Month: November 2024
Rapid Alert: Crackdown Against Falsified/Illegal Products
Rapid Alert
| DRAP Alert No | No I/S/11-24-44 |
| Action Date | 08th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public |
| Problem Statement | The Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by (as per label claim) | Lab Test Results |
| 1 | Ativan 2mg Tablets Reg# 000084 | Lorazepam | 17C7019 | Purported to be manufactured by Pfizer Pakistan Ltd, Karachi Pakistan | Spurious |
| 2 | Klozen 5 mL Eye Drops Reg# 040124 | Tobramycin 0.3%, Dexamethasone 0.1% | 134 | Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, Peshawar | Spurious |
| 3 | S-Kyne 10mg Tablets Reg# Nil | Dydrogesterone | 566 | Purported to be manufactured by Weather Folds pharmaceuticals, Hattar | Spurious & Misbranded |
| 4 | Efaston 10mg Tablets Reg# 31067 | Dydrogesterone | 064835 | Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. Lahore | Spurious |
| 5 | Dydowen 10mg Tablets Reg# 101507 | Dydrogesterone | 462 | Purported to be Manufactured by Weather Folds Pharmaceuticals, Hattar | Spurious |
| 6 | Phenobar 30mg Tablets Reg# 018862 | Phenobarbitone | QA030 | Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road Lahore | Spurious |
| 7 | Duphaston 10mg Tablets Reg# 006654 | Dydrogesterone | 230672 | Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, Lahore | Spurious |
| Risk Statement: | The impact of the use of falsified / Substandard 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 the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market. |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link. 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 on this link |
| Advice for Consumer | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. |
All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
Rapid Alert: Recall of 04 Batches of Drug Products from Market
Rapid Alert
| DRAP Alert No | No I/S/11-24-45 |
| Action Date | 08th November, 2024 |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · Veterinary Healthcare Professionals · General Public |
| Problem Statement | Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under: |
| S# | Product Name | Composition | Batch No. | Manufactured by | Test Results |
| 01 | Nida Infusion 100ml Reg. No. 079630 | Metronidazole 500mg/100ml | 23E317 | GMP Pharmaceuticals, 28-Km Sheikhupura Road, Lahore. | Substandard due to visible particles and Bacterial Endotoxin. |
| 02 | Metroin Infusion 100ml Reg. No. 071279 | Metronidazole 500mg/100ml | MT24-055 | Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, Lahore | Substandard due to presence of visible particles. |
| 03 | Tylosan 20 Injection 100ml Reg. No. 027416 (For vet use only) | Tylosin base 200mg/ml | TS-259 | Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad. | Substandard due to presence of visible particles. |
| 04 | Melacam-10 injection 50ml Reg. No. 063542 (For vet use only) | Meloxicam 10mg/ml | 23U-03 | Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, Lahore | Substandard on the basis of visible particles and extractable volume. |
| Threat to Public Health | Administration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc. which may have fatal consequences. |
| Action Initiated | The manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market. 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) should have increased surveillance in the market to ensure the effective recall of defective products(s). |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. 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 on this link |
| Advice for Consumer | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. |
All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
Recall Alert: Drug Products; Recall of 02 Substandard Batches Manufactured by M/s Gulf Pharmaceuticals from the Market
Recall Alert
| DRAP Alert No | No I/S/11-24-47 |
| Action Date | 08th 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 | Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Hi-Z syrup (Reg. no. 075129) | 20mg Elemental Zinc/5ml | Batch No. S1427 Mfg Date: 07-2024 Exp Date: 06-20226 | M/s. Gulf Pharmaceuticals, Islamabad |
| Ufen Oral Suspension (Reg. No. 090274) | 100mg Ibuprofen/5ml | Batch No. S1451 Mfg Date: 08-2024 Exp Date: 07-20226 | M/s. Gulf Pharmaceuticals, Islamabad |
| Risk Statement: | Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batches of products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s). –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: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market
Rapid Alert
| DRAP Alert No | No I/S/11-24-42 |
| Action Date | 07th November, 2024 |
| Target Audience | · National Regulatory Field Force. · Distribution, Pharmacies and Medical Stores · Healthcare Professionals – Physician, Pharmacist, Nurses · Maternal and Child Health Centres |
| Problem Statement | M/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number. |
| Product name | Batch/Lot No. | Manufacturer Name (as per label) | Mfg. date | Exp. date |
| Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin | P100547971 P100644011 Barcode Batch: P100585096 | M/s CSL Behring AG, Wankdorfstrasse 10, CH-3000 Bern 22,Switzerland. | 10-2023 | 09-2026 |
| Threat to Public Health | The Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link. 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 on this link |
| Advice for Consumer | Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. |
All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
Draft Guidance Document For Clinical Trials Of Biological Products (Manufacture Locally)
For comments of stakeholders
Minutes of 51st Meeting of Clinical Studies Committee
Notification for GCP Inspections
Decisions of 72nd Meeting of Medical Device Board; Deficiency letters for Medical Devices Applications
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 72nd meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.