The government has proposed the Bio-Pharma SHAKTI scheme in the Union Budget 2026-27 at an outlay of ten thousand crore rupees over five years. The initiative is aimed at strengthening India’s ecosystem for production of biologics and biosimilars. It is also designed to support domestic development and manufacturing of high-value biopharmaceutical products and medicines. It also aims to reduce import dependence, and enhance India’s competitiveness in global biologics supply chains.

 

The Union Budget links manufacturing scale, skilled human resources, clinical research capacity and regulatory credibility into a single framework. The government proposed the expansion and strengthening of the Biopharma-focused network through the establishment of three new National Institutes of Pharmaceutical Education and Research (NIPERs) and the upgradation of seven existing NIPERs. The measure seeks to address the growing requirement for highly specialised human resources in biopharma research, development, manufacturing and regulation.

 

Another key announcement in the Union Budget includes the creation of a large-scale clinical research ecosystem, with a proposal to develop over one thousand 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.

 

The government also announced the strengthening of the regulatory framework for biologics, including enhancing the capacity of the Central Drugs Standard Control Organisation (CDSCO) through the induction of specialised scientific and technical personnel. The move focuses on improving regulatory efficiency, aligning approval timeframes with global standards, and enabling faster evaluation of complex biopharmaceutical products. Talking to media, Science and Technology Minister Jitendra Singh said that India is among the very few nations having a dedicated exclusive policy for bio-technology.

 

The 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.