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Stakeholders Comments are invited on Draft Guidelines On Submission of Expenditure Details Under the Ethical Marketing To Healthcare Professionals Rules, 2021

Asad Ullah Advertisements, Drugs, General

The Healthcare Industry, comprising various sectors, is interlinked and highly dependent on frequent interactions, coordination, and supportive activities for a sustainable healthcare environment. Among this industry, therapeutic goods establishments and healthcare professionals are two important stakeholders and their interaction is vital and prone to criticism due to its repercussions on patients and the public.

To ensure innovation, progress, and improvement in healthcare and healthcare products while preserving professional ethics and transparency, the Drug Regulatory Authority of Pakistan (DRAP) has taken significant steps in line with the provision of Section 7(q) of the DRAP ACT 2012, which mandated the Authority to monitor and regulate marketing practices to ensure the rational use of drugs and ethical criteria for the promotion of therapeutic goods in line with international practices. In exercising this function, DRAP has notified the “Ethical Marketing to Healthcare Professionals Rules 2021” via S.R.O. 1472(I)/2021 on the 12th of November 2021. These rules outline the major forms of interaction between companies and healthcare professionals.

To facilitate the implementation, DRAP has developed a draft guideline on submitting expenditure details related to marketing activities targeted towards healthcare professionals to provide clarity and ensure compliance with the Ethical Marketing to Healthcare Professionals Rules 2021.

These guidelines are uploaded on the official website of DRAP on the 9th of August, 2024 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on how to submit comments visit the DRAP website or click here. Comments and suggestions can be forwarded via email to aqsa.hashmi∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Chak Shehzad, Islamabad.

DRAFT Guidelines on Data Submission under Ethical Marketing RulesDownload

DRAP issued Consolidated Notification for Regulatory Fees

Asad Ullah Advertisements, Alternative Medicines, Clinical Trials, Controlled Substances, Drugs, General, Licensing and Inspections, Medical Devices, Notifications, SROs

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: –

DRAP-Consolidated-Fee-17.04.2023Download

DRAP invited Comments from Stakeholders on the Draft Therapeutic Goods (Advertisement) Rules, 2022

Ijaz Mustafa Advertisements, Drugs, Notifications, Publications

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

Draft-Therapeutic-Goods-Advertisement-Rules-2022Download