What Happened
- India's medical device sector is witnessing a regulatory conflict over the import of refurbished (pre-owned) high-end medical equipment such as MRI machines, CT scanners, and robotic surgical systems.
- The Central Drugs Standard Control Organisation (CDSCO) clarified in January 2025 that refurbished medical devices cannot be imported into India for sale and distribution, as no specific regulation exists for them under the Medical Devices Rules, 2017.
- However, the Ministry of Environment, Forest and Climate Change (MoEFCC) has approved multiple consignments of refurbished high-end medical equipment, creating a regulatory contradiction.
- Global manufacturers support the policy review, arguing refurbished devices expand affordable healthcare access; domestic manufacturers oppose imports, warning they undermine the Make in India initiative and PLI-backed investments.
Static Topic Bridges
Medical Devices Rules, 2017 and CDSCO
Medical devices in India are regulated under the Medical Devices Rules, 2017, notified under the Drugs and Cosmetics Act, 1940. The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India (DCGI), is the national regulatory body responsible for the approval and quality control of drugs and medical devices. The 2017 rules classify medical devices into four risk categories (Class A to D), with increasing regulatory oversight for higher-risk devices.
- Medical Devices Rules, 2017 notified under Section 12 of the Drugs and Cosmetics Act, 1940
- Classification: Class A (lowest risk, self-certification), Class B (low-moderate), Class C (moderate-high), Class D (highest risk, requiring clinical investigation)
- CDSCO functions: approval of new devices, import licensing, quality testing, post-market surveillance
- No specific provision exists in the 2017 Rules for refurbished or pre-owned devices, creating a regulatory vacuum
- E-waste (Management) Rules, 2022 under MoEFCC govern import of used electronic equipment, creating jurisdictional overlap with CDSCO
Connection to this news: The absence of a regulatory framework for refurbished devices under the Medical Devices Rules, 2017, is at the heart of the current conflict -- CDSCO interprets this absence as a prohibition, while MoEFCC's environmental clearance for imports creates a parallel approval pathway.
PLI Scheme for Medical Devices Manufacturing
The Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices was launched in 2020 with a total financial outlay of Rs 3,420 crore and a production tenure from FY 2022-23 to FY 2026-27. It provides a 5% incentive on incremental sales of medical devices manufactured domestically across four target segments: cancer care/radiotherapy, radiology and imaging, anaesthetics and cardio-respiratory, and all implants.
- Outlay: Rs 3,420 crore (FY 2022-23 to FY 2026-27)
- Incentive: 5% on incremental sales of domestically manufactured devices for five years
- 32 applicants selected; 19 greenfield projects commissioned for 44 products including MRI, CT scan, mammogram, linear accelerator
- Total investment realised: Rs 33,534 crore (surpassing projected Rs 17,275 crore)
- Cumulative sales: Rs 8,039.63 crore (including exports of Rs 3,844 crore)
- Target segments: high-value devices previously imported (CT scanners, MRI machines, C-arms, ultrasound machines)
Connection to this news: Domestic manufacturers argue that allowing refurbished imports directly undermines the PLI scheme's objective of building indigenous manufacturing capacity, as low-cost refurbished equipment from global companies would compete with newly manufactured domestic products.
Healthcare Access and Universal Health Coverage
India's healthcare system faces a dual challenge: high disease burden with inadequate infrastructure, particularly in tier-2 and tier-3 cities and rural areas. High-end diagnostic equipment (MRI, CT scanners) is concentrated in urban centres. The pre-owned medical equipment market, valued at approximately Rs 1,500 crore (about 10% of the total medical equipment industry), has historically filled gaps in equipment availability at district hospitals and smaller healthcare facilities.
- India's doctor-to-population ratio: approximately 1:834 (WHO recommendation: 1:1,000)
- India spends approximately 2.1% of GDP on health (National Health Policy 2017 target: 2.5% of GDP by 2025)
- Ayushman Bharat - PM Jan Arogya Yojana (AB-PMJAY) provides health cover of Rs 5 lakh per family per year for secondary and tertiary care
- Over 1.5 lakh Health and Wellness Centres (HWCs) aim to deliver comprehensive primary healthcare
- National Health Policy 2017 emphasises strengthening public health infrastructure, especially in underserved areas
- Only about 45% of district hospitals have functional CT scanners; the gap is wider for MRI machines
Connection to this news: The debate over refurbished medical device imports fundamentally pits two policy objectives against each other: expanding affordable healthcare access (especially in underserved areas) versus nurturing domestic manufacturing capacity under Make in India and PLI schemes.
Key Facts & Data
- Pre-owned medical equipment market in India: approximately Rs 1,500 crore (10% of total medical equipment industry)
- PLI scheme outlay for medical devices: Rs 3,420 crore
- PLI investment realised: Rs 33,534 crore (surpassing target of Rs 17,275 crore)
- Medical Devices Rules, 2017: four risk classes (A through D)
- CDSCO position: refurbished imports barred (no regulatory provision exists)
- MoEFCC position: has approved consignments under environmental import clearance
- India's health expenditure: approximately 2.1% of GDP
- PLI scheme covers: cancer care, radiology/imaging, anaesthetics/cardio-respiratory, and implants