Author: Ijaz Mustafa
DRAP issued guidance on Remote Virtual Inspection (RVI) for GMP Assessment of overseas manufacturing facilities for registration of finished Pharmaceutical Drugs and Biologicals
Tender document / terms & conditions for hiring of janitorial services for DRAP head office & NCLB, Islamabad
Notification: Expert members of the Medical Device Board (MDB)
Auction notice
Recall Alert; Drug Product: Molimax 5mg/5ml Oral Suspension (Batch # L2165) by M/s. Alliance Pharmaceuticals Pvt Ltd, Peshawar
Recall Alert
| DRAP Alert No | NoI/S/07-22-17 |
| Action Date | 6th July, 2022 |
| Target Audience | 1. 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 | Molimax 5mg/5mL Oral Suspension, Active Ingredient(s): Domperidone Company: M/s Alliance Pharmaceuticals Pvt Ltd, Peshawar. Batch No. L2165 Manufacturing Date: January-2022, Expiry Date: December-2023 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the sample of Molimax 5mg/5ml Oral Suspension (Registration No. 044548) bearing Batch No. L2165, 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. |
Invitation to bid (For Stationery & other Miscellaneous Items)
Falsified Alert; Drug Product: Presence of falsified Glucantime (meglumine antimonate) in market purported to be manufactured by M/s. Tillotts pharma AG, Switzerland
Falsified Alert
| DRAP Alert No | NoI/S/07-22-18 |
| Action Date | 5th August, 2022 |
| Target Audience | 1. 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 | Product Name: GLUCANTIME (Meglumine Antimoniate) Purported to be Manufactured By: TILLOTTS PHARMA AG, Switzerland Batch No. 1119-078 Manufacturing Date: December-2019, Expiry Date: November-2022 |
| Problem Statement | Suspected falsified GLUCANTIME (Meglumine Antimoniate) has been found in in the market of Quetta, Pakistan. World Health Organization, Regulation and Safety Unit, has informed regarding the availability of falsified GLUCANTIME (Meglumine Antimoniate) purported to be manufactured by the TILLOTTS PHARMA AG, Switzerland . The stated manufacturer listed on the falsified product TILLOTTS PHARMA AG, Switzerland has confirmed that they do NOT manufactured this product and neither they sub-contract the manufacturing, nor distribute these products anywhere in the world. The following discrepancies can be identified in this falsified product:- • The outer packaging has English and French labeling but contains visible spelling mistakes and questionable information • Medicine – spelt “medecine” • Use of a Gmail email address for manufacturers contact • Statement that the product is an over the counter medicine. Pictures of Falsified GLUCANTIME (Meglumine Antimoniate) can be viewed on this link. |
| Action to be taken | -All Pharmacists and chemists working at distributions and Pharmacies are required to be alert and immediately inform the DRAP upon the presence of this falsified product in the market or any information related to the supply of this falsified product. -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 eradication of falsified product(s) and initiation of relevant legal proceedings. |
| 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 | -If anyone posses this falsified product, it is advised to not use this product9s) and shall immediately inform the DRAP. -Consumers are also advised to 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: Sterile Water for Injection (Batch # 739 and 751) by M/s. Zafa Pharmaceutical Laboratories (Pvt) Ltd., Karachi
Recall Alert
| DRAP Alert No | NoI/S/07-22-18 |
| Action Date | 25th July, 2022 |
| Target Audience | 1. 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 | Sterile Water for Injection, Company: M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd., Karachi. Batch No. 739 and 751 Manufacturing Date: February-2022, Expiry Date: February-2024 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection bearing Batch No. 739 and 751 and declared it as Adulterated and 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: Phenerzine Elixir (Batch # 037) by M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi
Recall Alert
| DRAP Alert No | NoII/S/07-22-20 |
| Action Date | 2nd August, 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, clinics and healthcare institutions 3. General Public |
| Product(s) Affected | Phenerzine Elixir, Company: M/s Epoch Pharmaceuticals (Pvt) Ltd., Karachi Batch No. 037 Manufacturing Date: March-2022, Expiry Date: March-2024 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the sample of Phenerzine Elixir bearing Batch No. 037 and declared it as Adulterated and 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. |