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New Delhi: India’s top drug regulator is collecting information on adverse events caused by medical devices to take timely action against manufacturers and ensure appropriate measures are taken to reduce risks to public health as such incidents occur. The numbers are increasing.
The Drug Controller General of India has issued a prescribed format for collecting information about unwanted effects from medical devices and in-vitro-medical devices (IVDs), ensuring that the ‘patient’ or ‘complainant’ Will not be identified. public. The proforma has to be filled with details like details of the medical device including brand name, manufacturer, importer or distributor.
DCGI has urged people to send the duly filled form to the Indian Pharmacopoeia Commission, a body under the Health Ministry, which runs the government’s Materiovigilance Program of India (MVPI) platform to monitor adverse events associated with medical devices in India. Runs.
The regulatory action is aimed at tightly monitoring side effects from medical devices, a market that is projected to grow from $11 billion to $50 billion by 2030. peppermint Earlier, DCGI had directed all medical device license holders and manufacturers to report any adverse event related to life-saving medical devices on the MVPI platform.
security concerns
According to Rajeev Nath, forum coordinator of AiMeD, a leading body of medical device manufacturers in India, unlike drugs, complete safety in medical devices – which are engineering, not chemical products – may not be possible.
They added that serious adverse events should be monitored post-marketing, including death or injury requiring surgical intervention. He said that the important thing is that such incidents should be reported to the manufacturers so that swift and direct redressal can be taken or the feedback can be used for systemic review to the Indian Pharmacopoeia Commission or the regulator.
Medical devices are therapeutic, diagnostic, therapeutic and diagnostic, implantable, non-implantable, invasive and non-invasive, single-use devices, reusable, sterile and non-sterile, and for personal use and home care.
Nath said reports on adverse events from such devices should not result in witch-hunts and a trust factor needs to be built to persecute the person making the report – be it a health care provider or a patient or the manufacturer itself.
lack of clarity
The DCGI, in its public notice, said that submitting a Medical Devices Adverse Event (MDAE) does not constitute an admission that medical personnel or the manufacturer or product caused or contributed to the adverse event and “has no legal effect”. “
“The identity of the patient/reporter is kept strictly confidential and completely secure. Program staff are not expected to disclose the identity of a patient/reporter in response to a public request.”
Citing US and EU regulations, Nath stressed on clarity for “what is reportable and what is not – what is a serious adverse event and what is a non-serious adverse event”.
“Currently there is a lot of confusion and lack of clarity at various levels, so there is either under-reporting or over-reporting in some organizations or reporting to regulators by not reporting to the manufacturer,” he said. “Webinars and public education will help bring clarity and build the trust factor.”
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