Vaccine Valley: Can India Become the World’s Biopharma Hub?

Explore India’s potential to become the world’s biopharma hub, led by vaccine innovation, Make in India policy, and Atmanirbhar Bharat strategy.

Science Apr 8, 2025 31 Add to Reading List

India has always been known as the “pharmacy of the world,” but its role has largely focused on generic drug manufacturing. Today, that identity is being redefined. With a massive biopharma infrastructure, a rising tide of innovation, and policy-driven momentum from Make in India and Atmanirbhar Bharat, the country is poised to evolve from supplier to superpower. Nowhere is this potential more evident than in its vaccine capabilities. From COVID-19 response to global immunization programs, India’s vaccine ecosystem has demonstrated its ability to lead. But the question now is deeper: Can India become the world’s biopharma hub, not just for vaccines but for the entire biotech spectrum?

This ambition is neither far-fetched nor aspirational fiction. It’s rooted in reality, infrastructure, talent, and a series of systemic transformations taking place across the country. India has the highest number of USFDA-approved manufacturing plants outside the United States. It supplies nearly 60% of the global vaccine demand. It has research institutions with global collaborations and private players investing heavily in biotechnology, biosimilars, and next-generation therapeutics. However, reaching the top of the biopharma ladder involves more than capacity—it demands credibility, consistency, compliance, and continual innovation.

The study on product and process development compliance in the Indian biopharmaceutical sector highlights the compliance strides Indian companies are making. This blog explores how India can channel its vaccine success into building a comprehensive biopharma hub and what challenges must be addressed to turn this goal into a lasting legacy.

Vaccine Valley: The Case for India

During the COVID-19 pandemic, India became one of the few countries capable of producing large quantities of vaccines for both domestic use and international distribution. Institutions like the Serum Institute of India, Bharat Biotech, and Biological E became household names across continents. India supplied vaccines to over 90 countries, many of them as part of humanitarian efforts. This earned global goodwill and revealed India's unmatched scalability in vaccine production.

This capacity didn’t arise overnight. It is the result of decades of investment in cold chain logistics, quality-controlled production, and adherence to international standards. More importantly, the government created regulatory flexibility during the pandemic without compromising safety—a model of how responsive governance can enable swift innovation.

Make in India further amplifies this momentum by focusing on infrastructure support, technology transfer, and R&D incentives. Atmanirbhar Bharat strengthens the foundation by reducing import dependency and encouraging domestic excellence in biotech research. Together, they lay the groundwork for India's broader biopharma future.

Beyond Vaccines: The Larger Biopharma Landscape

While vaccines are a major part of India's pharmaceutical identity, becoming a global biopharma hub involves much more. Biopharma includes monoclonal antibodies, recombinant proteins, biosimilars, cell and gene therapies, and advanced biologics. Indian companies are making rapid strides in each of these segments.

Biocon, Dr. Reddy’s Laboratories, Zydus Lifesciences, and Cipla are now developing biosimilars that are approved or under review in regulated markets. Research is being conducted in cancer immunotherapy, mRNA technologies, and personalized medicine. CROs and CDMOs are also supporting this ecosystem with specialized services for drug discovery, development, and delivery.

The study points out how firms are increasingly adopting strong compliance systems and standard operating procedures (SOPs) that match international benchmarks. This operational maturity is essential for attracting global partners and regulators alike.

Infrastructure: The Biopharma Corridors of India

The government has launched several initiatives to establish biopharma corridors—dedicated industrial zones for biotechnology and pharmaceutical research. These include:

Biotech Parks in Tamil Nadu, Telangana, and Maharashtra

Pharmaceutical clusters under the Promotion of Bulk Drug Parks scheme

Genome Valley in Hyderabad as a leading life sciences hub

Gujarat's growing status as a manufacturing epicenter for APIs and formulations

These facilities offer plug-and-play labs, GMP-certified production spaces, clinical research units, and regulatory support. They are built to attract both domestic innovators and multinational corporations seeking manufacturing partnerships or R&D bases in India.

By consolidating expertise and resources, these zones reduce operational costs, improve timelines, and foster cross-disciplinary collaboration—critical features of any biopharma supercluster.

Talent: India’s Intellectual Capital in Biotech

One of India's biggest strengths lies in its scientific talent. The country produces thousands of graduates in biotechnology, microbiology, pharmacy, and life sciences every year. Premier institutes like the Indian Institute of Science (IISc), National Institute of Immunology (NII), and Indian Institutes of Technology (IITs) are engaged in world-class research and biotech innovation.

Indian professionals also hold leadership roles in global pharmaceutical and biotech companies. This global exposure is now returning home, as many seasoned scientists and entrepreneurs launch biotech startups or join domestic firms.

Make in India and Atmanirbhar Bharat policies recognize the importance of talent development. Initiatives such as skill enhancement programs, regulatory science courses, and industry-academia linkages are creating a robust pipeline of qualified biopharma professionals ready to meet international demands.

Compliance and Credibility: The Global Access Factor

A key requirement for becoming a global biopharma hub is the ability to meet international compliance norms. Regulatory approvals from agencies like the USFDA, EMA, MHRA, and WHO are non-negotiable. They determine market access, consumer trust, and partnership potential.

As detailed in the study, Indian companies are increasingly aligning their development and manufacturing practices with global standards. This includes:

Implementing electronic batch records and audit trails

Adopting Quality by Design (QbD) frameworks

Digitizing SOPs and training platforms

Conducting internal audits modeled after international inspections

CDSCO, India’s central regulatory body, has also upgraded its systems. It now offers online submissions, risk-based inspections, and faster review pathways. These advancements help reduce time-to-market and improve transparency, attracting more global collaboration.

Strategic Alliances and Contract Services

Many global pharmaceutical companies are choosing India as a base for contract development and manufacturing services. This includes formulation development, biologics fill-finish, analytical testing, and pharmacovigilance.

India’s strength lies in offering high-quality services at cost-effective rates. The presence of full-service CROs and CDMOs allows even smaller biotech startups to move from discovery to commercial production without building massive infrastructure.

These strategic alliances serve a dual purpose. They provide revenue for Indian companies and position India as an indispensable node in the global biopharma supply chain. This network effect is key to evolving from a “country of suppliers” to a “hub of solutions.”

Intellectual Property and Innovation Ecosystem

India has made significant improvements in its intellectual property regime, a critical factor for biopharma innovation. The Indian Patent Office has increased efficiency, transparency, and professionalism in handling applications.

Fast-track patent processing for startups and female inventors, improved timelines, and the use of digital tools have made IP protection more accessible. Global firms now view India not just as a manufacturing destination, but also as a safe environment to co-develop proprietary technologies.

This IP-friendly environment encourages Indian companies to invest in their own novel research, further reducing dependency on reverse engineering or licensing.

Sustainability and Ethical Manufacturing

Becoming a global biopharma hub is not just about economic metrics—it’s about ethical leadership. Indian firms are increasingly adopting sustainable manufacturing practices, responsible sourcing, and waste management systems. Environmental compliance is now a boardroom discussion, not just a factory-floor checklist.

Moreover, India’s track record during COVID-19—producing affordable vaccines at scale without exploiting intellectual property constraints—has cemented its reputation as an ethical innovator in healthcare.

This trust capital is essential. In a world where healthcare choices are often driven by perception as much as performance, India’s credibility as a responsible manufacturer is one of its strongest assets.

Challenges on the Road to Global Leadership

Despite these advances, certain challenges must be addressed:

More harmonization is needed between central and state drug regulators

Clinical trial capacity must expand while maintaining ethical rigor

Infrastructure gaps exist in Tier-2 and Tier-3 cities

Greater investment is needed in high-risk R&D areas like cell therapy and personalized medicine

Streamlined, transparent, and stable policy frameworks are essential to de-risk long-term planning

Resolving these issues will determine whether India becomes a permanent leader or a temporary player on the global stage.

Conclusion

India has the infrastructure, the talent, the compliance strength, and the policy support to become the world’s next great biopharma hub. The success of its vaccine ecosystem—its own “Vaccine Valley”—has already laid the foundation. Now, the country is scaling up across the spectrum of biologics and therapeutics, not just to serve the world but to lead it.

Under the guiding vision of Atmanirbhar Bharat and the strategic direction of Make in India, India’s biopharma transformation is well underway. The shift from volume to value, from followership to leadership, is happening in real time. The world is watching—and India is ready.

Bibliography (APA 7th Edition)

Uppal, S., & Dadwal, N. (2024). Product and process development compliance in the Indian biopharmaceutical industry: Challenges and innovations. Environment Conservation Journal, 25(4), 1085–1091. https://doi.org/10.36953/ECJ.28462883