Focus on Promoting Domestic Manufacturing through PLI Scheme
In a significant policy update, India will reduce import duties on medical devices covered under the production-linked incentive (PLI) scheme starting from the sixth year of implementation, as part of its Free Trade Agreement (FTA) with the United Kingdom. This phased approach aligns with the government’s vision to boost domestic manufacturing under the Make in India initiative while safeguarding local manufacturers.
Details of the FTA Agreement
The FTA, announced on May 6, 2025, is expected to double India–UK trade in goods and services to USD 120 billion over the next five years, up from the current USD 60 billion. Under the agreement:
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- India will gradually reduce tariffs on 90% of UK imports.
- 85% of product categories will become tariff-free within 10 years.
- Import duty on PLI-covered medical devices will only reduce from the sixth year, not be fully eliminated.
This provision was made to balance consumer access with domestic capacity-building, especially for medtech products under the PLI scheme.
Rising Imports and Industry Concerns
India’s medical device imports from the UK rose over 35% in FY 2023–24, reaching ₹2,295 crore, while exports stood at approximately ₹1,000 crore. Key traded items include:
- Spectacles
- Orthopaedic appliances
- Radiography apparatus
- Breathing aids
- Surgical and dental instruments
Experts have expressed concerns over potential dumping of low-cost products, especially from non-FTA countries. To counter this, India may implement high value-addition norms to ensure only eligible imports benefit from concessional duties.
Role of the PLI Scheme in India's Medtech Growth
The PLI Scheme for Medical Devices is designed to reduce dependency on imports and promote the local production of high-end equipment. To date, it has supported:
- 19 greenfield projects across India
- Local production of 44 advanced medical devices, including MRI machines, CT scanners, mammography units, and ultrasound systems
This initiative not only enhances India’s self-reliance but also supports job creation and export competitiveness in the global medtech industry.
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How Operon Strategist Supports Medical Device Manufacturers
Operon Strategist is a leading regulatory and compliance consultancy specializing in medical device regulatory approvals, PLI consulting, plant setup, and quality management systems. With deep expertise in FDA 510(k), ISO 13485, CE Marking, and global regulatory pathways, we empower medical device manufacturers, importers, and exporters to:
- Navigate the PLI scheme and unlock incentives
- Set up compliant manufacturing units
- Secure timely regulatory clearances
- Ensure end-to-end product lifecycle compliance
Whether you’re a startup or an established manufacturer, we provide customized, turnkey consulting services to help you capitalize on India’s growing medical device ecosystem.
