Strengthening Pharmaceuticals Industry (SPI) Scheme
Background and Context
- India is already a pharmaceutical powerhouse.
- It is the 3rd largest producer by volume (number of medicines manufactured).
- But by value, it ranks 14th—which means that though we produce a lot, much of it is low-cost generics.
- India also has the second-highest number of US-FDA approved plants outside the United States, showing global trust in Indian quality.
- Yet, gaps remain:
- Pharma clusters often lack common infrastructure like modern testing labs or training centers.
- Many units, especially MSMEs, struggle to upgrade to Schedule M (mandatory under Drugs & Cosmetics Act) and WHO-GMP (World Health Organization–Good Manufacturing Practices) standards.
- To address these challenges, the government launched the SPI Scheme in FY 2021–22, to run till FY 2025–26.
Quick Facts
- Purpose: To make India a global leader in the pharmaceutical sector.
- Project Management Consultant: SIDBI (Small Industries Development Bank of India).
- Tenure: FY 2021–22 to FY 2025–26.
- Project Approval: Done by a Scheme Steering Committee (SSC), chaired by the Secretary of the Department of Pharmaceuticals (DoP).
Objectives of SPI
- Strengthen pharma cluster infrastructure through financial aid for common facilities.
- Upgrade individual production units to Schedule M and WHO-GMP standards via subsidies.
- Promote knowledge generation in pharma and medical devices industry through:
- Studies and surveys
- Database creation
- Collaboration with academia, industry leaders, and policymakers
Salient Features – Three Components of SPI
(A) Assistance to Pharmaceutical Industry for Common Facilities (API-CF)
- Objective: To strengthen existing pharma clusters by creating shared facilities.
- Examples of common facilities: Testing Centers, Training Centers, R&D Centers.
- Beneficiaries:
- Pharma units that form a Special Purpose Vehicle (SPV) with at least 5 members.
- State-promoted pharma clusters.
- Financial Assistance:
- Up to 70% of the project cost (or 90% in Himalayan/North-East regions).
- Maximum cap: ₹20 crore.
(B) Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS)
- Objective: To help pharma units upgrade to Schedule-M & WHO-GMP standards.
- Eligibility: Pharma units needing technology upgrades, with priority to MSMEs.
- Incentives:
- Subsidy for utilities, testing labs, waste management, etc.
- Can be linked with state schemes for added benefits.
- Financing Approach:
- Unlike older credit-linked models, this uses a reimbursement-based subsidy, making it flexible.
- Verification: Accountability ensured through a Project Management Agency.
(C) Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)
- Objective: To support the overall growth of pharma and medical device sectors.
- Activities Covered:
- Studies, surveys, and awareness programs
- Database creation
- Industry promotion activities
Why is SPI Important?
- Bridges the gap between India’s low-cost pharma dominance and the need for high-value, high-quality production.
- Encourages cluster-based development, which is cost-effective and globally competitive.
- Helps Indian pharma units achieve international certification standards (like WHO-GMP), which are essential for exports.
- Promotes not just manufacturing, but also knowledge building and industry–academia collaboration.
✅ In summary: The Strengthening Pharmaceuticals Industry (SPI) Scheme is a holistic initiative. It combines infrastructure development (API-CF), technology upgradation (RPTUAS), and knowledge promotion (PMPDS). Together, these pillars aim to transform India from being the “pharmacy of the world” in terms of generics, into a true global leader in the pharmaceutical and medical devices sector.