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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. |
Recall Alert: Recall of Substandard Folic Acid Tablet Batches (490, 612) Manufactured By M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi.Recall Alert:
Recall Alert
| DRAP Alert No | No I/S/12-24-56 |
| Action Date | 18th December, 2024. |
| 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 | The Provincial Inspector of Drugs of various districts of Balochistan collected the samples of Folic acid Tablet and sent for test / analysis. The Drug Testing Laboratory, Quetta has declared following batches of Folic acid Tablet, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as of substandard quality based on uniformity of weight: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Tablet Folic Acid Reg. No. 000859 | Folic acid 5 mg | Batch No. 490 Batch No. 612 | M/s. Zafa Pharmaceutical Laboratories (Pvt.) Ltd. 4/1, A&B, Block-21, Federal “B” Industrial Area, Karachi-75950 |
| Risk Statement: | Folic Acid Tablets not complying with the uniformity of weight specification could result in inconsistent dosages of the active pharmaceutical ingredient (API), potentially leading to reduced therapeutic efficacy or an increased risk of adverse effects in patients. |
| 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. |
Recall Alert: Substandard Dexyken 300 mg Tablet Batch No. Kf23006 Manufactured By M/s. Kanel Pharma, Plot 6, Street SS-3, Rawat Industrial Estate, Islamabad
Recall Alert
| DRAP Alert No | No I/S/12-24-55 |
| Action Date | 12th December, 2024. |
| 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 | Federal Government Analyst, CDL Karachi vide test report No. KQ-9-24-000142 has declared the subject mentioned batch of product Dexyken 300mg tablet as of substandard quality. Details of CDL test report are as under: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Dexyken Tablet Reg# 075234 | Dexibuprofen 300 mg | Batch no. KF23006 Mfg date: 06/2023 Expiry date: 06/2025 | M/s. Kanel Pharma, Islamabad |
| Risk Statement: | Dexibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk. |
| 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. |
Recall Alert: Recall of 6 Batches of Neutrozole Infusion Manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore
Recall Alert
| DRAP Alert No | No I/S/11-24-51 |
| Action Date | 29th November, 2024. |
| 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 | The Provincial Inspector of Drugs, Punjab collected the samples of Neutrozole Infusion from various districts of Punjab and sent for test / analysis. The Drugs Testing Laboratory, Multan has declared various batches the said product, manufactured by M/s Neutro Pharma (Pvt.) Ltd, Lahore, as a Substandard product. The details of the case are as under: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Neutrozole Infusion 100ml Reg. No. 046878 | Metronidazole (500mg/100ml) | Batch No. MZ023, MZ028, MZ010, MZ007, MZ006, MZ003 | M/s. Neutro Pharma (Pvt.) Ltd., 9.5 Km, Sheikhupura Road, Lahore-Pakistan. |
| Risk Statement: | Administration of products containing bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market -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. |