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In such cases, or where there is no international classification or approval for the product (such as FDA, CE, Japanese, Canadian, or Australian), the DCGI may set up an
expert committee to look into the subject.
It must be noted that licensing under the DCA is quite
separate from any other approval, such as the approval required for building plans, environmental clearance, or corporate laws. There are no statutory timelines for approval
or denial of permits under the DCA, unlike the practices
in some other jurisdictions. However, the past experience
of foreign manufacturers shows that the actual time for
approval is not unreasonable. A plant could be ready for
manufacture within a year, assuming that prior product
approval or clinical trials are not required.
Compliance
A license to manufacture notified devices requires compliance with the relevant parts of Schedule M and Schedule
M III of the DCA, which embody GMP. While Schedule M
is meant for drugs and devices, Schedule M III is only for
devices. It should be noted that large parts of these schedules, in particular Schedule M III, are general purpose in
nature and are not substantially different from GMP and
quality assurance standards elsewhere in the world. But
certain prescribed standards, such as those pertaining to
air quality and the minimum floor area of facilities, may be
more stringent than those usually required for devices. The
licensing authorities are permitted to relax requirements in
these schedules depending on the individual circumstances.
The licensee must also comply with the requirements of
Rule 76, which mandates the qualification and experience
requirements for the key technical personnel in the plant.
Application for Manufacturing License
The application for a manufacturing license is in Form
27. This also includes a dossier that contains details about
the facility and product, including the site master file,
product specifications, ISO and other standards and certifications, the manufacturing process, and particulars of
technical personnel. The total application fee is about $160
($137 for license, $33 for inspection). The license grants
the authority to manufacture the specific devices applied
for––not to manufacture devices in general. Although
manufacturing of a complete product range may not take
place initially, it is possible to apply to manufacture a family of products at one time. Up to 10 items may be applied
for together; any additional items would entail a fee of
about $7 each.
The application must be submitted to the state drug
controller and the zonal office of DCGI. At the time of
the application, the plant should be ready for inspection
or should be able to be ready within a short period. It also
must be GMP compliant and have a competent technical
staff; specifically, the head of the testing unit and the ex-
