2025 – Drug Regulatory Authority of Pakistan

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED DUPHALAC SYRUP 100 ML

DRAP Alert No	N^o I/S/12-25-127
Action Date	30 December, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	The Drug Testing Laboratory (DTL), Punjab has informed the Drug Regulatory Authority of Pakistan that a sample of the below-mentioned drug product has been declared spurious upon analysis. The contract manufacturer, M/s Highnoon Laboratories Ltd., 17.5 Km Multan Road, Lahore (DML No. 000155), for the genuine registration/marketing authorization holder, M/s Abbott Laboratories (Pakistan) Ltd., Karachi, of Duphalac Syrup, has confirmed that the impugned batch was not manufactured by them and is therefore spurious. The product is purported to be manufactured by M/s Abbott Laboratories Co., Canada, and has been declared “Unregistered (Falsified)”.

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Syrup Duphalac 100ml Each 100 ml contains: Lactulose ……. 66.7 g	251986	Purported to be manufactured by M/s Abbott Laboratories Co. Canada.	The sample has been declared “Spurious” as per Section 3(zb)(i) & (ii) of the Drugs Act 1976.

Risk Statement	The circulation of a spurious and unregistered Duphalac Syrup (Lactulose) poses a significant risk to public health, particularly to pediatric patients, elderly individuals, and patients with chronic constipation or hepatic disorders, who are the primary users of this product. As the impugned batch was not manufactured by the authorized contract manufacturer and lacks regulatory oversight, there is a heightened risk of incorrect composition, contamination, reduced or excessive strength, and therapeutic failure, which may lead to worsening of disease, electrolyte imbalance, dehydration, or other serious adverse health outcomes.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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.

126. Recall Alert (Class-I) – Injection Cara-Doba 5ml – Substandard

Salateen Philip Recall Alerts December 30, 2025December 30, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.

DRAP Alert No	N^oII/S/12-25-126
Action Date	30 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection Cara-Doba 5ml Each 5ml Ampoule contains: Dobutamine HCl eq. to Dobutamine …. 250mg (Reg. # 054987)	24J009 & 25E004	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	Batch # 24J009 The sample has been declared Sub-Standard, on the basis of Physical Description and Visible Particulates. Batch # 25E004 The Color has been changed to dark brown with crystallization. (Physical Description and Visible Particulates).

Risk Statement:	The administration of sub-standard injectable Dobutamine with visible particulates, discoloration, and crystallization poses a serious and immediate risk to patient safety, particularly for critically ill patients, cardiac patients, and those receiving intensive or emergency care, where Dobutamine is commonly used for acute cardiac support. Such quality defects may lead to embolism, phlebitis, systemic infections, reduced therapeutic efficacy, or unpredictable pharmacological response, potentially resulting in treatment failure, hemodynamic instability, or life-threatening complications, thereby warranting urgent regulatory intervention.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has 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 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, 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/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.

125. Rapid Alert – Crackdown Against Falsified / Spurious/ Unregistered Aphrodisiac Drug Products.

Salateen Philip Recall Alerts December 30, 2025December 30, 2025RapidAlert

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Rapid Alert

Crackdown Against Falsified / Spurious/ Unregistered Aphrodisiac Drug Products

DRAP Alert No	N^o I/S/12-25-125
Action Date	30 December, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Central Drugs Laboratory (CDL), Karachi informed that the following drug product have been declared ‘spurious/falsified/unregistered’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification d

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	KNIGHT RIDER TABLET Contains Sildenafil Citrate	NIL	Made in UK	‘Unregistered (Falsified)’ drug product
2.	Dapox 60mg Tablet Contains Dapoxetine HCl	8288	M/s Cheap USA Pharmacy	‘Unregistered (Falsified)’ drug product

etails are as under: –

Risk Statement	The above-mentioned products have been declared Unregistered and Falsified as they are not confirmed to have been manufactured, imported, or distributed through any supply chain duly authorized or licensed by the Drug Regulatory Authority of Pakistan (DRAP) or the respective Provincial Governments. The origin, composition, and quality of these products remain unverified; therefore, their safety and efficacy cannot be assured. The unregulated presence of such aphrodisiac preparations containing Sildenafil Citrate and Dapoxetine HCl poses significant public health risks, including potential cardiovascular complications, neurological adverse effects, and misuse in vulnerable populations. The continued sale or use of these products outside the legal distribution framework represents a serious threat to consumer safety and undermines regulatory control mechanisms intended to ensure the availability of genuine and quality-assured therapeutic goods.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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.

124. Rapid Alert – Crackdown Against Unlicensed / Unauthorized Manufacturers.

Salateen Philip Recall Alerts December 30, 2025December 30, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/12-25-124
Action Date	30 December, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Central Drugs Laboratory, Karachi informed that the following purported products have been declared “unregistered” and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer (unlicensed)	Remarks
1.	Tablet Taskeen-e-Dard	091	M/s LEO HEALTH CARE & RESEARCH LABORATORIES KARACHI.	The sample has been declared “Unregistered / Falsified” as it contains Diclofenac Sodium, an active pharmaceutical ingredient, while the manufacturing facility is not registered with DRAP.
2.	Tablet Pain Nil	01	M/S HAKEEM PURANA DAWAKHANA KARACHI	The sample has been declared “Unregistered / Falsified” as it contains Diclofenac Sodium, an active pharmaceutical ingredient, while the manufacturing facility is not registered with DRAP.

Risk Statement	The above-mentioned purported products have been confirmed as falsified, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels. The presence of Diclofenac Sodium in unregistered and falsified tablet products manufactured by unlicensed facilities poses a serious public health risk, particularly to low-income patients, elderly individuals, and persons with chronic pain conditions who may use such products without medical supervision. As Diclofenac is associated with gastrointestinal bleeding, renal impairment, and cardiovascular risks, the absence of regulatory oversight, quality control, and proper labeling significantly increases the likelihood of overdose, adverse drug reactions, and treatment failure, thereby endangering public safety.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified 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 suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. 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 Consumers	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 the above mentioned 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.

Requirements for Grant of Drug Manufacturing License by the Way of Basic and Semi-Basic Manufacturing for Blood/Plasma Establishments

Yasir Mahmood Licensing and Inspections December 29, 2025December 29, 2025

The Drug Regulatory Authority of Pakistan has revised and updated the requirements for Establishment of pharmaceutical unit and also developed new guidance annexure VI (A) for requirements for grant of Drug manufacturing license by way of Basic and semi basic manufacturing for Blood and plasma Establishments in line with DRAP Act 2012, Drug Act 1976 and rules framed there under.
These requirements serve a reference document for the applicants intended to apply for grant of Drug Manufacturing Licenses for Blood/Plasma Establishments by way of basic/semi-basic manufacturing. The requirements aim to facilitate harmonization with international regulatory requirements, enabling Pakistani plasma establishments to meet the stringent standards required by international fractionators and foreign regulatory authorities.
These requirements are applicable to a broad range of entities and activities within the plasma supply chain. All Plasma Establishments that hold Drug Manufacturing Licenses and engage in the collection, testing, processing, storage, or distribution of plasma intended for fractionation must comply with these requirements. This also includes blood establishments that collect whole blood from which plasma is recovered, and plasma warehouses and distribution facilities that handle plasma after collection.
Accordingly, the 3rd version of guidance document titled “ESTABLISHMENT OF PHARMACEUTICAL UNIT AND POST LICENSE CHANGES “along with newly drafted Annexure VI ( A) REQUIREMENTS FOR GRANT OF DRUG MANUFACTURING LICENSE BY THE WAY OF BASIC & SEMI-BASIC MANUFACTURING FOR BLOOD/ PLASMA ESTABLISHMENTs are uploaded on the official website of DRAP on the 29th of December , 2025 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to akbar.ali∂dra.pk and drapakbar∂gmail.com or can be posted at the mailing address, Director, Division of Drug Licensing , Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.

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