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Aimed & Regulatory Update

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.


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.


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