- Addressing patient safety and quality needs by regulations etc, and need for separate medical devices law.
- Having possibly BioMedical engineers to play the corresponding role of Pharmacists in hospitals to ensure healthcare providers abides by law in ensuring single use of devices where they are so labelled and proper storage and upkeep of equipment and its calibration etc, to avoid sad incidents like BRD Medical College, Gorakhpur tragedy.
- Product development and research & development prioritisation and acquisition of enabling critical technologies from overseas and role of Kalam Institute of Healthcare Technologies in creating a corpus for this as well as assisting in commercialisation of patents lying unutilised in Government institutions.
- Possible ways of consumer protection and ensuring affordable access by self regulations or a regulatory framework.
- Other factors which could boost domestic manufacturing
- Recommendations for basic import tariff to be 10% for medical devices (whose Export is over 5 Crores) and duty on components to be 5% next year and 7.5% thereafter as a make in India enabler. Concessional duty on raw material may be retained at 2.5% for now and to cover the devices which had not been addressed in Jan 2016 notification.
- Expedite Medical Devices Law to regulate all devices and ensure: i) Definition of ‘Manufacturer’ needs to disallow legalization of Pseudo Manufacturers and Traders to pass themselves off as Manufacturer ii) Voluntary Compliance backed by 3rd Party ICMED Certification to be considered as a Compliance option / reduced oversight.
- Buy Indian Policy of Preferential Market Access and Preferential Pricing (as per World Bank Terms) for Indian medical device for Indian Public Healthcare Tenders and have weightage of 5% for ICMED Certification, 2% for ISO 13485 Certification and 3% for Design India Certification for promoting quality and indigenous development.
- Ban on refurbished medical equipment for next five years till such time we have a strong regulatory regime to ensure validated and calibrated equipments for limited access for enabling patient safety.
- MRP to be enforced on unit of sale of medical devices. We requested that No NPPA / DPCO for Medical Devices other than case of Stents (Combination Device, having Drug). We recommended to introduce price cap mechanism of Ex-Factory / Import Landed Price in a phased manner or bring in a 1% Cess on GST to act as disincentive for putting exorbitant MRP and to incentivise ethically correct Lower MRP.
- Medical Device Promotion Council – to focus on aspects of sectoral export promotion and indigenisation, to address India’s 70% import dependency, 90% on medical electronics.