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The Medical Device Regulation Bill, 2006
The Medical Device Regulation Bill, 2006, will
Create an autonomous regulator for medical devices
Provide for rules governing safety, efficacy, design and
manufacturing
Create panels to classify devices, and for testing and
evaluation
Classify devices by risk, and link regulation to the level
of risk
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Background :
In the early 1980s, the
government sent a senior health ministry official to
an international meeting on medical devices regulation
in the US. He was shocked to find that of about 50
countries that were represented, India was the only
country with no regulation. Thus began a long-winded
process that has culminated in the Medical Devices
Regulation Bill, 2006. The one institution that has
been a constant in the process is Kerala’s Sri Chitra
Tirunal Institute for Medical Sciences & Technology.
The state-owned hospital has been pushing for
regulation since 1980. The reason, says its now
retired founder director Sankaran Valiathan, is
simple. “At the time, Sri Chitra was on the cusp of
developing a range of local alternatives to imported
devices, but we had no clue whose approval to take to
launch the product.” Sri Chitra chose to apply to the
ministry. After much discussion, the drugs regulator
approved Sri Chitra’s blood bags. Yet Sri Chitra kept
pushing for regulation. “Until there’s a new law, all
decisions are ad-hoc,” says Valiathan, who became the
‘go to’ person for any government that looked at
medical devices regulation. In 2000, six years after
he retired, he chaired a committee set up by the
Indian Council of Medical Research. The latest Bill is
based on its suggestions.
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The
Business World in its issue dated Nov. 19, 2007 carried an
in depth analysis of the situation with respect to the
Regulation for Medical Devices as it exists to-day which
includes opinions from the leaders of the Indian Medical
Device Industry.
We reproduce below the abstracts of the contents of the
Report :
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India’s medical implants and devices industry is a poor
cousin of the country’s biopharmaceuticals and technology
sectors.
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According to Frost & Sullivan, the global medical devices
industry, at $196 billion, is dwarfed by its
$500-billion-plus pharmaceuticals counterpart.
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In India too, at $1.8 billion, the market is just about as
large as Ranbaxy or Dr. Reddy’s Labs, the country’s
largest drug makers.
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while India’s pet sunrise industries have been richly
rewarded with tax breaks and other incentives for putting
the nation on the global map, makers of bone plates,
pacemakers, intra-ocular lenses, heart valves and stents
do not even have a law to govern them. “It’s almost like
we don’t exist,” says Pitre , Managing Director of Pune
based Sushrut-Adler Group manufacturing orthopaedic
implants.
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Without effective regulation, bonafide producers compete
with barnyard operators and local traders who use scrap
metal as raw material, and import goods of unproven
quality. “We have to compete on price with those who cut
corners,” says Pitre.
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Also, Indian companies often fare poorly against premium
global brands such as America’s Medtronic or Boston
Scientific, which are approved by stringent western
regulators and backed by huge amounts of clinical trials
data. Imports account for most of the Indian market.
“Quality has always been a concern with Indian players in
the past,” says Vaibhavi Ananthanarayanan, programme
manager of healthcare practice at Frost & Sullivan. “But
it is more of a perception issue.”
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The Medical Devices Regulation Bill, 2006 proposes to set
up an autonomous regulator for the sector. Its primary aim
will be to set standards on a par with the rest of the
world. “Once a device is tested and approved in India,
there should be no testing needed in any importing
country,” says B. Hari Gopal, adviser to the ministry. The
Bill will also regulate imports into the country.
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“With more stringent regulations, Indian products will
fare better than some foreign brands as they are less
expensive and are made for the Indian consumer,” says
Ananthanarayanan.
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Confusing Regulatory Status: Another regulation is
threatening to undo this promise. Since 2005, 10
categories of products are subject to the Drugs &
Cosmetics (D&C) Act of 1940. An October 2005 notification
requires importers and local manufacturers in these
categories to be licensed by the Indian drugs regulator,
the Drugs Controller General of India (DCGI). It gave
existing players a grace period, now lapsed, to obtain
licences. Companies allege the Act was not written for the
devices industry and that it is endangering their
survival.
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The cause lies in the Act itself, say players, some of
whom spoke under condition of anonymity. In Europe and the
US, separate laws govern medical devices and implants. The
pre-independence D&C Act was meant for drugs and
cosmetics. Some of its requirements add to cost but not
necessarily to quality, they add.
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The Trouble With The Law
Take the concept of sterility. A sterile drug, like an
intravenous fluid, has to be manufactured in ‘clean room’
conditions. This requires a certain type of flooring,
furniture, air flow and energy requirement to minimize
impurities. Importantly, a sterile drug is tested in-house
for impurities.
A sterile medical device can even be one that is
sterilized at the point of use. For instance, a doctor
orders different sizes of an orthopaedic implant from a
company and, at the time of surgery, sterilizes only that
which fits the patient. “You need a dust-controlled
environment for processing plastic components since dust
particles could get permanently embedded in it,” says K.
Sunil, vice-president of TTK Healthcare, the country’s
sole maker of heart valves. “But this is not so for metal
components such as bone plates, which can be cleaned.” An
in-house sterility testing laboratory will be expensive
but hardly utilized.
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