Biopharma SHAKTI Scheme
Biopharma SHAKTI Scheme
With a view to strengthen the domestic biopharmaceutical sector and enhance global competitiveness in biologics and biosimilars, the Government has announced the Biopharma SHAKTI scheme with an outlay of ₹10,000 crore over five years with an objective to build a globally competitive domestic ecosystem for biologics and biosimilars to support affordable healthcare in India and enable India to emerge as a global biopharma manufacturing and innovation hub. The contours of the scheme are under deliberation.
The Biopharma SHAKTI aims to focus on following components:
Under the scheme, it is envisaged to enable faster, globally credible approvals by strengthening the CDSCO through creation of a dedicated Scientific Review Cadre of reviewers and specialist positions for advanced fields like gene therapy. It is also envisaged to expand India’s clinical research footprint by creating a nationally accredited network of 1,000 clinical trial sites under ICMR.
The Biopharma SHAKTI initiative envisages to build the ecosystem for domestic production of biologics and bio-similars. Further by supporting research and development, strengthening clinical trial infrastructure and promoting collaboration between academia, research institutions and industry, the Scheme seeks to encourage domestic innovation and manufacturing capabilities in the biopharmaceutical sector. Such initiatives are expected to contribute towards reducing import dependence over time and enhance India’s participation in the global biopharmaceutical market.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in the Rajya Sabha today.
- Biopharma Discovery Grant Fund & Discovery & Development Equity Fund
- Biopharma-focused NIPER Network + National Biopharma R&D Network
- India Clinical Trial Sites Network (1,000 accredited sites)
- Fermentation-based Bulk Drugs & Building Blocks Manufacturing Incentive
- Biopharma Delivery Devices & Packaging Manufacturing Ecosystem
- Biosimilars & Emerging Biologics Manufacturing Initiative
- Regulatory Strengthening for Global-best Drug Review Standards and Approval Timeframes