The Indian Pharmacopoeia Commission (IPC) in consultation with Central Drugs Standard Control Organisation (CDSCO) is in the process of developing a registered medical device information sharing portal to ensure that safe medical devices are available in the country. This portal would serve the purpose of India specific tool which would help IPC to facilitate the baseline study of products available with medical devices companies in India and assure patient safety.
“The companies have been told to share the details of products registered with them to conclude the baseline study. It would help the Indian drug regulators to verify about faulty medical devices available or banned in other countries also. A case in point is Johnson & Johnson (J&J) faulty hip implants which were banned first from Australia promptly as they have in place a system to track faulty medical devices,” according to a senior official associated with the development. As many as 4,700 patients in India had received articular surface replacement (ASR) hip implants manufactured by J&J subsidiary DePuy Orthopaedics Inc between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patient’s body and pose risk to human health.
Union health ministry is also planning to create a Registry of High Risk Medical Devices to effectively study and follow medical device associated adverse events (MDAE) and enable dangerous ones to be withdrawn from the market. The registry would track usage of high risk medical devices in India mandatorily. The same would be worked out taking reference of international scenario so that serious adverse events (SAE) can be prevented soon before it arises from the manufacturer’s end.
The Materiovigilance Programme of India (MvPI) which was launched in 2015 to ensure safety of medical devices is also currently being coordinated by the IPC at Ghaziabad. The Commission functions as the national coordination centre and Sree Chitra Tirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram acts as the collaborating centre. Technical support is being provided by the National Health System Resource Centre (NHSRC) in New Delhi.
Uptill now, MvPI has put 15 exclusive centres under it to collect and disseminate reporting of adverse events due to medical devices at the point of care besides the 250 adverse drug reaction monitoring centres (AMCs) across the country. IPC has also launched a reporting form for MvPI. The reporting form called as MDAE reporting form will help generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.
The reporting form includes adverse event details, severity of the event, date, location, device category, model of the device available with the organisation, its use after the event, name of medical device, manufacturer, brand name, model number, serial number, batch number etc.
Source : www.pharmabiz.com
Published on: January 9, 2019