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Changing Scenario For Medical Device industry Regulations
In India
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Mr. Rajiv
Nath
Forum Coordinator,
Association of Indian Medical Device Industry (AIMED)
And Managing Director,
Hindustan Syringes & Medical Devices Limited. |
Mr. Rajivnath started his
presentation by acknowledging Gujarat as the pioneer for
the medical device industry in India. He also appreciated
the contribution of the publication, “MEDICAL PLASTICS
DATA SERVICE” and Mr D L Pandya in particular for
initiating awareness and education programmes for the
Indian Medical Device Industry.
The presentation focused on
issues related to what Medical Device Regulations : the
previous situation, what its currently undergoing and
what changes are expected in the future. He also shared
his VISION for the future of the Indian Medical Device
Industry.
Talking about his vision, he
mentioned that we would like the Indian Companies to be
the preferred suppliers worldwide. For any product family, whether it is Syringes or medical electronics or heartvalves, the Indian Companies in that particular
product family should be in the top five of the world.
Similarly for the Regulatory body, the Regulatory body for
the Pharmaceuticals Industry has done.
The regulatory body for the
pharmaceuticals industry has done very good job. His
vision is to have something similar for the Medical
Devices. Unfortunately Medical Devices have not been much
in focus. He would like to have more focus from the
regulatory bodies for the Medical Device Industry. The
Medical Device industry size is more bigger and more
varied. And we hope the regulatory bodies will adopt that
vision. |
That they would become centre
for excellence, they would help in assisting Medical
Device industry to produce products with adequate and
appropriate systems and controls for ensuring patients
safety. He also further mentioned that we as industry must
be accountable to the public through the regulator. The
industry should be well run, well managed, we must legal
obligations. We must make high quality, low cost
affordable products.
Regarding The Role of
Regulators:
The regulator should work with
the industry in transparent manner. It should supervise
industry directly or by subcontracting it through related
bodies. There should trust between the consumers and
Indian products. The regulators should help in
facilitating their trust for Indian medical device
industry. The role should not only be of just policing, it
should be of guidance and advice, nurturing role for the
industry to help meet the legal obligations which will in
turn help us achieve safety for the consumers.
This will help to industry to
grow and gain the international recognition. Also the
regulators and regulations should be such that they help
in introducing innovative and emerging technologies that
is very important because medical device industry is
always changing and always going through innovation. We
are constantly getting feedback from our customers,
clients, users, patients, doctors, nurses and we are
incorporating those changes in our product designs which
takes them beyond the product standards sometimes. So the
regulators need to allow room for that innovation and
welcome that change. Otherwise we will restrict good
quality products or innovative products from reaching the
patient.
Regarding the current status
of the regulation, he mentioned that, “around 18 to 20
medical devices have been covered under drug act. that is
not even 1 % of our range”. There are more than 1000
medical devices which are made in the country,
unfortunately whenever they have brought in to the purview
of the regulations, they have been treated as drugs and
pharmaceuticals. So whole prism at the Medical Device
industry was unfortunately flowed currently, the scenario
is that medical, devices, the once which are covered or
regulated, are expected and controlled by the Drugs
Controller and General of India and CDSCO and the
implementation of the Act and the supervision is done
through the State drug controllers’ department and
products samples are randomly tested in the centre and
state designated laboratories for certain products
specific standards. This Act is very old Act. Because of
this old Act and similar old laws in India it was,
unfortunately getting opposition where we had a short of
licence raj scenario.
The inspections or the
inspectors from the various state authorities are with
pharmacy background and excellent knowledge in medicines
were naturally not trained or they were slightly
illiterate to regulate these medical devices. So
sometimes, even the help of IIT was used to help the
regulator in supervising factories, like I think for
copper Ts. The inspections were done based on looking at
the rules for pharmaceuticals and medicines so the
inspectors also felt a little bit helpless because the
interpretation they would follow just by the book would be
very difficult to apply to the medical devices. So in some
states where there was more dialogue between the
regulators and the industry, slight flexibility was shown
and more openness was shown and the industry could
progress in those states. Over here, interestingly, the
first time medical devices regulation was formulated for
schedule M3; the first draft was done by the Gujarat FDA.
But that time the industry was also young and the
regulations were also young and even internationally also
they were not so developed. Now we have an advantage .The
current regulations also do not address risk based
assessment. If a product is having a faulty label, it is
treated as misbranding. Whether it will affect the life of
the patient or the risk factors involved that is not
looked at. Also is the question as to how to address new
products, new technologies because for example when the
regulations came they covered hypodermic syringes, but now
you have insulin syringes, auto disabled syringes, safety
syringes, , blood collection needles, ring needle sets, so
it was not able to address the issue of the innovation or
changes over that. For some things, there can be Indian
standards and for some there is no international standard
and the more new and more innovative the product,
international standard will not be there and the more
critical, the more risky products, will never be having
those standards also.
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