1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Government of Punjab has reported that the sample of the following drug product has been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.
Purported to be manufactured by Hansel Pharmaceuticals (Pvt.) Ltd., Lahore
Declared Spurious, API not identified; assay 0%; fails identification test
Risk Statement
Use of this spurious injectable product may result in complete therapeutic failure and may expose patients to serious health risks, particularly in conditions requiring anabolic steroid therapy.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Drug Testing Laboratory (DTL), Government of Punjab has reported that the samples of the following drug products have been declared as “Spurious” under Section 3(z-b)(i) of the Drugs Act, 1976.
S#
Product Name
Batch
Manufacturer
Remarks
1
Dropha Tablets Each Tablet contains Dydrogesterone ……. 10mg
DRP-0011
Purported to be manufactured under M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, Karachi
(Dydrogesterone) is commonly prescribed for gynecological and obstetric indications. Use of a spurious product containing no active ingredient may result in therapeutic failure, leading to serious clinical consequences, including unmanaged hormonal conditions, pregnancy-related complications, and risk to maternal health.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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.
Recall of Specified Batches of Curosurf (Poractant alfa) Intratracheal Suspension on Account of Microbial Contamination (Class II Recall)
DRAP Alert No
No II/S/04-26-19
Action Date
14 April, 2026.
Target Audience
· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue
The Drug Regulatory Authority of Pakistan (DRAP) has received a Rapid Alert notification from the World Health Organization (WHO) regarding quality defect (Class II recall) of Curosurf (Poractant alfa) Intratracheal Suspension (80 mg/ml) manufactured by M/s Chiesi Farmaceutici S.p.A., Italy. The defect has been identified by the State Institute for Drug Control (SUKL), Czech Republic, indicating a risk of microbial contamination in certain batches of the products. Review of distribution data confirms that the following batches have been supplied to Pakistan:
Therapeutic Goods (s) Affected: –
S#
Name of product
Batch #
Manufacturer details
Remarks
1.
Curosurf 1.5ml Vial(Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 120mg/1.5ml
Curosurf 3ml Vial(Pulmonary surfactant of Natural origin 80mg / ml – Corresponding to approx 74.0 of total phospholipids) Each vial contains: Poractant Alfa 240mg/3 ml
1226985
Risk Statement:
Curosurf (Poractant alfa) is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants. The identified defect relates to microbial contamination, which poses a serious sterility risk due to intratracheal administration. Use of affected batches may result in severe infections, treatment complications, and potentially life-threatening outcomes, particularly in premature neonates who are highly vulnerable. The most likely affected population includes neonates admitted in Neonatal Intensive Care Units (NICUs) requiring surfactant therapy. Healthcare professionals are advised to immediately discontinue use of affected batches and ensure availability of safe alternatives.
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 Veterinarian
This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners
Farmers and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.
1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement
Atco Laboratories Limited, Karachi has intimated identification of suspected spurious batches of its registered products, namely Terbiderm Forte Tablet (Terbinafine 250 mg) and Glantrim Ophthalmic Solution, during market surveillance. Analytical testing conducted by the manufacturer’s Quality Control Laboratory confirmed that the Active Pharmaceutical Ingredient (API) content was not present in the tested samples. Comparative evaluation with retained samples further revealed significant discrepancies in packaging, labeling, and physical characteristics. Based on these findings, the following batches of these drug products have been found to be Spurious.
S #
Name of Product
Batch
Purported to be Manufactured by
Remarks
1
Terbiderm Forte Tablet (Terbinafine 250 mg) (Reg # 053367)
Terbinafine is indicated for treatment of fungal infections, while Glantrim Ophthalmic Solution is used in management of glaucoma and ocular hypertension. Laboratory findings confirm absence of active ingredients, resulting in complete therapeutic failure. Use of the mentioned batches of these drug products may lead to disease progression, treatment failure, and serious complications, particularly risk of vision-related complications in case of ophthalmic product. The public health risk is assessed as high.
Action Initiated
The Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
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 the mentioned batches of these drug 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.
Note:- “comments may be forwarded to the Authority either through email at director.legal∂dra.gov.pk or by post to the official postal address of DRAP within fourteen days of the publication of the Notification.”
