Last Updated on February 23, 2022
Enlistment of a Company
Division of Health & OTC (non-drugs) is responsible to perform enlistment of manufacturers and importers of Alternative Medicines & Health Products. Local manufacturers and importers are separately enlisted under Alternative Medicines & Health Product (Enlistment) Rules 2014. An applicant may choose to apply from the given below application processes under these categories:
a. Company Enlistment as Local Manufacturer
This application process is divided into following three phases which require separate application form and processing fee at each stage:
- Site verification of the proposed premises
- Approval of Layout plan of the proposed site
- Final Inspection for verification of manufacturing and testing facilities and grant of provisional enlistment certificate (Form-6)
After grant of enlistment as local manufacturers, DRAP periodically verifies cGMP compliance of the manufacturers through its inspectorate.
b. Company Enlistment as Importer
Applicants must submit their application on prescribed Form-2 along with the requisite documents and processing fee.