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AiMeD & BCIL Seek Regulatory Framework On
Medical Devices
New Delhi, Oct 5 (IANS) A
joint conference was organised in New Delhi on Saturday by
Association of Indian Medical Device Industry (AiMeD) and
Biotech Consortium India Limited (BCIL) supported by
Department of Pharmaceuticals (DoP) on comprehensive
regulation of medical devices.
The discussion highlighted
the current state of the beleaguered domestic industry of
Indian medical devices. The private sector urged the
government to expedite steps to end the 80-90 per cent
import dependence forced on the industry, which results
into an import bill of over Rs 38,837 Crore.
"Expedite steps for
patients'' protection, stronger quality & safety
regulations, price control, to make medical devices and
quality treatment accessible and affordable and ethical
indigenous manufacturing viable", said a statement.
Dr. Vinod Paul, Member, NITI
Aayog, emphasized on the need for integrated efforts to
promote innovations and development of indigenous medical
devices for having a vibrant domestic medical devices
industry.
He assured full support of
NITI Aayog to ensure that the intent of domestic industry
to provide access to safe, effective and quality medical
devices to the patients is incorporated in government
policies.
Gurmit Chugh, Joint
Coordinator (AiMeD) said that the manufacturers have been
confused with informally choosing of products and
notifying them as drugs.
"They seek a comprehensive
regulatory framework that allows for adequate transition
and is predictable. Only then will investments speed up as
they get discouraged to be regulated as Drugs," said Chugh.
GST on medical devices is in favour of imports and is
detrimental to Make in India, he added.
"MSME sector has been worst
hit with huge job losses...MSME dominated medical domestic
manufacturing which took a hit post GST as imports became
11 per cent cheaper. Imports of medical devices are up by
record 24 per cent, from 31,386 crore in 2017-2018 to
38,837 crore in 2018-2019", said the private sector
statement.
The private sector sought a
pro-active policy formulation to regulate medical devices
differently than drugs, as it will lead to free market
dynamics and keep regulations simple, consumer friendly
and incentivise ''Make in India''.
"The Indian Medical Device
Industry is very hopeful that right from trade margin
rationalization to ensuring a separate set of legislation
and regulatory framework to govern the medical device
sector and everything in between will be looked afresh and
hastened up by Modi Government to galvanise the domestic
medical device manufacturing sector." said Rajiv Nath,
Forum Coordinator, AiMeD.
https://www.outlookindia.com/newsscroll/aimed-amp-bcil-seekregulatory-framework-on-medical-devices/1634729
Govt
Issues Draft Notification To Bring All Medical Devices
Under Single Regulatory Framework
 The
union health ministry has come out with the draft
notification, making it mandatory for all the devices to
get certified by the Central Drugs Standard Control
organisation, India’s drug regulatory authority.
According to the draft
notification, while certification by the regulatory
authority will be on voluntary basis up to 18 months from
date of notification, thereafter it will be made
mandatory.
To ensure that all imported
as well locally made medical devices meet certain quality
standards, the health ministry has proposed to regulate
all such equipment used on human beings or animals. The
union health ministry has come out with the draft
notification, making it mandatory for all the devices to
get certified by the Central Drugs Standard Control
organisation (CDSCO), India’s drug regulatory authority.
According to the draft
notification dated Oct 18, "In pursuance of sub-clause
(iv) of clause (b) of section 3 of the Drugs and Cosmetics
Act, 1940, the Central Government, after consultation with
the Drugs Technical Advisory Board, hereby specifies the
following devices intended for use in human beings or
animals as drugs with effect from
the 1st day of December, 2019," the draft notification
reads.
According to the draft
notification, while certification by the regulatory
authority will be on voluntary basis up to 18 months from
date of notification, thereafter it will be made
mandatory.
The country's top advisory
body on drugs, the Drugs Technical Advisory Board (DTAB),
had in April recommended that all medical devices should
be notified as drugs under the existing Drugs and
Cosmetics Act.
ET had first reported about
the government’s agenda to bring medical devices under
regulation. The government decided to update its review
process in the wake of recent case of Johnson & Johnson
(J&J) hip implants which left many people permanently
disabled due to the faulty device.
As part of the draft
notification, “all devices, including instruments,
apparatus, appliances and implants, whether used alone or
in combination for various purposes like diagnosis,
prevention, monitoring, treatment, alleviation of any
disease, investigation, replacement or modification or
support of the anatomy among others”, will be regulated
under the legislation. Such medical devices also include
those which are used for the purpose of supporting or
sustaining life, disinfection of medical devices.
Rajiv Nath, Forum
Coordinator, AiMeD “What’s missing in covering note is
assured road map to a separate medical devices law with a
defined transition period and in a phased manner, in
addition to the voluntary registration as a temporary
measure under the current Drugs Act”.
The stakeholders have been
given a month to respond to the draft notification.
The manufacturers, importers
will have to upload information about their devices on the
“Online System for Medical Devices” established by CDSCO
for this purpose. Once the information is uploaded a
registration number will be generated which the
manufacturers will have to put on the label of the medical
device. The manufacturers will also have to have
certificate of compliance with respect to ISO 13485
standard accredited by National Accreditation Board for
Certification Bodies or International
Accreditation Forum in respect of their medical
device.
The importers will also have
to also obtain free sale certificate from country of
origin before they enter the Indian market.
Once notification comes into
effect, the Central Drugs Standard Control organisation (CDSCO)
will be the nodal authority to investigate quality, safety
related failure, complaints and can suspend the
registration based on the outcome of investigation.
Currently there is no mechanism for reporting the
malfunctioning
of non-notified medical devices.
Once notified, there will be
an effective product recall system, inspection of
manufacturing sites by CDSCO.
(Ref : The Economic Times ,
Octo.18, 2019)
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