The Drug Registration Board convened 342nd meeting on November 30, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Month: January 2025
Minutes of 341st meeting of Registration Board held on 26th November, 2024
The Drug Registration Board convened 341st meeting on November 26, 2024, in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Notification regarding Therapeutic Goods (Advertisement) Rules, 2025
Recall Alert: Substandard Flagyl Injection Batch No. Ad482 Manufactured by M/S. Sanofi Aventis Pakistan Limited, Karachi.
Recall Alert
| DRAP Alert No | No I/S/01-25-13 |
| Action Date | 28th January 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 | Senior Drug Inspector ICT Islamabad has informed DRAP that samples below product has been reported substandard by Drug Testing Laboratory (DTL) Rawalpindi: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Flagyl Injection 100ml | Metronidazole 500mg | Batch No. AD482 | M/s. Sanofi Aventis Pakistan Limited, Plot No. 23, Sector 22, Korangi industrial area, Karachi |
| Risk Statement: | Endotoxin containing intravenous products can lead to a range of consequences, including fever, chills, shock, organ failure, which can even prove fatal. Even small amounts of endotoxin in an injection can cause significant harm, particularly in vulnerable individuals like immunocompromised patients or those with pre-existing medical conditions. |
| 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. |
Annual Schedule for the CSC Meetings for the year 2025
The Clinical Studies Committee (CSC) of Drug Regulatory Authority of Pakistan (DRAP) is mandated under Bio Study Rules 2017 for the regulatory oversight of clinical trials and clinical studies related to therapeutic goods in the country. The CSC reviews and approves clinical study protocols, ensuring they adhere to ethical and scientific standards. It also monitors ongoing clinical trials to assess participant safety and efficacy, makes informed decisions regarding study design, and collaborates with researchers, sponsors, and other stakeholders to ensure quality clinical research and safety of the participants.
The Committee has decided that the CSC meetings will be convened after every 45 days and an annual CSC meeting schedule for 2025 (tentative) has been issued with the aims to enhance transparency, efficiency, and collaboration.
| S. No. | CSC Meeting | Proposed Date |
| 01 | 54th CSC Meeting | 28th – 31st January 2025 |
| 02 | 55th CSC Meeting | 03rd – 08th March 2025 |
| 03 | 56th CSC Meeting | 21st – 25th April 2025 |
| 04 | 57th CSC Meeting | 26th – 31st May 2025 |
| 05 | 58th CSC Meeting | 07th – 11th July 2025 |
| 06 | 59th CSC Meeting | 25th – 29th August 2025 |
| 07 | 60th CSC Meeting | 01st – 03rd October 2025 |
| 08 | 61st CSC Meeting | 08th – 12th December 2025 |
Rapid Alert: Presence of Falsified Mirzpan Suspension 100mg/5ml Purportedly Manufactured by M/s. Miraz Pharma, Kasur.
Rapid Alert
| DRAP Alert No | No I/S/01-25-12 |
| Action Date | 23rd January, 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 | Secretary, PQCB Balochistan, has informed DRAP that sample of following product, manufactured by M/s Miraz Pharma, Kasur, has been declared “Spurious”, “Unregistered” and “Misbranded” by the Drug Testing Laboratory, Quetta. The sample portion “Suspension Mirzpan” contains no Active Pharmaceutical Ingredient (Cefixime), bears a fake registration number in seven digits, and exhibit a pH value of 6.51, which is outside the USP specified range of 2.5 – 4.5. Additionally, the outer packaging contains multiple spelling errors, as well as ambiguous and misleading information. The details of sample are as under:: |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Mirzpan Suspension 100mg / 5ml Reg. No. 0326422 | 007 | 11-2023 | 11-2025 | Purported to be manufactured by M/s Miraz Pharma, Plot No. 23, Qasoor Industries, Kasur. | Spurious |
| Risk Statement: | The presence of falsified cefixime suspension poses significant risks to patient health, including potential therapeutic failure, inadequate treatment of bacterial infections, and the development of antibiotic resistance. |
| Action Initiated | The field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market. |
| 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. |
Recall Alert: Recall of Adulterated Safemed Infusion Batch No. SJU-0824 Manufactured by M/s Ahad International Pharmaceuticals Ltd, Dera Ismail Khan
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 in Distribution, Pharmacies and Medical Stores – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The Senior Drug Inspector, District Health Office, Quetta collected the samples of Infusion Safemed and sent them for test and analysis. The Provincial Drug Testing Laboratory, Quetta, has declared the following batch of Infusion Safemed, manufactured by M/s. Ahad International Pharmaceuticals Ltd., Sheikhupura, as Adulterated. The injection was found to contain foreign matter, which is visible to the naked eye: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Safemed 500mg Infusion Reg. No. 045824 | Metronidazole | Batch No. SJU-0824 | M/s. Ahad International Pharmaceuticals Ltd. 13-Km, Gomal University, Multan Road Dera Ismail Khan |
| Risk Statement: | An injectable product that contains foreign matter is considered adulterated and may compromise the standard quality of the drug, as it may not be sterile. Sterility is a fundamental quality attribute for all injectable drugs. The presence of adulterated material can lead to serious adverse reactions in patients, including, but not limited to, the following: (i) Anaphylactic shock, which can be fatal. (ii) Skin rashes, itching, and difficulty in breathing. (iii) Suboptimal or no therapeutic effect for the intended medical treatment. |
| 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 “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 “Incip Infusion 100ml” Batch No. Cpv-147 Mfg. By Inventor Pharma (Pvt.) Ltd., Karachi.
Recall Alert
| DRAP Alert No | No I/S/01-25-10 |
| 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 below product has been reported substandard by Drug Testing Laboratory (DTL) Lahore: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Incip Infusion 100ml | Ciprofloxacin (as lactate) 200mg | Batch No. CPV-147 | Inventor Pharma (Pvt.) Ltd., Plot No. K/196, S.I.T.E. (SHW) PH-II, Karachi. |
| Risk Statement: | The use of substandard injection 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. |
Rapid Alert: Crackdown Against Falsified Products
Rapid Alert
| DRAP Alert No | No I/S/01-25-09 |
| Action Date | 16th January, 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 | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples below product has been identified as spurious (falsified): |
The product identification details are as under:
Therapeutic goods affected:
| Product | Batch No* | Mfg Date | Exp. Date | Manufacturer Name (as per label) | Remarks |
| Duphaston tablet (Dydrogesterone 10mg) | 233493 | – | – | Purported to be manufactured by Highnoon Laboratories Ltd., Lahore | Spurious |
| Depasrone tablet (Dydrogesterone 10mg) | 0363 | Purported to be manufactured by Alpine Laboratories, Karachi (Fictitious firm) | Spurious |
| Risk Statement: | The impact of the use of falsified products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems. |
| Action Initiated | The field force under administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market. |
| 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. |