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Year: 2024

Submission of Replies against Deferred Form-5/5A Applications of Human Drugs

Ijaz Mustafa General

In its 339th Meeting, convened from August 6-8, 2024, the Registration Board has issued a directive that all applicants should submit clarifications or replies for their deferred Form-5/5A applications by December 31, 2024. It is imperative to note that any submissions received after this deadline will not be considered, and will be be classified as disposed of, necessitating the submission of a new application on Form 5F.

This initiative is designed to enhance the efficiency of the registration process and ensure strict adherence to current regulatory standards. This directive is in accordance with the implementation of the Form 5F (CTD) format for drug registration, effective March 31, 2019, which requires that all applications be evaluated based on the updated Form 5F data guidelines.

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Caution Regarding Fake Emails Impersonating DRAP Officials

Yasir Mahmood General ,

It has come to our attention that some individuals are receiving fraudulent emails impersonating officials of the Drug Regulatory Authority of Pakistan (DRAP). Please be advised that all official DRAP correspondence comes from email addresses ending with @dra.gov.pk.

Stakeholders and the public are urged to remain vigilant and verify the authenticity of any communication. If in doubt, kindly contact DRAP through official channels.

Thank you for your attention to this matter.

Drug Regulatory Authority of Pakistan

Switch over from Web Based One Customs (WEBOC) to Pakistan Single Window (PSW) for submission and issuance of all types Drug Import Licenses (DILs) and issuance of electronic release orders through PSW’s Single Declaration (SD) system.

Ijaz Mustafa General

We are pleased to announce that, effective October 8, 2024, the clearance of commercial imports (HC type) of all commodities (Drugs) requiring a Drug Import License (DIL) mandated by the Drug Regulatory Authority of Pakistan (DRAP) being imported at customs stations of Peshawar and Islamabad are being switched from WeBOC to PSW system. All the DRAP-related commodities (Drugs) will be completely shifted over to PSW, and clearance will be subject to the electronic issuance of a Release Order by DRAP through the filing of a Single Declaration (SD) on all customs stations located in Peshawar and Islamabad.

All traders/importers engaged in the import of these commodities falling under the purview of DRAP are informed to file Single Declaration (Imports) through PSW System for issuance of electronic Release Order from DRAP and Customs clearance of their import consignments w.e.f. 08th October 2024.

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Rapid Alert: Drug Product; Suspected Falsified Rabies Vacine

Asad Ullah Recall Alerts
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Rapid Alert

DRAP Alert NoNo I/S/09-24-37
Action Date27th September 2024
Target Audience·         Regulatory Field Force.
·         Healthcare Professionals – Physicians, Pharmacists, and Nurses.
·         Hospitals, Clinics, Pharmacies and other Healthcare Institutions
·         General Public.
Problem StatementDRAP has received information about the presence of a suspected rabies vaccine in the supply chain. The product is not registered by DRAP and may be a falsified product.
Product NameBatch/Lot No.Stated ManufacturerMfg. dateExp. date
Rabies Vaccine, Human IP
(SURE RAB)  
(unregistered)		RO10821M/s Bio-Med Private Limited,
C-96, SITE No. 1, B.S. Rd. Indi, AREA, Ghaziabad
(U.P.) – 201009,INDIA.		10-202310-2026
Threat to Public HealthRabies vaccine is used for the prevention of rabies in children and adults resulting from dog bite. Falsified rabies vaccines pose a significant threat to public health as the safety and efficacy of such products cannot be established therefore failing to provide adequate immunity, leaving individuals vulnerable to rabies infection
Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. 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 to halt the distribution/supply of this product. Information related to the supplier of this product 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 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 Products; Recall of 11 Substandard Batches from the Market

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/09-24-36
Action Date26th September 2024.
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 The Directorate of Drugs Control (DDC) in Punjab has identified the following substandard batches of pharmaceutical products based on analyzing their samples from Drug Testing Laboratories, revealing out-of-specification results.
The Details of affected product batches are tabulated below:-

Therapeutic Good(s) Affected: –

Human Use Products

S#Product NameCompositionBatch No.Manufactured byTest Results
01Painsa 75mg/3ml Injection
Reg. No. 077269		Diclofenac SodiumPA415M/s. Wimits Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
02Metroin Infusion 100ml  

Reg.No 071279		Metronidazole 500mg/100mlMT24-058, MT24-060, MT24-061, MT24-062, MT24-063M/s. Saturn Pharmaceuticals (Pvt.) Ltd., Lahore. Substandard

Veterinary Use Products

Sr.Product NameCompositionBatch No.
Manufactured by		Test Results
03Oxytocin Injection

Reg.No 019928		Oxytocin
10 I.U/ml		V6-143M/s. ISIS Pharmaceutical & Chemical Works, Karachi.Substandard
04Selmec Injection 50ml

Reg.No. 071087		Ivermectin 20mg/mlSN-113M/s. Selmore Pharmaceuticals (Pvt.) Ltd., Lahore.Substandard
05Rasomycin-10 Injection

Reg.No. 003791		Oxytetracyclin 100mg/mlVJ. 1340M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
06Rasomycin LA 20% Injection

Reg.No. 003791		Oxytetracyclin 200mg/mlVG. 1626M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
07Rasomycin-5 Injection

Reg.No 003791		Oxytetracyclin 50mg/mlVK. 1467M/s. Star Laboratories (Pvt.) Ltd., Lahore.Adulterated
Action Initiated–The manufacturers have been directed to immediately recall the defective batches of their products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of the abovementioned product. The remaining stock should be quarantined and returned to the supplier/ company.

-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, by phone at +92 51 9255969, or by Email at gsms∂dra.gov.pk.

-The regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased market surveillance 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 products 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.