Drug Regulatory Authority of Pakistan (DRAP) issued a consolidated notification of Regulatory fess for various functions and services. This notification is issued under the section (1) of section 20 of the Drug Regulatory Authority of Pakistan Act, 2012 (XX.I of 2012) read with sub-rule (3) of rule 4 of the Drug Regulatory Authority of Pakistan (Fee and Levy) Rules, 2022, and in supersession of all such previous Notifications. The Drug Regulatory Authority of Pakistan with the approval of the Policy Board has specified these regulatory fees. The Notification is provided as under: –
Drug Regulatory Authority of Pakistan Act, 2012 under section 7 (c)(iii) and (x) mandated the DRAP for the regulation of Advertisements, enforcement and monitoring of advertisement rules and ban on false advertisement. Schedule II- B of the DRAP Act, 2012 prohibits the advertisements of any therapeutic goods except in accordance with the prescribed conditions.
The current changing trend of advertisement and promotional activities by pharmaceutical companies and the requirement of extension of scope from drugs to therapeutic goods has led to the development of these draft rules. These draft rules contain provisions almost similar to the ones given in Rule 31 of the Drugs (Licensing, Registering & Advertising) Rules 1976, included but not limited to; amended Schedule with the list of drugs permissible for advertisement as earlier consulted with stakeholders, Schedule with diseases for which advertisement is prohibited, schedule with the details on advertisement or promotional material keeping in consideration the ethical criteria; Forms for submitting applications of advertisement approval, Formats for granting approval for advertisement and schedule with details on advertisement or promotional material keeping in consideration the ethical criteria.
These draft Therapeutic Goods (Advertisement) Rules, 2022 were uploaded on the official website of DRAP dated 21st November, 2022, seeking comments and suggestions from stakeholders on the draft rules. Stakeholders can submit their comments and suggestions within 14 days of uploading this draft using prescribed format, (further information on comments submission can be accessed on this link). Comments and suggestions can be forwarded via email to aamar.latif∂dra.gov.pk , copying at aqsa.hashmi∂dra.gov.pk , or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.
Click here to View/Download the draft Therapeutic Goods (Advertisement) Rules, 2022
(For suggestions and comments)