With a view to strengthening the domestic biopharmaceutical sector and enhancing 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.

India’s disease burden is observed to be shifting towards non-communicable diseases, like diabetes, cancer and autoimmune disorders. Biologic medicines are key to longevity and quality of life at affordable costs. To develop India as a global Biopharma manufacturing hub, an initiative like Biopharma SHAKTI for the biopharma sector is intended to benefit the Indian pharma industry in the following manner:

i.          The initiative aims 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 chain.

ii.         Expansion and strengthening of Biopharma-focused network through establishment of three new National Institutes of Pharmaceutical Education & Research (NIPERs) and upgradation of seven existing NIPERs to address growing requirement of specialised human resource in biopharma research, development, manufacturing and regulation.

iii.        Creation of large-scale clinical research ecosystem with a focus on improving India’s capacity to conduct advanced clinical trials.

iv.        The Central Drugs Standard Control Organisation (CDSCO) to be reinforced to strengthen regulatory framework which will enable faster, globally credible approvals by creation of a dedicated Scientific Review Cadre. It will reduce number of days currently being taken for regulatory approvals.

v.         The initiative focuses on early-stage innovation funding and structured equity support to help startups and industry take promising candidates from concept through key development milestones.

This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in the Rajya Sabha today.

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