India Pharma Monitor

Pharmaceutical Industry in India

Policy and Government Initiatives

1. Biopharma SHAKTI Initiative (Rs. 10,000 crore)

On February 2, 2026, the PIB announced the Biopharma SHAKTI initiative with a Rs. 10,000 crore (USD 1.08 billion) investment to boost domestic biopharma capabilities, reduce import dependence, and enhance R&D in biologics, vaccines, and clinical research.

2. Production Linked Incentive (PLI) Scheme

The PLI scheme with Rs. 15,000 crore (USD 2.04 billion) outlay for 2020-21 to 2028-29 to boost manufacturing, investment, and product diversification, with Rs. 604 crore (USD 69.76 million) disbursed in H1 FY25 alone, supporting domestic API and drug manufacturing.

3. Rs. 60,000 crore API-Push Announcement

On December 5, 2025, India announced a Rs. 60,000 crore (USD 7 billion) API-push to boost domestic pharmaceutical manufacturing, cut import dependence (currently 70% for APIs from China), and strengthen cholera supply chain security.

4. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

16,912 Jan Aushadhi Kendras are operational as of June 30, 2025, with a target of 25,000 by March 2027, offering 2,110 medicines and 315 devices/consumables to promote affordable quality generic healthcare across India.

5. New Drugs and Clinical Trials (Amendment) Rules 2026

Revised New Drugs and Clinical Trials Rules 2026 reduced approval timelines from 90 to 45 working days for several regulatory actions, introducing prior-intimation system for low-risk categories and fast-track drug testing from June 1, 2026.

6. 100% FDI Policy via Automatic Route

India allows up to 100% FDI via automatic route for Greenfield pharma projects and up to 74% for Brownfield projects (beyond that with government approval), with sector receiving Rs. 2,10,940 crore (USD 24.62 billion) from April 2000-June 2025.

7. Union Budget 2025-26 Allocation

Rs. 5,268 crore (USD 602 million) allocated for the Department of Pharmaceuticals in Union Budget 2025-26, marking a 28.8% increase over previous budget estimates to support pharma sector growth and innovation.

8. Strengthening of Pharmaceutical Industry (SPI) Scheme

Department of Pharmaceuticals launched SPI scheme for MSMEs to address infrastructure gaps, with focus on technology upgradation, common facility centers, and quality compliance for small and medium pharmaceutical manufacturers.

9. 9th India Pharma 2026 Policy Push

The 9th India Pharma 2026 (April 13–14, New Delhi) highlighted policy emphasis on sectoral innovation, domestic manufacturing, and Vision Pharma 2047, with government urging pharma sector to anchor global supply chains via quality and innovation.

10. National Pharmaceutical Policy (2023 Draft)

National Pharmaceutical Policy 2023 is being drafted aligned with Vision Pharma 2047, serving as comprehensive framework to address pricing, accessibility, R&D, manufacturing capacity, and positioning India as “healthcare custodian of the world”.

India's pharma sector is witnessing notable activity in policy and india&#039, with important updates emerging around pharma. The Policy and Government Initiatives section provides a curated, regularly updated overview of developments that matter to professionals across the value chain.

Sources in this section include Business Standard, The Economic Times, and ET Auto. The coverage spans regulatory updates, corporate news, and research findings — providing professionals with a well-rounded perspective on current developments in policy and adjacent areas.

Key reference resources include World Health Organisation for official guidelines and CDSCO for industry intelligence. Those tracking the science underpinning these developments will find PharmaBiz a reliable resource for peer-reviewed evidence and data.

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