In the global pharmaceutical landscape, biologics, biosimilars and specialty drugs now account for over 40 per cent of pharmaceutical revenues. Long termed as the ‘Pharmacy of the World’ due to its leadership in generic medicines, India’s pharma industry is now ready to shift gears from scale to innovation. The Government is driving a forward-looking policy framework to ensure that the country captures a greater share of these emerging segments while retaining its strengths in generics.
The announcement of the ₹10,000 crore Mission Biopharma Manufacturing SHAKTI in Budget 2026-27 marks a decisive step in this direction. It signals India’s resolve to evolve into a global hub for biopharma innovation and high-value therapeutics over the next 8-10 years. This vision will be anchored in building deep scientific capabilities, fostering innovation-led enterprises, and enabling India to emerge as a leader in next-generation medicines.
The programme aims to accelerate domestic capabilities in biologics, biosimilars and advanced therapeutics. It complements the existing initiatives of the Department of Pharmaceuticals, Department of Science & Technology and Department of Biotechnology like Promotion of Research and Innovation in Pharma MedTech Sector (PRIP), Research Development & Innovation Scheme, BioNEST, etc., aimed at promoting R&D in the life sciences sector including biopharmaceuticals. Together, these initiatives are designed to strengthen India’s innovation ecosystem, promote industry-academia collaboration, and enable a transition from generic drugs to innovation driven drug discovery and development.
Domestic capacity
A critical pillar of this strategy is the development of fermentation-based manufacturing capabilities. Despite its importance in manufacture of antibiotics, vaccines, enzymes, and biologics, this segment has long been import-dependent. By investing in infrastructure, facilitating technology development and transfer, and offering targeted incentives, India is working to build domestic capacity and enhance global competitiveness in this domain.
Equally significant is the expansion of India’s clinical research ecosystem. One thousand accredited clinical trial sites that shall be set up would substantially elevate India’s profile as a global drug development destination. With its cost advantages, and growing pool of skilled investigators, India offers unparalleled opportunities for efficient and high-quality clinical trials. At the same time, strengthening regulatory frameworks and enhancing institutional capacities will further align India with global benchmarks, enabling faster approvals and fostering confidence among global stakeholders.
In the last few years, India has made rapid strides in localisation of Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs), on the back of PLI and Bulk Drug Park schemes. This has helped reduce the price of drugs in the country, which are among the lowest in the world, and has been responsible for keeping the cost of healthcare affordable for the citizens. Pradhan Mantri Bhartiya Janaushadhi Pariyojana has expanded access to quality generic medicines at affordable prices, with over 19,000 Jan Aushadhi Kendras serving millions. Complementary measures, including customs duty rationalisation on critical therapies such as cancer and rare disease drugs, are further improving access to life-saving treatments. As advanced therapies become more widespread, ensuring affordability and equitable access will remain a central policy priority.
As the industry evolves, India aims to deepen its footprint not only in established markets but also in emerging regions, particularly in innovation-driven segments. Reforms are central to this transformation. Efforts towards regulatory harmonisation, digitalisation of approval processes, and faster clearances are improving ease of doing business. Strengthening quality standards and regulatory processes ensure continued global trust in Indian pharmaceutical products. However, increasing R&D investment remains a key challenge. Addressing this will require stronger public-private collaboration to sustain long-term innovation.
Looking ahead, the convergence of policy support, technological advancement, and market opportunity presents a unique growth window for the pharmaceutical sector. India’s domestic market, already valued at over ₹4 lakh crore, is poised for steady expansion. Over the next decade, India is well-positioned to emerge not only as a leader in generics but also as a powerhouse in innovative medicines, fermentation-based products, and next-generation therapies.
The writer is Union Minister of Health & Family Welfare and Chemicals & Fertilizers
Published on April 14, 2026