RapidAlert – Drug Regulatory Authority of Pakistan

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o I/S/09-25-81
Action Date	26th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Directorate of Drugs Control Punjab (DDCP) have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Саpsule Eskem 40 MG Each Capsule Contains: Enetric Coated Pellets of Esomeprazole Magnesium Tri-hydrate Equivalent to Esomeprazole ……. 40 Mg (Reg.# 044310)	Not mentioned	Purported to be manufactured by M/s High-Q Pharmaceuticals, Plot No. 224 & 225/1, Sector 23, Korangi Industrial Area, Karachi.	‘Substandard’ with respect to physical characteristics and “Misbranded” as defined under clause (i) of sub-section (s) of section 3 of The Drugs Act, 1976 and “Spurious” as defined under clause (i) & iii of subsection (zb) of section 3 of The Drugs Act, 1976. Details: Product label on outer carton does not bear batch number and immediate blister have illegible embossed marking. Moreover, as per the manufacturer’s method, the product is described as amethyst-colored capsules with the cap imprinted ‘High Q’ in black and the body imprinted Eskem 40, However, no such printing was observed on the actual capsules. Esomeprazole is not identified. Omeprazole is identified.

Risk Statement	Critical non-compliances include absence of batch number on the outer carton, illegible embossed markings on immediate blister packs, and deviation from the manufacturer’s approved description of capsule appearance (color and printing). Analytical testing confirmed that Esomeprazole was not identified and instead Omeprazole was detected, representing potential therapeutic failure and risk of inappropriate treatment. The presence of a spurious and misbranded product in the supply chain poses a serious threat to patient safety due to lack of assured identity, quality, and efficacy and requires immediate regulatory and field action to prevent its distribution and use.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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 – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

Ahsan Hafiz Recall Alerts September 19, 2025September 19, 2025RapidAlert

Download

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o I/S/09-25-74
Action Date	19th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Provincial Drug Testing Laboratories have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’*. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Efaston tablet (Dydrogesterone 10mg)	41160	Purported to be manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore.	Spurious (Does not contain active ingredient)
2.	Paracare 60ml suspension (Paracetamol 120mg/5ml)	PE-042	Purported to be manufactured by Wellcare Pharmaceuticals, Sargodha.	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as the laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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.

SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025RapidAlert

Download

Rapid Alert

SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)

DRAP Alert No	N^o I/S/09-25-70
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Directorate of Drugs Control Punjab informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘*Spurious*’.

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection Daizelive 2ml Each 2ml ampoule contains: Diazepam …… 10 mg	DZ44	M/s Liven Pharmaceuticals (Pvt) Ltd. Sray Road, 49 KM, Multan Road, Phool Nagar, District Kasur (DML # 000881)	Drug Testing Laboratory, Rawalpindi has declared the sample as ‘spurious’ since it does not contain the claimed active ingredient (Diazepam) and instead contains an undeclared ingredient (Chlorpheniramine Maleate 45.283 mg/2ml).

Risk Statement	Laboratory testing has confirmed that the product labeled as Daizelive Injection 2ml (Diazepam 10mg/2ml) is spurious/falsified, as it does not contain Diazepam, instead contains Chlorpheniramine Maleate (45.283mg/2ml). Use of this falsified product poses a serious and life-threatening risk, particularly for patients requiring Diazepam for seizures, severe anxiety, or emergency care, as they will not receive the intended treatment. Healthcare professionals and the public are strongly advised to immediately discontinue use of this product, ensure recall compliance, and report any suspected adverse outcomes or suspicious stock to DRAP.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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 – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025RapidAlert

Download

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o I/S/09-25-68
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Azomax 500mg (Azithromycin 500mg)	C1699	Purported to be manufactured by AGP Limited Karachi	Spurious (Does not contain active ingredient)
2.	Klaricid 500mg tablet (Clarithromycin 500mg)	722269XV	Purported to be manufactured by Abbott Laboratories Karachi	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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 – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025RapidAlert

Download

Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/09-25-67
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
	Dytron Tabelt 10mg (Dydrogesterone 10mg)	D1T	Purported to be manufactured by an unlicensed /illegal entity claimed to be Pax Pharmaceuticals Karachi	Spurious (Does not contain active ingredient)
	Levontis 375mg (Amoxicillin trihydrate: 250, Clavulanic Acid: 125mg)	LF2	-do-	Spurious (Does not contain active ingredient)
	Levontis 625mg (Amoxicillin trihydrate: 500, Clavulanic Acid: 125mg)	LF2	-do-	Spurious (Does not contain active ingredient)
	Levontis 625mg (Amoxicillin trihydrate: 875, Clavulanic Acid: 125mg)	LF4	-do-	Spurious (Does not contain active ingredient)
	Sulfira suspension (Sucralfate 1g/5ml)	SL6	-do-	Spurious (Does not contain active ingredient)
	Furin 50mcg aerosol spray (Mometasone Furoate 50mcg)	NF4	-do-	Spurious (Does not contain active ingredient)
	Droxel capsule 500mg (Cefadroxil Monohydrate 500mg))	RC5	-do-	Spurious (Does not contain active ingredient)
	Bromiz tablet (Bromazepam 3mg)	0007	Purported to be manufactured by an unlicensed /illegal entity claimed to be Miraz Pharma Kasur (Fictitious firm)	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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.

Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025RapidAlert

Download

Rapid Alert

Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

DRAP Alert No	N^o I/S/09-25-66
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Vigamox® Sterile Ophthalmic Solution bearing Batch # VHF02A is identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain.

Please click downlaod button on top of page for Rapid Alert with pictorial guidance to identify the falsified comparsion with original product.

Risk Statement	In the case of Vigamox® (Batch No. VHF02A), such falsification may result in ineffective treatment of bacterial eye infections, potential worsening the infection, and risk of serious eye damage or vision loss. This alert applies only to Batch No. VHF02A and does not affect other batches of Vigamox® in the market supplied by the authorized registration holder. The falsified batch poses a particular risk to patients with eye infections, especially children, the elderly, and those with weakened immune systems, who may experience rapid deterioration if untreated or improperly treated.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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 – Unregistered / Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

Ahsan Hafiz Recall Alerts September 12, 2025September 12, 2025RapidAlert

Download

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / UNREGISTERED DRUGS

Unregistered Indian-Origin Illegal & Unsafe Sildenafil Tablets (PENAGRA, VEGA, COBRA) Being Sold Illegally

DRAP Alert No	N^o I/S/09-25-62
Action Date	12th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	DRAP has identified dangerous and illegal brands of Sildenafil tablets being sold in the market under the names PENAGRA 100 mg, VEGA 100 mg, and COBRA 125 mg tablets. Laboratory testing has declared PENAGRA substandard and all three products unregistered and falsified Indian-origin medicines. These tablets were being sold illegally by paddler in the local market, who has now absconded. Unregistered Drug Products Involved PENAGRA TABLETS 100 mg · Generic: Sildenafil 100 mg/tablet · Batch No.: BPTE-24134 · Manufacturer (as per label): M/s BANSON PHARMACEUTICALS PVT. LTD. · Finding: Declared Substandard on basis of assay of sildenafil; also Unregistered (Falsified) VEGA 100 TABLETS · Generic: Sildenafil 100 mg/tablet · Batch No.: NIL (untraceable) · Manufacturer (as per label): M/s HAB PHARMACEUTICAL & RESEARCH INDIA · Finding: Declared Unregistered (Falsified) COBRA 125 MG TABLETS · Generic: Sildenafil 125 mg/tablet · Batch No.: BCB-98 · Manufacturer (as per label): M/s Combitic Global Caplet Pvt. Ltd., India Finding: Declared Unregistered (Falsified)

Risk Statement	The use of these unregistered brands of sildenafil tablets poses a serious threat to public health. Since PENAGRA has been declared substandard, patients may experience ineffective treatment, unpredictable dosing, or harmful side effects. In addition, PENAGRA, VEGA, and COBRA tablets are all unregistered and falsified products, which means they bypass DRAP’s strict quality, safety, and efficacy checks and may contain unsafe or misleading ingredients. Medicines obtained from the black market, paddlers, or online sellers are especially dangerous, as their authenticity and safety cannot be verified, putting patients at high risk of treatment failure and potential harm. Unregistered medicines are strictly prohibited in Pakistan and may cause serious health risks, including treatment failure and harmful side effects. The public is strongly advised: do not buy or use these unregistered products from pharmacies, online sellers, social media, or black market sources.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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: Medical Devices; Unregistered Intravenous Medical Devices in the market

Asad Ullah Recall Alerts August 11, 2023August 12, 2023DRAP, Drugs, Medical Devices, QA & LT, QualityDefects, RapidAlert

Download

Rapid Alert

Unregistered Intravenous Medical Devices in the Market

DRAP Alert No	N^oI/S/08-23-31
Action Date	10th August 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 and clinics etc. 4. General Public
Problem Statement	The Medical Device Rules 2017 provides the regulatory framework for medical devices in the country. SRO 224(I)/2023 dated 27-02-2023 extended the transition period for the registration of medical devices to licensed importers and manufacturers as per risk-based classifications. However, medical devices specified in Schedule D and E of this SRO are always mandatory to be registered with DRAP before marketing in the country. DRAP has received reports/complaints that some unregistered medical devices (e.g., IV cannulas, infusion sets, syringes, etc.) are being proliferated in the open market. The product detail as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Manufacturer/importer (as stated on label)
1	Euro Plus Infusion Set	Apex Medical Devices
2	Chiron Infusion Set	Not mentioned
3	Health Plus Infusion Set	Not mentioned
4	O’Divine Infusion Set	Not mentioned
5	Cath-Tec I.V Cannula	Nilhol Enterprises East Lane Business Park Wemby, UK
6	Healthflon I.V. Cannula	Healthylife medical equipment Trading, Alfajar Business Centre, airport road, Dubai, UAE

Risk Statement:	The use of unregistered medical devices poses significant risks to patients as they may not meet the necessary standards of safety, quality, and performance. Such medical devices can be nonsterile, or their sterility can be compromised from damage during shipping and storage. The hazards associated with the use of unregistered medical device includes inaccurate or unreliable results, Infection or other adverse reactions, Failure of the device’s intended purpose, and Injury or death.
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 products where available. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these products. Any 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 these unregistered 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 products. -Procurement staff in healthcare settings must obtain the registration status of medical devices falling in schedules D and E of the Medical Device Rules, 2017, from the suppliers. It’s imperative to note that authorized manufacturers and importers hold the exclusive right to provide medical devices in the market. -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 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.

Consultative Workshop on Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods

Asad Ullah Events July 21, 2023July 26, 2023DRAP, Inspectors, Patient Safety, QualityDefects, RapidAlert, Recall

National Regulatory Authorities are responsible to ensure that recalls are handled properly and promptly, including alerting the public, classifying the type of drug recall, and safely removing the affected product from the market. DRAP in collaboration with WHO, organized one-day consultative workshop on “Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods” held at DRAP Headquarter in Islamabad on 20th July, 2023. The workshop was aimed at ensuring strong communication skills and knowledge to effectively handle the SF threat and execution of recalls and rapid alerts. Government Analysts from all Quality Control Laboratories (QCLs) working under the DRAP Act 2012 and Drug Act 1976, as well and representatives from drug control administration of all federating units participated in the workshop.

The workshop focused on the following key objectives:

Implementation of effective and integrated Recall and Rapid Alert system in Pakistan.
Emphasizing the need and importance of Recall and Rapid Alert System.
Training and building capacity of all the participants.
Enhancing coordination and communication with provincial governments and related departments.
Safe disposal system of SF products
Improvement in DRAP’s guidelines and harmonization with International best practices.

**Risk Communication flow chart for handling SF threats**

Core Activities and Topics Covered

1. Introduction and Objectives of Workshop The day began with an overview of current system for rapid alerts and recalls for removing defective therapeutic goods from the market. Director Quality Assurance and Lab Testing, DRAP briefed the participants on the strategies designed to strengthen the collaboration among regulators and QCLs of all federating units. He emphasized the importance of timely and accurate communication to combat the challenge of SF therapeutic goods.

2. Overview of DRAP’s guidelines on Recalls and Rapid Alerts of Defective products This session explained the guidelines of DRAP and action response currently opted by DRAP, highlighting its strengths and limitations. Participants engaged in group discussions to evaluate which methods would be most effective in different scenarios.

3. WHO recommendation on Recalls and Rapid Alerts System in the benchmarking visit Participants were introduced to the WHO GBT indicators, sub-indicators and IDPs, WHO recent visit and their recommendation for the improvement of the current Rapid Alert system. The trainer comprehensively delivered the details, ensuring that the information provided is easily comprehensible and actionable.

4. Harmonization of Terminologies for Defective Products and Role of QCLs in Detection and Disposal of SF products This segment focused on the terminologies being used nationally and their harmonization with WHO recommended terminologies. Later the role of Quality Control Laboratories was emphasized and discussed in group discussion.

5. Best practices for storage and disposal of SF products This session highlighted the current available practices and international practices as recommended by the WHO for safe storage and disposing of the SF products.

6.Effective communication among stakeholders for their removal from the market ;Recall is an effective means of protecting the public from a defective or potentially harmful product, and strong communication among relevant stakeholders is essential for the effective recall of SF Products. It was suggested to utilized modern communication channels by all federating units to ensure in time action on trigger information to safeguard public health. It was agreed by all the participants that prompt and effective communication is very crucial for implementing an proficient Rapid Alert and Recall System to removal of SF product from markets.

7. Practical Exercises The afternoon session involved hands-on practical exercises. Participants were divided into groups and tasked with case studies for different hypothetical scenarios. Case studies and simulations illustrated the effective collaboration between all the relevant stakeholders. This interactive exercise encouraged teamwork and allowed attendees to apply the concepts learned throughout the day.

8. Concluding Remarks and Distribution of Certificates Director Pharmaceutical Evaluation & Registration (PE&R) concluded the workshop with his closing remarks on appreciating the active participation from all regulatory entities and QCLs across Pakistan. The certificates of participation were distributed among the participants at the end of session.

Rapid Alert: Falsified Sildenafil Citrate 100mg Tablets identified in the market

Asad Ullah Recall Alerts May 8, 2023May 16, 2023Alert, DRAP, QA & LT, QualityDefects, RapidAlert

Download

Rapid Alert

Falsified and Unregistered Sildenafil Citrate 100mg Tablets

DRAP Alert No	N^oI/S/02-23-18
Action Date	3^rd May 2023
Target Audience	1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and, Medical Stores 3. General Public
Problem Statement	Federal Inspector of Drugs Karachi seized a sample of an unregistered product “Viagra 100mg Tablet” from the market and also sent the samples to Central Drug Laboratory, Karachi for testing/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (i) 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	Viagra 100mg Tablets Mfg. Date: 03-2021 Exp. date: 03-2025	Sildenafil Citrate	19990544AG	Ms. Brooklyn, Ne.

* Tablet Viagra sold in the black market is not registered with DRAP, hence considered Spurious /Falsified and unregistered, and its Quality, Safety, and Efficacy are not ascertained, hence its consumption may be harmful.

Risk Statement:	Consequences of the use of unregistered, Spurious/ Falsified Drugs include but are not limited to the followings: · Falsified/Spurious drugs may contain toxic ingredients which are manufactured under unhygienic conditions without the proper inspection and approval of the product, which are highly injurious to human health. · Poor-quality medicines compromise the treatment of diseases and may intensify the existing condition.
Action Initiated	The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.
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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.

← Previous