Prequalification of panel hospitals
Minutes of 324th meeting of Registration Board held from 24th to 26th January, 2023
The Drug Registration Board convened its 324th meeting from 24th to 26th January, 2023 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.
Recall Alert: Drug Product; Oscal-D Tablets (Batch # 6904) by M/s Aries Pharmaceuticals (Pvt) Ltd, Peshawar.
Recall Alert
| DRAP Alert No | NoI/S/02-23-14 |
| Action Date | 24th February 2023 |
| 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 | Oscal-D Tablets Manufactured by: M/s. Aries Pharmaceuticals (Pvt) Ltd, Peshawar. Batch No. 6904 Manufacturing Date: 07-2022 Expiry Date: 07-2024 |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the Batch No. 6904 of product “Oscal-D Tablets” as of substandard quality. |
| Risk Statement | Oscal-D Tablets may be used to treat conditions caused by low calcium levels such as osteoporosis, osteomalacia/rickets, hypoparathyroidism and latent tetany. Inaccurate use of the product may lead to adverse reactions including but not limited to irregular heartbeat, weakness, drowsiness, headache, dry mouth or a metallic taste in your mouth or muscle or bone pain. Impact of use of substandard product on basis of assay test may leads to low to no therapeutic effect etc. |
| Action Initiated | -The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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; Calcium Gluconate Injection (Batch # 220325) by M/s Shaheen Agency Karachi
Recall Alert
| DRAP Alert No | NoI/S/02-23-11 |
| Action Date | 23rd February 2023. |
| 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 | Calcium Gluconate Injection Company: Importer Name; M/s. Shaheen Agency, Karachi , Manufactured by: M/s. China National M/H Shanghai China Batch No. 220325 Manufacturing Date: 03-2022 Expiry Date: 03-2025 |
| Problem / Issue | Drug inspector Quetta took the sample of Calcium Gluconate Injection Batch no. 220325 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta. Details of the product is given as under: |
| Risk Statement | injection Calcium gluconate is a lifesaving drug which is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Wrongful use /misleading information due to delible printing upon label of Injection Calcium Gluconate, may disturb the patient’s body calcium balance and may lead to adverse reactions including but not limited to following: (i) Arrhythmias with Concomitant Cardiac Glycoside Use. (ii) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates. (iii) Tissue Necrosis and Calcinosis. (iv)Hypotension, Bradycardia, and Cardiac Arrhythmias. |
| Action Initiated | -The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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. |
SRO 224(I)/2023: Notification of Amendment in the Medical Devices Rules, 2017 dated 27th February, 2023
Recall Alert: Drug Product; Chloroquine Injection (Batch # 201238) by M/s Mehran International Karachi
Recall Alert
| DRAP Alert No | NoI/S/02-23-12 |
| Action Date | 23rd February 2023. |
| 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 | Chloroquine Injection Company: Importer Name; M/s. Mehran International, Karachi , Manufactured by: M/s. Shanxi Shuguana Pharma Co Ltd, China Batch No. 201238 Manufacturing Date: 12-2020 Expiry Date: 12-2023 |
| Problem / Issue | Drug inspector Quetta took the sample of Chloroquine 5ml Injection Bach No. 201238 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta. |
| Risk Statement | Chloroquine is used to prevent and treat of Malaria and Amebiasis. Improper labels due to delible printing of label may lead to misleading information, accidentally administering the wrong medication or wrong dose, may cause a patient to experience a negative health outcome. Further it may lead to adverse reactions including but not limited to Allergic reactions, Cardiac effects, Nausea, Vomiting, Abdominal cramps, Headache, and Diarrhea. |
| Action Initiated | -The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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: Falsified / Spurious Cilapen 500mg Injection identified in the market
Rapid Alert
Falsified / Spurious Cilapen 500mg Injection
| DRAP Alert No | NoI/S/02-23-13 |
| Action Date | 21st February 2023 |
| 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 | Federal Inspector of Drugs Karachi took the sample of Cilapen 500mg Injection and sent to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (ii) of the Drugs Act 1976. The product detail as mentioned on the label is as under: – |
Therapeutic Goods Affected:-
| Sr | Product Name | Composition as per label | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Cilapen 500mg Injection Mfg. Date: 06-2022 Exp. date: 03-2024 | Imipenem + Cilastatin | CP19014 | Ms. Bosch Pharmaceuticals (Pvt.) Ltd., Karachi. |
Following is the comparison of sample against the original pack of the product: –
| S.N | Description | Original pack of the manufacturer (Bosch) | Sample pack (Spurious/Falsified) |
| 1 | Batch number for vial | CP19014 | CP19014 |
| 2 | Manufacturing date | 11-2018 | 06-2022 |
| 3 | Expiry date | 10-2020 | 03-2024 |
| 4 | M.R.P | Rs.810.90/= | Rs.1,140/= |
| 5 | Batch number of WFI on the ampoule and carton | Both same as WI19085 | WI21042 on the ampoule where as WI19085 on the carton |
| 6 | Color of WFI ampoule | Blue | Orange |
| 7 | Printing of descriptions of product | Over-printing batch no. manufacturing date and expiry date | Plain printing (pre-printing) |
| 8 | Font size and style | As per standard approved Bosch Artwork. | Different from the company. |
| 9 | Direction insert/leaflet | As per standard approved Bosch Artwork. | Paper size and quality, color, printing is totally different from that of the company. |
| Risk Statement: | Imipenem and Cilastatin injection is used to treat certain serious infections that are caused by bacteria, including endocarditis and infection of respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint. Wrongful use / misleading information as mentioned above may leads to adverse reactions including but not limited to following: · Severe stomach pain, diarrhea that is watery or bloody. · Upper stomach pain, loss of appetite. · Jaundice and fever. · Seizure; light-headed feeling, like you might pass out. Consequences of use of Falsified/Spurious Drugs are: · Falsified/Spurious drugs may contain toxic doses of dangerous ingredients and cause mass poisoning. · Contributes to the progression of antimicrobial resistance and drug-resistant infections. · Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death. |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities in the market to confiscate this batch of product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch 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 this 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 products. -Adverse reactions or quality problems experienced with the use of these 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 these products 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; Hydralazine 25mg Tablets (Batch # 257) by M/s Zafa Pharmaceuticals (Pvt) Ltd, Karachi .
Recall Alert
| DRAP Alert No | NoI/S/02-23-12 |
| Action Date | 21st February 2023. |
| 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 | Hydralazine 25mg Tablets Active Ingredient(s): Hydralazine Company: M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. Batch No. 257 Manufacturing Date: 10-2022 Expiry Date: 10-2027 |
| Problem / Issue | CDL Karachi has declared the batch No. 257 of Hydralazine 25mg Tablets, manufactured by M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi. 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 should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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. |