In recent years, medicines have increasingly moved beyond traditional chemical drugs to therapies that are developed using biology itself. This shift has brought biopharma to the forefront of modern healthcare. Biopharma, or biopharmaceuticals, refers to the part of the pharmaceutical industry that focuses on developing and manufacturing medicines using living biological systems, rather than relying solely on chemical synthesis.

In simple terms, biopharma medicines are produced by working with cells, microorganisms or other biological materials. These may include human or animal cells, bacteria, fungi or similar biological platforms that are used to grow or produce therapeutic substances. Using biotechnology-based research methods, these living systems are guided to produce medicines that can prevent, diagnose or treat disease. Because they are created through biological processes, biopharma products are often more complex and targeted than conventional drugs, allowing them to interact more precisely with biological pathways.

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Some of the most widely used modern medicines fall under biopharma, including vaccines, therapeutic proteins, biosimilars and other advanced biologic therapies. These products have become essential to public health programmes and clinical care, particularly for infectious diseases, chronic conditions and disorders where traditional drugs may be less effective.

Acknowledging the growing burden of non-communicable diseases and the increasing global reliance on biologics and biosimilars, the Budget positions biopharma as a high-value, future-facing segment critical for both public health and economic growth.

Biopharma involves the production, manufacturing, or extraction of therapies through biological organisms, such as human cells, fungi, or microbes. Some examples of biopharmaceuticals include vaccines, antibody treatments, gene therapies, cell implants, modern insulin, and recombinant protein drugs.

Launch of Biopharma SHAKTI, a dedicated national initiative with an outlay of Rs.10,000 crores over five years, aimed at strengthening India’s end-to-end ecosystem for biologics and biosimilars. The initiative is designed to support domestic development and manufacturing of high-value biopharmaceutical products and medicines, reduce import dependence, and enhance India’s competitiveness in global biologics supply chains.

Expansion and strengthening of the Biopharma-focused network through the establishment of three new National Institutes of Pharmaceutical Education and Research and the upgradation of seven existing NIPERs. This measure seeks to address the growing requirement for highly specialised human resources in biopharma research, development, manufacturing and regulation.

Creation of a large-scale clinical research ecosystem, with a proposal to develop over 1,000 accredited clinical trial sites across the country. This is expected to significantly improve India’s capacity to conduct advanced clinical trials for biologics and biosimilars, accelerating innovation and positioning the country as a preferred global destination for ethical, high-quality, and efficient clinical trials.

Strengthening of the regulatory framework for biologics, including enhancing the capacity of the Central Drugs Standard Control Organisation through the induction of specialised scientific and technical personnel. The focus is on improving regulatory efficiency, aligning approval timeframes with global standards, and enabling faster evaluation of complex biopharmaceutical products.

The Budget links manufacturing scale, skilled human resources, clinical research capacity and regulatory credibility into a single framework. This signals a clear intent to move India up the pharmaceutical value chain, from being a cost-efficient producer of generic medicines to a global hub for high-quality, innovation-driven biopharmaceutical products.

This Budget push further strengthens the groundwork for India to compete in the global biopharma market while improving domestic access to advanced and affordable biologic therapies.

The Indian pharmaceutical industry is no longer limited to making low-cost generic medicines; it is increasingly investing in research and developing complex, high-value products such as biopharmaceuticals and biosimilars. The country has emerged as a global hub for affordable, high-quality medicines, ranking 3rd in pharmaceutical production by volume and 11th by value.

Over the past several years, India has implemented a series of policy initiatives and schemes aimed at strengthening the biopharmaceutical sector across the value chain, from research and early-stage product development to manufacturing, innovation and commercialisation.

Various initiatives focus on bringing together government, academia, industry and start-ups. They aim to build shared infrastructure, encourage innovation, and strengthen domestic manufacturing to make India a global biopharma and biomanufacturing hub.