31 facilities had been licensed for manufacture of these
implant devices.
Planning
A potential device manufacturer would be well advised
to make a drug plan that identifies the critical regulatory
activities and their potential time frames. This plan should
be integrated with the overall project plan. Unforeseen
regulatory issues might cause delays and incur substantial
costs. Before construction begins, it would be prudent for
a company to engage the relevant government departments
and professionals who are familiar with manufacturing
regulations. This stage should include the elimination of
doubt as to whether the proposed product is a “drug” or
“new drug,” a determination of whether prior product approval and clinical trials are required, and issues of compliance with Indian GMP. Matters should be discussed in person before exchanging written correspondence, but major
issues should be clarified later in writing.
Licensing
Manufacture of medical devices falling under the drugs
classification requires a specific license under the DCA.
Manufacture is widely defined and includes packaging,
labeling, and assembling. The Drug Controller General of
India (DCGI), located in New Delhi, is the final license-approving authority, but the drug controller of the specific
state in which the plant is located assists with the registration process. The foreign manufacturer needs to be in
contact with these agencies as soon as possible and must
clarify whether the product is a drug or otherwise. If it is
not a drug, then there is no requirement for licensing under
the DCA. If the product is deemed to be a “new drug” (one
which is not in use in India or which has been used for less
than four years), the DCGI may require clinical trials and
dossier approval before granting a license for manufacture.
