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Aimed & Regulatory Update

India Eyes Japanese Tech For Med Devices

NEW DELHI : India is seeking to leverage its partnership with Japan to manufacture medical equipment as part of a five-year $42 billion investment and financing package agreed by prime ministers Fumio Kishida of Japan and Narendra Modi in March.

Such equipment may include patients monitoring systems, cardiac catheters, dialysers, speciality needles, thermometers, glucometers and personal weighing scales.

The matter was further discussed during Modi’s visit to Japan in May.

India’s department of pharmaceuticals now plans to invite large Japanese MNCs to use India as a global manufacturing supply hub as part of their China-plus policy.

The department has sought suggestions for investment from stakeholders such as the Indian Pharmaceutical Alliance (IPA), Indian Drugs Manufacturing Association (IDMA), Bulk Drug Manufacturers Association India (BDMAI), Association of Diagnostics Manufacturers of India (ADMI) and Association of Indian Manufacturers of Medical Devices (AiMED).

“At AiMeD, we have suggested targeting 1,200 Indian ventures for ₹25 crore each with foreign technical collaboration from countries like Japan who have the know-how but may not have the organizational capabilities to set up their own factories in India or their own sales organizations. And then we can target 200 joint ventures where the foreign partner may be willing to coinvest in factories of ₹50 crore each and also invite large MNCs (including from Japan) to use India as a global manufacturing supply hub in their supply chain as part of China-plus policy whereby they consider derisking their investments and dependence on their Chinese factories," said Rajiv Nath, Forum Coordinator, AiMeD.

He added that a target of 50 investments of over 200 crore each is feasible.

“We currently import many basic devices like thermometer, glucometer, personal weighing scales and more sophisticated technologies like patients monitoring systems, cardiac catheters, dialysers, specialty needles etc which may no longer be of strategic importance to Japanese manufacturers for making in Japan but that technical knowledge can reap benefits for them in India," Nath said.

According to pharma industry experts, India, which is over 80% import dependent has a potential for ₹50,000 crore of investments in the medical devices sector. They said that Japan is one of the leading manufacturers of medical devices and most of the production is by MSME companies that have specialised and created niche products.

Darra Patel, General Secretary, IDMA noted it has disseminated the information to their member companies. “We have sought comments and suggestions from our member companies in this regard and we are hoping that they will soon share their ideas."

( https://www.livemint.com/industry/manufacturing/india-eyesjapanese-tech-for-med-devices-11654705992525.html )

IPC Launches MvPI Internship Course To Strengthen
Medical Device Adverse Event Reporting In India

In a bid to strengthen medical device adverse event reporting in the country, the Indian Pharmacopoeia Commission (IPC), the national coordination centre (NCC) for Materiovigilance Programme of India (MvPI) has launched internship programme for pharmacy, medical, dental, and allied health science professionals. The programme will enhance the knowledge of the professionals on importance of materiovigilance programme and medical device adverse event reporting.

Talking about the importance of the MvPI internship programme, Dr Vivekanandan Kalaiselvan, senior principal scientific officer, IPC said, “Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical deviceassociated adverse events in India. There are medical device adverse events which can not be reported through conventional medical device adverse event reporting mechanisms. To address this gap, IPC has come up with an MvPI internship programme. The internship course will help professionals gain valuable research experience, develop and refine medical device adverse event reporting skills.”

The candidates pursuing or completed pharmaceutical sciences such as B. Pharm, M. Pham, Pharm D, Ph. D; medical sciences such as MBBS, MD, DM; dental sciences such as BDS, MDS, Ph. D; engineering such as BE/ME/B. Tech/M.Sc./MSc/MS/Ph. D in biomedical engineering, medical electronics, clinical engineering, electronics, instrumentation & related courses; nursing such as ANM, GNM, DNA, BSc/M.Sc. Nursing and allied health science courses, can apply for short-term or long-term projects which could be an exclusive learning experience for them.

The duration of internship shall be preferably: three months (short-term), six months (long-term), one year (long-term).

Interested candidates can fill the following google link:


They can also send their updated resume to shatrunjay.ipc@gov.in

Applications will be accepted throughout the year. Students are required to apply directly (via google link/e-mail) of their interest at NCC-MvPI, IPC with an updated resume. Students shall submit a recommendation letter from the head of the department / head of the institute from their college/university/institute indicating the requirement of training and duration as necessary for the fulfilment of their degree.

In 2017, the government of India issued the Medical Devices Rules 2017 for regulating medical devices used throughout the country. The rules came into effect on 1 January 2018.

As per the MDR, the devices are classified, based on degree of risk associated with Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk).

As per the MDR, G.S.R. 78, Chapter 4, Section 26 (ii) the adverse events reporting associated with medical devices to the relevant authority is mandatory; the license holder shall inform the state licensing authority or central licensing authority, as the case may be, of the occurrence of any suspected unexpected serious adverse events and take necessary action thereon including any recall within 15 days of such event coming to the notice of license holder.

Although medical devices adverse events reporting is compiled by law, the reporting to the authority and its surveillance system are a grave concern. Therefore, besides the MDR, in order to promote the culture of adverse events reporting, the health ministry had launched Materiovigilance Programme of India (MvPI) in order to monitor and assure the safety of medical devices used in the country in 2015.

The MvPI aims to collect, collate and analyze the voluntarily reported adverse events associated with medical devices and thus arriving at meaningful or evidence-based information that is being recommended to the regulatory authority and general public for promoting the safe use of medical devices.

In order to facilitate adverse events reporting from the region, a structured programmatic approach has been made by recognizing medical colleges/hospitals/other related institutions as Medical Devices Adverse Events Monitoring Centres (MDMCs) across the country.


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