Indian Medical Device Sector - Blue Print & Regulatory Policy Roadmap

  • Suchita Markan
  • Rajiv Nath
  • Jitendar Sharma
  • Dilip Kumar Chekuri

Abstract

Good quality, affordable and comprehensive healthcare to all its citizens is the new age universal mantra in Government lexicon. While healthcare infrastructure and indigenous medical device manufacturing are the areas in which most countries have achieved self-sufficiency, the medical device sector in India with about 80% import dependency needs focused attention and policy interventions to achieve self-sufficiency. In 2015, Government of India included medical device sector in its ambitious Make in India program. Since then, there have been various policy initiatives by the Government to address ecosystem requirements including rolling out of the Medical Device Rules 2017 to regulate devices, introduction of 100% FDI policy to attract foreign investments, addressing infrastructure gaps by setting-up Medical Device parks, incubators, accelerators, boosting innovation by supporting start-ups etc. The policies in this sector are evolving, changing frequently which brings in unpredictability and lack of confidence in manufacturers and importers e.g. notification of medical devices to be regulated as drugs, price capping etc. Indigenously developed medical devices lack credibility due to lack of comprehensive regulation of devices. The medical device industry in India is at its surge with about 800 manufacturers and 1000+ start-ups. The industry has expectations in terms of policy roadmap for catalyzing this sector and making it self-sustainable. This article covers key policy initiatives to boost medical device sector by the Government of India, highlights medical device industry expectations and the envisaged roadmap for developing a conducive ecosystem for fostering this sector in India with immense growth potential.

Keywords: Medical Device, In Vitro Diagnostics, Regulation, Policy, Medical Device Rules, Medical Device Industry, CDSCO, DCGI, FDI, CE mark, MDI, Government of India (GoI)

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References

1. Medical Devices by Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India [Internet]. 2020 [Cited 2020 Feb 03]. Available from:
https://pharmaceuticals.gov.in/medical-devices
2. Make in India sector survey: Medical Devices, [Internet]. Makeinindia; 2020 [Cited 2020 Feb 03]. Available from: http://www.makeinindia.com/article/-/v/sector-survey-medical-devices
3. Medical Devices by Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India [Internet]. 2020 [Cited 2020 Feb 03]. Available from:
https://pharmaceuticals.gov.in/medical-devices
4. Recommendations of the Task force on the medical Devices sector in India – 2015, by Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India [Internet]. 2015 [Cited 2020 Feb 03]. Available from:
https://pharmaceuticals.gov.in/important-document/ recommendations-task-force-medical-devices-sector-india-2015.
5. The Medical Device Industry in India, SKP Business Consulting LLP [Internet]. 2016 [Cited 2020 Feb 04]. Available from:
https://www.skpgroup.com/data/resource/skp_the_medical_device_industry_in_india_.pdf
6. Medical Device Manufacturing in India - A Sunrise, by WHO [Internet]. WHO; 2017 [Cited 2020 Feb 02]. Available from:
https://pharmaceuticals.gov.in/sites/default/files/medicaldevicemanufacturinginindia-asunrise-170221053503%20%281%29.pdf
7. Export-Import Databank, Department of Commerce, Ministry of Commerce and Industry, Government of India [Internet]. 2020 [Cited 2020 Feb 03]. Available from:
https://commerce-app.gov.in/eidb/
8. Data from the Ministry of Commerce, compiled by the Association of Indian Manufacturers of Medical Devices (AiMeD), Import of medical devices up by record 24%, Reports/white papers by Biospectrum [Internet]. biospectrumindia; 2019 [Cited 2020 Feb 02]. Available from:
https://www.biospectrumindia.com/reports-white-papers/59/14035/import-of-medical-devices-up-by-record-24.html
9. Indian Biomedical Skill Consortium [Internet]. 2020 [Cited 2020 Feb 04]. Available from:
https://ibsc-amtz.in/
10. Preferential Procurement Order guidelines for procurement by public healthcare institutes under GoI, Guidelines for implementing the provisions of Public Procurement, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India [Internet]. 2018 May 18 [Cited 2020 Feb 04]. Available from:
https://pharmaceuticals.gov.in/sites/default/files/Final%20Guidelines.pdf
11. Medical devices reforms and the Landscape in India, World Health Organization by Dr Madhur Gupta; MD, DM Technical Officer- Pharmaceuticals, WHO India Country Office [Internet]. WHO: India; 2020 [Cited 2020 Feb 07]. Available from:
http://www9.who.int/medical_devices/global_forum/3rd_gfmd/reformslandscapeIndia.pdf
12. Draft National Medical Device Policy 2017 by Association of Indian Medical Device Industry (AiMeD) [Internet]. 2017 [Cited 2020 Feb 05]. Available from:
https://aimedindia.com/comments-activities/details?k=national-medical-device-policy2017-1436977100
13. About the Drugs Technical Advisory Board of CDSCO, Ministry of Health and Family Welfare, Government of India [Internet]. CDSCO; 2020 [Cited 2020 Feb 02]. Available from:
https://cdsco.gov.in/opencms/opencms/en/dcc-dtab-committee
14. Minutes of the 82nd Meeting of Drugs Technical Advisory Board held on 02.04.2019 at DGHS, Nirman Bhawan, New Delhi [Internet]. CDSCO; 2018 [Cited 2020 Feb 02]. Available from:
https://www.cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/82nddtab1.pdf
15. Gazette Notification GSR 102 (E) Dated 11th February, 2020– All Medical Devices will be Regulated w.e.f. 1st April, 2020 [Internet]. CDSCO; 2020 [Cited 2020 April 19]. Available from:
https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications/
16. Constitution of Medical devices Technical Advisory Group (MDTAG) to advise CDSCO on matters related to regulation of Medical devices, dated 22 July, 2019 [Internet]. CDSCO; 2019 [Cited 2020 Feb 02]. Available from: https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/Officeordermd.pdf
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How to Cite
Markan, S., R. Nath, J. Sharma, and D. K. Chekuri. “Indian Medical Device Sector - Blue Print & Regulatory Policy Roadmap”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 2, June 2020, pp. 25-35, doi:10.22270/ijdra.v8i2.392.