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Med Devices Import up 16.8%, Export By 25.7% During 2012-16
Between FY12 to FY16, the import of medical devices into India has increased by
16.8 per cent, whereas export increased by 25.7 per cent, as per the key
findings of a government led study in collaboration with Andhra Pradesh MedTech
Zone (AMTZ) and World Health Organisation (WHO).
India is one of the top 20 global medical device markets and
the 4th largest medical device market in Asia.
The import of medical devices has grown from USD 2.46 billion
( Rs.15,990 crore) in FY12 to USD 2.87 billion ( Rs.18,655 crore) in FY16. The
export of medical devices has grown from USD 0.78 billion ( Rs.5,070 crore) in
FY12 to USD 0.98 billion (Rs.6,370 crore) in FY16.
Diagnostic imaging (e.g. CT scan, X-Ray, MRI, USG, X
ray-tubes etc.), IV Diagnostic (lab equipment and reagents, etc.) and Other
Medical Device (ECG, opthal equipment, heart lung machine, etc.) form 70% of
total import in India in FY16.
However it is estimated that import trade will fall with
increasing number of international and Indian manufacturers setting up medical
device manufacturing in India.
Diagnostic imaging, consumables and total export trade in
India in FY1613. Amongst the exporters’ portfolio, USA was the chief destination
for export and contributes close to 15 per cent of the export trade. Singapore,
Germany and China were the other leading export destinations with shares of 7.0
per cent, 6.7 per cent and 6.4 per cent respectively.
The European Union (including Germany) cumulatively
constitutes of 21.7 per cent of the total export trade13. USA, Germany, China,
Japan, and Singapore constitute the five largest exporters of high technology
medical equipment to India.
In FY 2015 imports alone from these five countries accounted
for approximately 65 per cent of total import of high technology medical
equipment while USA, remained the largest exporter accounting for 28.1 per cent.
Diagnostic imaging medical device import trade has grown by
19% from USD 636 million ( Rs.4,134 crore) in FY12 to USD 757 million ( Rs.4,921
crore) in FY 16. IV Diagnostic medical device import trade has grown by 43.2%
from USD 225 million ( Rs.1,463 crore) in FY12 to USD 322 million ( Rs.2,093
crore) in FY 16. Other Medical Device (e.g. ECG, opthal equipment, heart lung
machine, etc.) has grown by 9.6% from USD 878 million ( Rs.5,707 crore) in FY12
to USD 964 million (Rs.6,266 crore) in FY 16.
Diagnostic imaging medical device export trade has grown by
27.2 per cent from USD 210 million ( Rs.1,365 crore) in FY12 to USD 267 million
( Rs.1,736 crore) in FY16. Medical Consumables export trade has grown by 26.1
per cent from USD 228 million ( Rs.1,482 crore) in FY12 to USD 288 million (
Rs.1,872 crore) in FY16. IV Diagnostic devices export trade has grown by 58.7
per cent from USD 24 million ( Rs.156 crore) in FY12 to USD 39 million ( Rs.254
crore) in FY16.
While technological advancement and expertise that the global
market leaders offered has proved to be an advantage, India’s medical device
sector is dominated by multi-national companies, which is evident from the fact
that about 78% of the sales are generated by imported medical devices.
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DCGI begins registration of notified bodies
to carry out audit of mfg sites of Class A & Class B medical devices
The Drugs Controller General of India (DCGI) has started the
process of registration of notified bodies to carry out audit of manufacturing
sites of Class A & Class B medical devices as laid down in the Medical Device
Rules 2017 which will come into effect in the country from January 1, 2018.
The Medical Device Rules 2017 have already been published
vide G.S.R. 78 (E) dated 31.01.2017 under Drugs and Cosmetic Act, 1940 to
regulate the clinical investigation, manufacture, import, sale and distribution
of the medical devices. The Chapter III (Rule 13) of Medical Device Rule 2017
provides for the registration of notified bodies with the DCGI office (CDSCO).
Subsequently, with effect from July 1, 2017, the notified
bodies have to file their application to the Central Licensing Authority (DCGI)
for registration in Form MD-1 through online portal to carry out the audit of
manufacturing sites of Class A & Class B medical devices to verify conformity
with the Quality Management System and other applicable standards. In this
regard, CDSCO has put in place an online portal for the registration of notified
bodies.
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