National Bio-Pharma Mission

The National Bio-Pharma Mission (NBM) is a strategic initiative launched by the Government of India to accelerate the development of an ecosystem that supports biopharmaceutical innovation, product development, and manufacturing within the country. Implemented by the Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology (DBT), Ministry of Science and Technology, the mission aims to transform India into a globally competitive hub for the biopharmaceutical sector by enhancing indigenous research capabilities and reducing dependency on imports.

Background and Genesis

The National Bio-Pharma Mission was formally launched in 2017 with financial support from the World Bank. It is also known as the Innovate in India (i3) programme. The mission was conceived in response to the growing demand for affordable healthcare solutions and the need to strengthen India’s biopharmaceutical sector, which was already emerging as a significant component of the biotechnology industry.
Before the launch of NBM, India’s biopharma sector faced challenges such as limited research infrastructure, weak industry–academia linkages, inadequate funding, and delays in product development. The mission was thus designed to address these bottlenecks by creating a collaborative and enabling environment for innovation and entrepreneurship.
The total cost of the project was around USD 250 million, jointly funded by the Government of India (50%) and the World Bank (50%). The mission has a defined implementation period, initially planned for five years (2017–2022), with scope for extensions based on emerging needs.

Objectives of the Mission

The core objectives of the National Bio-Pharma Mission include:

• To enhance India’s capacity for product development and manufacturing of affordable vaccines, biotherapeutics, diagnostics, and medical devices.
• To strengthen translational research and industry–academia partnerships for innovation.
• To accelerate the development of biosimilars, vaccines, and biologics to meet domestic and global health demands.
• To build shared research infrastructure for product evaluation and validation.
• To train and nurture a skilled workforce for the biopharmaceutical sector.
• To promote regulatory harmonisation and improve clinical trial capabilities.

Key Components of the Mission

The National Bio-Pharma Mission operates through a multi-pronged approach involving capacity building, infrastructure creation, and financial support mechanisms. Its major components include:

1. Strengthening Translational Research and Product Development:
   • Funding support for early-stage and late-stage research projects.
   • Encouragement of academia–industry collaborations to bridge the innovation gap.
   • Development of affordable vaccines, biotherapeutics, and biosimilars targeting major public health concerns such as tuberculosis, dengue, malaria, and cancers.
2. Enhancement of Clinical Trial and Testing Infrastructure:
   • Establishment of Good Clinical Practice (GCP)-compliant trial networks.
   • Upgradation of bioassay and analytical facilities for vaccine and biologic testing.
   • Development of pre-clinical toxicology and validation centres.
3. Building Shared Research and Manufacturing Infrastructure:
   • Creation of facilities for scale-up, formulation, and bio-process validation accessible to start-ups, academic institutions, and MSMEs.
   • Promotion of Bio-Clusters and Bio-Incubators to facilitate entrepreneurship and collaborative innovation.
4. Regulatory Strengthening and Policy Support:
   • Streamlining approval processes for biopharmaceutical products.
   • Training regulators and establishing standard operating procedures (SOPs) for faster evaluation.
   • Facilitating harmonisation with international regulatory standards to enhance export potential.
5. Human Resource Development:
   • Implementation of training programmes in bio-manufacturing, regulatory affairs, and clinical research.
   • Partnerships with universities and research institutes to foster skill development.

Implementation Framework

The National Bio-Pharma Mission is implemented by BIRAC, a not-for-profit public sector enterprise established by the DBT to promote innovation and entrepreneurship in biotechnology.
The mission follows a public–private partnership (PPP) model, engaging multiple stakeholders such as:

• Academic and research institutions.
• Start-ups and biotech industries.
• Government agencies and public health bodies.
• International organisations and funding agencies.

BIRAC serves as the central coordinating body for fund allocation, project monitoring, and partnership facilitation. The governance structure includes a Project Steering Committee, a Technical Advisory Group, and a Monitoring and Evaluation Unit to ensure effective implementation and accountability.

Achievements and Impact

Since its inception, the National Bio-Pharma Mission has achieved significant progress in building infrastructure, developing products, and fostering innovation across the biopharmaceutical sector. Some notable achievements include:

• Establishment of 30+ facilities including vaccine testing, bioassay laboratories, and manufacturing centres across India.
• Development of indigenous vaccine candidates for diseases such as COVID-19, dengue, and rotavirus.
• Support for over 100 start-ups and MSMEs engaged in biopharma innovation.
• Strengthening of clinical trial capabilities through pan-India clinical networks and bio-repositories.
• Enhanced collaboration between industry and academia for translational research.
• Promotion of affordable healthcare products that cater to both domestic and international markets.

A major highlight of the mission was its contribution to India’s COVID-19 response, where facilities and networks established under NBM were utilised for vaccine trials, testing, and regulatory coordination.

Significance to the Indian Economy and Public Health

The National Bio-Pharma Mission holds immense strategic significance for India’s healthcare and economic landscape:

• Boosts Indigenous Capability: Reduces dependence on imported biologics and pharmaceuticals.
• Promotes Self-Reliance: Aligns with the government’s Atmanirbhar Bharat vision.
• Encourages Innovation: Facilitates the translation of academic research into commercial products.
• Improves Public Health: Ensures affordable access to life-saving vaccines and biologics.
• Enhances Global Competitiveness: Positions India as a major player in the global biopharma market.

Challenges and Limitations

Despite notable progress, the mission faces challenges such as:

• Regulatory Delays: Need for continuous simplification of clinical and product approval processes.
• Funding Constraints: Sustained financial support is essential for long-term projects.
• Skill Gaps: Shortage of trained manpower in advanced bio-manufacturing technologies.
• Intellectual Property Issues: Need for stronger protection mechanisms and technology transfer policies.
• Infrastructure Gaps: Some regions still lack advanced R&D and testing facilities.

Future Prospects

The success of the National Bio-Pharma Mission has prompted discussions about extending and scaling up its initiatives. The government aims to further:

• Strengthen vaccine research and pandemic preparedness.
• Promote biopharmaceutical clusters with integrated R&D, manufacturing, and training units.
• Enhance collaboration with global research networks for advanced therapeutic development.
• Foster innovation-driven entrepreneurship to achieve leadership in biologics, biosimilars, and diagnostics.