Amendment in Medical Devices Rules, 2017 (S.R.O 1049(I)/2025)
Recall Alert: PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES
Recall Alert
| DRAP Alert No | No I/S/05-25-45 |
| Action Date | 2nd June, 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 |
|---|---|---|---|---|
| AMLOshine Tablet Reg. No. 062420 | Each tablet contains: Amlodipine as besylate…..5mg | 7840 | M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan. | ‘Substandard’ on the basis of Impurities test. |
| AMLOshine Tablet Reg. No. 062420 | Each tablet contains: Amlodipine as besylate…..5mg | 7623 | M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan. | ‘Substandard’ on the basis of Impurities test. |
| AMLOshine Tablet Reg. No. 062419 | Each tablet contains: Amlodipine as besylate…..5mg | 7361 | M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad Gujranwala – Pakistan. | ‘Substandard’ on the basis of Impurities test. |
| FLAZOL Infusion 100mL Reg. No. 070611 | Each 100ml vial contains: Metronidazole….500mg | F250028 | M/s Bosch Pharmaceuticals (Pvt) Ltd., 209, Sector 23, Korangi Industrial Area, Karachi. | ‘Substandard’ on the basis of Bacterial Endotoxin 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. |
MINUTES OF 57TH MEETING OF CLINICAL STUDIES COMMITTEE HELD ON 20th MAY, 2025.
Bidding Document for Provisioning of Electronic Payment Gateway (EPG)
Services to Drug Regulatory Authority of Pakistan
Priority Processing of Mexiletine & Systeamine Registration Application
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. |
Minutes of the 347th Meeting of the Registration Board Held on 28th – 30th APRIL, 2025
The Drug Registration Board convened its 347th meeting on 28th – 30th APRIL, 2025 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Pharmacovigilance Newsletter
Recall Alert: RECALL OF XARELTO 15MG TABLET, BATCH NO. BXK4E11, DUE TO A LABELING ERROR ON SECONDARY PACKAGING
Recall Alert
| DRAP Alert No | No I/S/05-25-43 |
| Action Date | 20th May, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The firm M/s Bayer Pakistan (Pvt.) Ltd., Karachi has requested for correction of a typographical error identified on the secondary packaging of Xarelto 15 mg Tablets, Batch Number BXK4E11. The error pertains to the incorrect indication of product strength on the outer label, which may lead to potential dosing errors. The details of the product are as under: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Xarelto 15mg Tablet Reg. No. 072549 | Each film coated tablet contains: Rivaroxaban…15mg | BXK4E11 | M/s Bayer Pakistan Private Limited., Plot No. 23, Sector No.22, Korangi Industrial Area, Karachi. |
| Risk Statement: | Incorrect labeling can cause a patient to receive the wrong dosage of a medication. This may result in underdosing, where the medication is not effective, or overdosing, which can lead to harmful side effects or toxicity. |
| 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 the mentioned batch of product from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying the mentioned batch. 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. |
| 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 the 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. |