|
Medical Devices Like Stents, Catheters
May Be Notified As Drug
More medical devices may fall under the category of drug in the country as the
subcommittee, formed to set up standards for 10 notified medical devices, plans
to recommend the authority to notify devices including orthopaedic implants as
drugs. The committee has identified three drug-testing laboratories in the
country to be upgraded for testing standards of the medical devices.
The subcommittee may recommend the Union Health Ministry to notify devices
including stents other than drug eluting stents, catheters and orthopaedic
implants as drugs, in order to smoothen the preparation of Schedule M standards
for the already notified devices. According to the revised Schedule M norms, the
premises for manufacturing drug products should not be used for any other
manufacturing activities unless it is not in the same category.
The subcommittee members are planning to visit various manufacturing facilities
in a month's time to finalise the list of fresh devices to be added in the drug
list. "The idea to add more devices into the list is in our mind and the
decision may vary according to the progress of our analysis on the same issue.
Though we think that a number of devices have to be added, it would be finalized
only after our visit to the manufacturing facilities of various medical
devices," said an official from the subcommittee.
In the first meeting of the subcommittee, in early April, the Drugs Controller
General of India (DCGI) had identified Sree Chitra Thirunal Institute of Medical
Sciences and Technology, Thiruvananthapuram, Kerala to upgrade to the laboratory
facilities for testing medical devices. The Central Drug Testing Laboratory,
Guwahati, under Central Drugs Standard Control Organisation (CDSCO) and the
Drugs Control Laboratory, Maharashtra Food and Drug Administration (FDA) had
also voluntarily agreed to add the testing facilities with the existing
facility.
Sources said that facilities in more labs would be upgraded for testing
standards of medical devices at a later stage on need basis. "We have not
started inviting applications for granting licensing to the medical devices at
present. The process of upgrading more laboratories will be executed in the
areas where more number of license applications get filed," the official told
Pharmabiz.
The second meeting of the subcommittee is scheduled in mid July mainly to
analyse whether the Schedule M should be revised for setting standards for
sterile devices. The subcommittee will take further steps by accepting the
definition of medical implants as in the medical dictionary and at a later stage
will come up with a definition for 'implants'.
As Pharmabiz reported earlier, the subcommittee was constituted with officials
from Central Drugs Standard for Good Manufacturing Practices for the notified
medical devices, and to take care of setting rules for testing and qualification
of technical staffs both in production and testing process.
(Ref: The Chronicle Pharmabiz Dated June 28, 2007)
|
