Journal of Intellectual Property Rights

Open Access Open Access  Restricted Access Subscription Access

Current Status and Challenges of Medical Device Innovations-Indian Perspective


Affiliations
1 Amity Institute of Biotechnology, Amity University, Noida, Sector 126, UP 201 303, India
 

Medical devices and diagnostics cater an integral component of the health care system with a mandate of 'access and equity'. Medical device is an instrument which is applied for diagnosis, therapy, or alleviation of diseases in human beings or animals. Indian medical device sector is emerging with innovative and indigenous solutions. However, the sector seeks support from key stakeholder to contribute to public health. This paper reviews the need of diagnostic capacity building with robust regulatory regime to mitigate the challenges of accessibility in resource poor settings, import dependency, limited innovations with technological & funding constraints and skill set of experts. Further, emphasizes upon promising initiative of government like Make-in-India, which opens new avenues to a flourishing future of indigenous medical health technologies and innovations for delivering affordable healthcare to India's billion-plus population.

Keywords

Medical Devices Rules, 2017, Indian Patents Act, 1970, Central Drug Standard Control Organization, Who, Medical Device, Innovation, Regulatory Capacity Building.
User
Notifications
Font Size

  • CDSCO, Frequently Asked Questions on Registration and Import of Medical Devices in India, Doc. No: CDSCO/MD/FAQ/RC/01/00 http://www.cdsco.nic.in/forms/Default.aspx.

  • Khandpur R S, Handbook of Biomedical Instrumentation (Tata Mcgraw- Hill Publishing Company Limited, New Delhi), 2nd Edition, 2003, p. 29.

  • Department of Industrial Policy and Promotion, 2016, Consolidated FDI Policy 2016 http://dipp.nic.in/circulars/ consolidated-fdi-policy-circular-2016.

  • World Health Organization, 2014, Non-communicable Diseases (NCD) Country Profiles.

  • KPMG Knowledge base, 2015, Excellence in Diagnostic Care, https://www.kpmg.com/IN/en/IssuesAndInsights/ThoughtLead ership/Excellence_in_Diagnostic_Care.pdf (accessed on 21 September 2015).

  • Confederation of Indian Industry and Boston Consulting Group, 2015, Medical Technology: Vision 2025, http://www.cii.in/PublicationDetail.aspx?enc=EbZtU40L2 R/DO/16COvqUyLUl4b9ZucYGShFIxAEyT4=.

  • Deloitte, 2015, Medical technology industry in IndiaRiding the growth curve, www2.deloitte.com/.../in-lshcmedicaltechnology-in-India-noexp.pdf (accessed on 19 September 2015).

  • Diagnostics Opportunities in India- Guide for Finnish Companies, https://www.tekes.fi/globalassets/julkaisut/ diagnostics_guide_india.pdf (accessed on 19 September 2015).

  • Markan S, Indian medical device sector: Insights from patent filing trends BMJ Innovations 2017,

  • http://innovations.bmj.com/content/early/2017/06/10/bmjin nov-2016-000131.

  • Desai N, The Indian Medical Device Industry, 2015, http://www.nishithdesai.com/fileadmin/user_upload/pdfs/R esearch%20Papers/The_Indian_Medical_Device_Industry.pdf (accessed on 19 September 2015).

  • World Health Organization, 2015, Local Production and Technology Transfer to Increase Access to Medical Devices, http://www.who.int/medical_devices/1240EHT_ final.pdf (accessed on 19 September 2015).

  • Intellectual Property India, 2015, Manual of Patent Office Practice and Procedure http://www.ipindia.nic.in/ipr/patent/ manual/HTML%20AND%20PDF/Manual%20of%20Paten t%20Office%20Practice%20and%20Procedure%20-%20 pdf/Manual%20of%20Patent%20Office%20Practice%20an d%20Procedure.pdf. (accessed on 19 September 2015).

  • Asif E, Exclusion of Diagnostic, Therapeutic and Surgical Methods from Patentability, Journal of Intellectual Property Rights, 18 (3) (2015) 242-50.

  • Axelsson O et al., A particle for use in x-ray imaging, Pat No: 242040 (to GE Healthcare), 6 August 2010.

  • Long et al., SGKL as a Diagnostic and Therapeutic Target, Application No: 1537/KOLNP/2006 (to Chiron Corporation), http://ipindiaonline.gov.in/patentsearch/ search/dublicateExamLetter.aspx?ID=EHMyzpjIsI8K%2f9 ZOgZz%2fMg%3d%3d (accessed on 21 September 2015).

  • Therapeutic methods and pharmaceutical compositions for treating warts with tellurium compounds, Application no: 3044/CHENP/2006, (to Biomas Ltd), http://ipindiaonline. gov.in/patentsearch/search/dublicateExamLetter.aspx?ID=o k4R4tAU9or3LcRs1uIXZA%3d%3d (accessed on 21 September 2015).

  • Fisher et al., An anesthetic machine for use with a partial rebreathing circuit and a method thereof, Application no.: 4170/DELNP/2005, (to Fisher et al, Canada), http://ipindiaonline.gov.in/patentsearch/search/dublicateExa mLetter.aspx?ID=HU%2fyrW+HBrY4SgXTyhQ8QQ%3d %3d (accessed on 21 September 2015).

  • Kadri H & Saikhedkar M V, 2011, Post-TRIPS patenting trends in India with special reference to USA: A comparative analysis, SRRN Elsevier. http://ssrn.com/abstract=1986798.

  • Singh N & Abrol D, Challenge of in-Vitro Diagnostics For Resource Poor Settings: An Assessment, Institute for Studies in Industrial Development & Public Health Foundation of India, 2015, http://isid.org.in/pdf/WP166.pdf (accessed on 19 September 2015).

  • Gupta, P, Why 2017 is a landmark year for the medical device industry in India, The Financial Express, 2017, http://www.financialexpress.com/industry/why-2017-isalandmark-year-for-the-medical-device-industry-inindia/ 550425/.

  • Unnikrishnan C H, RBI formalizes automatic 100% FDI in medical devices sector, Live Mint, 2015,

  • http://www.livemint.com/Industry/RFpbUUbDdYzkB6Xm UMdJUN/RBI-formalizes-automatic-100-FDI-in-medicaldevicessector.html (accessed on 23 September 2015).

  • Panja et al., Global research on medical cotton- evidence from patent landscape study, Journal of Intellectual Property Rights, 20 (1) (2015) 39-50.

  • Foundation for Innovation and Technology Transfer (FITT), IIT Delhi, http://fitt-iitd.in/.

  • SIDBI Innovation & Incubation Centre (SIIC), IIT Kanpur, http://www.iitk.ac.in/siic/.

  • Technology Business Incubator at University of Madras, http://www.unom.ac.in/index.php?route=department/depart ment/about&deptid=69.

  • Rural Technology & Business Incubator at IIIT Madras, http://www.rtbi.in/.

  • Prime Minister’s Fellowship Scheme for Doctoral Research, http://www.primeministerfellowshipscheme.in/.

  • Sun Pharma Science Scholar Awards for Young Scientists, http://www.sunpharma.com/responsibility/csr/ranbaxysciencefoundation.

  • Ministry of Commerce and Industry, 2016, Startup India, http://startupindia.gov.in/index.php.

  • Department of Industrial Policy and Promotion, 2016, National Intellectual Property Rights Policy, http://dipp.nic.in/policies-rules-and-acts/policies/nationaliprpolicy.

  • Sidharthal, Soon 100% FDI in medical devices, The Times of India, 2014, http://timesofindia.indiatimes.com/ business/india-business/Soon-100-FDI-in-medical-devices /articleshow/45443018.cms (accessed on 23 September 2015).

  • Organization for Economic Co-operation and Development, Benchmark Definition of Foreign Direct Investment, Fourth Edition, 2008, https://www.oecd.org/ daf/inv/investmentstatisticsandanalysis/40193734.pdf.

  • Kaul R, Govt notifies Medical Devices Rules, 2017, 2017, http://www.hindustantimes.com/india-news/govt-notifiesmedicaldevices-rules-2017/story-TwkF6ZLb8MKPVuA2EuqvcN.html.

  • Aranca, Budget 2017–18: It is What You Make of It, 2017, https://www.aranca.com/knowledgelibrary/

  • articles/investment-research/budget-2017-18-it-iswhatyou-make-of-it.


Abstract Views: 170

PDF Views: 123




  • Current Status and Challenges of Medical Device Innovations-Indian Perspective

Abstract Views: 170  |  PDF Views: 123

Authors

Smita Sahu
Amity Institute of Biotechnology, Amity University, Noida, Sector 126, UP 201 303, India
Saikat Panja
Amity Institute of Biotechnology, Amity University, Noida, Sector 126, UP 201 303, India

Abstract


Medical devices and diagnostics cater an integral component of the health care system with a mandate of 'access and equity'. Medical device is an instrument which is applied for diagnosis, therapy, or alleviation of diseases in human beings or animals. Indian medical device sector is emerging with innovative and indigenous solutions. However, the sector seeks support from key stakeholder to contribute to public health. This paper reviews the need of diagnostic capacity building with robust regulatory regime to mitigate the challenges of accessibility in resource poor settings, import dependency, limited innovations with technological & funding constraints and skill set of experts. Further, emphasizes upon promising initiative of government like Make-in-India, which opens new avenues to a flourishing future of indigenous medical health technologies and innovations for delivering affordable healthcare to India's billion-plus population.

Keywords


Medical Devices Rules, 2017, Indian Patents Act, 1970, Central Drug Standard Control Organization, Who, Medical Device, Innovation, Regulatory Capacity Building.

References