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Guidelines
for Medical Devices notified as "Drugs"
The
Ministry of Health and Family Welfare ("Ministry") has
now provided the guidelines ("Guidelines") for the licensing,
registration and manufacture of specified medical devices, which
were notified as "drugs" by Notification dated October 6, 2005.
The following devices have been declared as "drugs" under Section
3 (b) (iv) of the Drugs and Cosmetics Act, 1940 ("Act").
- Cardiac
Stents
- Drug-Eluting
Stents
- Catheters
- Intra
Ocular Lenses
- I.V.
Cannulae
- Bone
Cements
- Heart
Valves
- Scalp
Vein Set
- Orthopedic
Implants
- Internal
Prosthetic replacements.
These
Guidelines are effective from March 1, 2006.
IMPORT OF MEDICAL DEVICES
For the purpose of import of the devices specified above, the
procedure for registration and import licence as prescribed under
the Drugs and Cosmetics Rules, 1945 ("Rules") are to be followed.
The Guidelines provide that the application for the import and
registration should be made within 60 days after the publication
of the Guidelines. However, in respect of the devices, which were
not imported into India prior to March 1,2006, the import would
be permitted only with the approval of the competent authority.
The
specified devices, which are currently in use, will be permitted
to be sold for six months from March 1, 2006 or until an application
for import is approved or rejected, whichever is earlier. However,
this provision will not be applicable to stents or drug eluting
stents if the applicant has not sold at least one thousand (1000)
stents of the particular specification prior to the date of issue
of Guidelines.
It is also suggested in the Guidelines that separate committees
consisting of subject experts and representatives of the office
of the Drug Controller General of India ("DCGI") would be set
up for their expert advice on the evaluation of specific categories
of devices. Such expert committees would formulate their own benchmarks
and procedures for evaluation and determination of the standards
to which such devices should conform.
The
Guidelines have also prescribed norms regarding the documents
and information to be submitted along with the application for
import and registration of medical devices.
MANUFACTURE
OF MEDICAL DEVICES IN THE COUNTRY
For
manufacture of notified devices in India, an application for the
grant of licence is required to be made in a stipulated form to
the State Licensing Authority, accompanied by the requisite fee
in the form and manner as prescribed in the Rules, along with
a copy marked to the office of the DCGI. If the devices mentioned
in any specified category have not been manufactured in the country
before the date of notification, no manufacture would henceforth
be permitted without the approval of the competent authority as
per the norms prescribed.
SALE
OF MEDICAL DEVICES IN THE COUNTRY
The importers, stockists and retail sellers of the specified devices
will be required to obtain appropriate sale licences from the
State Licensing Authorities within a period of three months from
the date of issue of these Guidelines.
The
amendments to the Act and subsequent Guidelines are an outcome
of litigation in the Bombay High Court. Till recently, there was
no specific provision in the Act or any other statue by which
the manufacture, sale, distribution or importation of medical
devices was regulated. While hearing a writ petition challenging
the Maharashtra Foods & Drugs Authority order for regulating the
sale of some of the devices, the Bombay High Court expressed astonishment
with regard to the lack of such regulation involving medical devices
and directed the DCGI to enact a specific legislation pertaining
to such devices at the earliest.
The
amendment and the Guidelines are however silent in respect of
the clinical trials of such devices in India and it remains to
be seen how the government reacts to applications for clinical
trials of medical devices in India.
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You
can direct your queries or comments to the authors
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Source:
Central
Drugs Standard Control Organization
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