India: Union Cabinet Approves National Medical Devices Policy 2023

1.Regulatory Streamlining - NMDP proposes to: (a) set up a single window clearance system on portal of Central Drugs Standard Control Organisation , in alignment with the National Single Window System for filing applications for medical device manufacturing license, import license and clinical investigation approval; (b) expand applicability of Indian standards by the Bureau of Indian Standards (BIS) and such other similar standards setting bodies for medical devices; (c) incorporate framework for coherent pricing regulation for incremental number of medical devices under the Drugs Prices Control Order, 2013 (DPCO); and (d) implement an institutional arrangement for aligning industry practice with code of ethics prescribed by the National Medical Commission to strive towards ethical marketing of medical devices.

Comment:

Under the Medical Devices Rules, 2017 (MDR), MedTech companies are required to procure a wide range of regulatory approvals which creates substantive regulatory burden and compliance challenges leading to delayed timelines. The single window clearance system is expected to reduce such timelines of procuring licenses and aims to integrate all key stakeholders involved in the medical devices licensing framework. Applicability of established standards such as BIS will result in better quality compliance and standardisation. However, timelines for ensuring standard compliance will be a key factor in assessing efficiency. A coherent pricing framework applicable to wider scope of medical devices under the ambit of DPCO will be able to make the medical devices sector much more affordable to the general public. The implementation of an institutional arrangement applicable to ethical marketing by medical device companies, perhaps in the nature of the draft Uniform Code of Medical Devices Marketing Practices, has been long awaited and is expected to be instrumental in comprehensive regulation of unethical advertisement practices in India.

2.Infrastructure Development - The NMDP recommends bolstering state governments' efforts to set up large medical device parks (as also provided for under the MDR) and mid-sized medical devices clusters with common infrastructure facilities in proximity to economic zones. Further, while testing and certification facilities for medical devices are available in some governmental bodies, the NMDP envisages setting up of additional medical device testing laboratories to bolster testing and certification efficacy.

Comment:

The "Promotion of Medical Device Parks" scheme notified by DoP dated 21 July 2020 provides for common medical device testing laboratories to be set up at one place to reduce manufacturing costs of MedTech companies significantly, as these laboratories carry out test or evaluation of the medical devices on behalf of manufacturers. Establishing more medical device parks, medical devices clusters with accredited laboratories are expected to result in significant reduction of manufacturing costs, facilitation of manufacturing of high-end medical devices, increased competitiveness, better availability and affordability of reliable medical devices in the domestic market.

3.Measures to attract investments in MedTech sector - The NMDP envisages to encourage private investment and external resources funding in the sector through measures such as: (a) inviting venture capital funds for screening of start-ups to incubate; and (b) engage, leverage and systematically build upon the 'Startup India' initiatives by Department for Promotion of Industry and Internal Trade to actively support startups in the MedTech sector.

Comment:

India has been witnessing strong inflows of FDI in the MedTech sector after 100% FDI was permitted under automatic route for manufacturing medical devices. The focus points set out herein are expected to promote indigenous manufacturing of medical devices and build competitiveness and competence amongst start-ups in the sector. Clarity on effectiveness of such promotional activities will invariably depend on the execution of the above propositions.