New Delhi: India’s apex drug regulator has asked medical device makers to self-report all adverse events related to their equipment through the Centre’s Materiovigilance Programme of India (MvPI), ThePrint has learnt.
In a circular issued to states and associations of medical device makers last week, the Central Drug Standard Control Organisation (CDSCO) has said that it is important that all license holders establish robust systems and processes for the timely identification, documentation, and reporting of adverse events associated with such equipment.
ThePrint has accessed a copy of the circular.
Senior CDSCO officials said that while the MvPI has been in place since 2015, so far only 451 hospitals designated as medical device adverse event monitoring centres were required to report such events to Indian Pharmacopoeia Commission — which sets standards for medical products — on a voluntary basis.
“The latest circular, however, is aimed at developing a system of robust post-marketing surveillance (PMS) of medical devices as these devices are approved based on clinical trials in small groups of patients but later used in much larger numbers of people,” a senior CDSCO official told ThePrint.
“We, therefore, want companies to self-report adverse events related to medical equipment and licensing authorities to keep an eye on the circular’s implementation,” the official added.
The circular issued by Rajeev Singh Raghuvanshi, Drugs Controller General of India who heads the CDSCO, said that the PMS of medical devices is a crucial tool to ensure safety and performance of the medical devices.
“PMS supports in identifying and addressing any potential risk or adverse event associated with the medical devices,” the circular said.
Such timely reporting of the adverse events allows for the “identification of unidentifiable risks, analysing frequency of already identified risks and enabling the manufacturers and regulatory authorities to take appropriate measures to mitigate these risks and safeguarding public health”, it added.
Under the government norms, currently all medical devices, including in-vitro diagnostics tests used on biological samples such as blood, are regulated through The Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017, and license or approval is required for the import or manufacture for marketing of the devices in the country.
As per the government estimates, the size of the Indian medical devices market is estimated at $11 billion, and is expected to grow to $50 billion by 2025 and the sector has been growing steadily at a compound annual growth rate of 15 percent over the past 3 years. As of now, more than 6,000 different kinds of medical devices are used in the country.
‘Need to report only events that are serious in nature’
The CDSCO has said that the MvPI is an important programme for reporting of adverse events and coordinated analysis related to the medical devices, including in-vitro diagnostic devices.
“Therefore, it is suggested that all license holders should also use the MvPI platform for reporting of any adverse events/serious adverse events associated with the devices to enhance the procedure for identifying risk associated with them,” it said, adding training sessions may be organised for companies to facilitate the system if required.
But some industry veterans caution that adverse event reporting by manufacturers, patient and medical device users and hospital care providers needs to be only in cases that are serious in nature that can lead to death or serious injury requiring surgical intervention and not for every customer complaint.
“It should not lead to witch hunting but enable systematic review for ensuring patient safety. Only then manufacturers are motivated to self-report,” Rajiv Nath, forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), a network of a large number of firms making medical devices, said to ThePrint.
On many occasions, Nath said, serious adverse events may not necessarily be caused due to manufacturing defects but due to incorrect or abnormal usage of a medical device, for which one can’t blame the manufacturer but seek better product familiarisation training.
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