Mumbai : 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 device-associated 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: https://docs.google.eom/forms/d/e/lFAIpQLSedMo_gD8gv01DGIKxQkSLJ7r4MMSu6XHDNTWdlysMukUoLCQ/viewform
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.
