QualityDefects – Drug Regulatory Authority of Pakistan

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: Drug Product; Suspected increase in the availability of falsified versions of Glucagon-like Peptide-1 Receptor Agonist (GLP-1-RA) in the markets.

Asad Ullah Recall Alerts July 14, 2023July 17, 2023QA & LT, QualityDefects, SafetyAlert

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Rapid Alert

Suspected Falsified GLP-1 Receptor Agonists

DRAP Alert No	N^oI/S/07-23-24
Action Date	12^thJuly 2023
Target Audience	1. Regulatory Field Force 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics, etc. 3. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores 4. Patients, Caregivers, and General Public.
Problem Statement	Glucagon-like Peptide 1 Receptor Agonists (GLP-1-RA) are a class of Pharmaceuticals indicated to manage Diabetes type II. In Pakistan, only a single brand i.e. Ozempic injection manufactured by Novo Nordisk is registered by DRAP currently and is available as a “prescription only” product. It is reported that there has been a surge of online information promoting the use of GLP-1 RA products for weight loss which is its unapproved use and this situation is encouraging risky procurement behaviors. Numerous online sources offer GLP-1 RA products for sale without requiring a prescription. The quality and safety of these medical products manufactured and distributed in poorly controlled environments (such as the internet) cannot be assured. Due to the stated reasons, an increased demand resulting in a global shortage of these products has risen which may create environments favorable for the availability of falsified medical products. Reports have been received by WHO regarding an increase in the availability of falsified GLP-1-RA products in the past six months. It is possible that several versions of falsified GLP-1 RA – regardless of the brand name – are in circulation and available online.
Therapeutic Goods Affected:-	GLP-1 receptor agonists Products containing the following active ingredients:- -semaglutide -exenatide -liraglutide -dulaglutide -lixisenatide
Threat to Public Health	Falsified medical products have been known to lack efficacy and/or cause toxic reactions. They are neither approved nor controlled by DRAP and may have been produced in unhygienic conditions by unqualified personnel, contain unknown impurities, and are sometimes contaminated with bacteria. It is also possible that people living with diabetes type II who miss treatment due to the unavailability of GLP-1-RA products may also suffer clinical consequences.
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 the above-mentioned products. -Endocrinologists and Pharmacists present at healthcare facilities are requested to remain vigilant and inform patients of procuring medical products only from authorized channels. -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. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	To ensure authenticity, consumers should always obtain medical products from authorized licensed pharmacies /outlets. The authenticity of these products should be carefully checked and If the consumer has any doubt, advice must be sought from your pharmacist. In case a consumer has experienced any problem related to taking or using these drug product(s), they should cease the use of the product in question immediately and contact their Physician or Pharmacist and should also report the incident to the Drug Regulatory Authority of Pakistan.

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

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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.

Recall Alert: Drug Product; Spadix Injection (Batch# 570) by M/s. Tabros Pharma Karachi

Asad Ullah Recall Alerts April 20, 2023April 20, 2023DRAP, Patient Safety, QA & LT, QualityDefects, Recall

Recall Alert

DRAP Alert No	N^oI/S/20-23-21
Action Date	20^th April 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	Spadix 4mL Injection Composition: Phloroglucinol and Trimethylphloroglucinol Manufactured by: M/s. Tabros Pharma, (Pvt) Ltd., Karachi Batch No. 570
Problem / Issue	A video is circulating on social media regarding presence of a fly/insect in a liquid injection ampoule visible with naked eye, apparently seems to be having adulterated quality. The matter is still under investigation, however as a precautionary measure, to prevent any public health hazard, the alleged drug is being recalled from market.
Risk Statement	Drug Product contains fly/insect is of adulterated quality which may compromise the standard quality of drugs as not being sterile. The sterility is a basic quality attribute of all Injectable drugs. In this case such adulterated drug may initiate but not limited to following reaction in patients/users (i) Anaphylactic shock in patients which may lead to death of patient (ii) Skin rashes, itching, difficulty in breathing (iii) Sub optimal to no therapeutic effect for indicated medical treatment.
Action Initiated	-The manufacturing company / 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-of-Spadix-Injectin Download

Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

Asad Ullah Product Recalls, Recall Alerts, Safety Info February 21, 2023February 22, 2023Alert, DRAP, HOTC, Pharnacovigilance, QA & LT, QualityDefects, RapidAlert, Recall

Rapid Alert

Urgent Recall of Suspected Product for contamination of DEG / EG

DRAP Alert No	N^oI/S/02-23-8
Action Date	20^th 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	Medical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG). The details of suspected contaminated products are as under: –

Therapeutic Goods Affected:-

Sr	Product Name	Composition	Batch #	Manufactured by (as stated on label)
1	Bromgen Syp 100mL (Reg. Export Only)	Bromhexine HCl	L392	M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan
2	Kof Relief Syp 100mL (Reg, Export Only)	Chlorpheniramine Maleate Ammonium Chloride Sodium Citrate Menthol Green Banana Flavour	L394	-do-
3	Macofen Syp 100mL (Reg, Export Only)	Ibuprofen	L395	-do-
4	Vomitil Suspension 120mL (Reg, Export Only)	Domperidone	L400, L408, L414,	-do-
5	Asperfin Syp 60mL	Ketotifen	L401	-do
6	Davis Tonic Syrup (250mL, 120ml)	Vitamin B12 Vitamin B1 HCl Vitamin B2 Vitamin B6 Vitamin B3 Folic Acid Vitamin B5 Sodium Glycerophosphate Manganese Sulphate Ferric Ammonium Citrate	CS07, CS20, CS21, CS23, CS30, CS31, CS42, CS70, CS71, CS159	-do-
7	Zinc Syp 60mL	Zinc Sulphate Monohydrate	CS06, CS36, CS37, CS38, CS39, CS45, CS46, CS47, CS48, CS60, CS75, CS76, CS80, CS81, CS83, CS92, CS93	-do-

Action Initiated	The manufacturing company has been directed to immediately recall the suspected batches of these 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. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
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.

Davis-Rapid-Alert-of-Suspected-Contaminated-Products Download