India to Invest ₹10,000 Crores in Biologics and Drug Discovery!
Can the BioPharma SHAKTI Scheme Change Pharma Forever?
India is now preparing to make one of its big investments in pharmaceutical innovation with the proposed BioPharma SHAKTI scheme, which is backed by an estimated ₹10,000 crore over the next five years. This initiative is designed to strengthen the country’s capacity in discovering, developing, testing and manufacturing advanced biological medicines.
For many years, India has been recognised as the “Pharmacy of the World” because of its leadership in generic medicines. Since the world is now driven by biologics, cell therapies, and precision medicine, the Indian government started BioPharma SHAKTI to help pharmaceutical companies move beyond generic manufacturing and become innovators in biopharmaceuticals.
What is the BioPharma SHAKTI Scheme?
This scheme is announced as part of the Union Budget 2026-27, where the BioPharma SHAKTI is expected to receive an allocation of ₹10,000 crore over five years.
This scheme is currently awaiting final approvals, after which the Department of Pharmaceuticals is expected to release detailed guidelines and invite proposals from pharmaceutical companies, research institutes, startup companies, and academia-industry collaborations.
The objective of this scheme is to build a complete ecosystem that will support every stage of drug development.
Why Does India Need BioPharma SHAKTI?
India has already built a strong reputation in producing affordable generic medicines, but the development of biologics remains a challenge for Indian pharmaceutical companies.
Unlike conventional medicines, which are synthesized chemically, biologics are developed using living cells and also require sophisticated research and specialised manufacturing facilities, and extensive clinical testing. Developing these medicines also demands many years of research, advanced laboratories, and highly skilled professionals.
Currently, many Indian pharmaceutical companies depend on organisations from overseas for specialised biological research, analysis, and certain stages of drug development. This also increases the cost and extends the development process.
The BioPharma SHAKTI scheme aims to strengthen these capabilities within India.
Major Focus Areas of the Scheme
This scheme is going to support many high-priority areas of research in India. They are:
Development of Novel Biologics
The government is planning to encourage research on innovative biological medicines for diseases where the treatment options are evolving.
These include therapies for Cancer, autoimmune disorders, Rare Diseases, Metabolic disorders, and obesity.
Biosimilars
India already has experience in manufacturing biosimilars. The new scheme aims to strengthen this segment further by improving the research infrastructure and speeding up the product development process.
Monoclonal Antibodies
Monoclonal antibodies have now become one of the fastest-growing therapeutic categories globally. These medicines are widely used in oncology, immunology, and inflammatory disorders.
BioPharma SHAKTI will help to improve India’s capacity in developing and manufacturing these therapies.
Advanced Cell Therapies
Emerging therapies like CAR-T Cell Therapy represent the future of personalised medicine.
The scheme aims to encourage research and manufacturing capabilities in these advanced therapies, reducing dependence on imported technologies
NIPER Expansion
A major highlight of this scheme is the expansion of pharmaceutical education and research infrastructure. The government plans to establish three new National Institutes of Pharmaceutical Education and Research (NIPERs) while upgrading seven existing NIPER Campuses into dedicated Biopharma Centres of Excellence.
This initiative is expected to strengthen advanced research, industry collaboration, translational science, and skill development, creating better opportunities for pharmacy students and researchers.
Expansion of Clinical Trials Infrastructure
The scheme proposes the creation of a national network of more than 1,000 accredited clinical trial sites across India.
Strengthening the country’s clinical research infrastructure is expected to accelerate the development of biologics, improve patient access to innovative therapies, and position India as a preferred destination for global clinical trials.
Regulatory Reforms for Faster Drug Evaluation
The government also plans to strengthen the Central Drugs Standard Control Organisation (CDSCO) by introducing a dedicated Scientific Review Cadre.
This specialised regulatory workforce is expected to improve scientific evaluation and speed up the review of complex biopharmaceutical products while maintaining stringent safety and quality standards.
Promotion of Non-Animal Methodologies (NAMs)
Another important component of the scheme is the promotion of Non-Animal Methodologies (NAMs) for drug safety assessment.
The initiative encourages the adoption of advanced technologies such as 3D bioprinting, organ-on-a-chip systems, and organoid models, which can improve the accuracy of safety testing, reduce dependence on animal studies, and support faster, more ethical drug development.
Strengthening India’s Biopharma Ecosystem
This scheme will not only fund the research, but it also aims to strengthen India’s entire biopharmaceutical ecosystem by expanding the clinical trial networks, upgrading the research infrastructure, and promoting the adoption of electronic health records.
It also aims to encourage collaboration between hospitals, research institutions, industry, and academia.
The major focus will be on supporting Contract Research, Development and Manufacturing Organisations (CRDMOs), which play a crucial role in biological drug discovery, protein characterisation, analytical testing, process development, preclinical research, clinical trials, and large-scale manufacturing.
The government also consulted key stakeholders, including some pharmaceutical companies, academic institutions, government research laboratories, the Indian Council of Medical Research (ICMR), the Department of Biotechnology (DBT), the Biotechnology Industry Research Assistance Council (BIRAC), and the National Institute of Pharmaceutical Education and Research, to ensure the scheme addresses the industry needs.
While artificial intelligence is expected to speed up the early stage of the drug discovery process by helping researchers identify promising drug candidates and analyse complex data, experts say that AI cannot replace laboratory validation, safety testing, manufacturing optimisation, or clinical trials.
So by investing in advanced research facilities, CRDMOs, and collaborative innovation, the scheme aims to reduce India’s dependence on overseas and establish the country as a stronger global hub for biologics research and development.
India’s Ambition in the Global BioPharma Market
India’s Biopharmaceutical industry has now grown steadily over the past few years.
With BioPharma SHAKTI, the government aims to increase India’s Participation in the global biologics market by supporting innovation instead of just relying on generic manufacturing.
If this scheme is implemented successfully, the initiative could help Indian pharmaceutical companies develop globally competitive biologics while attracting greater investments in research and development.
