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“Current Status of
Medical Devices Regulation in India”
by
DR. G.S.Bhuvaneshwar
Head, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences and
Technology, Trivandrum
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Advances in
science, technology and medicine have produced a huge variety
and number of medical devices, which have become an important
part of healthcare delivery today. The term “Medical devices” as
generally defined, covers very simple, low risk ones like
contact lenses and syringes to critical life-saving and
life-supporting devices like artificial heart valves and
hemodialysers; the numbers are increasing rapidly every year,
with the development of new advanced materials and technologies.
However, poorly designed or manufactured devices have the
potential to cause harm and injury to patients and care givers.
Current
international experience in the use of medical devices has
clearly shown that the optimum assurance of medical device
safety has several essential elements:
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Absolute safety
cannot be guaranteed
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It is a risk
management issue
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It is closely
aligned with device effectiveness and performance
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It must be
considered throughout the life span of the device
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It requires
shared responsibility amongst the stakeholders
Medical devices
are manufactured using a wide variety of technologies and are
different from drugs. Consequently, ensuring the safety of the
public in the use of medical devices requires an entirely
different system from the current national and international
practices that are being applied for ensuring the safety of
drugs and cosmetics.
The present
approach under the Drugs and Cosmetics Act, is very similar to
the FAILED approach taken by USA in 1976 under their Food and
Drugs Act. They had to make many amendments from 1990 onwards to
make their system practical and workable. Most importantly, the
present approach is NOT IN CONFORMITY with the recommendations
of the Global Harmonizing Task Force. Hence, in taking this
approach, the medical devices industry in the country is going
to be burdened and things made more difficult for them to
compete internationally.
The talk will
explain these points and the draft Medical Devices Regulatory
bill that has been placed on the DST web site for feedback. |
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Dr. G. S.
Bhuvaneshwar is the Head, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences &
Technology, Trivandrum. He obtained his B.Tech (Electronics)
and M.S. (Biomedical Engineering) degrees from IIT Madras
and PhD (Biomedical Technology) from Sree Chitra Tirunal
Institute for Medical Sciences & Technology, Trivandrum.
He joined Sree
Chitra in 1976 and has been associated with the Biomedical
Technology Wing right from its inception.
He has
received several awards including the Distinguished Alumnus
Award (2001) of IIT Madras, shared FIE foundation award
(1995) for the development of Chitra Heart Valve and NRDC-Awards
for meritorious invention for Chitra Heart Valve (1994) and
Spictra Membrane Oxygenator (2006).
Main research
interests are in the development of cardiovascular devices
and blood compatibility of materials. His major
contributions are in the development of medical devices such
as tilting disc heart valve prosthesis (TTK-CHITRA HEART
VALVE -- TTK Health Care Ltd, Chennai), Hydrocephalus Shunt
System (CEREDRAIN - Hindustan Latex Ltd, Trivandrum), Hollow
Fiber Membrane Oxygenator (SPICTRA - SIDD Lifesciences Ltd.,
Chennai) and Woven Arterial Prosthesis (developed in
collaboration with South India Textile Research Assn,
Coimbatore. Technology transfer to TTK Healthcare Ltd,
Chennai in progress). He has two US, one European and 5
Indian patents and has authored 25 research papers and a
book chapter.
A quality
system conforming to ISO17025 for biomedical testing
services has been implemented in the Biomedical Technology
Wing of the institute under his leadership and accredited by
COFRAC of France. The wing is currently in the process of
implementing a major expansion programme for providing
greater support to the medical devices industry in the areas
of testing, R&D and GMP.
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Dr. G.S. Bhuvaneshwar
Head, Biomedical Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences &
Technology
medtec@vsnl.com |
