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Recall Alert; Drug Product: Pantoloon 20mg Tablets (Batch # 5611) By M/S. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoII/S/09-22-22
Action Date5th October, 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 Pantoloon 20mg Tablets,
Active Ingredient(s): Pantoprazole
Company: M/s. Rock Pharmaceutical Laboratories (Pvt.) Ltd. Risalpur .
Batch No. 5611
Manufacturing Date: May-2022,
Expiry Date: Mar-2024
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Pantoloon 20mg Tablets (Registration No. 095091) bearing Batch No. 5611, 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.

Recall Alert; Drug Product: Zatranex 50mg/mL injection (Batch # 622) by M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.

Asad Ullah Product Recalls, Recall Alerts, Safety Info

Recall Alert

DRAP Alert NoNoI/S/09-22-23
Action Date5th October, 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 Zatranex 50mg/mL Injection,
Active Ingredient(s): Tranexamic Acid
Company: M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi.
Batch No. 622
Manufacturing Date: April-2022,
Expiry Date: April-2025
Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Zatranex 50mg/ml Injection (Registration No. 014217) bearing Batch No. 622, 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.
DRAP Recall Alert Zatranex Inj (Zafa) Batch 622Download

110th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee

The 110th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 3rd August, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

Deficiency-letter-of-110th-meeting-of-EEC-CopyDownload

109th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee

The 109th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 5th July, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

Deficiency-letter-of-109th-meeting-of-EECDownload

108th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee

The 108th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 22nd June, 2022. The detailed of applications which required further information and documentation is attached hereunder for information by all stakeholders.

Deficiency-letter-of-108th-meeting-of-EECDownload

107th Meeting of Enlistment Evaluation Committee (EEC); Notice for Submission of Deficient Information / Documents

Asad Ullah Enlistment Evaluation Committee, Meeting Minutes, Publications

The 107th meeting of Enlistment Evaluation Committee (EEC), Division of Health and OTC, DRAP was held on 23rd May, 2022. The detail of applications which required further information /clarification and documentation is attached hereunder for information by all stakeholders.

Deficiency-letter-of-107th-meeting-of-EECDownload

DRAP issued Guidelines on Management of High Alert Medication

Asad Ullah Pharmacovigilance, Regulatory Updates , ,

DRAP envisions advancement in the healthcare system of Pakistan by working at par with international standards, and best regulatory practices through effective management and regulation of therapeutic goods. The National Pharmacovigilance Centre (NPC) at DRAP issues guidelines from time to time for different activities relating to Pharmacovigilance and promotion of pharmacy services to cater to the needs of different stakeholders.

High Alert medicines are those that have a high risk of causing injury or harm if they are misused or used in error. NPC, DRAP has issued a a Guidelines on Management of High Alert Medication to illustrate recommended practices for safe handling of those drug products that are classified as High Alert Medication (HAM). 

The main objective for issuing this guidance document is to support healthcare professionals working at hospitals and healthcare services providing institutes for ensure safe practices for prescribing, dispensing, administration and monitoring of high alert medication (HAM) and applies to all healthcare settings and healthcare professionals involved in the handling and usage of HAM. The outlined and recommended strategies are intended to educate HCPs, prevent risks associated with HAM, implement safety checks and encourage reporting of Adverse Events /Adverse Drug Reactions. 

This draft guideline was uploaded on the official website of DRAP dated 16th June, 2022 with request of comments submissions by the stakeholders. The National Pharmacovigilance centre, Division of Pharmacy Services has finalized the documents after careful evaluation of the comments and input received from internal and external stakeholder consultation.

Suggestions can be forwarded via email to npc∂dra.gov.pk, copying at aqsa.hashmi∂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.

click to view the Guidelines on Management of High Alert Medication (Edition 01). For more information related the regulatory guidelines and guidance documents issued by the DRAP please navigate to the Publications > Guidelines tab of our website.

National Task Force (NTF) for Eradication of Spurious and Unregistered Therapeutic goods; CEO DRAP Chaired the meeting of NTF Core Team

Asad Ullah Press Releases
National Task Force (NTF) for Eradication of Spurious and Unregistered Therapeutic goods; CEO DRAP Chaired the meeting of NTF Core Team

On 28th September, 2022; The meeting of Core Team of National Task Force for Eradication of Spurious and Unregistered Therapeutic Goods held on 28th September, 2022 at DRAP, HQ Islamabad. The Chief Executive Officer (CEO) of Drug Regulatory Authority of Pakistan (DRAP) chaired the meeting of Core Team for the National Task Force in light of the recommendation of Senate’s Standing Committee on Ministry of National Health Service, Regulation & Coordination (M/o NHSR&C) today at the DRAP Head Quarters, Islamabad. The Director of Quality Assurance & Lab Testing, DRAP, Director of Licensing, DRAP and All the Chiefs of Drug Inspectorates from across the Pakistan attended the meeting. The CEO, DRAP emphasized on enhancing the collaboration among federal and provincial inspectorate of drugs for market surveillance, ensuring the availability of life saving medicines and mitigation of shortage of medicines. The CEO, DRAP further added the measures to control overpricing and particularly the products for public health emergencies should be focused upon. Rapid Alert System for immediate eradication of substandard and falsified product posing high level threats and effective recalls of defective therapeutic goods were deliberated upon in details. Finally, the communication mechanism for National Task Force was discussed in detail and agreed upon by the participants.