2025 – Drug Regulatory Authority of Pakistan

Rapid Alert : Unregistered Supply of Lucentis (Ranibizumab) 10mg/Ml Solution For Injection Purportedly Manufactured By M/s. Novartis Pharma Stein Ag, Switzerland.

Muhammad Ayub Naveed Recall Alerts January 2, 2025January 6, 2025

Rapid Alert

DRAP Alert No	N^oI/S/01-25-04
Action Date	2nd January, 2025
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments · Healthcare Professionals (Physicians, Pharmacists & Nurses) · General Public
Problem Statement	The firm M/s Novartis Pharma (Pakistan) Ltd, Karachi, has notified DRAP, regarding the supply of unregistered Lucentis Solution for Injection in the market across Pakistan. The firm has confirmed that they do not market any product under the name of Lucentis in Pakistan. Details of unregistered product are as under:

S#	Product Name	Composition	Batch No.	Manufactured by (as per label claim)	Lab Test Results
1	LUCENTIS Solution for Injection, 10mg/ml (For Intravitreal Injection only)	(Ranibizumab)	SKVJ1	M/s Novartis Pharma Stein AG, Stein, Switzerland. -For Novartis Pharma AG, Basle,Switzerland	Spurious

Risk Statement:	Ranibizumab is a humanized monoclonal antibody fragment produced by recombinant DNA technology used in the treatment of Age-Related Macular Degeneration (AMD). The unregistered supply of LUCENTIS Solution for Injection (Ranibizumab) in the market poses several risks, such as risks of contamination, incorrect formulation, or improper storage, leading to adverse reactions such as eye infections, retinal detachment, or even vision loss.
Action Initiated	The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the mentioned 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 product should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product from the circulation.
Advice for Healthcare Professionals	DRAP 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 at this link. Any adverse events or quality problems experienced with the use of these products should be reported to the 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 Consumer	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 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: Recall of Substandard Cefradin Capsules Batch No. 3591 Manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar.

Muhammad Ayub Naveed Recall Alerts January 2, 2025January 2, 2025

Recall Alert

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DRAP Alert No	N^oI/S/01-25-03
Action Date	2nd January, 2025.
Target Audience	– National Regulatory Field Force of DRAP and Provincial Drug Control Departments. – Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	The Federal Inspector of Drugs, Peshawar collected the samples of Cefradin Capsules and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 3591 of the said product, manufactured by M/s Aries Pharmaceuticals (Pvt.) Ltd, Peshawar, as of Substandard quality.DDCP PV Lahore has informed DRAP regarding the recall of the following batches of the mentioned products:

Therapeutic Good(s) Affected: –

Sr.No.	Product Names	Composition	Manufactured by	Test Results
1.	Cefradin Capsule Reg. No. 036991	Cefradine (250mg/Capsule) Batch No. 3591 Mfg date: 05/24 Expiry date: 05/26	M/s. Aries Pharmaceuticals (Pvt.) Ltd., 1-W, Industrial Estate, Hayatabad, Peshawar.	Substandard

Risk Statement:	The cefradine capsules have been identified as substandard due to deviations in weight variation, which could impact their efficacy, safety, and quality. If the weight of the capsules is not within the prescribed limits, there is a risk of inaccurate dosing. As a result, patients may not receive the correct amount of medication, which could lead to therapeutic failure, side effects, or the development of resistance.
Action Initiated	-The manufacturer has been directed to immediately recall the defective batch of product from the market. The field force under the administrative control of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of the presence and removal of the mentioned batches from the market. – 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 distributors 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 gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).–
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions, pharmacies, and 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 the product bearing the affected batch number(s). They should 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 PRODUCTS

Muhammad Ayub Naveed Recall Alerts January 2, 2025January 6, 2025

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Rapid Alert

DRAP Alert No	N^oI/S/01-25-01
Action Date	2nd January, 2025
Target Audience	1· National Regulatory Field Force of DRAP and Provincial Drug Control Departments 2· Healthcare Professionals (Physicians, Pharmacists & Nurses) 3. General Public
Problem Statement	Directorate of Drugs Control (DDC) Punjab has informed DRAP that samples various products have been identified as spurious (falsified). Details of test reports are as under:

The product identification details are as under:

Therapeutic goods affected:

Product	Batch No*	Mfg Date	Exp. Date	Manufacturer Name (as per label)	Remarks
Injection Penbiotic (Procaine Penicillin 1500000IU, Benzyl Penicillin 500000IU, Streptomycin Sulphate 5g) Reg# 0221448	V044B23	–	–	Purported to be manufactured by Nawan Laboratories, Karachi	Substandard & Spurious
Orthoplast Plaster of Paris bandage 10cm x 2.7cm Reg# MDME-0000149	03E24	–	–	Purported to be manufactured by Cotton Craft (Pvt.) Ltd., Lahore	Spurious
Suspension Carfen 90ml (Ibuprofen 100mg/5ml) Reg# 066500	CN-035	–	–	Purported to be manufactured by Well care Pharmaceuticals Sargodha	Spurious & Misbranded
Novidat tablet 500,g (Ciprofloxacin 500mg) Reg# 011837	FIM063	–	–	Purported to be manufactured by Sami Pharmaceuticals Karachi	Spurious

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 Initiated	The 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 Professionals	DRAP 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 at this link.
Advice for Consumer	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 these products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

Recall Alert: Recall Notices Issued by Provincial Drug Testing Laboratories

Muhammad Ayub Naveed Recall Alerts January 2, 2025January 2, 2025

Recall Alert

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DRAP Alert No	N^oI/S/01-25-02
Action Date	2nd January, 2025.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	DDCP PV Lahore has informed DRAP regarding recall of following batches of mentioned products:

Therapeutic Good(s) Affected: –

Sr.No.	Product Names	Composition	Manufactured by	Test Results
1.	Rasmic suspension 60ml Reg# 032405	(Mefenamic acid 50mg/5ml) Batch Number 4H099	Rasco Pharma 5.5Km, Raiwind road, Lahore	Contains Ethylene Glycol (EG) 2.19% that is above permissible limits.
2.	Resfyl cough syrup 60ml Reg# 057214	(Acefylling Piperzine 45mg, Diphenhydramine HCl 8mg) Batch Number 4A009	Rasco Pharma 5.5Km, Raiwind road, Lahore	Contains Ethylene Glycol (EG) 1.676 % that is above permissible limits
3.	Neocobal Injection 1ml Reg# 071447	(Mecobalamin 0.5mg/ml) Batch Number S-2214	Pulse Pharmaceuticals (Pvt.) Ltd., Sua Aasil, Raiwind road, Lahore	Substandard & Adulterated
4.	Safemed infusion 100ml Reg# 045824	(Metronidazole 500mg/100ml) Batch Number S-790	Ahad International Pharmaceuticals Ltd., 13Km Gomal University, Multan Road, Dera Ismail Khan	Substandard

Action Initiated	-The regulatory field force of DRAP and Provincial Drug Control departments have been requested to immediately conduct market surveys for detection and removal of these products from the market. –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 gsms∂dra.gov.pk.
Advice for Healthcare Professionals	DRAP request 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 products bearing the affected batch number(s). Consumers should contact their physician or healthcare provider(s) if they have experienced any problems that may be related to using this product. -All therapeutic products must be obtained from authorised licensed pharmacies/outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.