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AIDCOC Urges Health Ministry To Empower
State Licensing Authorities (SLAs) To Grant License To Critical Medical Devices
The All India Drugs Control Officers Confederation (AIDCOC)
has urged the Union health ministry that the State Licensing Authorities (SLAs)
should be made competent authority for grant of license to manufacture medical
devices of all classes for the purpose of clinical investigations or test or
evaluation or demonstration or training.
As per the proposed draft of Medical Device Rules, 2016, the
licensing of medical devices is divided into two categories which are critical
and not so critical. The SLAs were entrusted to license the not so critical
medical devices and the Central Drugs Standard Control Organization (CDSCO) will
handle the critical ones.
With this proposed rules, AIDCOC is of the view that the
draft is focusing towards the centralization of powers rather than ease of
delivering goods.
“It is to bring to the kind attention of the government that
the state authorities have been handling all the more critical drugs like
vaccines, sera, rDNA and high end critical medical devices like cardiac stents
all these years successfully and it is pertinent to mention that there is no
specialized knowledge or wherewithal existing with CDSCO to be specifically
entrusted with the handling of critical medical devices. It clearly shows that
the proposed draft rules are focusing towards the centralization of powers
rather than ease of delivering goods and making the system more complex,” opined
Ravi Uday Bhaskar, secretary of AIDCOC.
The proposed rule says that the SLA shall be the competent
authority for enforcement of rules in matters relating to manufacture of class A
or class B medical devices, sale, stock, exhibit or offer for sale of medical
devices and other related functions, provided that where any person who intends
to manufacture any medical device which does not have its predicate medical
device shall obtain prior approval from the Central Licensing Authority before
applying to the State Licensing Authority for grant of manufacturing licence.
It further says, the Central Licensing Authority shall be the
competent authority for enforcement of these rules in matters relating to
import, manufacture of Class C and Class D medical devices, clinical
investigation and clinical performance evaluation, of medical devices and other
related functions.
Whereas, the AIDCOC has proposed that the Class A medical
devices need not be licensed at all, the Class B medical devices may be licensed
by the SLA only and the Class C and Class D medical devices be licensed by SLA
and approved by Central Licensing Approving Authority (CLAA).
(Ref:
http://www.pharmabiz.com/NewsDetails.aspx?aid=98933&sid=1)
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