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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

Medicine Safety Week 2022; DRAP’s Call to Healthcare Professionals and Patients to Report Suspected Adverse Reactions of drugs and vaccines.

Asad Ullah News & Updates, Pharmacovigilance, Press Releases

The seventh annual Social Media Campaign #MedSafetyWeek was launched on the 7th of November, 2022 by the National Pharmacovigilance Centre, DRAP, which was observed until 13th November 2022, to encourage everyone to report suspected side effects of medicines. The International campaign was led by the Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring.

This year’s global campaign involved medicines regulators from 81 countries and focused on the key role of every healthcare professional, patient, and caregivers who reports a suspected side effect and contributes to using medicines safely. This campaign was supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA)

#MedSafetyWeek 2022

Every report to the National Pharmacovigilance Centre, DRAP helps to improve the safety of medicines for all patients.

People are encouraged to report suspected side effects of medicines as part of the global #MedSafetyWeek social media campaign

Why Reporting is required?

All medicines may cause side effects in some patients, so there are steps in place to continuously monitor their safety after they are placed on the market. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Regulatory bodies operate systems to detect and analyse those side effects and prevent harm to future patients.

The National Pharmacovigilance Centre, DRAP, collects, organises, and investigates reports of suspected side effects / Adverse effects.

By reporting suspected side effects, you are actively participating in identifying emerging safety issues, so that DRAP can take action when necessary and protect you and others from harm.

Every Report is important for us

Every report made by a patient, a healthcare professional, or a caregiver plays a key role in gaining more knowledge about the benefits and risks of medicines in clinical use and allows action to be taken to minimize risks and can result in better tailored prescribing advice, which can improve patient outcomes.

Patients / care givers and all healthcare professionals can report suspected side effects to the National Pharmacovigilance Centre, DRAP. You can submit a report in many ways:

Are you a Pharmacist?

You are the first person patients go to when they have questions about their medicines.  Please report any new side effects of a medicine via the [Med Safety App & E reporting https://primaryreporting.who-umc.org/PK 

DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

Asad Ullah News & Updates, Press Releases
DRAP Signed MoU with Pakistan Single Window to Foster Cooperation

The Islamabad 11th Nov, 2022; Drug Regulatory Authority of Pakistan signed a memorandum of understanding with the Pakistan Single Window (PSW) in a ceremony held on 11th Nov 2022 at Islamabad. This MoU is aimed at enhancing cooperation among two departments through digital integration of IT System of PSW with the regulatory processed of DRAP. This will enable therapeutic goods industry to utilize an integrated electronic platform for import and export of raw materials and finished products using single entry point.  PSW will support international trade of therapeutic goods by recognizing standardized information and documents on an online platform which will fulfill all import, export, and transit regulatory requirements.

Speaking to the participant at the ceremony, Mr. Asim Rauf, CEO DRAP lauds the efforts and contribution of PSW team and stated that DRAP is continuously transforming its regulatory operations into IT based electronic solutions and various initiatives are underway to revamp drug regulatory system in the country. DRAP is one of the largest organizations in public sector that has fully replaced the manual filling system with an electronic office module for intradepartmental communication and decision making. This MoU will mutually benefit both Regulators and Industry by enabling one window working environment in electronic format which support compliance with all regulatory requirement and processes for cross border trade of therapeutic goods. DRAP and PSW will continue to support each other for provision of more facilitating regulatory environment to industry. In future, DRAP will also integrate licensing and registration systems for therapeutic goods with PSW.         

Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

Asad Ullah Recall Alerts, Regulatory Updates

Rapid Alert

DRAP Alert NoNoI/S/10-22-29
Action Date28th October 2022
Target Audience1. Regulatory Field Force
2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
4. General Public
Problem StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
SrProduct NameCompositionBatch #Manufactured by (as stated on label)
101 IMMUNORHO 300µg (1.500iu)
(PFS; Pre-filled syringe) 		Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

-Adverse reactions or quality problems experienced with the use of these product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

-All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
Pictures of Suspected falsified product
immunorho-safety-alert-revisedDownload

Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

Date:   31st October, 2022

Target Audience: –  

  • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
  • General Public

Problem or Issue: –

Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

Advice for healthcare professional: –

Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information on how to report a problem to DRAP is available on this link.

Advice for general public: –

Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

ADVISORY-TARGOCID-final-revisedDownload

DRAP finalizes Guidelines on the Preparation of Summary of Product Characteristics (SmPC)

Asad Ullah Drugs, Regulatory Updates

The Summary of Product Characteristics (SmPC) are the basic information for healthcare professionals on the use of drug products to ensure safety, efficacy and quality, and also provides a basis for preparation of the Patient Information Leaflet (PiL). SmPC describes the set of characteristics of a drug product as determined through the assessment process during registration of a drug product.

SmPC guidelines are intended to provide supportive information for preparation of Summary of Product Characteristics (SmPC) for registration / market authorization of pharmaceutical and biological products of all types including New drug products, Generic drug products and Biosimilars.

Rule 26 of the Drugs (Licensing, Registering & Advertising) Rules, 1976, as amended vide S.R.O 713(I)/2018 dated 8th June 2018, under 26(1) section 1.5.14 requires that in order to obtain registration/marketing authorization of drug product, a Summary of Product Characteristics (SmPC) is required to be included in the application dossier. The SmPC is part of drug registration / marketing authorization approval, and its contents can only be changed with the approval of Competent Authority. In this context, Registration Board has deliberated the contents of summary of Product Characteristics for pharmaceutical and biological drug products. This document transforms the decisions and advices of Registration Board into a guidance document for preparation of SmPC with application dossier submission in the CTD module.

The draft guidelines were prepared three years ago and was available on the DRAP’ s website. Stakeholders have submitted their comments on the draft document and accordingly guidelines have been finalized after careful consideration of stakeholder’s comments.

Please click to view the final document, GUIDELINES ON Preparation of Summary of Product Characteristics

For more information on Regulatory Guidelines published by DRAP, please navigate to Publications tabs on our website.

Notification: Applications for Registrations of Pharmaceutical drugs submitted on Form 5/5D requiring submission of Product Stability Data

Asad Ullah Drugs, Notifications, Regulatory Updates ,

Registration Board in 320th meeting held on 29th – 31st August 2022 has issued a direction with regards to the applications received on Form 5 / 5-D for registration of pharmaceutical drugs, which requires submission of stability study data for further processing. The list of such applications is available on official website of DRAP (link).

The decision of Registration Board is notified and attached hereunder for information and compliance by all relevant stakeholders.

Notification-Form-5Download