SRO 1710; MRP Fixation of Drugs
Decisions of 63rd Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 63rd 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.
Recall Alert: Drug Product; IS-NS (0.9%) Infusion (Batch # B6-24) by ISIS Pharmaceutical & Chemical Works, Karachi
Recall Alert
| DRAP Alert No | No I/S/12-23-48 |
| Action Date | 2nd January, 2024 |
| Target Audience | · Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared Batch No. B6-24 of product “IS-NS 0.9% INFUSION” as of Substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| IS-NS 0.9% Infusion Reg.No 104066 | 0.9% Sodium Chloride | Batch No. B6-24 Mfg. Date: 08-23 Exp. date: 08-25 | M/s. ISIS Pharmaceutical & Chemical Works, Karachi |
| Risk Statement: | The use of substandard products based on assay tests may alter the dose and hamper the efficacy of the product leading to sub-therapeutic effects. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase 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 through phone at +92 51 910 73 17, 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 this 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; Drug Product: Crackdown on Illegal Manufacturing and Seizure of Falsified Drugs
Rapid Alert
| DRAP Alert No | No I/S/12-23-46 |
| Action Date | 29th December, 2023 |
| Target Audience | 1. Regulatory Field Force. 2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 3. Healthcare Professionals – Physicians, Pharmacists, and Nurses, Procurement officer at hospitals and institutions 4. General Public. |
| Problem Statement | On December 12, 2023, the regulatory field force in Karachi raided and shut down an illegal drug manufacturing facility. They collected product samples and sent them to the Central Drugs Laboratory (CDL) in Karachi for testing. The Federal Government Analyst at the CDL confirmed that the products seized by FID-III Karachi from the illicit site were “spurious”. The test results showed that these products lacked the stated active ingredients. There is a possibility that the fake manufacturers have infiltrated the supply chain with some of their falsified products. |
| Threats to Public Health | The use of falsified products will result in ineffective treatment. This may cause therapy failure which may lead to increased morbidity and also, mortality, in case of untreated infections. Moreover, the safety of these falsified products is also unknown. |
The product identification details are as under: –
Therapeutic Goods Affected*:-
| Product Name | Composition (as per label) | Batch / Lot | Mfg Date | Exp Date | Manufacture Name (as stated on label) | Illustrative Images |
|---|---|---|---|---|---|---|
| AL Coxime 400mg Capsule | Cefixime | 110 | 04-23 | 03-25 | M/s. Alpine Laboratories (Pvt) Ltd., Karachi | See DRAP Alert |
| Sinoxime 100mg/5ml Dry Suspension | Cefixime | 101S13 | 10-23 | 09-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Flox-G 500mg Tablet | Levofloxacin | 760 | 01-23 | 12-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Flox-G 250mg Tablet | Levofloxacin | 761 | 01-23 | 12-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Amcox 125mg/5ml Suspension | Amoxicillin | 23217 | 04-23 | 03-25 | M/s. Alcons Laboratories Pvt Ltd., Karachi | |
| Snagxone 1g injection | Ceftriaxone | L23-4 | 06-23 | 06-25 | M/s Leckman Laboratories Pvt Ltd., Karachi | |
| Leckzolid 600mg Tablets | Linezolid | 002 | — | 09-24 | M/s Leckman Laboratories Karachi | |
| Uniclav 156.25mg/5ml Suspension | Co-amoxiclav | 126 | 09-23 | 08-25 | M/s. Uni-Tiech Pharmaceutical Pvt Ltd., Karachi |
| Action Initiated | The Regulatory Field Force has been directed to increase the surveillance activities at Health facilities (Hospitals) in addition to markets and confiscate/seize these falsified products without any delay. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and halt the distribution/supply of these falsified products. Information related to the supplier of these falsified products should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of these falsified 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 these falsified products. -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products 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 not use these falsified products and should contact their physician or healthcare provider if they have experienced any problem related to taking or using any of these falsified 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. |
Minutes of 293rd Meeting of Central Licensing Board held on 20th November 2023
Recall Alert: Drug Product; Ketovet 100mg Injection (Veterinary use) (Batch # 2324108) by Vetz Pharmaceutical Pvt. Ltd, kotri
Recall Alert
| DRAP Alert No | No I/S/11-23-45 |
| Action Date | 21st Dec, 2023 |
| Target Audience | • Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores • Veterinarians • General Public |
| Problem / Issue | Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Ketovet injection” Batch No. 2324108 manufactured by M/s. Vetz Pharmaceuticals (Pvt.) Ltd., Plot #Q1, S.I.T.E Area, Kotri, Hyderabad has been declared as of “Substandard” quality |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Ketovet 100mg Injection (Veterinary Use) Reg.No 102014 | Ketoprofen | Batch No. 2324108 Mfg. Date: 10-23 Exp. date: 09-25 | M/s Vetz Pharmaceutical (Pvt) Ltd. Kotri |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and veterinary pharmacies should immediately check their stocks and stop supplying this batch of product. 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) has increase 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 through phone at +92 51 910 73 17, 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 Veterinary Healthcare Professionals | DRAP requests increased vigilance within the supply chains of veterinary pharmacies and facilities likely to be affected by this faulty batch. |
| Advice for Consumers | -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. |
Recall Alert: Drug Product; Espezar 20mg Tablets (Batch # A401) by Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan
Recall Alert
| DRAP Alert No | No I/S/11-23-44 |
| Action Date | 21st Dec, 2023 |
| Target Audience | · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores · Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc. · General Public |
| Problem / Issue | Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Espezar tablet” Batch No. A401 manufactured by M/s. Avant Pharmaceuticals (Pvt.) Ltd., Plot No. 28 Hub Industrial Estate, Hub Balochistan has been declared as of “Substandard” quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| Espezar 20mg Tablets Reg.No 102983 | Esomeprazole | Batch No. A401 Mfg. Date: 11-22 Exp. date: 11-24 | M/s Avant Pharmaceutical Pvt. Ltd, Hub, Baluchistan |
| Risk Statement: | Esomeprazole is used to treat certain stomach and oesophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid the stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Esomeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). Impact of use of substandard product may leads to sub optimal therapeutic effect which may cause therapy failure or other associated problems. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase 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 through phone at +92 51 910 73 17, 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 this 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 332nd meeting of Registration Board held on 5th December, 2023
The Drug Registration Board convened 332nd meeting on 5th December 2023 in the Committee Room of the Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)
The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.
We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.
We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npc@drap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.
Together, we can ensure the safe and effective use of medicines in Pakistan.