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on the basis of the registration certificate. The device
manufacturer can purchase the drug directly from overseas
as an importer or purchase it locally through an authorized
Indian importer. Registration certificates, but not import
licenses, can be waived in certain circumstances, such as
cases in which the material is used for export. Registration is a long-lead-time activity. Because it has to be done
by the overseas manufacturer, it should be started well
in advance. The DCA does not govern the purchase of
machinery, whether from India or overseas.
Sales
Sales can be made freely within India to licensed distributors or retailers. Export sales require a No-Objection
Certificate (NOC). Manufacturers can easily obtain an
NOC by submitting to the DCGI an application that demonstrates a valid license (Form 28) with Schedule M and
Schedule M-III compliance. If necessary, the DCGI would
also issue a Free Sales Certificates (FSC). The regulatory
authorities in importing countries frequently require an
FSC to ensure that the medical product is licensed in
India.
Other Permits and Approvals
Besides approvals under the DCA, a manufacturing unit
would need permissions and registrations from other government departments at the national or state level relating
to Indian product standards, import-export procedures,
EOU license, building permits, environmental-related
approval, factories registration, boilers, income-tax, VAT,
excise duty, company law, and specific industry regulations. The company must comply with various labor laws,
including those related to minimum wage, provident fund,
gratuity, health insurance, profession tax, equal remuneration, etc.
Drawbacks
Opening a manufacturing plant in India is not the right
choice for every device company. A small company may
not benefit from the enterprise unless there is a large
market in India for its specific product. Companies should
also determine the number of Indian players that would
compete with their products. If strong local competition
exists, manufacturers may want to consider forming a
joint venture with Indian companies to reduce the risks.
Additionally, device makers planning to export products
to their home countries should analyze the cost of exportation and demand in the home country to make sure it is a
profitable undertaking.
Conclusion
Regulation has not proved to be an impediment for
manufacturing in India. In fact, the stringent standards
tend to favor companies, concerned about quality assurance, that can make higher investments and produce on a
large scale for both local and export purposes. A manufacturing facility in India provides the opportunity to lower
unit costs and increase overseas margins while, at the same
time, reducing prices for the Indian market. ■
