Budget 2026: Biopharma Shakti plan aims to make India a biologics hub

Union Budget 2026: Finance Minister Nirmala Sitharaman unveils Biopharma Shakti, a ₹10,000 crore, five-year plan to boost domestic biologics, biosimilars, clinical trials and regulatory capacity

Finance Minister Nirmala Sitharaman on Sunday announced ‘Biopharma Shakti’, a ₹10,000 crore initiative aimed at developing India into a global biopharma manufacturing hub, as she presented the Union Budget 2026–27 in Parliament.

What is Biopharma Shakti announced in Budget 2026?

“BioPharma Shakti, meaning, BioPharma Strategy for Health Advancement through Knowledge, Technology and Innovation. India’s digital disease burden is observed to be shifting towards non-communicable diseases like diabetes, cancer and autoimmune disorders,” Sitharaman announced. 

“Biologic medicines are key to longevity and quality of life at affordable costs,” Sitharaman said, while outlining the government’s push to scale up domestic capabilities in advanced drug manufacturing. “To develop India as a global biopharma manufacturing hub, I propose the Biopharma Shakti with an outlay of ₹10,000 crore over the next five years. This will build the ecosystem for domestic production of biologics and biosimilars.”

Why the government is focusing on biologics and biosimilars

Explaining the rationale, the finance minister pointed to India’s changing disease profile. “India’s disease burden is observed to be shifting towards non-communicable diseases like diabetes, cancer and autoimmune disorders,” she said, adding that biologics will play a central role in managing these conditions.  ALSO READ | Budget 2026: Biopharma to medical tourism, push for healthcare value chain

Expansion of NIPERs and biopharma institutions

As part of the strategy, the government plans to create a biopharma-focused institutional network. “The strategy will include a biopharma-focused network with three new National Institutes of Pharmaceutical Education and Research, popularly known as NIPERs, and upgrading seven existing ones,” Sitharaman announced.

Clinical trials push under Biopharma Shakti

Clinical research capacity will also be expanded significantly. “It will also create a network of 1,000 accredited India clinical trial sites,” she said, a move expected to strengthen India’s ability to conduct large-scale trials for complex biologic drugs.

Regulatory reforms to speed up drug approvals

Regulatory reforms form another key pillar of the programme. “We propose to strengthen the Central Drugs Standard Control Organisation to meet global standards and approval timeframes through a dedicated scientific review cadre and specialists,” the finance minister said, signalling faster and more predictable drug approvals.

 

Linking Biopharma Shakti to broader reforms, Sitharaman said the initiative would also strengthen India’s digital ecosystem in healthcare, aligning drug development, clinical research and regulation with emerging health technologies. 

What are biologics and biosimilars, and why do they matter?

Biologics are a class of medicines made from living organisms or cells rather than simple chemical synthesis. They often consist of highly complex proteins and large molecules used to prevent, treat or manage serious conditions such as cancer, autoimmune disorders and diabetes. Their production requires advanced biotechnology because living systems are involved in growth and extraction, making these medicines significantly more intricate than traditional chemically derived drugs. Common examples include:

• Insulin used in diabetes treatment
• Monoclonal antibodies such as trastuzumab for breast cancer
• Adalimumab for autoimmune diseases like rheumatoid arthritis
• Erythropoietin, used to treat anaemia in kidney disease
• Growth hormone for certain hormonal disorders

Biosimilars are biologic medicines that are highly similar to an already approved biologic medicine, known as the reference product, and have no clinically meaningful differences in safety, purity or effectiveness. Because biological systems are inherently variable, biosimilars cannot be exact chemical copies, but stringent testing ensures they deliver comparable therapeutic results. Examples include:

• Biosimilar versions of insulin used widely in India
• Biosimilar trastuzumab for breast cancer treatment
• Biosimilar adalimumab for arthritis and autoimmune conditions
• Biosimilar rituximab used in blood cancers and autoimmune disease

The major advantage is cost. Biosimilars are typically 30–50 per cent cheaper than original biologics, helping expand access for patients and easing pressure on public healthcare systems. Countries that have invested early in biosimilar manufacturing have seen sharp reductions in treatment costs for diseases such as cancer and autoimmune disorders.

 

By pushing domestic production of biologics and biosimilars, the government aims to reduce import dependence, make advanced therapies more affordable and position India as a global supplier of complex medicines beyond low-cost generics.

How biosimilars differ from generics

Biologics are made from living cells, while generics are chemically synthesised. Generics are exact chemical copies of small-molecule drugs and are much simpler to make. Common examples include:

• Paracetamol for pain and fever
• Metformin for diabetes
• Amlodipine for high blood pressure
• Atorvastatin for cholesterol control
• Amoxicillin and other common antibiotics

Biosimilars, by contrast, are closer to biologics in structure and complexity and therefore require more extensive testing for approval. Unlike conventional generics, which can be exact molecular copies, biosimilars are only highly similar but are still held to the same safety and efficacy standards as their reference biologics.