Union Budget 2026: Government announces ₹10,000 crore outlay for Biopharma Shakti scheme

Union Finance Minister Nirmala Sitharaman announced in the Union Budget 2026 on Sunday a comprehensive scheme to strengthen the Central Drugs Standard Control Organisation (CDSCO), while also announcing a Biopharma Shakti scheme with ₹10,000-crore outlay.

The initiative aims to enhance the regulatory framework by significantly increasing manpower and operational efficiency. This development was first reported by Mint on January 16. The Finance Minister introduced a ₹10,000 crore proposal to bolster the biopharma sector, specifically designed to support the domestic manufacturing of biosimilars.

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To support this massive industrial expansion, the budget outlines a significant upgrade to India’s intellectual and physical infrastructure. This includes the creation of a specialized Biopharma-focused network that will see the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPER), alongside the modernization of seven existing institutes. Furthermore, to accelerate the drug approval process and ensure scientific rigor, the government plans to create a network of over 1,000 accredited clinical trials sites across the nation. This expansion is intended to provide the necessary data-driven environment for innovators to test and validate new biopharmaceutical products.

The dual focus on funding and regulation through the CDSCO overhaul ensures that as the industry grows, quality remains the highest priority. By increasing the manpower and efficiency of the national regulator, the government is signaling to global markets that Indian-made biosimilars will meet the most stringent safety standards. Combined with the educational and clinical infrastructure of Biopharma SHAKTI, this budget provides a comprehensive roadmap for India to transition from a leader in traditional generics to a dominant force in the global biotechnology landscape.

The FM has proposed interventions in 6 sectors, including manufacturing, strategic and frontier sectors, healthcare and advanced technology.

Sitharaman, in her speech, said that the scheme Bio Pharma Shakti is aimed at building an ecosystem for biopharma as well as biosimilar products.

Among other announcements, she proposed scaling up manufacturing in strategic and frontier sectors and developing city economic regions.

In her initial remarks, Finance Minister Nirmala Sitharaman said since her government assumed office, Indian economic trajectory is marked by fiscal discipline and sustained growth.

Sitharaman stressed that the central government, under the leadership of Prime Minister Narendra Modi, has chosen action over ambivalance, and reform over rhetoric, keeping Atmanirbharta or self-reliance as lodestar.

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"Since we assumed office 12 years ago, India's economic trajectory has been marked by stability, fiscal discipline, sustained growth and moderate inflation," she said. The FM revealed that India will balance ambition with inclusion going ahead.

Biocon chief Kiran Mazumdar-Shaw has hailed the announcements related to biotechnology in the Budget, saying, “By placing biopharma among the seven strategic frontier sectors and launching Biopharma Shakti with an outlay of ₹10,000 crore over five years, the Union Budget makes a decisive investment in India’s health and innovation future. As India’s disease burden shifts toward cancer, diabetes and autoimmune disorders, biologics and biosimilars will be central to improving longevity and quality of life. This initiative—spanning manufacturing scale-up, global-grade regulation, new NIPER institutions and a nationwide clinical trials network—can firmly position India as a global biopharma manufacturing hub.”

Other healthcare-related announcements:

1. Sitharaman has also planned to set up three new All India Institutes of Ayurveda.

2. The FM has announced an addition of 100,000 Allied Health Professionals (AHPs) over the next five years.

3. A scheme to support states in establishing five regional medical hubs.

4. 1.5 lakh caregivers are to be trained.

5. A NIMHANS-2 is to be set up.

6. District hospitals to see 50% capacity increase by establishing Emergency & Trauma Care Centres.

With agency inputs