DRAP Newsletter: Volume 03-Issue -II, November, 2024

The Drug Regulatory Authority of Pakistan (DRAP) has released a new issue of its quarterly newsletter, featuring several key updates and initiatives. DRAP has extended the scope of its Industry E-Reporting System for Adverse Drug Reactions to all registration holders, following a successful pilot project. The newsletter details recent actions on the promotion of clinical trials regulatory oversight, the stakeholder queries management system, and interprovincial coordination for the implementation of the Institutional Development Plan as per WHO recommendations. Additionally, the newsletter covers ongoing efforts to enhance public health and safety, including increased surveillance and regulatory actions to ensure the quality and safety of therapeutic goods.

Recall Alert: Recall of Nabaxo 10mg Film Coated Tablet Manufactured By M/s. Wenovo Pharmaceuticals, Taxila

Recall Alert

DRAP Alert NoNo I/S/11-24-48
Action Date15th November, 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 Senior Drug Inspector Islamabad has informed DRAP that batch number 263 of product namely Nabaxo 10mg film coated tablet has been declared as out of specifications by Drug Testing Laboratory Rawalpindi. Details of test reports are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Nabaxo 10mg film coated tablet
 (Reg. No. 087751)
RivaroxabanBatch No.263M/s. Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.
Risk Statement:Nabaxo tablet contains Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is used to treat deep vein thrombosis (blood clot, usually in the leg) and pulmonary embolism (blood clot in the lung) in adults. Substandard Rivaroxaban may lead to therapy failure in patients..
Action Initiated-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

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 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 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.

Rapid Alert: Crackdown Against Falsified/Illegal Products

Rapid Alert

DRAP Alert NoNo I/S/11-24-44
Action Date08th November, 2024
Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
·        General Public
Problem StatementThe Directorate of Drugs Control (DDC) Punjab has identified the following falsified products in the market. The samples of these products were also analyzed by provincial Drug Testing Laboratories in Punjab. The details of the identified products are as under:

S#Product NameCompositionBatch No.Manufactured by
(as per label claim)
Lab Test Results
1Ativan 2mg Tablets

Reg# 000084 
Lorazepam  17C7019Purported to be manufactured by Pfizer Pakistan Ltd, Karachi PakistanSpurious
2Klozen 5 mL Eye Drops

Reg# 040124
Tobramycin 0.3%, Dexamethasone 0.1%134Purported to be manufactured by Zinta Pharmaceutical Industry, Hayatabad, PeshawarSpurious
3S-Kyne 10mg Tablets

Reg# Nil
Dydrogesterone566Purported to be manufactured by Weather Folds pharmaceuticals, HattarSpurious & Misbranded
4Efaston 10mg Tablets

Reg#  31067
Dydrogesterone064835Purported to be Manufactured by Lahore Chemical & Pharmaceutical Works (Pvt) Ltd. LahoreSpurious
5Dydowen 10mg Tablets

Reg# 101507 
Dydrogesterone462Purported to be Manufactured by Weather Folds Pharmaceuticals, HattarSpurious
6Phenobar 30mg Tablets

Reg# 018862
PhenobarbitoneQA030Purported to be Manufactured by Star Laboratories (Pvt) Ltd (Human Healthcare Division) 23-KM Multan Road LahoreSpurious
7Duphaston 10mg Tablets

Reg# 006654
Dydrogesterone230672Purported to be Manufactured by Highnoon Laboratories Ltd. Marketed by Abbot Laboratories (Pakistan) Ltd, LahoreSpurious
Risk Statement:The impact of the use of falsified / Substandard products may lead to sub-optimal therapeutic effects whereas the use of a spurious product will lead to therapy failure or other associated problems.
Action InitiatedThe field force under the administrative control of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for the detection of the presence and removal of the mentioned batches from the market.
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link.

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 ConsumerConsumers 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 these 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: Recall of 04 Batches of Drug Products from Market

Rapid Alert

DRAP Alert NoNo I/S/11-24-45
Action Date08th November, 2024
Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments
·         Healthcare Professionals (Physicians, Pharmacists & Nurses)
·         Veterinary Healthcare Professionals
·  General Public
Problem StatementDirectorate of Drugs Control (DDC) Punjab has informed DRAP that samples following products have been analyzed by the provincial DTLs in Punjab and have been declared as substandard due to reasons mentioned below. The detail of affected products is as under:

S#Product NameCompositionBatch No.Manufactured byTest Results  
01Nida Infusion 100ml   Reg. No. 079630Metronidazole 500mg/100ml  23E317GMP Pharmaceuticals, 28-Km Sheikhupura Road,  Lahore.Substandard due to visible particles and Bacterial Endotoxin.
02Metroin Infusion 100ml   Reg. No. 071279Metronidazole 500mg/100ml  MT24-055Saturn Pharmaceuticals, 23-Km, thokar Raiwind Road, LahoreSubstandard due to presence of visible particles.
03Tylosan 20 Injection 100ml   Reg. No. 027416 (For vet use only)Tylosin base 200mg/ml  TS-259Sanna Laboratories, 1019-B, P.I.S.E., Sargodha road, Faisalabad.Substandard due to presence of visible particles.
04Melacam-10 injection 50ml   Reg. No. 063542 (For vet use only)Meloxicam 10mg/ml  23U-03Medi-vet (Pvt) Ltd., 17-Km Sheikhupura road, LahoreSubstandard on the basis of visible particles and extractable volume.
Threat to Public HealthAdministration of products containing visible solid particles and/or bacterial endotoxins through IV infusion may lead to complications, such venous thromboembolism, septic shock etc.  which may have fatal consequences.
Action InitiatedThe manufacturing companies of these products have been directed to immediately recall the affected batches of their products from the market. The Regulatory Field Force of DRAP and Provincial Drug Control Administrations have been directed to conduct market surveys for monitoring the recall process to ensure effective removal of defective batches from the market.

All Pharmacists and Chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should have increased surveillance in the market to ensure the effective recall of defective products(s).
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link.

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 ConsumerConsumers 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 these 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.

Recall Alert: Drug Products; Recall of 02 Substandard Batches Manufactured by M/s Gulf Pharmaceuticals from the Market

Recall Alert

DRAP Alert NoNo I/S/11-24-47
Action Date08th November, 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 Federal Government Analyst, CDL Karachi vide test report No. IP-9-24-000082 dated 15-10-2024 has declared the product namely Hi-Z syrup batch No. S1427 as of substandard quality. Details of CDL test report are as under:

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch DetailsManufactured by
Hi-Z syrup

(Reg. no. 075129)
20mg Elemental Zinc/5mlBatch No. S1427
 
Mfg Date: 07-2024
Exp Date: 06-20226
M/s. Gulf Pharmaceuticals, Islamabad
Ufen Oral Suspension

(Reg. No. 090274)
100mg Ibuprofen/5mlBatch No. S1451
 
Mfg Date: 08-2024
Exp Date: 07-20226
M/s. Gulf Pharmaceuticals, Islamabad
Risk Statement:Elemental Zinc syrups are used for reduction of duration and severity of diarrhea in children who are undernourished. Moreover, in patients suffering from Wilson disease, taking zinc by mouth improves symptoms by blocking how much copper is absorbed and increases how much copper the body releases. Sub-standard Zinc preparations may lead to complications in above mentioned conditions.
Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce fever, pain, and inflammation. Altered pH of an oral preparation may lead to gastrointestinal irritability, decreased stability and altered absorption of the product. These factors can ultimately lead to the therapy failure.
Action InitiatedThe manufacturer has been directed to immediately recall the defective batches of products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased 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 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 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.

Rapid Alert: Falsified Rhophylac 300mcg PFS, Human Anti-D Immunoglobulin Injection Identified in Market

Rapid Alert

DRAP Alert NoNo I/S/11-24-42
Action Date07th November, 2024
Target Audience·         National Regulatory Field Force.
·         Distribution, Pharmacies and Medical Stores
·         Healthcare Professionals – Physician, Pharmacist, Nurses
· Maternal and Child Health Centres
Problem StatementM/s Hakimsons Impex (Private) Ltd, Karachi, has notified DRAP regarding the presence of falsified Rhophylac 300mcg PFS in the market across Pakistan and also referred to letter No. 438/PDI-ZR/PWR, received from Provincial Inspector, Peshawar for verification of the sample. The packaging of the product shows two different batch numbers while barcode scan displays another batch number.
Product nameBatch/Lot No.Manufacturer Name
(as per label)
Mfg. dateExp. date
Rhophylac 300mcg PFS,
Human Anti-D Immunoglobulin
P100547971
P100644011
­­­­
Barcode Batch:
P100585096
M/s CSL Behring AG,
Wankdorfstrasse 10,
CH-3000 Bern 22,Switzerland.
10-202309-2026
Threat to Public HealthThe Anti-D immunoglobulin is a commercial biological antibody derived from human plasma that targets red blood cells (RBCs) positive for the Rh (D) antigen (also referred to as the D antigen). It is used to treat immune thrombocytopenic purpura (ITP) in patients with Rh-positive blood. Falsified Injectable products may cause severe and lethal adverse effects as the safety and quality attributes of the products are unknown
Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in market to confiscate the product. All pharmacists and chemist working at distributions and pharmacies are once again directed to not procure / supply unregistered drugs. The stocks of any suspected should be quarantined and supplier’s information should be provided to the Regulatory field force in order to ensure the removal of this product. Regulatory action will be taken against the persons involved in manufacturing/ storage /distribution/sale and use of any unregistered product
Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information of reporting problems to DRAP is available on this link.

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 ConsumerConsumers 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 these 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.