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Need To Standardise
Methodology To Evaluate Medical Devices: NITI Aayog Member
V K Paul
NITI Aayog member Dr V K Paul
has stressed on the need to standardise the methodology
for evaluating innovative medical devices.
"…We know how to conduct
clinical trials for a drug test. There are set rules. But,
as far as testing a medical device is concerned, the
methodology for it is still evolving as it should be done
in a safe manner,” he said.
This is an important area
because young people are offering innovative (medical)
products.
"A lot of products are there,
but they stay as products and have to be tested. We would
like the methodology for it to be standardised for
clinical evaluation of such innovative products,” Dr Paul
said.
The products developed by the
innovators should not be stopped at one stage, but should
go through the evaluation process, like safety,
effectiveness and validation, and this area needs work
from the academia and industry, he added.
He was speaking at the
inauguration a new spacious R&D facility of Boston
Scientific, a US-based medical device company and an
innovator of less-invasive medical solutions.
https://www.moneycontrol.com/news/india/need-tostandardise-methodology-to-evaluate-medical-devices-nitiaayog-member-v-k-paul-8242311.html
DoP
Releases Approach Paper To National Medical Device Policy
To Make India “Diagnostic Capital Of The World”
The Department of
Pharmaceuticals (DoP) has released an approach paper to
the National Medical Device Policy, a draft for
stakeholder discussion, to position the country as the
true “Diagnostic Capital of the World”. The Policy, which
envisages various developments including setting up of
NIPER-like institutions for the medical devices sector, is
expected to be valid for a period of 10 years following
which it will be revised.
The policy, envisaged to
bring together the range of interventions government has
taken into a coherent policy framework, will have focus on
quality standards and safety of the devices, regulatory
streamlining, support to build competitiveness through
fiscal and financial support, infrastructure development,
facilitation of R&D and innovation, human resource
development, and brand positioning.
The efforts of the government
is to reduce import dependence from 80% to below 30% in
next 10 years and ensure self reliance quotient of 80% in
MedTech by ensuring Make in India with SMART milestone and
the policy lay down clear roadmap for accelerated growth
of the medical devices sector while promoting safety and
quality to systemically achieve the key objectives of
access, equality and university; affordability; patient
centres and quality care; preventive and promotive health;
and security.
The policy interventions
would include a single window clearance system for
licensing of medical devices integrating all key
stakeholders, making Indian standard setting bodies such
as BIS to gradually E Pam the standards for processes,
products, and performances, promotion of Global Medical
Devices Nomenclature and Universal Medical Devices
Nomenclature System, providing consideration for
international retest reports for product compliance
without further testing requirements.
The policy aims to
incorporate a framework for a coherent pricing regulation,
and the National Pharmaceutical Pricing Authority shall be
strengthened with adequate manpower of suitable expertise
to provide effective price regulation balancing the
patient and industry needs and incorporating innovation
and life cycle costs as factors pricing regulation of
medical devices. The Department also proposes
implementation of a Uniform Code for Medical Devices
Marketing Practices (UCMDMP). Setting up medical devices
parks with common infrastructure facilities will also be a
part of the policy recommendation. It also proposes to
develop additional NABL accredited laboratories for
medical device testing, amongst other infrastructure
development supports.
It proposes to allot a
dedicated fund for encouraging joint research with
industry players, academic institutions, small and medium
enterprises, and start ups for research and development
activities targeted at leveraging state-of-the-art
technology for domestic manufacturing of medical equipment
and to support consortiums comprising industry, academics,
startups and SMEs, to undertake joint R&D projects with
pre-defined agreements around intellectual property
related issues. The policy also proposes to promote
industry-academia linkage and innovation hubs, Centres of
Excellence in premier academic and research institutions,
purposeful investment in few priority institutes to build
CoEs focusing on medical technology innovation and R&D,
among others.
Strengthening IP rights, encouraging private investments
and external resources funding, promoting start ups and
inviting Venture Capital firms for screening of start-ups,
among others. For Human Resources development, the policy
envisages to set up National Institutes of MedTech
(Medical Devices Education and Research [NIMERs], on lines
of NIPERs, as institutes of National Importance),
formulating a National Registry for priority which
correlates to skills required in production of specific
technologies and will maintain a databank having details
related to latest technology and the skill required to do
the production, and financing of such skills through
hands-on trainings, internships/training in specialised
industry locations as par with Junior Research Fellow
stipends made available by UGC got universities.
It also envisages to promote
awareness on medical devices safety standards and ensure
proactive communication and outreach on the value
proposition, promote various national and international
events and road shows and promote Made in India for the
World movement.
The performance metrics is
expected to reach an outcome with a target of $50 billion
market size by FY 25, increasing global market share,
reducing disease burden and increasing disability adjusted
life years in India comparable to developed economies such
as the US and UK by 2030.
It is envisaged that by
20147, India’s will be one amongst top five global
manufacturing hubs in terms of value and technology for
Medical Devices, and will be home to 25 MedTech Billion
Dollar companies and home and originator to 25 high end
futuristic technologies in MedTech. India will achieve
10-12 percent of global market share of the medical
devices sector to reach a $100-300 billion industry and
will have 50 medical devices clusters across the country
for faster clinical testing of medical
devices to boost product development and
innovation, says the approach paper.
http://pharmabiz.com/NewsDetails.aspx?aid=147370&sid=1
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