Last Updated on February 23, 2022
Following are application processes as stipulated by Alternative Medicine and Health Products (Enlistment) Rules 2014:
Enlistment of a Company
DRAP enlists both local manufacturers and importers of alternative medicines and health products separately. An applicant may choose to apply from the given below application processes:
a. Company Enlistment as a 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 an Importer
Applicants must submit their application on prescribed Form-2 along with the requisite documents and processing fee.
Enlistment of an Alternative Medicine or Health Product
Application for enlistment of locally manufactured product is submitted on Form-3 along with requisite documents and processing fee whereas application for enlistment of locally manufactured product is submitted on Form-5 along with requisite documents and processing fee.