Budget 2026 unveils Rs 10,000 Crore ‘Biopharma Shakti’ scheme to fight India’s rising non-communicable diseases

New Delhi: Finance Minister Nirmala Sitharaman has flagged India’s fast-changing disease profile, noting that non-communicable diseases (NCDs) are emerging as the country’s biggest healthcare challenge, and biologic medicines will play a defining role in improving longevity and quality of life.

Presenting the Union Budget 2026, Sitharaman announced Biopharma Shakti, a new flagship initiative with an outlay of Rs 10,000 crore over five years, aimed at strengthening India’s bio-pharma ecosystem across the entire value chain.

The focus is on building ecosystems for domestic production of biologicals and biosimilars, strengthening regulatory capacity, and creating 1,000 accredited clinical trial sites.

“The future of healthcare lies in innovation-led biologic medicines,” Sitharaman said, adding that Biopharma Shakti will focus on boosting research, scaling up manufacturing, and accelerating innovation in biotechnology and pharmaceuticals. The programme is expected to support cutting-edge R&D, facilitate industry–academia collaboration, and enable the creation of world-class biomanufacturing infrastructure.

Industry observers see Biopharma Shakti as a timely intervention, especially as global demand for biologics rises sharply and India looks to replicate its success in small-molecule generics in the high-value biologics segment.

Nilesh Maheshwari, Partner and Pharma, Bio Tech & Life Sciences Leader, Grant Thornton Bharat, commented: “The Rs 10,000 crore outlay under Biopharma Shakti will significantly accelerate India’s transition towards innovation-driven pharmaceuticals by strengthening research infrastructure, advanced technology hubs, and clinical standards, enabling progress in biologics, vaccines, and next-generation therapies. It will enhance domestic capacity, lower the cost of life-saving biologics, and support broader healthcare affordability- critical as India faces a rising burden of non-communicable diseases.

Shreehas Tambe, CEO & MD, Biocon Biologics called Biopharma Shakti a well-timed and much-needed step, especially when seen alongside the earlier Rs 1 lakh crore commitment announced in November 2025, to research, development and innovation.

“The acknowledgement that non-communicable diseases such as cancer, diabetes and autoimmune disorders are now the dominant healthcare challenge is important, as is the focus on complex therapies of biologics through affordable biosimilars as the new standards of care. Encouraging investment in advanced manufacturing, building global scale, and strengthening regulatory capacity through a dedicated scientific review cadre at CDSCO are all critical to meeting global benchmarks. Equally transformative is the emphasis on academic research, skill development, training and clinical infrastructure through new and upgraded NIPERs and accredited trial sites. These steps reinforce Atmanirbhar Bharat while positioning India as a credible global biopharma hub delivering affordable, high-quality complex therapies at scale. At Biocon we are fully ready to support India’s march to be a leader in biopharma,” said Tambe.

Dr Sharvil Patel, Managing Director, Zydus Lifesciences Limited said: “The thrust on Lifesciences is a welcome step as the Indian Lifesciences Sector looks at building capabilities for leadership and growth in the future. The Biopharma Shakti programme heralds a long-term vision that can catapult India to the next orbit of growth. The focus on upgrading NIPERs and strengthening the talent pipeline, benchmarking regulatory infrastructure to global standards, creating a network of over a thousand accredited India Clinical Trials Sites, are all steps in the right direction. Exempting 17 cancer drugs and 7 rare disease drugs from customs duty will greatly improve patient access. The budget 2026 has touched upon the important pillars of accessibility, affordability and patient-centricity that are an urgent need.”

Meenakshi Nevatia, Country President, Pfizer India said, “The Union Budget 2026 reflects the Government’s continued commitment to strengthening India’s healthcare and life sciences ecosystem as a key pillar of the Viksit Bharat vision. It builds on earlier efforts that encouraged domestic manufacturing, innovation, and improved access to medicines. We particularly welcome the announcement of Biopharma Shakti, with a dedicated outlay of ₹10,000 crore over the next five years to position India as a global biopharma manufacturing hub. For companies with long-standing manufacturing and R&D operations in India, these measures provide greater confidence to scale high-quality, globally compliant production in and from India. With non-communicable diseases accounting for over 60% of India’s disease burden, sustained investment in prevention and timely treatment is critical. Measures such as exempting basic customs duty on select cancer medicines reflect this patient-centric approach that can improve access and health outcomes. At Pfizer, we remain committed to partnering with the Government and broader healthcare ecosystem – to improve access to medicines for patients across the country.

Sanjay Vyas, President, Managing Director, GCC Head India at Parexel, said, “The Budget 2026’s Biopharma Shakti strategy marks a pivotal moment for clinical research in India. The creation of 1,000 clinical trial sites directly address long-standing gaps in research infrastructure and scale. This can materially improve trial quality, speed and geographic reach, while making India a more reliable destination for global clinical development. For patients, it means earlier access to innovative therapies. For the industry, it brings clarity and confidence that clinical research is now a strategic national priority.”

Shweta Rai, Managing Director – India and Country Division Head – South Asia, Bayer Pharmaceuticals in her comments stated that the Budget 2026 positions healthcare and life sciences as a critical pillar of India’s long-term economic and social progress, aligned with the vision of Viksit Bharat.

“We welcome the government’s focus on the Biopharma Shakti initiative. The Budget’s emphasis on supportive R&D tax incentives will further encourage innovation in biologics and biosimilars while rationalisation of customs duties on APIs, raw material and medical devices will strengthen domestic value chains. In parallel, patient-focused measures addressing India’s growing non-communicable disease burden, including the exemption of Basic Customs Duty on 17 drugs and medicines and the addition of seven rare diseases under import duty exemption for personal medical use, will help improve access to critical therapies. We particularly appreciate the measures aimed at strengthening clinical research capabilities through a nationwide network of 1,000 accredited clinical trial sites, alongside efforts to enhance the capacity of the Central Drugs Standard Control Organisation to enable globally aligned regulatory standards and faster approval timelines. These steps will support innovation, translate scientific advances into real-world clinical impact, improve patient access to high-quality therapies, and reinforce India’s transition from volume-based manufacturing to value-driven pharmaceutical leadership,” said Rai.

Dr Saurabh Arora, Managing Director, Auriga Research said: “Budget 2026 reflects a clear and deliberate push to strengthen India’s manufacturing and research ecosystem, particularly in biopharma. The Biopharma Shakti initiative is a significant boost for a sector driven by high value, high skill and high technology products. The creation of 1,000 clinical trial sites and the move to strengthen CDSCO to global standards demonstrate a deep understanding of what it takes to build a globally competitive biopharmaceutical industry. Repeated emphasis on quality upgradation and R and D infrastructure, seen across initiatives from biopharma to textiles, will provide a strong lift to the testing, inspection and certification ecosystem. The commitment to upgrading drug testing facilities for Ayurveda, with a focus on quality and skilled manpower to support exports, further reinforces the government’s intent to build robust quality infrastructure across healthcare segments. Overall, the budget sets a strong foundation, with execution now becoming the key differentiator.”

Ashok Nair, Managing Director, RPG Life Sciences believes Biopharma Shakti is a strong and timely signal that India wants to scale up capabilities in biosimilars and compete more confidently in global markets.

“The Budget proposes an outlay of Rs 10,000 crore over the next five years to build the ecosystem for domestic production of biologics and biosimilars. What makes this announcement practical, not just aspirational, is the focus on enabling infrastructure – a biopharma‑focused network with three new NIPERs, upgrades to seven existing NIPERs, a network of 1,000+ accredited clinical trial sites, and strengthening the CDSCO to meet global standards and improve approval timelines. For RPG Life Sciences, the value will come from improved ecosystem readiness, especially clinical‑trial output and predictable regulatory timelines. These enablers can potentially accelerate market entry and expand patient access, subject to effective and timely implementation,” said Nair.

Dr. K. Anand Kumar, MD, Indian Immunologicals Ltd commented: “Union Budget presented a defining moment to strengthen the country’s position as a global vaccine and biologics manufacturing hub. India already supplies nearly 60% of the world’s vaccines, and this initiative has the potential to accelerate our transition from being a volume-driven supplier to an innovation-led biopharma leader. Targeted investments in advanced manufacturing infrastructure, high-containment facilities, and indigenous production of key raw materials such as culture media, adjuvants, and single-use systems will significantly improve supply chain resilience.”

Amitabh Rath, Director, Finance Shared Services, Illumina mentioned, “We welcome the Union Budget 2026 and commend the government’s continued focus on building a strong, future-ready biopharma ecosystem in India. The emphasis on developing India as a global biopharma manufacturing hub through the Biopharma Shakti initiative, along with investments in clinical trial infrastructure, regulatory strengthening, and advanced skill development, reflects a clear intent to drive innovation-led growth. As genomics and data-driven science increasingly underpin drug discovery, clinical research, and precision healthcare, these measures help strengthen India’s potential to emerge as a globally competitive biopharma and healthcare innovation hub. They also encourage deeper collaboration across industry, academia, and healthcare systems.”

Siddharth Daga, Managing Director, VINS Bioproducts Limited said, “VINS Bioproducts welcomes the Union Budget 2026’s Biopharma SHAKTI initiative and its allocation of Rs 10,000 crore, which positions India to emerge as a leading global biopharmaceutical manufacturing hub. This strategic framework establishes a comprehensive ecosystem for domestic biologics and biosimilars production through the establishment of new National Institute of Pharmaceutical Education and Research (NIPER) centres, institutional upgrades, an expanded clinical trials network, and substantial strengthening of the Central Drugs Standard Control Organisation (CDSCO). The enhancement of CDSCO represents a particularly significant development, encompassing increased staffing levels, the creation of a dedicated scientific review cadre to expedite approval processes, accelerated drug development timelines for faster market access, enhanced safety and quality oversight mechanisms to strengthen stakeholder confidence, and harmonization with international regulatory standards to facilitate export growth and reinforce India’s global standing in pharmaceutical regulation. These initiatives collectively address critical gaps in talent development, infrastructure capacity, and regulatory efficiency. VINS Bioproducts is committed to contributing to this transformative national endeavour, advancing innovation and self-reliance in the biopharmaceutical sector while serving both domestic and international markets.”

Mohan Jain, Director, Naprod Life Sciences stated:”The initiative provides a timely push to strengthen domestic capabilities in advanced formulations and biologics, while faster regulatory approvals and a stronger CDSCO will significantly improve ease of execution for quality-focused manufacturers. Equally important are the measures aimed at creating ‘Champion MSMEs’ through targeted equity support, improved liquidity and professional compliance assistance, enabling pharma MSMEs to scale manufacturing, invest in quality systems and create high-skilled jobs. The Budget’s intent to rationalise GST structures and address inverted duty issues is a critical step in improving cost competitiveness and cash-flow efficiency for domestic manufacturers. Along with customs duty exemptions on select life-saving drugs, these measures will reduce import dependence, boost self-reliance, and advance India’s Aatmanirbhar Bharat vision, ensuring affordable medicines and a resilient, Viksit Bharat.”

Anuj Sethi, Senior Director, Crisil Ratings opined, India’s pharmaceutical sector has long been a leader in low-cost, small-molecule generics. The Biopharma Shakti initiative, with a Rs 10,000 crore outlay over 5 years and the setting up of 1,000 accredited trial sites will support development of India as a global bio-pharma hub and will enable domestic companies expand into more complex products such as biosimilars. This support is crucial as biosimilars require significant investments in clinical studies and capital. The initiative will help reduce gestation periods and regulatory hurdles for US FDA and EMA approvals, positioning India to capitalise on the $100-110 billion opportunity arising from the patent expiries for blockbuster biologics over the next decade.”

Aditya Sharma, Head of Process Solutions, India Region, Merck Life Science said, The Finance Minister’s announcement of the “Biopharma Shakti” initiative is a decisive move towards positioning India as a global center for biopharma manufacturing. The initiative provides timely momentum to strengthen domestic capabilities in biologics and biosimilars, while enhancing scale, quality, and global competitiveness across the sector. The proposed biopharma-focused network, including new and upgraded NIPERs and a nationwide ecosystem of 1,000 accredited clinical trial sites, will significantly reinforce India’s research, talent, and translational capabilities. Equally important is the government’s focus on strengthening the Central Drugs Standard Control Organisation (CDSCO), which will enable faster, science-led approvals aligned with global regulatory benchmarks.”

Rajwinder Mehdwan, Managing Director & CEO – Roche Pharma India & Neighbouring Markets mentioned, “We welcome the emphasis on Biopharma Shakti with the proposed outlay of Rs 10,000 cr over 5 years and the strengthening of CDSCO to global standards, recognising that biopharma innovation, manufacturing, research and regulatory standards must advance in parallel. This integrated approach is timely and critical to bringing innovative medicines to patients with quality and speed. The expansion of NIPER capacity and the creation of a nationwide network of 1000 accredited clinical trial sites further reinforce India’s potential as a global biopharma and research hub, while enabling broader and more inclusive participation in high-quality clinical research.”

Shakthi M. Nagappan, CEO, Telangana Life Sciences opined, “Telangana has been setting the direction for the next phase of life sciences growth well ahead of the curve. Guided by the Hon’ble Chief Minister Shri Revanth Reddy’s long-term vision and Shri D. Sridhar Babu, Hon’ble Minister for Industries, Commerce and IT  passionate leadership, our Life Sciences Policy 2026–30 anticipated this shift by prioritising advanced and complex manufacturing, deep innovation and R&D, and the creation of a strong, globally integrated clinical research and clinical trial network. The Union Budget’s focus on precisely these areas now amplifies this momentum, accelerating our goal of attracting USD 25 billion in investments and generating 500,000 jobs while reinforcing Hyderabad’s position as a global life sciences innovation hub.”

The initiative is also positioned as a strategic move to cement India’s ambition of becoming a global bio-pharma hub, while ensuring affordable access to advanced therapies for domestic patients. By strengthening local capabilities, the government aims to reduce import dependence, enhance export competitiveness, and prepare India’s healthcare system to manage the long-term burden of chronic diseases.

With this announcement, Budget 2026 places biopharma innovation firmly at the centre of India’s public health and industrial growth strategy, aligning healthcare priorities with long-term economic and demographic realities.