EU Model Systems
For Medical Devices With BIS Fixing Approval Standards
The Central Government
is likely to come out with a European Union model regulatory system
for medical devices that are manufactured or marketed in the country.
The highlight of the proposed system is that it will entrust Bureau of
Indian Standards (BIS) to fix the quality standards for the medical
devices. The Central drugs regulatory authority will, however,
continue as the inspection and licensing agency but the approvals will
not be under them.
The sub committee on
medical devices set up by the Drugs Consultative Committee of the
Centre is known to have favoured the EU model rather than the US model
and is in the process of preparing the guidelines.
According to reliable
sources, the health ministry is to ask BIS to set up a separate
committee consisting of both internal and external experts to approve
each and every medical device in the country. The representatives from
the central drug regulatory authority would also be part of this
committee. The committee would classify the medical devices into
various classes depending on the nature of the device. Some categories
would be considered as safe, others will have to go through rigorous
approval procedures before being cleared for marketing. As per the
current plan, the Central Drugs Standard Control Organisation (CDSCO)
may be the licensing and inspecting agency for the approvals given by
the BIS. There would be a BIS quality certification with specific
class mentioned for every product.
The health ministry
officials said that the proposal is being worked out and would take
minimum one year to get finalised.
The lack of proper
regulatory control over most of the medical devices came to the lime
light recently after the Maharashtra FDA banned the use of some of the
drug coated stents due to doubtful quality. The DCGI later clarified
that the approval of drug coated stents comes outside the purview of
the existing rules and regulations. He had also suggested the need for
changes to bring in strict regulations in this segment.
Sterile Devices To Be
The union health
ministry will soon notify sterile medical devices as drugs as part of
the move to bring in medical devices under the regulatory ambit of the
central drugs control department.
Disclosing this to
Pharmabiz, Ashwinin Kumar, Drugs Controller General of India (DCGI),
said the department has started collecting data on sterile medical
devices and a list will be notified soon.
"So far we have not
looked into the regulatory aspect of medical devices marketed and
manufactured in India. Bringing all the medical devices under the
regulatory framework is an elaborate process and requires some time.
To begin with, we will notify sterile medical devices. The Drug
Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
have to study this for notification" said the DCGI.
Sources said the
government's move is in the wake of Maharashtra FDA's decision to
mandate quality standards for marketing drugs eluting stents, and to
obtain prior approval from DCGI to market such products in the state.
The DCGI had informed Pharmabiz that the present rules do not empower
his office to regulate the quality of medical devices like drug
eluting stents and granting of marketing permissions.
Sources said sterile
medical devices must be free from live bacteria or other
microorganisms and their spores, and undergoes the sterilization
process. Hundreds of such products are freely manufactured, imported
and marketed in the country, and so far no mandatory quality standards
are laid down.
So far the government
has notified only disposable hypodermic syringes, disposable
hypodermic needles, disposable perfusion sets, intrauterine devices
like Copper T and Condoms and they are classified as drugs.
Sources said the US FDA
and Australian TGA have enforced strict and elaborate guidelines for
regulating medical devices, since many decades ago.
Talking to Pharmabiz,
Joseph X Phillips, former US FDA official and advisor to ISPE on
international regulatory affairs said the US FDA started regulating
medical devices, way back in 1938. The guidelines were changed from
time to time, and during the 1980's and 1990's elaborate revamping of
the regulations were done.
Australia also has
enforced guidelines for regulating medical devices, and its many year
old Therapeutic Goods (Medical Devices) Regulations Act was amended
during October 2002 to strengthen its medical devices regulatory
officials pointed out that a comprehensive Medical Devices Act,
something similar to the Drugs and Cosmetics Act, needs to be in place
or at least a schedule has to be brought under the Drugs & Cosmetics
Act to regulate medical devices. Thousands of medical devices like
stethoscope, thermometer, spectacles or contact lens, placemakers or
steel rods used for implants are currently outside the purview of
regents, which are used in determining the quality of drugs in
laboratory tests, are now outside the purview of the regulatory
framework, noted sources.
(Ref : Chronicle
Pharmabiz dated June 23, 2005)