**Executive Summary**
The Union Budget 2026-27 includes key initiatives aimed at strengthening India's pharmaceutical and biopharma sector. A major focus is the 'Biopharma SHAKTI' program, designed to develop India into a global biomanufacturing hub with an outlay of ₹10,000 crore over the next five years. The budget also includes provisions for expanding clinical research capacity and strengthening pharmaceutical education and research.
**Key Points / Main Content**
* **Biopharma SHAKTI Program:**
* Aims to develop India into a global biopharmaceutical manufacturing hub.
* Includes a total outlay of ₹10,000 crore over the next five years.
* Focuses on building a strong and self-reliant ecosystem for domestic production of biologics and biosimilars.
* Intends to catalyse investments in advanced biomanufacturing infrastructure.
* **Expansion of Clinical Research Capacity:**
* Will establish a network of over 1,000 accredited clinical trial sites across the country.
* Aims to enhance the quality and credibility of clinical research in India.
* Aims to accelerate drug development timelines.
* Seeks to improve access to cutting-edge therapies for Indian patients.
* Will generate significant opportunities for researchers, medical professionals, and allied sectors.
* **Strengthening Pharmaceutical Education and Research:**
* Will establish three new National Institutes of Pharmaceutical Education and Research (NIPERs).
* Will upgrade the existing seven NIPERs.
* Aims to enhance India's capacity for advanced pharmaceutical education, high-end research and innovation.
* **Strengthening Regulatory Framework:**
* The Central Drugs Standard Control Organisation will be strengthened.
* Will enhance global standards and approval timeframes through a dedicated scientific review cadre and specialists.
**Impact Analysis**
**Stakeholder: Pharmaceutical and Biopharma Industry**
* **Impact**: Increased investment opportunities, enhanced manufacturing capabilities, access to a larger network of clinical trial sites, and a more skilled workforce.
* **Action Required**: Monitor developments and participate in initiatives related to Biopharma SHAKTI, clinical research expansion, and NIPER development.
**Stakeholder: Researchers, Medical Professionals, and Allied Sectors**
* **Impact**: Increased opportunities for research and development, access to cutting-edge therapies, and potential for career advancement.
* **Action Required**: Stay informed about new research opportunities, collaborate with industry and academia, and participate in training programs.
**Stakeholder: Patients**
* **Impact**: Improved access to affordable biologic medicines and cutting-edge therapies.
* **Action Required**: Stay informed on available treatments and clinical trial opportunities.
**Stakeholder: Central Drugs Standard Control Organisation**
* **Impact**: Increased resources and expertise.
* **Action Required**: Implement the strengthening measures outlined in the budget, including the establishment of a dedicated scientific review cadre and specialists.
Key Entities Referenced
Biopharma SHAKTI: A program with an outlay of ₹10,000 crore to develop India into a global biopharmaceutical manufacturing hub.
National Institutes of Pharmaceutical Education and Research (NIPERs): Aim to strengthen pharmaceutical education and research in the country, with three new institutes and upgrading seven existing ones.
Central Drugs Standard Control Organisation: To be strengthened to meet global standards and approval timeframes.
Ministry of Chemicals and Fertilizers: Government ministry overseeing the Department of Pharmaceuticals, which is the source of the document.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
BUDGET PUSH TO MAKE INDIA A GLOBAL
BIOPHARMA HUB
‘SHAKTI’ TO BOOST DOMESTIC PRODUCTION BIOLOGICS
& BIOSIMILARS WITH AN OUTLAY OF ₹10,000 CRORE
1,000+ ACCREDITED CLINICAL TRIAL SITES TO
STRENGTHEN RESEARCH
3 NEW NIPERs, UPGRADATION OF 7 EXISTING INSTITUTES
प्रव तथ: 01 FEB 2026 2:07PM by PIB Delhi
The Union Budget 2026–27, presented by the Hon’ble Union Minister for Finance and Corporate Affairs
Smt. Nirmala Sitharaman in the Parliament today, has announced several key initiatives to strengthen
India’s pharmaceutical and biopharma sector. The Finance Minister stated that the Government has
undertaken comprehensive economic reforms towards creating employment, boosting productivity and
accelerating growth. The Minister emphasised scaling up of manufacturing in 7 strategic and frontier
sectors including Pharmaceuticals to further accelerate and sustain economic growth.
Biopharma SHAKTI to Position India as a Global Biomanufacturing Hub
Underlining the importance of Biologic medicines at affordable costs to longevity and quality of life, the
Finance Minister announced ‘Biopharma SHAKTI (Strategy for Healthcare Advancement through
Knowledge, Technology & Innovation)’ with a total outlay of ₹10,000 crore over the next five years. The
programme is designed to develop India into a global biopharmaceutical manufacturing hub by building a
strong and self-reliant ecosystem for the domestic production of biologics and biosimilars.
This initiative will catalyse investments in advanced biomanufacturing infrastructure, promote innovation
and enhance India’s capabilities in high-value, next-generation therapies, thereby reducing import
dependence and strengthening healthcare security.
Expansion of India’s Clinical Research Capacity
To further strengthen India’s position as a preferred destination for clinical research, under Biopharma
SHAKTI, the Finance Minister said a network of over 1,000 accredited clinical trial sites across the
country would be created.
This large-scale expansion will:Enhance the quality and credibility of clinical research in India
Accelerate drug development timelines
Improve access to cutting-edge therapies for Indian patients
Generate significant opportunities for researchers, medical professionals and allied sectors
The Finance Minister also announced that the Central Drugs Standard Control Organisation would be
strengthened to meet global standards and approval timeframes through a dedicated scientific review cadre
and specialists.
Strengthening Pharmaceutical Education and Research: New NIPERs
Emphasising strengthening of pharmaceutical education and research in the country, the Finance Minister
announced the establishment of three new National Institutes of Pharmaceutical Education and
Research (NIPERs) along with the upgradation of the existing seven NIPERs. This step will enhance
India’s capacity for advanced pharmaceutical education, high-end research and innovation. The expansion
and modernisation of these premier institutes will help in developing a highly skilled workforce,
promoting industry–academia collaboration, and supporting the growth of a globally competitive
pharmaceutical and biopharmaceutical sector.
These measures collectively mark a significant step toward building a robust, innovation-driven, and
globally competitive pharmaceutical and biopharmaceutical sector in India.
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