India calls for tougher medical-device testing as quality concerns surface
Pharma Secretary Manoj Joshi said India needs stronger finished-product testing and a device-specific regulatory framework amid concerns over poor-quality products. The government is also targeting 40–45% domestic value addition through component and SME incentives.
What happened
Department of Pharmaceuticals · Pharma Secretary Manoj Joshi called for stronger finished-product testing and a medical-device-specific regulatory framework,
Key facts
- 10-15 years
- 40-45% domestic value addition
Why this matters
Strategic buyers should prioritize targets with validated quality systems, testing capabilities, and localized component supply chains.
What to watch
- Publication of a device-specific regulatory framework, mandatory testing rules or revised Medical Devices Rules.
- New CDSCO enforcement actions, warning notices, recalls, import holds or license cancellations.
- Government announcements detailing component-manufacturing and SME incentive eligibility.
- Testing-lab capacity expansion, turnaround times and accreditation requirements.
- Price movement and in-stock rates for imported home-health and diagnostic-device categories.
- Audit medical-device SKUs by manufacturer registration, testing evidence, import dependency and adverse-event history.
- Require supplier indemnities, quality certificates, batch traceability and recall-service commitments before renewing listings.
- Shift procurement toward certified domestic manufacturers while dual-sourcing critical consumables to avoid approval-related stockouts.
- Build compliance-ready product pages and staff training for regulated claims, usage guidance and recall communication.
- Model margin and demand sensitivity under higher device acquisition costs and selectively pass through price increases.