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.
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:
Sr
Session Title
Date
No. of Participant* (approx)
1
Training on Regulatory Data Standards for Pharmaceutical Manufacturers
19th 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.
-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.
1. 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
The 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.
1. 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
Suspected 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.
1. 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 Statement
The 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.
1. 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
The 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.
1. 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
The 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.
Drug Regulatory Authority of Pakistan (DRAP), in collaboration with the United States Pharmacopoeia (USP), Promoting Quality of Medicine Plus Program, Pakistan, conducted a one-day pharmacovigilance training session for the staff of the National Pharmacovigilance Centre on the newly introduced Pharmacovigilance (PV) Module in Pakistan Integrated Regulatory Information Management System (PIRMIS) on the 29th of July, 2022.
Dr Noor Muhammad Shah, Director of Division of Pharmacy Services (Head of National Pharmacovigilance Centre) along with his team of Additional Director, Deputy Director and Assistant Directors, Pharmacovigilance Centres, Division of Pharmacy Services participated in the training session. A team of USP facilitated the training session and the technical input and training was conducted by Mr Tayyab, PIRIMS Consultant-PQM+. The PIRMIS management system facilitates the submission of data by the registration holders and would be helpful in the quick disposal of work. The new PV Module has been introduced in the PRIMIS to facilitate the submission of pharmacovigilance data by registration holders as per Pharmacovigilance Rules, 2022.
