The Drug Registration Board convened its 322nd meeting on 8th and 10th November, 2022 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
Holding of Khuli E-Kachehri
Recall Alert: Drug Product; Tosson 0.4mg SR Capsule by M/s MTI Medical Pvt Ltd, Lahore.
Recall Alert
| DRAP Alert No | NoI/S/12-22-41 |
| Action Date | 5th December 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Tosson 0.4mg SR Capsules, Active Ingredient(s): Tamsulosin Company: M/s. MTI Medical Pvt Ltd, Lahore Batch No. 487 |
| Problem / Issue | DTL Lahore has declared the Batch No. 487 of Tosson SR 0.4mg Capsule manufactured by M/s. MTI medical Lahore as substandard drug product. |
| Action Initiated | -The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -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(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |
Decisions of 51st Meeting of Medical Device Board (Deficiency letters Local/Import)
The Medical Device Board (MDB) of Drug Regulatory Authority of Pakistan in its 51st meeting has deferred the following applications of registration of medical devices due to various deficiencies / shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information / documentations as directed by the Medical Device Board. The detail is provided in the below attachment.
Minutes of 288th Meeting of Central Licensing Board held on 18th October 2022
Recall Alert: Drug Product; Ximex 100mg/5mL Suspension by Farmaceutics International Karachi
Recall Alert
| DRAP Alert No | NoI/S/11-22-39 |
| Action Date | 30th November 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Ximex 100m/5mL Suspension, Active Ingredient(s): Cefixime 100mg/5mL Company: M/s. Farmaceutics International Karachi Batch No. F-C-539 Manufacturing Date: 06-2022 Expiry Date: 06-2024 |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the batch No. F-C-539 of product ‘Ximex 100mg/5mL Suspension” manufactured by M/s. Farmaceutics International Karachi, as of substandard quality based on the analysis report. |
| Action Initiated | -The manufacturing company has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -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(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |
Recall Alert: Drug Product; Kempol 120ml/5mL Pediatric Syrup by M/s Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad
Recall Alert
| DRAP Alert No | NoI/S/11-22-39 |
| Action Date | 30th November 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Kempol 120mg/5mL Syrup, Active Ingredient(s): Paracetamol 120mg/5mL Company: Ms. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad Batch No. P-707 Manufacturing Date: 09-2022 Expiry Date: 08-2024 |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the Batch No. P-707 of product ‘Kempol 120mg/5mL Syrup” manufactured by M/s. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad and declared it as “Substandard” based on the analysis. |
| Action Initiated | -The company is directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -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(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |
Rapid Alert: Drug Product; Falsified Restane Inhalational Solution Identified and Confiscated
Rapid Alert
| DRAP Alert No | NoI/S/12-22-40 |
| Action Date | 1st December 2022 |
| Target Audience | • Regulatory Field Force • Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses • Pharmacists and Chemists at Distribution, Institutional suppliers • General Public |
| Problem Statement | During the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated. The product detail is as under: – |
Therapeutic Good Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) | Marketed by (as label) |
|---|---|---|---|---|---|
| 1 | RESTANE Inhalation Solution 100ml | Isoflurane | N0111B24 N0892A10 | M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA | Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan. |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of product. The remaining stock should be quarantined immediately, and supplier’s information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this products. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said products. -Adverse reactions or quality problems experienced with the use of this product shall 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 you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product. |
Rapid Alert: Drug Product; Falsified Tablin 300mg Capsule identified in the market
Rapid Alert
Suspected Falsified Product
| DRAP Alert No | NoI/S/10-22-36 |
| Action Date | 24th November 2022 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | During the market surveillance activities in different areas of District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample for product and sent for analysis to laboratory. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious”. The stated manufacturers on the label has informed that they have not manufactured this batch number of product. Product detail is as under:- |
Therapeutic Good Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | TABLIN 300mg Capsule | Pregabalin 300mg | Batch No. 699 | M/s Theramed Pharmaceuticals (Pvt) Ltd, Lahore. |
| Action Initiated | The Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of suspected products. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned product. -Adverse reactions or quality problems experienced with the use of this product shall 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 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, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained from the 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 Product; Ponstan Forte 500mg Tablets (Batch # 2050533) by M/s Pfizer Pakistan Ltd, Karachi.
Recall Alert
| DRAP Alert No | NoI/S/10-22-35 |
| Action Date | 30th November 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Ponstan Forte 500mg Tablets, Active Ingredient(s): Mefenamic Acid Company: M/s. Pfizer Pakistan Ltd, Karachi Batch No. 2050533 Manufacturing Date: 09-2020 Expiry Date: 08-2025 |
| Problem / Issue | The Drug Testing Laboratory, Baluchistan has analyzed the sample of batch No. 2050533 of Ponstan Forte 500mg Tablets manufactured by M/s. Pfizer Pakistan Ltd Karachi, Pakistan and declared it as “Substandard” based on the analysis. |
| Action Initiated | -The company is directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / 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) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -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(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |