An Overview - PLI Scheme Medical Device Sales
Medical device manufacturers in India have achieved impressive sales of Rs 8,039.63 crore under the Production Linked Incentive (PLI) Scheme as of September 2024. This includes exports worth Rs 3,844.01 crore, highlighting the global reach of India’s medical devices industry.
The PLI Scheme for Medical Devices, approved by the Government of India on March 20, 2020, aims to promote domestic manufacturing and attract significant investments in this critical sector. The guidelines for its implementation were released on October 29, 2020.
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Key Features of the PLI Scheme for Medical Devices
- Scope of the Scheme: The scheme is applicable to greenfield projects and targets boosting domestic production of medical devices.
- Duration and Financial Outlay: It spans from FY 2020-21 to FY 2027-28, with a total financial allocation of Rs 3,420 crore.
- Financial Incentives: Eligible companies receive a financial incentive of 5% on incremental sales of medical devices manufactured in India under the targeted categories, for a duration of five years.
Addressing Manufacturing Challenges
The PLI scheme addresses key challenges faced by the Indian medical devices industry, including:
- High manufacturing costs due to inadequate infrastructure and domestic supply chains.
- Limited design capabilities and investment in R&D.
- High costs of logistics and financing.
- Skill development gaps.
Categories of Medical Devices Under the PLI Scheme
The targeted medical devices under the scheme are classified into four categories:
- Cancer Care/Radiotherapy Medical Devices
- Radiology & Imaging Devices (both ionizing and non-ionizing radiation products) and Nuclear Imaging Devices
- Anaesthetics & Cardio-Respiratory Devices, including catheters and renal care devices
- All Implants, including implantable electronic devices
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Role of Operon Strategist in Supporting the Medical Devices Industry
Operon Strategist plays a crucial role in facilitating the growth and compliance of the medical devices sector. With their expertise in regulatory consulting and business solutions, they assist manufacturers in navigating the complexities of the PLI Scheme Medical Device Sales and other industry requirements.
Services Provided by Operon Strategist:
- Medical Device Regulatory Services: Support with ISO 13485 certification, CE marking, and FDA compliance.
- Project Management Assistance: Guidance in setting up greenfield projects under the PLI scheme.
- Quality Assurance Consulting: Ensuring adherence to quality standards and regulatory frameworks.
- Business Strategy Development: Crafting strategies for market entry and scalability.
- Technical Documentation: Preparation of detailed reports and submissions for regulatory approval.
The PLI Scheme Medical Device Sales initiative, combined with the strategic support from organizations like Operon Strategist, is propelling India’s medical device industry toward global excellence.
