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Ministry Of
Health Launches Materiovigilance Programme To Monitor
Safety Of Medical Devices
In a strategic move to protect
the health of the patients, the ministry of health &
family welfare approved the commencement of the ambitious
Materiovigilance Programme of India (MvPI) to monitor the
safety of medical devices in the country. The MvPI was
formally launched on July 6 at Indian Pharmacopoeia
Commission (IPC), Ghaziabad by Dr G N Singh, Drug
Controller General of India (DCGI).
It is understood that while
IPC will function as the national coordination centre for
MvPI, Sree Chitra Tirunal Institute of Medical Sciences &
Technology (SCTIMST) will be functioning as National
Collaborating Centre for the same. At the same time, the
National Health Systems Resource Centre (NHSRC) under the
ministry of health will collaborate and work as technical
support and resource centre.
While stressing on the
importance of this initiative, Dr Singh said this is an
important step towards ensuring patient safety measures in
the country as medical devices are as crucial and
important aspect of healthcare as drugs.
“Considering the current
healthcare needs of the country, MvPI is a necessity
essential to safeguard the interest of the patients. Thus
we would ask all the stakeholders to come forward and
support us in this national cause.” He further stressed
that this will go a long way in generating India’s safety
data collection on the medical devices running in the
market in a systematic manner so that regulatory decisions
and recommendations on safe use of medical devices for
India could be based on data generated here.
Dr V Kalaiselvan, principal
scientific officer, IPC informed that following the
launch, the technical committee had a high level meeting
in which the members of the steering committee and working
group took important decisions on identifying the 10
adverse effect monitoring centres and data management
system, along with finalising the other aspects relating
to the modalities for the same.
Interestingly, this programme
is meant to monitor medical device associated adverse
events (MDAE), create awareness among health care
professionals about the importance of MDAE reporting in
India and to monitor the risk-benefit profile of medical
devices. It will also play key role in generating
independent, evidence-based recommendations on the safety
of medical devices so as to communicate its results to the
stakeholders.
At present, there is no
mechanism to monitor or regulate the use of medical
devices in the country against any possible adverse
events. Thus experts from the industry strongly feel that
this move will finally help in bringing some regulatory
semblance to the sector. Especially since monitoring for
possible adverse events pro-actively will not only help in
ensuring better patient safety but also improve the
standard of the industry as well.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=89344&sid=1)
AdvaMed
Demands Passage Of D&C Amendment Bill To Delineate Medical
Devices From Drugs
The Advanced Medical
Technology Association (AdvaMed), an association of
medical device manufacturers in India, has demanded the
passage of Drugs and Cosmetics Amendment Bill, delineating
medical devices from drugs, in the upcoming session of
parliament.
Though the government had
cleared the amendment to the Drugs and Cosmetics Act bill
delineating the medical devices from the pharmaceutical
and drug products in the year 2013, the bill has not got
complete formal nod of the parliament, due to which there
are so many legal hurdles that are becoming stumbling
blocks for the growth of medical devices sector in the
country.
“The Bill is historic because
it creates a distinction between drugs and medical devices
for the first time in India’s legislative history. We
believe that by establishing an appropriate regulatory
framework for medical devices, it will enable industry to
better address the needs of Indian patients,” says Sanjay
Banerjee, chair of AdvaMed India.
First introduced in the Rajya
Sabha in 2013, the Bill has since gone through several
revisions. The health ministry has organised a series of
consultations with other departments, industry and civil
society to ensure that the amendments address all concerns
adequately.
In fact, the nascent medical
devices sector entered the limelight last year with Prime
Minister Narendra Modi calling out to medical device
manufacturers to ‘Make in India’, and the department of
industrial policy and promotion (DIPP) opening up the
sector to 100 percent automatic foreign direct investment.
Once the final bill is passed,
then, it is regarded as benchmark legislation because it
outlines a regulatory system that is appropriate for
medical devices, and is broadly harmonised with
international regulations. It will ensure quality of
medical devices, and therefore patient safety, and remove
bottlenecks to easy availability. It will grow domestic
manufacturing capacity, allow domestic industry to compete
globally, and incentivise international industry to invest
in ‘Make in India’.
“Without the legal backing,
the medical devices are still considered as drugs. Because
of this, medical devices manufacturers are facing hurdles
in product registration and approval for manufacture of
new devices,” says Banerjee.
For decades, the medical
device industry has gone unrecognised in India. Currently,
of the 14000 types of medical devices that exist, only 22
are on the government’s list and even these are treated as
drugs. The obfuscation of the two categories in India has
created ambiguity about safety standards and quality
control, and limited the ability of the medical device
industry to address issues of access, availability,
affordability and safety.
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=89447&sid=1)
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