**Executive Summary**
The Government has announced the Biopharma SHAKTI scheme with a ₹10,000 crore outlay over five years to strengthen India's biopharmaceutical sector and enhance global competitiveness in biologics and biosimilars. The scheme aims to establish India as a global biopharma manufacturing and innovation hub and support affordable healthcare. The information was conveyed by the Minister of State for Chemicals and Fertilizers in a written reply to the Rajya Sabha on 10 March 2026.
**Key Points / Main Content**
* **Scheme Objectives:**
* Support domestic development and manufacturing of high-value biopharmaceutical products and medicines.
* Reduce import dependence and enhance India's competitiveness in the global biologics supply chain.
* Build a globally competitive domestic ecosystem for biologics and biosimilars.
* Support affordable healthcare in India.
* Enable India to emerge as a global biopharma manufacturing and innovation hub.
* **Human Resource Development:**
* Establishment of three new National Institutes of Pharmaceutical Education & Research (NIPERs).
* Upgradation of seven existing NIPERs.
* Focus on addressing the growing requirement for specialized human resources in biopharma research, development, manufacturing, and regulation.
* **Clinical Research Enhancement:**
* Creation of a large-scale clinical research ecosystem.
* Focus on improving India's capacity to conduct advanced clinical trials.
* **Regulatory Framework Strengthening:**
* Reinforcement of the Central Drugs Standard Control Organisation (CDSCO).
* Creation of a dedicated Scientific Review Cadre to enable faster, globally credible approvals.
* Reduction in the number of days taken for regulatory approvals.
* **Innovation and Funding Support:**
* Focus on early-stage innovation funding.
* Provision of structured equity support for startups and industry.
* Assistance to take promising candidates from concept through key development milestones.
**Impact Analysis**
**Indian Pharma Industry**
* **Impact:** Will benefit from support for domestic development and manufacturing of high-value biopharmaceutical products, reduced import dependence, and enhanced competitiveness. Will also receive support for early-stage innovation and structured equity funding.
* **Action Required:** Engage with the scheme's initiatives for funding, research, manufacturing, and regulatory support.
**Startups and Industry**
* **Impact:** Will benefit from early-stage innovation funding and structured equity support to advance their candidates through development milestones.
* **Action Required:** Leverage the available funding and equity support to develop promising biopharmaceutical candidates.
**Research and Development Ecosystem**
* **Impact:** Will be strengthened through the establishment of new NIPERs, upgradation of existing ones, and the creation of a large-scale clinical research ecosystem for advanced trials.
* **Action Required:** Utilize the expanded and strengthened research and educational infrastructure.
**Central Drugs Standard Control Organisation (CDSCO)**
* **Impact:** Will be reinforced with a dedicated Scientific Review Cadre, leading to faster and more credible regulatory approvals for biopharmaceutical products.
* **Action Required:** Implement the enhancements to the regulatory framework and establish the Scientific Review Cadre.
Key Entities Referenced
Bio Pharma SHAKTI scheme: A government initiative aimed at strengthening the domestic biopharmaceutical sector and enhancing global competitiveness in biologics and biosimilars.
Ministry of Chemicals and Fertilizers: The ministry responsible for the Bio Pharma SHAKTI scheme.
Central Drugs Standard Control Organisation (CDSCO): A regulatory body that will be reinforced to strengthen the framework for approvals under the scheme.
National Institutes of Pharmaceutical Education & Research (NIPERs): Institutes that will be established and upgraded to address the need for specialized human resources in the biopharma sector.
Smt. Anupriya Patel: Minister of State for Chemicals and Fertilizers, who provided the information about the scheme.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Bio Pharma SHAKTI scheme
Posted On: 10 MAR 2026 1:33PM by PIB Delhi
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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