Biopharma SHAKTI Scheme Explained: Budget 2026 Healthcare Innovation Push

Biopharma SHAKTI Scheme in Budget 2026 aims to boost healthcare innovation, strengthen India’s biopharmaceutical ecosystem, support R&D, and accelerate indigenous drug and vaccine development for global competitiveness.

Table of Contents

Context

The Union Budget 2026–27 marks a decisive shift in India’s pharmaceutical strategy, signalling a transition from being a low-cost generic producer to a global hub for biopharmaceutical innovation, biologics, and biosimilars.

Key Budget 2026–27 Announcements for Biopharma

Biopharma SHAKTI(Strategy for Healthcare Advancement through Knowledge, Technology & Innovation): Flagship initiative to strengthen domestic production of biologics and biosimilars and capture 5% of the global biopharma market.
- Outlay: ₹10,000 crore over five years
- Objective: Position India as a global biomanufacturing hub for biologics and biosimilars.
Expansion of Clinical Research Ecosystem: Under Biopharma SHAKTI, a network of over 1,000 accredited clinical trial sites across the country would be created.
Human Capital Strengthening: establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) along with the upgradation of the existing seven NIPERs.
Regulatory Strengthening (CDSCO): Induction of specialised scientific and technical personnel to improve regulatory efficiency, align approval timelines with global standards, and fast-track complex biologics.

Significance

It will catalyse investments in advanced biomanufacturing infrastructure
promote innovation and enhance India’s capabilities in high-value, next-generation therapies
reducing import dependence and strengthening healthcare security.

These measures collectively mark a significant step toward building a robust, innovation-driven, and globally competitive pharmaceutical and biopharmaceutical sector in India.

Government Initiatives Over the years to strengthen

National Biopharma Mission (NBM) – “Innovate in India (i3)”

Background and Objectives

Launched in May 2017 to transform India into a $100 billion global biotech industry.
Target to capture 5% of global pharmaceutical market share.
Total outlay: ₹1,500 crore, co-funded by the World Bank.
Implemented by BIRAC under the Department of Biotechnology (DBT).

Core Focus Areas

Development of new vaccines, biotherapeutics, biosimilars, diagnostics, and medical devices.
Addressing India’s rising burden of non-communicable and infectious diseases.
Improving affordability and accessibility of advanced therapies.

Collaborative Model

Triple-helix approach: Industry + Academia + Government.
Encourages translation of laboratory research into market-ready products.

BIRAC-led Biotech Innovation Support System

Institutional Role of BIRAC
- Established in 2012 under DBT.
- Acts as the implementation and funding arm for biotech innovation.
- Set up 95+ bio-incubation centres nationwide.
Key schemes include:
- Biotechnology Ignition Grant (BIG): Up to Rs. 50 lakh for 18 months to support early-stage startups; nearly 1,000 innovators supported.
- SEED Fund: Rs. 30 lakh equity support for proof-of-concept stage startups.
- LEAP Fund: Rs. 100 lakh equity support for commercialisation-ready innovations.
- जनCARE – Amrit Grand Challenge: Supported 89 digital health tech innovations in artificial intelligence, machine learning, telemedicine, and blockchain

Manufacturing and Industrial Strengthening Measures

Production Linked Incentive (PLI) Scheme
- Boosts domestic manufacturing capacity.
- Reduces dependence on imported APIs and intermediates.
Strengthening of Pharmaceutical Industry (SPI) Scheme
- Upgradation of MSMEs to WHO-GMP standards.
- Support for common infrastructure facilities in pharma clusters.
- Promotion of pharmaceuticals and medical devices.
Bulk Drug Parks Scheme
- Development of shared infrastructure for APIs.
- Enhances supply chain resilience and cost efficiency.
PRIP Scheme – Innovation in Pharma-MedTech
- Key Features
- Launched in 2023 with ₹5,000 crore outlay.
- Focus on:
  - New drugs
  - Biosimilars
  - Precision medicine
  - Complex generics
  - Novel medical devices

Bio-RIDE Scheme

Launched September 2024, outlay ₹9,197 crore.
Merged DBT’s umbrella schemes with new Biomanufacturing & Biofoundry components.
Three pillars:
- Biotechnology R&D
- Industrial & Entrepreneurship Development
- Biomanufacturing and Biofoundry

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