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About Compensation To
Patients For Faulty Medical Devices
Indian patients suffering due to
faulty medical devices may soon be empowered to demand
compensation for health problems caused by such products from the
company making or importing them.
The government has set up an expert
panel to frame rules for compensation in case of an adverse event
due to a faulty or unsafe medical device.
Health ministry’s apex panel – Drugs
Technical Advisory Board (DTAB) has cleared formation of the
sub-committee to amend Medical Device Rules 2017, t include
provisions for compensation on the ground of a malfunction in the
device, or it being unsafe or non-complaint.
The proposed rules will cover all
future cases of negligence in medical device sector.
The development assumes significance
as it would be the first such law which would provide teeth to the
government to prosecute medical device companies in case of an
adverse event or death. The proposed amendments will help cases
filed on the grounds of negligence and have been languishing in
consumer courts.
The DTAB, in its recent meeting, had
recommended constitution of a sub-committee to be headed by
Directorate General of Health Services principal consultant BD
Athani. The 10-member panel has representation from medical device
industry (Rajiv Nath from Aimed and Pavan Choudhary MTAL),
consumers (Bejon Misra), and doctors (Rajesh Malhotra and Ramesh
Chander), besides the regulators. The chairperson has the option
of including experts from relevant field if required, they added.
The decision to bring in separate
rules has been taken to simply the legal process, cut down time
and multiple stages. A case of an adverse event due to a medical
implant is difficult to prove in the existing system and lacks
clarity in law, experts said earlier.
The need for a legal provision for
compensation is especially important for India with its
socio-economic demographic, which may not have the strength to
fight against powerful corporate in courts. The compensation will
have to be given in the case where and adverse event or death is
reported only for already approved devices and not those which are
under clinical trials.
https://timesofindia.indiatimes.com/city/mumbai/faulty-medical-devices-govt-sets-up-panel-to-frame-rules-for-compensation-/articleshow/-compensation/articleshow/67263772.cms
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