Month: May 2024
Voluntary Recall Alert: Drug Product; Cadlec 30mg/mL Injection by Brooks Pharma Pvt Ltd., Karachi
Recall Alert
| DRAP Alert No | No I/S/05-23 |
| Action Date | 15th May 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 | M/s. Brookes Pharma Private Limited, Karachi, has initiated a voluntary recall of all batches of Cadlec 30mg/ml Injection due to the presence of tiny floating particles found in retained samples. Previously, Ketorolac injection was also recalled by Fresenius Kabi, USA, and Hospira Inc. Additionally, Hikma Pharmaceutical, USA, also recalled the injection for the same reason. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Cadlec Injection 30mg/ml Reg No. 095892 | Ketorolac | All Batches | M/s. Brookes Pharma Private Limited, Karachi |
| Risk Statement: | Administering products containing particulate matter may block blood vessels, leading to local irritation, swelling, tissue inflammation, blood clots, lung tissue scarring, and life-threatening allergic reactions. |
| Action Initiated | –The manufacturer has initiated recall of all batches of the affected product from the market. All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying this product. The remaining stock should be quarantined and returned to the supplier/ company. 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 these product and 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. |
Introducing Centralized Case Management System for Enhanced Efficiency and Transparency
The Drug Regulatory Authority of Pakistan (DRAP) has introduced a centralized case management system, aimed at boosting operational efficiency and ease of doing business processes for the therapeutic goods industry. This system is designed to monitor the processing of applications and to enable applicants to track their regulatory submissions and furnish additional details as required, marking as a significant step towards enhancing transparency and efficiency.
All licensed / applicant of therapeutic goods manufacturers/importers/exporters/ clinical trial sites/ CROs etc can access this system on eAPP module (www.eapp.dra.gov.pk) of DRAP through their existing secured account credentials, effective from 29th May, 2024. This module ensures that submissions are forwarded to the Director of the concerned Divisions with visibility for applicants to track their cases and receive timely responses, under monitoring by the DRAP’s higher management.
We are hopeful that implementation of this new system will significantly improve the visibility of application processing and streamline regulatory operations.
Rapid Alert: Drug Product; Falsified Froxime 100mg/5mL Powder for Oral Suspension
Rapid Alert
| DRAP Alert No | No I/S/05-24-22 |
| Action Date | 27th May 2024 |
| Target Audience | · Regulatory Field Force. · Healthcare Professionals – Physicians, Pharmacists, and Nurses. · Procurement Managers at Hospitals, Clinics, Pharmacies and other Healthcare Institutions · General Public. |
| Problem Statement | The Provincial Inspector of Drug Tehsil Kallurkot, Dist. Bhakkar inspected the premises of Ms. Dar ul Shifa Pharmacy near THQ Hospital Tehsil Kallur Kot district Bhakkar and collected samples of Froxime Suspension (Batch no FRX-100/S-005; manufactured by Ms. Froxx Pharmaceuticals Plot No 87 KIA Karachi). The Government analyst DTL Rawalpindi has declared the Froxime Suspension as Substandard and Spurious. |
The product identification details are as under: –
| Product | Composition | Batch Details | Purported to be Manufactured by (as per label) |
|---|---|---|---|
| Froxime 100mg/5mL Powder for oral Suspension Reg No. 555210 (It is fake number) | Cefixime USP | Batch No.FRX-100/S-005 Mfg. Date: 03-23 Exp. Date: 02-25 | Ms. Froxx Pharmaceuticals Plot No 87 Korangi Industrial Area, Karachi. (It is a Fake company) |
Note: There is no product registered in DRAP with the name “Froxime Powder for Oral Suspension”, and there is no licensed manufacturing company named as “Froxx Pharmaceutical Karachi”.
| Threat to Public Health | Spurious or falsified pharmaceuticals may contain harmful levels of toxic substances, posing a significant risk of widespread poisoning. These substandard medications have the potential to undermine the efficacy of disease treatment and exacerbate preexisting medical conditions. |
| Action Initiated | The Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any such falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products.. The remaining stock should be quarantined immediately, and supplier information should be provided to the Regulatory Field Force (DRAP, Provincial and State Drug Control Administrations) to ensure the removal of these 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. -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 stop using this product and shall contact 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 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 Product; Zaftolin 5mg/ml Solution by Zafa Pharmaceutical Pvt Ltd, Karachi
Recall Alert
| DRAP Alert No | No I/S/05-24-21 |
| Action Date | 15th May 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 | Provincial Drug Inspector, Karachi took the sample of Zaftolin Respiratory Solution for respirator. Federal Government Analyst, CDL Karachi has declared the Batch No. 104 of the product as of substandard quality. Details of the product are given as under: |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Zaftolin 5mg/ml Respiratory solution Reg No. 039618 | Salbutamol | Batch No. 104 Mfg. Date: 06-23 Exp. date: 06-26 | M/s. Zafa Pharmaceutical Laboratories Private Limited Karachi. |
| Risk Statement: | The impact of use of substandard Zaftolin solution for respirator on the basis of pH may cause sub optimal effect. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defected batch of product from the market. All pharmacists and chemist 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. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also 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 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. |
Minutes of 335th meeting of Registration Board held on 25th April, 2024
The Drug Registration Board convened 335th meeting on April 25, 2024 in the Committee Room of the Drug Regulatory Authority of Pakistan, Prime Minister National Health Complex, Park Road Islamabad. The minutes of the meeting are hereby circulated for the information of all stakeholders.
Rapid Alert: Contaminated Lot of Sorbitol Identified in Karachi
Rapid Alert
| DRAP Alert No | No II/S/04-24-19 |
| Action Date | 15th May 2024 |
| Target Audience | · Regulatory Field Force. · Therapeutic Goods industry · Manufactures of Oral liquid preparations |
| Problem Statement | The Federal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis report No. RM-2-24-000136 dated 22-03-2024 declared the sample of Sorbitol (Batch 09-LM-023) sent to CDL Karachi by M/s. Herbiotics Healthcare Rawalpindi in compliance to letter vide No. 03-41/2023-QC dated 01-12-2023. |
Details of CDL test/analysis report are as under:
| Product Name | Manufacturer as per label | Batch No. | Test Results | Limits |
| Sorbitol | M/s. Master Sweetener, Karachi | 09-LM-023 | Ethylene Glycol: 0.6431% Does not comply | Ethylene Glycol: NMT 0.1% |
| Risk Statement: | Ethylene Glycol (EG) contaminated raw materials when used in oral liquid preparations can lead to serious health risks. When ingested, EG is converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences. |
| Action Initiated: – | The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of Sorbitol. The Regulatory Field Force has also been instructed to seize all preparations manufactured using the same batch of Sorbitol if found in the market. |
| Advice for Therapeutic Goods Manufacturers: – | Manufacturers of therapeutic goods are required to follow these instructions: 1. Recall Products: If any batch was manufactured using the same lot of Sorbitol that has been identified as contaminated, all finished products from local and export markets should be recalled. 2. Hold Other Batches: All finished products manufactured from same lot of sorbitol should be kept on hold. These products should be tested for EG/DEG contamination before releasing them into the supply chain. 3. Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG. 4. Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products. 5. Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products. Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products. |
| Advice for Healthcare Professionals: – | DRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of DEG/EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centers. Adverse reactions 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. Further information on reporting problems to DRAP is available on this link. |
Recall Alert: Drug Product; Novarise 50mg/5ml Syrup by Sharooq Pharmaceuticals, Lahore
Recall Alert
| DRAP Alert No | No I/S/05-24-20 |
| Action Date | 15th May 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 | The Federal Government Analyst, CDL Karachi vide test report No. LHR-1-24-000001 dated 03-04-2024 has declared the Novarise Syrup Batch No. 113 as of substandard quality on the basis of presence of Ethylene Glycol impurity at unacceptable level. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufactured by |
|---|---|---|---|
| Novarise 50mg/5mL Syrup | Iron (iii) Hydroxide Polymaltose complex | Batch No. 113 | M/s Sharooq Pharmaceuticals (Pvt.) Ltd., Lahore |
| Risk Statement: | The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batches of affected products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of products. –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 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. |
Report on Availability Status and Supply Disruption of Eye Drops
The Drug Regulatory Authority of Pakistan (DRAP) has received information that certain brands of eye drops are short in supply in the market. The DRAP’s committee has conducted a quick survey of the market and found certain alternative brands available in the market. The main reason behind their short supply is the change of ownership globally from Allergan to AbbVie.
In this regard, Physicians are advised to consider prescribing the available alternative brands to their patients in light of the shortage. Patients should be informed about this during their consultations. Similarly, pharmacists should also communicate the availability of alternative brands to patients or caregivers.
Briefly, the availability status of eye drops reported short along with their alternative brands is presented in the table below:
| Sr. No. | Name of Drug Products | Manufacturer/ importer | Status | Reason / Stock position | Alternate brand available |
| 1 | Combigan Eye drops (Brimonidine and Timolol) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Brytim Eye Drops (Remington) Imosol eye Drops (Schazoo) |
| 2 | Lumigan Eye drops (Bimatoprost) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Allure Eye drops (Sante) |
| 3 | Alphagan Eye drops (Brimonidine tartrate) | M/s Barrett Hodgson | Short supply | Global merger/ acquisition (Change of ownership from Allergan to AbbVie) | Brimodine Eye drops (Sante) Brimod eye drops (Remington) |
| 4 | Cosopt eye drops (Dorzolamide and Timolol) | M/s OBS Pakistan | Short Supply | Stock of 30,000 packs is in transit. | Co-Dorzol eye drops (Sante) Co-Dorz eye drops (Ethical) |
Drug Safety Alert: Risk of Medication Errors resulting Errors resulting due to inadvertent intrathecal Tranexmic Acid Injection
Drug Safety Alert
Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan
| Date: | 28th of April, 2024 |
| Target Audience: | · Manufacturers and importers of tranexamic acid injection; · Healthcare Commissions/ Provincial Health Departments; and · Healthcare Professionals. |
| Background: | The WHO in its medical product alert on 16th March, 2022 informed healthcare professionals about the risk of administration errors that can potentially occur with tranexamic acid (TXA) injection. There have been reports of TXA being mistaken for obstetric spinal anaesthesia used for caesarean deliveries resulting in inadvertent intrathecal administration. In TXA administered intrathecally, potent neurotoxin and neurological sequelae are manifested, with refractory seizures and 50% mortality. The profound toxicity of TXA administered intrathecally was described in 1980. A 2019 review identified 21 reported cases of inadvertent intrathecal injection of TXA since 1988, of which 20 were life-threatening and 10 fatal. Sixteen were reported between 2009 and 2018. The WHO recommends early use of intravenous TXA within 3 hours of birth in addition to standard care for women with clinically diagnosed postpartum haemorrhage (PPH) following vaginal births or caesarean section. TXA should be administered at a fixed dose of 1g in 10 ml (100 mg/ml) IV at 1 ml per minute, with a second dose of 1g IV if bleeding continues after 30 minutes. The WHO also informed that TXA is frequently stored in proximity to other medicines, including injectable local anaesthetics indicated for spinal analgesia (e.g., for caesarean section). The presentation of some of the local anaesthetics is similar to the TXA presentation (transparent ampoule containing transparent solution), which can erroneously be administered instead of the intended intrathecal anaesthetic resulting in serious undesirable adverse effects. Recently, obstetricians from several countries have reported inadvertent intrathecal TXA administration and related serious neurological injuries. |
| Therapeutic Good(s) Affected: | Tranexamic acid (TXA) is used for the prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year. Specific indication inter-alia includes gynaecological surgery or disorders of obstetric origin such as postpartum haemorrhage. |
| Action in Pakistan | The case was discussed in the 4th meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the DRAP held on 26th of February, 2024 which decided the case as per Rule 10 (1) (b) and 10 (1)(h) (vi) of Pharmacovigilance Rules, 2022 and recommended National Pharmacovigilance Centre to issue safety alerts/ advisory related to the risk of medication errors due to inadvertent intrathecal tranexamic acid injection. |
| Advice for healthcare professionals: | Healthcare providers, particularly obstetricians and anesthesiologists, are urged to remain vigilant regarding the potential risk of unintended intrathecal administration of Tranexamic acid (TXA), leading to the development of potent neurotoxicity and subsequent neurological complications. It is recommended that healthcare professionals verify the labelling of Tranexamic acid (TXA) injections before administration. Instances have been documented where TXA has been mistaken for obstetric spinal anaesthesia during cesarean deliveries, resulting in inadvertent intrathecal administration. The similarity in presentation between some local anaesthetics and TXA (both typically packaged in transparent ampoules containing clear solutions) can lead to erroneous administration of the wrong medication instead of the intended intrathecal anaesthetic. Tranexamic acid (TXA) is a lifesaving medicine; however, this potential clinical risk should be considered and addressed by all operating theatre staff. Reviewing of existing operating theatres’ drug handling practices are required in order to decrease this risk, such as storage of TXA away from the anesthetic drug trolley, preferably outside the theatre. |
| Guidelines for reporting Adverse Drug Reactions (ADRs): | Both healthcare professionals and patients are requested to report any suspected Adverse Drug Reaction (ADR) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website. Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices). |
| References: | · Minutes of the 4th meeting of the Pharmacovigilance Risk Assessment Expert Committee. · WHO statement on risk of medication errors with tranexamic acid injection resulting in inadvertent intrathecal injection. |