Unlocking India's Innovation Potential in Pharma

Speaking at the IMC Bharat Calling conference, Meenakshi Nevatia, Country President & Managing Director, Pfizer India, shared her views on how India is a key player in pharma innovation through advanced manufacturing, clinical trials, and targeted R&D, as well as strategic tie-ups with startups, academia, and government institutions.

The pharmaceutical sector is literally on the cusp of future success and innovation is at its core, especially in the world of technology, rapid development, and global collaboration. The world’s leading pharmaceutical innovators can leverage India’s strengths to not only scale manufacturing but also ignite the engine of global healthcare innovation. There are several emerging opportunities, strategic imperatives, and structural changes that are needed to achieve the full potential of Indian pharma innovation.

India’s Three-Pronged Value Proposition in Global Pharma

The three critical ways in which India can develop into a global pharmaceutical capital are manufacturing, clinical development, and research and development (R&D). India’s strongest, particularly in generics, is manufacturing. India is currently operating at scale as a pharmaceutical exporter. It boasts of its capabilities and cost efficiency in production as a country that has Pfizer’s largest sterile injectable manufacturing plant outside the U.S.

The second pillar, which is now taking off, is Clinical Development. Currently, Pfizer runs about 45 clinical trials at any given time in the country. The clinical research not only aids in the drug discovery but also gives early access to advanced medicines to the Indian patients. This potential, however, needs solid frameworks, streamlined regulatory policies and a solid collaboration with the government to promote the high quality clinical research within the country.

Third one is an inspiration to R&D. India makes a significant contribution to global R&D efforts (e.g., Pfizer’s 1,500 member research team at IIT Madras Research Park but such efforts are predominantly development and not the product of pure discovery. India is a strong proponent of translation, from the molecules to the therapy, and has not yet become a hub of discovering novel targets and making key discoveries.

Decoding R&D: From Support to Discovery

Refining the understanding of R&D is required for the Indian pharmaceutical ecosystem as the current activity in R&D is mostly about development stages: process optimization, formulation, bioequivalence and regulatory compliance. In fact, true innovation takes place in the earliest stage of discovering new drug targets and developing first in class therapies.

Such discovery-driven R&D requires investment, infrastructure and a long term vision, which are often opposed to short term commercial pressures. Moreover, R&D has granular pieces and it is important to acknowledge that so that aligning expectations and maximizing impact are possible. In contrast to what many aspire for, India’s approach should be to build such capabilities on a phased basis, mastering each stage of the drug development process one phase at a time.

Nurturing Startups: From Grant Funding to Deep Mentorship

In itself, financial support is not enough to stimulate sustainable innovation. Pfizer chose a few startups but quickly discovered that they needed advisory support, especially in areas of regulatory strategy, clinical trial design, and compliance, more than funding.

Startups usually work under compression timelines and are in haste to market. It is fundamentally different from the pharmaceutical industry’s long term planning that takes multiyear and rigorous regulatory pathway. This gap was bridged by Pfizer thereby enabling startups to reframe their approach and develop a better understanding of the lifecycle of drug development and diagnostic innovation.

This included AI-powered diagnostic tools and cheap, scalable technologies for diseases such as cervical cancer, which show that India is able to lead in low cost and scalable healthcare solutions. Faced with this, Pfizer collaborated with NIPER and Dept of Pharmaceuticals to scale this up and tap into the underutilized infrastructure of the medical device facility in Ahmedabad.

Quality and Cost: Creating Incentives for Excellence

Cost pressures vs quality compliance is one of the most nuanced challenges. The conclusion that all stakeholders want to produce high quality products is fine, but the practice is that price frameworks often deter quality improvement. An example is price controls in current operation which apply equally to products processed in a facility approved by local, WHO or U.S. FDA standards.

Pfizer indicates that value-based pricing models could be a solution. If the industry were able to differentiate its reimbursement on the basis of quality metrics, this would reward high quality manufacturing practices and increase compliance with global standards. This could be a catalyst for the creation of a culture of quality of Indian pharma to boost country’s competitiveness at global level.

Leapfrogging Through Focused Innovation

Systemic transformation is a gradual process, but some areas of leapfrog innovation are possible. Pfizer identifies two such opportunities. Since India is a resource constrained country with such a huge population, there are vast opportunities to scale and develop AI driven diagnostic devices. With the help of global expertise, Indian startups could potentially dominate the global market of the accessible diagnostics for non?communicable diseases, infectious conditions and chronic care monitoring.

The current model of conducting clinical trials involves very high human touch, long timelines, and physical infrastructure. Given India’s large, dispersed population, patient follow-up is a unique issue. Trial design and execution could be revolutionized using technology, such as AI-based follow-up, mobile-enabled recruitment, or remote monitoring. Addressing this would not only enhance India as a clinical research destination; it would also help in generating better quality data.

Coalescing public private partnerships, academia collaboration and a patient centric mindset will be needed for India to truly lead in pharma innovation. While global players like Pfizer are investing in Indian capacity and the foundation is being laid, it will take deliberate, consistent and visionary effort to realize the full potential.