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Gujarat registers maximum number of 170 medical devices units in the country under CLAA scheme
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Shardul Nautiyal, Mumbai
September 19 , 2017
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Gujarat as of today has registered the maximum number of 170 licensed
medical device units under the Central Licensing Approval Authority
(CLAA) scheme as against a total of 284 medical device units in the
entire country. The state had 150 such high end medical device units 11
months back and has also granted licenses to 56 new drug manufacturing
units.
The devices currently regulated under CLAA scheme include
cardiac stents, drug eluting stents, catheters, intra ocular lenses,
I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic
implants and internal prosthetic replacements.
CLAA has been
formed to oversee the regulatory activities related to grant of
manufacturing license for hi-tech medical devices in India. It aims at
ensuring that the medical devices being manufactured in India follow the
standard requirements set by the government to ensure safety, efficacy
and quality of the devices.
This is a welcome change as the
government is working on formulating a policy of ease of doing business
with focus on making India a favoured investment destination. Other
states following Gujarat under CLAA scheme are Haryana, Uttar Pradesh,
Maharashtra, Tamil Nadu and Kerala out of the 19 states having medical
device manufacturing units.
The Central Drugs Standard Control
Organization (CDSCO) had released a guidance document on August 7, 2015
to file an application for grant of the license for manufacturing of
medical devices in India. The application for grant of the medical
device license is made in Form 27. Along with the duly filled Form 27,
several documents need to be submitted in order to get license in Form
28 for manufacture of medical devices in India under CLAA scheme.
The
Centre has also been mulling for quite some time for setting up the
medical devices park in Gujarat in a bid to make India self-reliant in
the sector. The creation of manufacturing park for medical devices will
boost the segment of hi-tech medical devices as medical devices
manufacturing requires certain high investment facilities which are too
capital intensive for individual manufacturers to invest upon. A park
with in-house high investment scientific facilities would help
manufacturers reduce the cost of manufacturing by more than 40 per cent
to 50 per cent.
This will also help facilitate to create an
ecosystem for manufacturing of high end medical device manufacturing
aimed at import substitution and export opportunities and would be a
major boost to SMEs.
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