Government Unveils ₹10000 Crore Biopharma SHAKTI Scheme to Boost Biologics, Biosimilars Ecosystem

Initiative aims to strengthen R&D, clinical trials and manufacturing to position India as a global biopharma hub

New Delhi: The government has announced the Biopharma SHAKTI scheme with an outlay of ₹10,000 crore over five years, aimed at strengthening India’s domestic biopharmaceutical sector and enhancing global competitiveness in biologics and biosimilars.

The scheme seeks to build a globally competitive ecosystem to support affordable healthcare while positioning India as a major biopharma manufacturing and innovation hub. The detailed contours of the scheme are currently under deliberation.

Multi-pronged push across R&D, manufacturing and regulation

The Biopharma SHAKTI initiative is designed as a comprehensive intervention spanning research, clinical development, manufacturing and regulatory systems.

Key components of the scheme include the creation of a biopharma discovery grant fund and equity funding mechanisms to support early-stage innovation, along with the establishment of a biopharma-focused NIPER network and a national biopharma R&D network to strengthen research capabilities.

The scheme also proposes development of an India clinical trial sites network comprising 1,000 accredited sites, aimed at expanding the country’s clinical research capacity and improving global credibility.

Strengthening manufacturing and supply chains

To reduce import dependence and enhance domestic production, the scheme includes incentives for fermentation-based bulk drugs and key building blocks manufacturing, as well as initiatives to develop a biopharma delivery devices and packaging ecosystem.

A dedicated push is also planned for biosimilars and emerging biologics manufacturing, which are seen as high-growth segments in the global pharmaceutical market.

Regulatory reforms for faster approvals

A major focus area of the scheme is regulatory strengthening to align India with global standards.

The government plans to enhance the capacity of the central drugs standard control organisation (CDSCO) by creating a dedicated scientific review cadre and specialist positions in advanced fields such as gene therapy.

This is expected to enable faster and globally credible drug approvals, improving India’s attractiveness as a destination for biopharma innovation and clinical research.

Expanding clinical research footprint

The scheme envisages collaboration with the Indian Council of Medical Research (ICMR) to establish a nationwide network of accredited clinical trial sites.

This move is aimed at improving the scale, quality and reliability of clinical trials conducted in India, a key requirement for global pharmaceutical companies.

Boost to innovation and global competitiveness

Officials said the initiative will promote collaboration between academia, research institutions and industry, helping build a strong pipeline of innovation in biologics and biosimilars.

By strengthening R&D, manufacturing and regulatory frameworks, the scheme is expected to reduce import dependence, enhance domestic capabilities and increase India’s share in the global biopharmaceutical market.

The information was shared in the Rajya Sabha by Minister of State for Chemicals and Fertilizers Anupriya Patel.