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Advancements in science has deeply impacted modern life.
Innovation in technology has played a significant role in improving
our health. Achievements in the field of biotechnology,
pharmaceuticals, information technology, physics, chemistry has led
to the development of medical devices and equipment, which have
proved to be life transforming. From administration of vital
lifesaving drugs to incorporation of critical medical devices such
as pacemakers, CT Scanners, X-Rays to an era of robotic surgery,
medical equipment have revolutionized human lives, at the same
time, the Government is vigilant to monitor the quality
control.
Legal framework
The Government regulates the commercialization of drugs and
medical devices under the provisions of the Drugs and Cosmetics
Act, 1940 under the authority of Central Drugs Standard Control
Organisation (hereinafter referred to as "CDSCO").
The faults revealed
With a view to help patients suffering from painful hip joint
with arthritis which is replaced by an artificial joint often made
from metal and plastic components. In 2006, a subsidiary company of
Johnson & Johnson, DePuy Orthopaedics started importing hip
implants for the purpose of facilitating hip replacement surgeries
in India.
The patients faced adverse reactions attributable to the
aforesaid hip implants being faulty in nature and resulting in
revision surgeries earlier than the prescribed period.
Penalizing the faulty
In order to determine the amount of damages payable to patients
suffering the consequences of the faulty implants, the Government
has constituted a Central Expert Committee (hereinafter referred to
as the "Committee").1 The new central
committee is chaired by RK Acharya, director of Safdarjung
Hospital's sports injury centre, and will consist of five
members.
The Committee shall be calculating the amount of compensation by
Johnson & Johnson to be paid on case to case basis.
The Government aims to ensure that the party committing the
fault does not evade of its liabilities and that damages suffered
by the victims are appropriately compensated for.
For further information please contact at S.S Rana &
Co. email: info@ssrana.in or
call at (+91- 11 4012 3000). Our website can be accessed at
www.ssrana.in
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