatory ecosystem evolves in step with scientific advancement.

Deeper engagement between the biopharma industry and regulators like the CDSCO and US FDA is not a nice-to-have — it is mission-critical. It is the bridge that connects India’s scientific potential with global impact. Through sustained collaboration, India can transform from a generics leader into a powerhouse of biotech innovation, delivering breakthrough therapies not just for its own population, but for the world.