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Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
Recall Alert
| DRAP Alert No | No I/S/05-25-44 |
| Action Date | 29th May, 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Inflamac Injection Reg. No. 036110 | Each 3ml contains: Diclofenac sodium…..75mg | 25L-001 | M/s. Ipram International, Plot No. 26, S.S-3, National Industrial Zone, Rawat, Islamabad. | ‘Substandard’ on the basis of Visible particulates in injection. |
| ZOLREST INFUSION 300mL Reg. No. 055916 | Each 300ml vial contains: Linezolid …….600mg | ZL250020 | M/s Bosch Pharmaceuticals (Pvt.) Ltd, 209, Sector 23, Korangi Industrial Area, Karachi. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| LAKSOL-NS INFUSION 100mL Reg. No. 110827 | Each 100ml contains: Sodium chloride…0.9g | 3021489 | M/s Lakhani Pharma (Pvt) Ltd., Sheikh Zayed Road, Rahim Yar Khan, Pakistan. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| QAD-FEN 90ml Syrup Reg. No. 121509 | Each 5ml suspension contains: Ibuprofen….100mg | LS0003 | M/s Qadir Pharmaceuticals, Fateh Garh Sahuwala Road, Sialkot. | ‘Substandard’ with regards to presence of impurity (Ethylene glycol), above the permissible limit. |
| BYTEC Tablet Reg. No. 036183 | Each film coated tablet contains: Cetirizine dihydrochloride ..…..10mg | E089 | M/s. Batala Pharmaceuticals, 23/B, Small Industrial Estate # 2, Gujranwala. | ‘Substandard’ with regards to Impurities test. |
| Risk Statement: | The use of substandard products can result in therapy failure, increasing the risk of complications, particularly in vulnerable groups such as immunocompromised individuals, as well as pediatric and geriatric population. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Stakeholders Comments are invited on revision of Guidelines for Conduct of Clinical Research in Pakistan
The Drug Regulatory Authority of Pakistan (DRAP) is revising Guidelines on Conduct of Clinical Trials in Pakistan with the aim to ensure the safety, quality, and efficacy of investigational products in clinical trials, as well as the ethical conduct and oversight of clinical research in Pakistan.
The revised guidelines cover various aspects of clinical trial activities, such as:
- The regulatory framework and approval process for clinical trials in Pakistan
- The roles and responsibilities of various stakeholders involved in clinical trial activities, such as DRAP, National Bio Ethics Committee, sponsors, investigators, and pharmaceutical associations
- The requirements and procedures for obtaining informed consent, protecting the rights and welfare of trial participants, and reporting adverse events and serious adverse events
- The standards and principles for designing, conducting, monitoring, recording, analyzing, and reporting clinical trials
- The good clinical practice (GCP) requirements for clinical trial materials and investigational products
- The data management and quality assurance systems for clinical trial data and documents
- The post-trial obligations and follow-up measures for clinical trial sponsors and investigators
The revised guidelines are based on the best regulatory practices as per the International Council for Harmonisation (ICH) guidelines, and the World Health Organization (WHO) guidelines.
The revised guidelines are open for public comments until June 05, 2025. DRAP invites all the relevant stakeholders, such as pharmaceutical companies, research institutions, clinical trial organizations, health professionals, patient groups, and civil society organizations, to review the revised guidelines and provide their feedback and suggestions. Stakeholders can submit their comments and suggestions using prescribed format (click here to visit how to submit comments) via email to shafqat.hussain∂dra.gov.pk or can be posted at mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, PM health Complex, Park Road, Islamabad.
DRAP appreciates the cooperation and contribution of all the stakeholders in the development and improvement of the guidelines on conduct of clinical trials in Pakistan. DRAP hopes that the revised guidelines will facilitate and promote the conduct of high-quality, ethical, and reliable clinical trials in Pakistan, and ultimately benefit the public health and well-being of the people of Pakistan.
Training of online CPI module for submission of applications(Wednesday May 21, 10:30 AM)
Zoom Link
DRAP Pakistan is inviting you to a scheduled Zoom meeting.
Join Zoom Meeting
https://us06web.zoom.us/j/81601656619?pwd=3xaAe5b0abhJL4o3VKPVj5rr5M1l1D.1
Meeting ID: 816 0165 6619
Passcode: 760526
Minutes of 305th Meeting of the Central Licensing Board held on 24th January, 2025
Rapid Alert: CRACKDOWN AGAINST FALSIFIED/SPURIOUS DRUGS
Rapid Alert
| DRAP Alert No | No I/S/02-25-18 |
| Action Date | 17th February, 2025 |
| Target Audience | 1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public |
| Problem Statement | Drug Testing Laboratory, Sindh has informed to Drug Regulatory Authority of Pakistan that samples of following products taken by various provincial drug inspectors, have been declared ‘Spurious’ (falsified). Moreover, the following firms and their associated products were found to be fictitious. The details of the reports are as below: |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Evosef 250mg capsule (Cephradine 250mg) | HF-001 | Purported to be manufactured by East Pharmaceutical 19-Km Sheikhupura road, Lahore | Spurious. Cephradine not identified | ||
| Mirzpan Suspension 100mg/5ml (Cefixime) | 0008 | M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur. | Spurious, Cefixime not identified | ||
| Mirzolam Tablet 0.5mg (Alprazolam) | 0007 | M/s Miraz Pharma, Plot No: 23 Kasur Industries, Kasur. | Spurious, Alprazolam not identified | ||
| Bromalax Tablet 3mg (Bromazepam) | B-01 | M/s Brom Pharmaceuticals (Pharmaceutical Industries), 21-Km Ferozpur Road, Lahore. | Spurious, Bromazepam not identified | ||
| Malixime Suspension 200mg/5ml (Cefixime) | 78011 | M/s Menakline Pharma, S Site Plot 11, Korangi Industrial Area, Karachi. | Spurious, Cefixime not identified | ||
| Lexopam Tablet 3mg (Bromazepam) | B-01 | M/s Porm Pharmaceuticals (Pharmaceutical Industries), 220 Industrial Estate Hayatabad, Peshawar. | Spurious, Bromazepam not identified | ||
| Zionex Tablet 0.5mg (Alprazolam) | 0032 | M/s Multicare Pharmaceutical, Plot # 23, Korangi Industrial Area, Karachi. | Spurious, Alprazolam not identified | ||
| Tramaking-225 Mega tablet 225mg (Tramadol HCl) | TRD2002 | Name of Manufacturer not mentioned. | Spurious | ||
| Alcoxime Suspension 100mg/5ml (Cefixime) | A2011 | M/s Alpine Laboratories (Pvt.) Ltd: Plot# A-41, S.I.T.E Indsutrial Area, Sector 3 North Karachi Super Highway 75500-Pakistan. | Spurious, Cefixime not identified |
| Risk Statement: | Falsified products having no active ingredient or identification of manufacturer pose a great risk to the health of patient and can cause adverse drug reactions or may lead to therapy failure that can result in fatal consequences. |
| Action Initiated | The Regulatory field force has been directed to conduct surveillance activities throughout the supply chain to confiscate the counterfeit product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such product should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of this product from the circulation. |
| Advice for Healthcare Professionals | All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) are advised to increase surveillance in the market to ensure the effective removal of this products. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link. Further information on reporting problems to DRAP is available at this link. |
| Advice for Consumer | Consumers in possession of mentioned batches should immediately report to Drug Regulatory Authority of Pakistan and 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 same to DRAP through Adverse Event Reporting Form or online through this link. |
Appointment of tax consultant
Tender for appointment of external auditors
Recall Alert: Substandard Product “Heparin-Indar Solution for Injection 5ml” Batch No. 64B0223B Mfg. By PRJSC <INDAR> Ukraine.
Recall Alert
| DRAP Alert No | No I/S/01-25-11 |
| Action Date | 16th January 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples of below product have been reported as substandard by Drug Testing Laboratory (DTL) Lahore: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Heparin-Indar solution for injection 5ml | (Heparin Sodium 2000IU/ml) | Batch No. 64B0223B | PRJSC <Indar>, Ukraine, 02099, Kyiv, 5 Zeoshyvalna Str. |
| Risk Statement: | The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions. |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |
Recall Alert: Substandard Product “Sterile Water for Injection 5ml” Batch No. 224 Mfg. By M/s Pharmedic Laboratories (Pvt.) Ltd., Lahore
Recall Alert
| DRAP Alert No | No I/S/01-25-06 |
| Action Date | 05th January 2025. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Sterile Water for Injection, 5ml | Sterile Water for Injection, | Batch no. 224 | Pharmedic Laboratories, Lahore |
| Risk Statement: | The use of substandard injections may pose serious health risks to patients, including reduced efficacy or lack of therapeutic effect and increased risk of adverse drug reactions such as allergic reactions, anaphylaxis, and hypersensitivity reactions. |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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 these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |