Decisions of 65th Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 65th 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.

Combating Substandard and Falsified Products : Public Alert Reporting

Islamabad, 4th April, 2024 —  The Drug Regulatory Authority of Pakistan (DRAP) is aiming for effective communication and public awareness on combating Substandard and Falsified (SF) products to protect public health; hence the frequency of public alerts is likely to increase, and media communication of key messages represents an important mediator of the behaviour of individuals in response to public health countermeasures. Since culpability is commonly used as a tool to influence public behaviour, it is important to keep the public informed while avoiding panic due to misinformation/disinformation,

In a recent event, DRAP issued an alert No I/S/03-24-15 regarding the presence of falsified Risek 40mg injections in the market. This alert was intended to caution healthcare providers and the public about the presence of counterfeit products in the market and to procure the product from authorized sources only. Unfortunately, some misinterpretations of the alert have led to widespread misinformation.

DRAP is committed to ensuring the safety and well-being of the public and calls for responsible reporting. We are working diligently to remove the falsified products from the market and to hold those responsible, accountable.

Rapid Alert: Drug Product; Falsified Risek 40mg Injection identified in the Market

Rapid Alert

DRAP Alert NoNo I/S/03-24-15
Action Date26th March 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 StatementThe Federal Inspector of Drugs Karachi identified suspected samples of Risek 40mg Injection co-packed with Sterile Water for Injection from the market and sent them to the Central Drug Laboratory (CDL), Karachi for testing/analysis. The Federal Government Analyst, CDL has declared the sample as falsified/spurious under section 3(z-b) (ii) of the Drugs Act 1976.  The samples were also declared as substandard for not complying with the assay test.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductCompositionBatch DetailsPurported to be Manufactured by
(as per label)
Risek 40mg injection
 
Reg No. 024170
OmeprazoleBatch No.059PA5

Mfg. Date: 11-22
Exp. Date:  05-25
Getz Pharma Pvt Limited Karachi.
(as per label)

During the investigation when the suspected samples were compared with the original product of Getz Pharma, Karachi, significant variations were revealed in various segments of the samples. Please click for details.

Threat to Public HealthSpurious 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 InitiatedThe Regulatory Field Force has been instructed to increase surveillance activities at health facilities (hospitals), as well as markets, and confiscate any falsified products. All pharmacists and chemists working at distributions and pharmacies should immediately check their stock and stop supplying any suspected products that differ from the original. Such 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 ConsumersConsumers 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; Barpon 100mg/5mL Suspension (Batch # 202) by M/s. JASM Pharmaceutical, KPK

Recall Alert

DRAP Alert NoNo II/S/03-24-13
Action Date13th March 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 etc.
Problem / Issue Federal Government Analyst, CDL Karachi vide test report No. KQ-11-23-000155 dated 12-12-2023 has declared the subject mentioned product namely Barpon 100mg/5mL (Batch No. 202) as of substandard quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Barpon 100mg/5mL Suspension
 
Reg No.114785
IbuprofenBatch No.  202
 
Mfg Dt: 07-2023
Exp.Dt: 06-2025
M/s. JASM Pharmaceutical
(Pvt.) Ltd., Risalpur.
Risk Statement:Barpon Infusion contains Ibuprofen, a medicine used to treat mild to moderate pain and fever (high temperature). Administration of substandard products may lead to complications, as well as an increased risk of failure of therapy. The age-profile of patients is important and young patients especially are at risk.
Action Initiated-The manufacturer has been directed to immediately recall the defective batch of above mentioned product from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to 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 DRAP and Provincial Health Departments are also informed regarding the matter and are directed to 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 gsmsdra.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 ProfessionalsDRAP 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: Contaminated Propylene Glycol Identified and Confiscated

Rapid Alert

DRAP Alert NoNo  II/S/03-24-14
Action Date8th March 2024
Target Audience1.Therapeutic Goods industry
2. Manufactures of Oral liquid preparations
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi vide test/analysis vide No. RM-2-24-000179 and No. RM-2-24-000180 dated 01-03-2024 declared the sample of Propylene Glycol (Raw material) sent to CDL Karachi by Federal Inspector of Drugs Islamabad-I as of substandard quality due to contamination of DEG and EG. ( Click for details)

Two samples were collected from separate containers which were labelled as Propylene Glycol, Batch# C815L44R41 and Batch# C815L44R52, purportedly manufactured by Dow Chemical Pacific (Singapore) Private Limited. However, upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false.

It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
Risk Statement:Diethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action Initiated: –The Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch of finished product has been manufactured using the same batch of the propylene glycol that has been identified as contaminated, the retained sample should be immediately analysed and these finished products should be recalled from local and export markets if found contaminated.


2       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.

3.     Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

4.    Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

5.     Follow Guidelines: Adhere to the pharmacopeial 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 ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

-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 ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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.

Rapid Alert: Substandard Propylene Glycol (Batch # G01821UG) claimed to be manufactured by SK Picoglobal Korea.

Rapid Alert

DRAP Alert NoNo  I/S/03-24-12
Action Date8th March 2024
Target Audience1. Regulatory Field Force.
2. Therapeutic Goods industry
3. Manufactures of Oral liquid preparations
4. Healthcare professionals
Problem StatementMs. MKB Pharmaceuticals (Pvt) Ltd., Peshawar sent the sample of Propylene Glycol (PG) to Central Drugs Laboratory Karachi for test/analysis that was used as a solvent in the manufacturing of oral liquid preparations. The batch was claimed to be manufactured by SK picoglobal Co. Ltd. Korea. Analysis of the sample by the Central Drug Laboratory, Karachi detected unacceptable level of Ethylene Glycol.

The product identification details are as under: –

Therapeutic Good Affected:-

ProductBatch NoMfg DateExp. DatePurported to be Manufactured by
(as per label)
Remarks
Propylene Glycol
(Raw Material)
G01821UG12-08-202311-08-2025SK Picoglobal Co. Ltd. Korea.The sample is declared substandard
for unacceptable levels of Ethylene Glycol (0.4671%).
Risk StatementPropylene Glycol (PG) contaminated with Ethylene Glycol (EG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
Action InitiatedThe manufacturer has been instructed to recall finished products that were manufactured using the contaminated lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol of Ms. SK picoglobal Co. Ltd. Korea and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batch was manufactured using the same lot (YF01200730) of propylene glycol 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 any other lot of propylene glycol of SK picoglobal Co. Ltd. Korea should be held. 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.      Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

5.      Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

6.      Follow Guidelines: Adhere to the pharmacopeial 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 ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

-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 ConsumersConsumers should stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately 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.

Switching Over to Pakistan Single Window (PSW) for Drug Import License and Import Release of Donations Medicines

The Drug Regulatory Authority of Pakistan has switched over submission, processing and release order of Drug Import License and Import release of donation medicines on Pakistan Single Window (PSW).

Drug Import License (DIL)

All Drug Manufacturing License (DML) holder companies are enabled o submit applications for all type of Drug Import License form March 05, 2024 through PSW System..

Import of Donations

All registered International Non-Governmental Organizations (INGOs), Donor Partners, Local NGOs/Hospitals, and Government Projects involved in donated drugs are required to submit applications for import clearance on through PSW System from February 29, 2024

Rapid Alert: Contaminated Propylene Glycol Identified and Confiscated

Rapid Alert

DRAP Alert NoNo I/S/02-24-11
Action Date07th March 2024
Target Audience1. Therapeutic Goods industry
2. Manufactures of Oral liquid preparations
Problem StatementFederal Government Analyst, Central Drugs Laboratory Karachi has identified contaminated Propylene Glycol (Raw material) by detecting highly unacceptable levels of Ethylene Glycol in the seven different samples of Propylene Glycol which were sent to the laboratory by the Federal Inspector of Drugs Lahore. 

Out of the seven samples collected from different containers, six of them had labels indicating that they were from Batch#C856H85R55 and were labelled as manufactured by Dow Chemicals, Thailand. However, one of them (sample 7) had a label indicating that it was from batch F8900L8PPD6 and was labelled as manufactured by Dow Chemicals, Germany. Upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false. The analysis reveals that these samples were highly contaminated.

It is important to note that on January 11, 2024, a rapid alert was also issued for contaminated Propylene Glycol with batch number C815N3OR41, which was labelled as being manufactured by Dow Chemicals, Thailand. However, Dow Chemicals, Thailand has clarified to DRAP that it was not their original product and was falsified by some miscreants. The company also analyzed the retained samples of the original product and shared an analysis report, which showed that it was in compliance with the required specifications.
Risk StatementDiethylene glycol (DEG) and Ethylene Glycol (EG) contamination in Propylene Glycol (PG) can lead to serious health risks when used in oral liquid preparations. Upon ingestion, these chemicals (EG and DEG) are converted into toxic metabolites which can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences.
Action TakenThe Regulatory Field Force has taken possession of contaminated raw materials and commenced an investigation to trace the supply chain of these containers. Manufacturers of therapeutic goods have been prohibited from using propylene glycol without testing for the presence of EG/DEG levels. These materials should only be obtained from authorized suppliers of original manufacturers with thorough verification of the integrity of the supply chain and originality of the product. The Regulatory Field Force has also been directed to ensure compliance and seize any such raw materials or products found to be contaminated in the market.
Advice for Therapeutic Goods Manufacturers: – Manufacturers of therapeutic goods are required to follow these instructions:
 
1.      Recall Products: If any batches were produced using the same lots of Propylene Glycol that have been identified as contaminated, it is crucial to test both the raw materials and finished products for contamination immediately. If any contamination is found, the affected products should be recalled promptly from the local and export markets.

2.      Hold Other Batches: All finished products manufactured from propylene glycol 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 of 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.

DRAP’s 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.

Guidelines on Risk Based Sampling and Testing of Drugs; Comments invited on draft Document

At the Drug Regulatory Authority of Pakistan (DRAP), our commitment to public health and safety drives our actions. We recognize that ensuring the quality and efficacy of pharmaceutical products is paramount. To achieve this, we emphasize risk-based sampling and testing strategies for assuring Safety and Quality of therapeutic goods to safeguard public health.

These Guidelines reflect a structured approach on regulatory oversight by allocating resources efficiently by prioritizing sampling collection, testing, and surveillance based on risk levels. This ensures that critical aspects of drug quality receive the attention at first and enable focusing regulatory efforts to high-risk areas. The draft guidelines are prepared based on the recommendation of ICH Q9 (Quality Risk Management), WHO working document QAS/15.630, and USP-PQM guidance document for implementing risk-based post-marketing quality surveillance in low and middle-income countries.

DRAP invites all interested parties and relevant stakeholders to provide their comments and inputs on the draft guideline. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to mehwish.tanveerdra.gov.pk with a copy to mahvash.ansaridra.gov.pk or can be posted at the following mailing address: Assistant Director (QC-II), Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.

DRAP appreciates your participation and contribution to this consultation process.