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Month: August 2022

Director General, Department of Drug Administration (DDA), Government of Nepal with a delegate visited DRAP HQ to foster mutual cooperation

Asad Ullah Events, Press Releases
Director General, Department of Drug Administration (DDA), Government of Nepal with a delegate visited DRAP HQ to foster mutual cooperation

An official delegate from Department of Drug Administration (DDA), Ministry of Health & Population, Government of Nepal under the leadership of Mr. Bharat Bhattarai, Director General, DDA visited DRAP HQ, Islamabad on Tuesday, August 23, 2022. Mr. Asim Rauf, CEO DRAP warmly welcomed the Mr. Bhattarai and other senior officials from DDA and MoH, Nepal.

Directors of Division of Pharmaceutical Evaluation & Regisatrion (PE&R), Medical Devices and Medicated Cosmetics (MDMC), and Health & OTC Products (H&OTC) demonstrated their respective presentations on the various regulatory functions of DRAP. The delegates shows keen interest in the journey of Pakistan toward successful implementation of WHO/ICH Common Technical Document (CTD) format for registration of pharmaceutical and biological drugs in Pakistan, and praises the IT Systems establish by DRAP for integrated regulatory data management in the country.

The officials of the international Health Partner, United States Pharmacopeia- Prompting Quality of Medicine Plus, from Nepal and Pakistan, were also present in these meetings.

National Pharmacovigilance Cell (NPC), DRAP released draft Guidelines on National Pharmacovigilance System (Edition 02) seeking comments from stakeholders

Asad Ullah News & Updates, Pharmacovigilance

DRAP has established the National Pharmacovigilance Centre (NPC), under the Division of Pharmacy Services, DRAP, Islamabad, to monitor the safety of therapeutic goods across the country. NPC is working with National and International coordination for the development of a functional Pharmacovigilance system in the country. Since 2018, Pakistan is the Full member of the World Health Organization Programme for International Drug Monitoring (WHO-PIDM), Uppsala Monitoring Centre (UMC), Sweden.

The NPC has developed multi channel reporting system, including electronic and manual reporting forms supported with the guidelines that are available through the official website for stakeholders. With the promulgation of Pharmacovigilance Rules, 2022, it is now the legal obligation of all pharmacovigilance stakeholders to establish their system and report the pharmacovigilance data to NPC.

The 1st Edition of National Pharmacovigilance Guidelines were published in October, 2019. This is the draft for 2nd Edition of National Pharmacovigilance Guidelines, being revised in the light of recently enacted Pharmacovigilance Rules, 2022. This Guidance document is intended to assist all pharmacovigilance stakeholders i.e. Healthcare professionals, Marketing Authorization Holders, Healthcare providing institutes, Patients and caregivers, etc., in playing their roles and responsibilities in the national pharmacovigilance system. The WHO Pharmacovigilance indicators have been incorporated in the chapter 11 of the draft 2nd edition to harmonize the procedure performance evaluation with international standards.

These guidelines are uploaded on the official website of DRAP on 24th of August, 2022 for seeking comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format. For further guidelines on how to submit comments visit DRAP website or click here. Comments and suggestions can be forwarded via email to npc∂dra.gov.pk, or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, 3rd floor TF Complex, 7th Mauve Area, G-9/4, Islamabad.

Please click here to view the draft document National Pharmacovigilance Guidelines 2022

DRAP and Islamia University of Bahawalpur (IUB) signed a Memorandum of Understanding (MoU) to promote scientific Collaboration

Asad Ullah Events, Press Releases
DRAP and Islamia University of Bahawalpur (IUB) signed a Memorandum of Understanding (MoU) to promote scientific Collaboration

The Drug Regulatory Authority of Pakistan (DRAP) and Islamia University of Bahawalpur (IUB) undergoes in a Memorandum of Understanding on August 19, 2022. A brief ceremony was organized at DRAP HQ, Islamabad where Mr. Asim Rauf, CEO, DRAP and Dr. Athar Mahboob, Vice Chancellor, IUB signed the MoU on behalf of their respective institutions. Senior members of both organizations were also present on this occasion.

Both organizations, Under this MoU has agreed to facilitate cooperation in academic research to fosters collective efforts in facilitating scientific progress through exchange of knowledge and expertise. It will open new opportunities for academic, research, trainings and mutual collaborations.

Training Sessions on Regulatory Data Standards for Manufacturers at Karachi and Lahore

Asad Ullah Events

Regulatory Data standard help Regulatory Authorities and Pharmaceutical Manufacturers for efficient exchange of regulatory data which ultimately reduces the processing time by avoiding clarifications due to variation in terminologies. These standards also facilitate data sharing between regulators and manufacturers in better understandable way, through both manual and electronic means, in a harmonized and consistent manner that is interoperable across the globe.

DRAP, in collaboration with United States Pharmacopeia, Promoting the Quality of Medicines Plus Program, is organizing a series of training sessions for regulators and industry on the regulatory data standards .The details of sessions are:

SrSession TitleDateNo. of Participant* (approx)
1Training on Regulatory Data Standards for Pharmaceutical Manufacturers19th August 2022 at Karachi.30
2 Training on Regulatory Data Standards for Pharmaceutical Manufacturers 22nd August 2022 at Lahore.30

Stakeholder associations (i.e Pakistan Pharmaceutical Association (PPMA), and Pharma Bureau) are requested to share nominations of technical and regulatory workforce for each training by 16th August 2022 positively. Nominated person can register themselves free of cost by filling out the following registration form at the earliest.

*Please note that :-

Registration will be granted on first come first serve basis.
only one participant from each manufacturer can join the session onsite.
After the completion of first 30 registration for onsite participation for each session, virtual link will be provided to the remaining registrants.

Registrations are closed now.

How to join Session Virtually:-

Those participants who submitted registration forms for the training sessions can join virtually using Microsoft team. Virtual participants are requested to join 15 minutes before the start of session, and advised to display their Names and Organizations while joining the session. Please keep your mic and camera off after joining the session. If you wish to ask a question from the presenter, please click the icon to show raise hand, and turn your mic and camera on while asking a question from the presenter.

Join using Microsoft Team

Join a Microsoft Teams Meeting by ID | Microsoft Teams 
Meeting ID: 251 494 560 025 Passcode: p2MTFn

Time: 10:00 AM to 03:30 PM  

Click to Join

-Sessions recordings and Training Materials will be available shortly after the session.
-E-Certificate will be issued to training participants after completion of feedback survey form that will be sent to them via email.

Training-Session-on-Regulatory-Standard-Lahore-and-KarachiDownload

Recall Alert; Drug Product: Molimax 5mg/5ml Oral Suspension (Batch # L2165) by M/s. Alliance Pharmaceuticals Pvt Ltd, Peshawar

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/07-22-17
Action Date6th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Molimax 5mg/5mL Oral Suspension,
Active Ingredient(s): Domperidone
Company: M/s Alliance Pharmaceuticals Pvt Ltd, Peshawar.
Batch No. L2165
Manufacturing Date: January-2022,
Expiry Date: December-2023
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Molimax 5mg/5ml Oral Suspension (Registration No. 044548) bearing Batch No. L2165, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may 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 bearing the affected batch number(s) 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.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
Molimax-oral-suspension-Recall-Alert-17.Download

Falsified Alert; Drug Product: Presence of falsified Glucantime (meglumine antimonate) in market purported to be manufactured by M/s. Tillotts pharma AG, Switzerland

Ijaz Mustafa Recall Alerts

Falsified Alert

DRAP Alert NoNoI/S/07-22-18
Action Date5th August, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Product Name: GLUCANTIME (Meglumine Antimoniate)
Purported to be Manufactured By: TILLOTTS PHARMA AG, Switzerland
Batch No. 1119-078
Manufacturing Date: December-2019,
Expiry Date: November-2022
Problem StatementSuspected falsified GLUCANTIME (Meglumine Antimoniate) has been found in in the market of Quetta, Pakistan. World Health Organization, Regulation and Safety Unit, has informed regarding the availability of falsified GLUCANTIME (Meglumine Antimoniate) purported to be manufactured by the TILLOTTS PHARMA AG, Switzerland .

The stated manufacturer listed on the falsified product TILLOTTS PHARMA AG, Switzerland has confirmed that they do NOT manufactured this product and neither they sub-contract the manufacturing, nor distribute these products anywhere in the world.

The following discrepancies can be identified in this falsified product:-

• The outer packaging has English and French labeling but contains visible spelling mistakes and questionable information
• Medicine – spelt “medecine”
• Use of a Gmail email address for manufacturers contact
• Statement that the product is an over the counter medicine.

Pictures of Falsified GLUCANTIME (Meglumine Antimoniate) can be viewed on this link.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to be alert and immediately inform the DRAP upon the presence of this falsified product in the market or any information related to the supply of this falsified product.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective eradication of falsified product(s) and initiation of relevant legal proceedings.
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may 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-If anyone posses this falsified product, it is advised to not use this product9s) and shall immediately inform the DRAP.

-Consumers are also advised to contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

04-Glucantime-FinalDownload

Recall Alert; Drug Product: Sterile Water for Injection (Batch # 739 and 751) by M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/07-22-18
Action Date25th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Sterile Water for Injection,
Company: M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.
Batch No. 739 and 751
Manufacturing Date: February-2022,
Expiry Date: February-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection bearing Batch No. 739 and 751 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may 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 bearing the affected batch number(s) 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.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Sterile-Water-for-Injetion-Zafa-Recall-Alert-18Download

Recall Alert; Drug Product: Phenerzine Elixir (Batch # 037) by M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/07-22-20
Action Date2nd August, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Phenerzine Elixir,
Company: M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 037
Manufacturing Date: March-2022,
Expiry Date: March-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Phenerzine Elixir bearing Batch No. 037 and declared it as Adulterated and Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may 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 bearing the affected batch number(s) 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.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Phenerzine-Elixir-Recall-Alert-20Download

Recall Alert; Drug Product: Faasgablin 75mg Capsules (Batch # 2210C001) by M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi

Ijaz Mustafa Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/07-22-19
Action Date28th July, 2022
Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions
3. General Public
Product(s) Affected Faasgablin 75mg capsules,
Company: M/s FAAS Pharmaceuticals (Pvt) Ltd., Karachi
Batch No. 2210C001
Manufacturing Date: January-2022,
Expiry Date: January-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Faasgablin 75mg capsules bearing Batch No. 2210C001 and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch(s) of product to the company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies.

-Adverse reactions or quality problems experienced with the use of this product may 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 bearing the affected batch number(s) 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.

All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.

Faasgablin-capsules-Recall-Alert-19Download