Regulation of Advertisement of Therapeutic Goods

Last Updated on March 11, 2024

Regulatory Overview

All registered pharmaceutical and biological drugs and enlisted Health & OTC Products require prior approval before any direct advertisement to consumers. The advertisements of therapeutic goods are regulated under DRAP Act 2012 and the rules framed thereunder. The Committee on Advertisement evaluates all such complete applications.

Applications for approval of advertisement can be made for the following platforms:

• Print Media
• Electronic Media (Radio)
• Electronic Media (TV/Cinema)

Application Procedure

1. Application on Form-8 of Drugs (Licensing, Registering & Advertising) Rules 1976
2. Application processing fee (Full fee for per product per advertisement specimen)
3. Specimen of Advertisement
4. Print media (which mode will be used)
5. Electronic media (Radio) CD and script
6. Electronic media (TV/Cinema) CD and storyboard

*one specimen can contain multiple products with the condition that form-8 of each product will be submitted accompanying processing fee.

Any queries identified during processing of the application will be conveyed to the applicant.

Complete applications are evaluated by the Committee on Advertisement. Recommendations are submitted to the Federal Government for final decision.

Approval letters and verified approved specimens are given to the applicants which are valid for two years.

For further details refer to the Guidelines on Advertisement of Therapeutic Goods

Approval of Advertisement of Therapeutic Goods:-

Complaint against illegal Advertisement of Therapeutic Goods :-