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Union health ministry will soon mandate medical device import licence holders to report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the State or Central licensing authorities in accordance to new Medical Device (MD) Rules, 2017.
As of today, there is no provision for import conditions to be complied with by import licence holder to report SUSARs within 15 days as per Rule 38 of MD Rules, 2017.
Drug Technical Advisory Board (DTAB) in its 83rd meeting held on June 11, 2019 in New Delhi had also recommended to amend the MD Rules, 2017 to incorporate necessary provision of SUSAR reporting.
The Board was apprised that, clause (ii) under Rule 26 in Chapter IV of MD Rules, 2017 specifies that “the licence holder shall inform the State or Central licensing authorities, as the case may be, of the occurrence of any SUSAR and action taken thereon including any recall within fifteen days of such event coming to the notice of licence holder.”
Chapter IV stipulates manufacture of medical devices for sale or for distribution.
SUSAR is an important aspect of clinical trials in drug testing or clinical care. Monitoring of adverse events related to medical devices is an important component of regulatory control because their performance depends to a considerable extent on their appropriate use.
A medical device monitoring system is also in place for this purpose through the Materiovigilance Programme of India (MvPI) launched in 2015 under the umbrella of Pharmacovigilance Programme of India (PvPI).
A suspected unexpected serious adverse reaction is known as a SUSAR. Sometimes during a clinical trial for a certain drug, a subject may experience serious adverse reactions that may or may not be dose-related but are unexpected, as they are not consistent with current information.
Medical device adverse events are reported by a wide range of stakeholders supplying or handling CDSCO-notified medical devices.
Reports are recorded on the Medical Device Adverse Event (MDAE) reporting form, which is forwarded by the Medical Device Monitoring Centres (MDMCs) to the National Coordination Centre (NCC).
Indian Pharmacopoeia Commission (IPC) which is the NCC of MVPI receives technical support from the National Health System Resource Centre (NHSRC) and collaborates with the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in providing advice to Central Drugs Standard CDSCO on regulatory actions for medical devices.
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