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Union
Budget 2022–Disappointing Budget For Medical Devices
Industry
Rajiv Nath,
Forum Coordinator, Association of Indian Medical Device
Industry (AiMeD) expressed deep disappointment and anguish
over the Union Budget 2022 giving cold shoulder again to
the Indian medical device industry and nothing laudable
for the healthcare.
We were
expecting the government to move forward on promised
reforms and anticipated conducive measures to boost
domestic manufacturing of medical devices. It is
frustrating that against our expectations, the government
has not included any measures to help end the 80-85 per
cent import dependence forced upon India and an ever
increasing import bill of over Rs 46000 Crore & promoting
growth Indian medical device industry other than repeating
last year’s assurance to end custom exemptions of products
that can be made in India.
Sadly the
union budget 2022 speech has no strategic stated measures
to boost domestic manufacturing. These are the same
domestic manufacturers, when imports got disrupted during
COVID-19 crisis, the government relied heavily on them to
meet the rising demand of essential COVID items for the
country pushing the Indian medical devices sector to
become self-reliant.
The Indian
medical devices industry’s expectations were:
• Predictable
tariff policy
• Graded increase of custom duty to 10-15 per cent from
current zero to 7.5 per cent
• Reduced GST on 18 per cent where being applied to 12 per
cent as medical devices are not luxury goods.
• Not clear if health ess applied on some medical devices
being also applied on other medical devices
• No announcement on R&D related tax breaks to motivate
indigenous development
We had been
hoping that this will be a Make in India push budget for
an Atmanirbhar Bharat and though the FM has highlighted
the need to support manufacturing sector, we, The Indian
medical device industry are disheartened not to notice any
changes in custom duty as done for other sectors and are
very hopeful that the fine print of the Union Budget would
have possibly acted upon our recommendations on a
predictable tariff policy for a Make in India push for
phased manufacturing plan for components and finished
medical devices and allocations for testing infrastructure
as well as for med tech parks and cluster developments.
Supporting policies are needed so that Indian medical
devices industry can make quality healthcare accessible
and affordable for common masses, aim to place India among
the top 5 medical devices manufacturing hubs worldwide and
help end the 80-85 per cent import dependence forced upon
us and an ever increasing import bill of over Rs 46000
Crore.
The only
positive announcement was on Public Procurement by
allowing 75 per cent prompt payments and bringing in a
weighted price preference on account of quality which is
especially critical in healthcare related medical devices.
https://www.expresshealthcare.in/news/union-budget-2022-disappointing-budget-for-medical-devices-industry/433305/
DCGI
Announces Classification For 133 Medical Devices In
General Hospital And Orthopaedic Instruments
The Drug Controller General
(India) has issued a notice classifying 133 medical
devices from general hospital and orthopaedic instruments
under the provisions of Medical Devices Rules, 2017.
The decision comes as the
latest in the drug regulator’s efforts to classify the
medical devices sold in the country based on the perceived
risk of the product type and its use in patients. The
measure is to help the authority to bring in all the
medical devices under the regulatory control, according to
experts.
According to the regulator, around 86
devices including bed exit monitor (fall prevention),
stand-on patient scale, clinical color change thermometer,
apgar timer, hydraulic and manual adjustable hospital bed,
non powered flotation therapy mattress, therapeutic
medical binder, burn sheet, neonatal eye pad, nipple
shield, lamb feeding nipple, suction snake bite kit,
therapeutic scrotal support, cardiopulmonary resuscitation
board, medical insole, medical examination light, skin
pressure protectors, body waste receptacle, washers for
body waste receptacles, handcarried and manual wheeled
stretchers, liquid crystal vein locator, blood bank
centrifuge, among others are classified as Class A medical
devices.
Another around 38 medical
devices including Liquid crystal forehead temperature
strip, spinal fluid manometer, electrically powered spinal
fluid pressure monitor, sterilisation process indicator,
paediatric medicare crib, medical bassinet, pressure
infusion for an I.V bag, intravascular administration set,
automated air removal system, patient care reverse
isolation chamber, jet lovage, electrically powered
patient lift, ultrasonic cleaner for medical instruments,
remote medication management system, ultraviolet radiation
environmental disinfection device, vacuum-powered body
fluid suction apparatus, sterilisation wrap, motorised
wheeled stretcher among others are classified as Class B
medical devices. Eight medical devices including
electronic monitor for gravity flow infusion systems,
ingestible event marker, ultraviolet radiation chamber
disinfection device, ethylene oxide gas steriliser,
dryheat steriliser, steam steriliser, liquid chemical
sterilants or high level disinfectants and hydrogen
peroxide gas plasma sterilisation system are classified as
Class C medical devices.
The only medical device in
the list under Class D is the chemical cold pack snakebite
kit.
The risk associated with the
Class A is perceived to be low, while B has low to
moderate risk, C has moderate to high risk and D has the
high risk, according to the widely accepted classification
criteria.
The safety, quality and
performance of medical devices are regulated under the
provisions of the Drugs and Cosmetics Act, 1940 and rules
and for the regulation of medical devices for imports,
manufacture, clinical investigation, sale and
distribution, the Central Government has notified the
Medical Devices Rules, 2017, which commenced from January
1, 2018.
http://pharmabiz.com/NewsDetails.aspx?aid=146057&sid=1
date : February 25, 2022
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