Aimed & Regulatory Update

Centre Set To Send Medical Device Policy for Final Nod

All stakeholder consultations have been completed and the government think tank NITI Aayog has asked the department to prepare a mechanism to attract venture capital funding and drive local production of medical devices.

• The aim is to make medical devices one of the champion sectors and boost India’s 10-12% share of the global medical devices industry.

The Department of Pharmaceuticals will shortly circulate a draft note of the proposed new Medical Device Policy 2022 for cabinet approval that will seek to turn India into a global manufacturing hub for medical devices.

All stakeholder consultations have been completed and the government think tank NITI Aayog has asked the department to prepare a mechanism to attract venture capital funding and drive local production of medical devices.

The aim is to make medical devices one of the champion sectors and boost India’s 10-12% share of the global medical devices industry.

The draft note envisages that by 2047, India will be among the top five global manufacturing hubs in terms of value and technology for medical devices, and it will emerge as a champion in critical components, cancer diagnostics, medical imaging and ultrasonic scans among others. India now ranks among the world’s top 20 global medical devices market, and is the 4th largest medical devices market in Asia after Japan, China, and South Korea.

“We have received remarks from all the stakeholders and departments. They have accepted and supported the policy also. So, we have got a very good response from all the people," said an official aware of the matter requesting anonymity. “In fact, NITI Aayog has told the Department of Pharmaceuticals to raise the capacity of domestic manufacturing by exploring venture capital and private equity," the official said.

Experts said the pandemic and ensuing lockdowns brought the government's focus on medical devices when international supply chains were disrupted, which in turn prompted the Atmanirbhar Bharat initiative or domestic production of medical devices.

“We are delighted that the union government has finally come out with a Medical Devices Policy. This was long awaited. Now over 20 ministries and government department can work in a coordinated manner to address the ever-rising graph of imports which went up by a steep 41% to ₹63,000 crore last year (approx $8.5 billion) leading to over 80% import dependence. India needs a predictable policy and regulatory ecosystem to consider manufacturing in India. There are now exciting Make In India possibilities for and we invite MNC and other mid-sized specialist manufacturers to put up green field manufacturing plants in India as 100% FDI or Joint Ventures or as technical collaborations," said Dr Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD).

"As far as data is concerned, till now 80%of medical devices are imported in India. The production of medical devices is restricted in some areas and we need to expand it. So, this can happen when there is a tech transfer happening in the medical device sector. A long-term policy can actually help to enhance production and India has a potential to be a hub for exports in medical devices," said Jatin Mahajan, managing director, J Mitra & Co. Pvt Ltd which deals in manufacturing of in-vitro diagnostics
and secretary of Association of Diagnostic Manufacturers of India.

https://www.livemint.com/news/india/centre-set-to-sendmedical-device-policy-for-final-nod-11660322824138.html

Govt reconstitutes National Medical Devices Promotion Council

The Council will brief the issues deliberated in its meetings with the minster for chemicals and fertilisers on a regular basis to take further guidance.

The Department of Pharmaceuticals (DoP) has reconstituted the National Medical Devices Promotion Council (NMDPC), with the Secretary of the Department as the head of the Council.

The reconstitution comes after the Department for Promotion of Industry & Internal Trade (DPIIT) under the Ministry of Commerce and Industry, which was heading the Council from its inception, decided to hand over the onus.

An office memorandum issued by the DoP said that since the DoP has the mandate for the promotion of the medical devices industry and has created dedicated institutional mechanisms such as a standing forum of medical device associations, the DPIIT has communicated its concurrence through an office memorandum dated June 16, 2022, to reconstitute the NMDPC under the chairpersonship of the Secretary, DoP, with appropriate representation from DPIIT.

Members

Accordingly, the Council has been reconstituted with the following members:

• Secretary of DoP as the chairperson,

• Chairman of the National Pharmaceutical Pricing Authority (NPPA),

• Joint secretary of DoP (in charge of NIPER division) and Advisor for Health, NITI Aayog, as the ex-officio members.

Another eight ex-officio members would be one representative each, not below the rank of joint secretary or equivalent, from the Department:

• Health and Family Welfare,

• Department of Health Research,

• Department of Commerce,

• DPIIT,

• Drug Controller General (India) (DCGI),

• Secretary Indian Pharmacopoeia Commission,

• Executive Director of Engineering Export Promotion Council of India (EEPC),

• Kalam Institute of Health Technology, Andhra Pradesh.

The representatives from:

• Medical devices industry associations

• Association of Indian Medical Device Industry (AiMeD),

• Association of Diagnostics Manufacturers of India (ADMI),

• Medical Technology Association of India (MTAI),

• Medical Devices wings of Federation of Indian Chambers of Commerce and Industry (FICCI),

• Confederation of Indian Industry (CII),

• Advanced Medical Technology Association (AdvaMed) etc.,

The Joint Secretary, DoP, who is in charge of the medical devices division, will be the convener of the council. Others are:

• The joint secretary or equivalent from the following departments:

• Ministry of Environment, Forest and Climate change,

• Department for BioTechnology,

• Ministry of Electronics and Information Technology,

• Ministry of Micro, Small and Medium Enterprises,

• Animal husbandary and dairying,

• Consumer Affairs,

• Telecommunications revenue, etc.

Representatives from:

• Atomic Energy Regulatory Board (AERB) Bureau of Indian Standard,

• CEOs of the National Accreditation Board for Testing and Calibration Laboratories (NABL),

• National Accreditation Board for Certification Bodies (NABCB),

Government E Marketplace (GeM), Quality Control India, and Technical experts in the field of medical devices are co-opted as and when required to deliberate on specific issues.

Further, the additional chief secretary or principal secretary of the industry department of the four states, which are Uttar Pradesh, Madhya Pradesh, Himachal Pradesh, and Tamil Nadu, where the government is supporting the creation of common infrastructure facilities under the scheme for the promotion of medical devices parks, will be invited to the meeting of NMDPC as may be needed, to bring the relevant issues for deliberations.

The setting up of the Council was first announced by the then Union Minister of Commerce and Industry, Suresh Prabhu, on December 14, 2018, and the DPIIT later issued an order on March 3, 2020, establishing the Council.

According to the initial decision, the council was headed by the Secretary of DPIIT, along with members from the concerned departments of the Government of India and also representatives from the healthcare and medical devices industry and quality control institutions.

The Council will try to meet once in three months and have not less than three meetings in a year. Besides, it may convene as and when a substantial issue is to be discussed.

The Council will brief the issues deliberated in its meetings with the minister for chemicals and fertilizers on a regular basis to take further guidance.

• To act as a facilitating and development body for the Indian medical technology industry,

• To achieve the objectives envisaged under the proposed National Medical Devices Policy, 2022, towards the goal of attaining Universal Health Coverage.

The other objectives include:

• To build synergies in the efforts of various departments in view of the diversity and multi-disciplinary nature of the sector to harness the potential of the Indian MedTech sector;

• To hold seminars, workshops, and related networking activities to garner the views of the industry;

• To further strengthen the institutional mechanisms established by the Department such as Standing Forum of Medical Device Association and Regulatory Roundtable meetings to deliberate on the issues put forth by the industry for resolution;

• To support dissemination and documentation of international norms and standards for medical devices by capturing the best practices in the global market and facilitate domestic manufacturers to rise to international level of regulatory and on-regulatory needs of the industry.

It will also deliberate on various issues related to public procurement of medical devices under the Public Procurement Order (Make in India) Policy of DPIIT with the goal to encourage investment and domestic manufacturing in all categories of medical devices.

https://thehealthmaster.com/2022/08/11/govt-reconstitutesnational-medical-devices-promotion-council/.