Prelims: Current events of national and international importance | Health
Why in News?
Recently, the Ministry of Health and Family Welfare has formed a committee to frame a policy for refurbished medical devices amid a dispute between domestic and global manufacturers.
- Refurbished medical devices – They are pre-used equipment restored to original operating specifications and resold at a lower cost.
- They are capital-intensive technologies.
- Components – Includes high-end systems like MRI, CT scanners, PET-CT systems, robotic surgery systems, endoscopy and laparoscopy equipment.
- Procurement Cost –
|
Device
|
New (Rs crore)
|
Refurbished (Rs crore)
|
|
MRI (1.5T)
|
4 – 8
|
1 – 3.5
|
|
PET-CT
|
20+
|
0.6 – 3.5
|
|
CT Scanner
|
2 – 4
|
0.2 – 2.5
|
- Lower cost helps hospitals in Tier-2, Tier-3 cities and standalone diagnostic centres.
- Regulatory Framework – Medical Devices Rules, 2017 – No dedicated regulatory pathway for refurbished medical devices.
- Drugs and Cosmetics Act, 2020 – Under which all medical devices are notified as “drugs”, but refurbished products are not separately defined.
- Import Regulations – Imports allowed through No-Objection Certificates (NOCs) issued by an expert committee under the Ministry of Environment, Forest and Climate Change (MoEFCC).
- Central Drugs Standard Control Organisation (CDSCO) –Provides quality assurance and other reports.
- Directorate General of Foreign Trade (DGFT) – Import authorisation.
- Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 – Primarily governs Imports of used medical equipment.
- Status – India has no legal definitions for “used”, “refurbished”, “reconditioned”, or “remanufactured” medical devices, causing regulatory ambiguity.
- Expert concern – Risk India becoming a dumping ground for outdated technology.
Reference
IE | Refurbished Medical Devices
