Page 14 - ie2 August 2019

SPOTLIGHT

line with the GHTF (global harmoni- ment by providing weighted deduction wants to become a member of the key
sation task force) guidelines and are in for the expenses incurred on that front. exporters of medical devices in the
line with these rules’ risk-based classi- There is minimal or no import duty on coming years, there is an urgent need
fication. The regulatory licenses issued certain medical devices. for the industry to move up the tech-
for import, manufacture, or sale of While these are positive steps towards nology ladder. With sufficient technol-
medical devices have been made per- further growth of the industry, there ogy infusion the Indian medical devices
petual in nature to cut down on un- are certain negative factors, too, the im- industry can flourish gradually. Fur-
necessary and time-consuming paper- pact the Indian industry thermore collaborations between gov-
work, in a bid to increase ease of doing First and foremost there is a need ernment and the private sector along
business in India. These modifications to restrict the import of refurbished with suitable policy initiatives and lo-
in the rules also enable Indian manu- or second-hand medical devices into cal-level innovation can make India a
facturers to export finished high-qual- India. While refurbished machines are global hub for medical devices in the
ity products from India to the world. supposedly properly restored devices coming years.
Looking at the growing importance of to the original safety and effectiveness
the industry, the government has taken by the original manufacturer as well as
several positive steps towards its devel- the certified refurbishing companies, Notes
opment. it is difficult to verify whether it has 1 http://info.evaluategroup.com/rs/607-
• In December 2018, the government actually been restored to the original YGS-364/images/WPMT2018.pdf
also formed the National Medical De- safety and effectiveness and adequately
vices Promotion Council under the calibrating this is difficult. Availability 2 https://www.usitc.gov/publica-
aegis of DIPP and includes represent- of spare parts after five-seven years of tions/332/journals/final_china_and_
atives from the healthcare industry and life is doubtful in any electronic item. medtech_gvc_jice_508_compliant.pdf
quality promotion institutions. This Most importantly, import of these de-
step is aimed to give a greater fillip to vices can lead to significant loss for the 3 https://www.ibef.org/arab-heatlh-2017/
the medical devices sector. domestic industry which majorly com- download/EEPC-IBEF-Arab-Health-
• The government has allowed foreign prises MSMEs, by bringing in: Supplement-30-Jan-201.pdf
direct investment in medical device • loss of job creation owing to the harm
manufacturing sector without any prior caused to local manufacturing, and 4 https://assets.kpmg/content/dam/
approval from the government, thereby • loss of revenue, owing to reduction of kpmg/xx/pdf/2017/12/medical-devic-
encouraging business to quickly scale- import duty revenue by ‘reduced cost’ es-2030.pdf
up existing operations by infusing cap- while increasing the healthcare burden
ital or engage in time-sensitive strategic owing to inadequate/ineffective treat- 5 https://www.medgadget.com/2018/06/
acquisitions. ments. africa-medical-devices-market-expand-
• The third feature is the presence of Furthermore since the industry is ing-tremendously-to-make-great-im-
laws that do not permit manufacturers regulated by multiple regulations, even pact-in-near-future-by-2023.html
and importers of medical device to pro- simple tasks such as rectification of er-
mote their product directly to the cus- roneous declaration on a label get de- 6 https://www.export.gov/article?id=Ni-
tomer as cures for certain prescribed layed. geria-Medical-Equipment
conditions and illnesses.
• The already robust intellectual prop- Conclusion 7 https://www.reciprocus.com/sites/
erty rights regime in India has been While the Indian medical devices in- default/files/2017%20Medical%20Devic-
strengthened further by tweaking the dustry is undoubtedly showing a high es%20Market%20Snapshot.pdf
rules for grant of patent and trademark growth prospect, high dependence on
in the last two years. imports is a significant factor that may 8 http://www.dedc.gov.ae/StudiesAndRe-
• The Government of India has intro- impact the growth in future. Though searchDocument/Medical-Devices-Sec-
duced various fiscal measures to pro- there are several factors that have been tor-Report.pdf
mote research, development, manufac- encouraging imports, dearth of high-
turing, and import of medical devices. end technology is a significant dis- 9 https://edition.cnn.com/2019/02/13/
For instance, the government has incen- couraging factor. Therefore, not only health/india-medical-tourism-indus-
tivised scientific research and develop- in terms of import reduction, if India try-intl/index.html

14 l INDIAN ENGINEERING EXPORTS l AUGUST 2019