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Medical Devices Industry Welcomes DCGI’s
Regulatory Guidance
INDIAMART NEWS, Thursday, Aug 19, 12:56:04 PM IST Share :
NEW DELHI : The Association of Indian Medical Devices
Industry (AIMED) has welcomed the new set of draft regulatory guidance issued by
the Drug Controller General of India (DCGI) for medical devices segment. The
regulatory guidance will prove to be a good beginning to address the issues in
medical devices industry.
AIMED is an umbrella organisation of the domestic medical
devices industry in the country. Mr Rajiv Nath, forum coordinator, AIMED, said,
“ We welcome the initiative from the DCGI to put in some guidance which would
help both regulators and industry to stick on to standards.”
Lack of strong regulatory norms has taken a toll on the
medical device industry, since only 50 to 60 manufacturers managed to get
licenses from the regulatory body while there are more than 200 domestic
manufacturers producing the medical devices enlisted under Drugs and Cosmetics
Act, through a notification a few years back.
http://news.indiamart.com/story/medical-devices-industry-welcomes-dcgis-regulatory-guidance
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Guj FDCA To Get Support From US FDA Office
In Medical Devices Regulation
The Gujarat state Food and Drug Control Administration (FDCA),
which has initiated efforts to achieve expertise and facilities to effectively
monitor and regulate the medical devices industry, is expected to receive tips
from the US Food and Drug Control Administration (US FDCA) on the latest
technology developments in the segment, it is learnt.
Senior officials from the Indian office of the US FDA, during
their visit to the Gujarat FDCA in the end of July, has agreed to work in
collaboration with the state drug regulator to share their expertise for the
effective regulation of medical devices industry in the state, said H G Koshia,
Commissioner, FDCA.
“Gujarat is the hub of medical devices industry in the
country and is expected to grow in higher pace with the central government’s
proposed medical devices cluster project. In our discussion with the US FDA
officials, they assured their support to improve our knowledge and manpower
skills on the segment,” said Koshia.
He added that the collaboration would be mutually beneficial,
since the state drug regulator could expect enhanced quality of medical devices
exported to its territory from Gujarat.
The medical devices segment is comparatively a new arena for
the Indian drug regulators, hence calling for more attention in training the
existing regulatory officials, who have worked more on pharmaceuticals, in areas
like metallurgy and related subjects for better monitoring.
(Chronicle Pharmabiz , August 12, 2010 ,Page No. – 10)
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