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136. Rapid Alert – Spurious Tablet EFASTON – Batch # 51062

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Rapid Alert

SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062

DRAP Alert NoNo I/S/01-26-136
Action Date23 January , 2026
Target Audience·         Regulatory Field Force of DRAP and Provincial Drug Control departments.
·         Healthcare Professionals (Gynecologists, Obstetricians, Pharmacists, Drug Distributors, Hospitals, Clinics,)
·         Consumers (General Public)
Problem StatementThe Drug Regulatory Authority of Pakistan has been informed through an official test/analysis report issued by the Drug Testing Laboratory, Government of the Punjab, that a sample of Efaston® (Dydrogesterone) 10 mg film-coated tablets (Reg. # 064835), Batch No. 51062, manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore (DML # 000064), has been declared SPURIOUS under Section 3(zb)(i) of the Drugs Act, 1976. Laboratory analysis confirmed that the declared active ingredient Dydrogesterone was not identified, and assay results showed 0.0 mg per tablet, despite a labeled strength of 10 mg.

The product identification details are as under: –

Risk StatementEfaston® (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 InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product.

·         The product has been declared SPURIOUS under the Drugs Act, 1976.
·         Provincial Drug Control Authorities and DRAP Field Forces have been directed to initiate immediate enforcement action, including market surveillance, seizure, and recall of the affected batch.
·         Further regulatory action is being taken in accordance with applicable laws.
Advice for Healthcare ProfessionalsHealthcare professionals are advised to immediately stop prescribing, dispensing, or using Efaston® (Dydrogesterone) 10 mg, Batch No. 51062. All available stock should be verified to ensure procurement from  authorized sources only, and any suspected presence of the affected batch in the supply chain must be promptly reported to DRAP or the concerned Provincial Drug Control Authorities. In addition, patients who may have received the said product should be appropriately identified, monitored, and managed clinically in accordance with standard medical practice.
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 ConsumersConsumers are advised not to use Efaston® (Dydrogesterone) 10 mg tablets of Batch No. 51062. If this product is currently being used, patients should immediately consult their healthcare provider for appropriate medical advice and further management. Medicines should only be purchased from licensed pharmacies, and any suspected or doubtful products should be promptly reported to the concerned drug inspectors or to DRAP.

134. Recall Alert (Class-II) – CDL declared substandard – Henafim Paediatric Suspension

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert NoNo II/S/01-26-134
Action Date14 January, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drug Laboratory (CDL) Karachi informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatchManufacturersRemarks
1.Henafim Paediatric Suspension
Each 5ml contains: Paracetamol …. 120mg Chlorphineramine Maleate …. 1mg
(Reg. # 078545)		558M/s Wisdom Pharmaceutical Industry. (DML # 000780) 78-A Industrial Estate Hayatabad Peshawar.The samples have been declared  “Sub-Standard” on the basis  of assay test of Paracetamol (71%) & Chlorpheniramine Maleate (81%).
Risk Statement:The use of Henafim Paediatric Suspension, Batch No. 558, poses a potential risk to public health, particularly affecting infants and children, who are the primary users of this product for the management of fever, pain, and allergic symptoms. The product has been declared sub-standard due to low assay results of Paracetamol (71%) and Chlorpheniramine Maleate (81%), which may lead to inadequate therapeutic response, resulting in poor fever control, persistent discomfort, and unresolved allergic symptoms. This may prompt caregivers to administer repeated or higher doses, increasing the risk of medication misuse. Although not adulterated, the reduced potency of this paediatric formulation may compromise effective treatment in a vulnerable population, warranting regulatory attention and appropriate risk management.
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 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 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.

    135. Rapid Alert – Unregistered OMNIVISC 2% (Substandard & Misbranded)

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    Rapid Alert

    Unregistered, Substandard /Misbranded – OMNIVISC 2%

    DRAP Alert NoNo I/S/01-26-135
    Action Date21 January , 2026
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementDrug Testing Laboratory, Punjab informed that samples of the below-mentioned products have been found unregistered and declared Substandard and Misbranded under the Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.

    The product identification details are as under: –

    S#Product NameBatch No.ManufacturerRemarks
    1.Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mLOMV190171(purported to be manufactured by)
    M/s Omni Lens Pvt. Ltd.,
    Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India    		The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to labeling discrepancies including mismatch of batch number on labels, absence of Pakistan Drug Registration Number, absence of Urdu instructions, and non-mentioning of maximum retail price.
    2Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mLOMV191171(purported to be manufactured by)
    M/s Omni Lens Pvt. Ltd.,
    Plot No. 17, Ambota, Sector-5, Parwanoo Distt. Solan (H.P.), India    		The sample has been declared Substandard on the basis of failed sterility test (Non-sterile) and Misbranded due to absence of Pakistan Drug Registration Number, incomplete labeling particulars including Urdu instructions and maximum retail price, in violation of Drugs Act, 1976 and Drugs (Labeling & Packing) Rules, 1986.
    Risk StatementThe use of Omnivisc 2% (HPMC) Ophthalmic Solution, Batches OMV190171 and OMV191171, poses a serious and vision-threatening public health risk due to failure of sterility testing, rendering the product non-sterile, and due to misbranding. Ophthalmic preparations are required to be sterile, and the use of a non-sterile eye product may lead to severe ocular infections, including conjunctivitis, keratitis, endophthalmitis, corneal ulceration, and potential irreversible loss of vision or blindness. The absence of proper labeling information, including DRAP’s Drug Registration Number and usage instructions in Urdu, increases the risk of misuse, inappropriate dosing, prolonged use, and delayed medical intervention. Patients undergoing eye surgery, those with corneal injuries, contact lens users, and immunocompromised individuals are at particularly high risk. Continued circulation and use of these batches may therefore result in serious ocular morbidity, warranting immediate regulatory action and strict removal from the supply chain.
    Action InitiatedThe 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 ProfessionalsHealthcare professionals, including ophthalmologists, general practitioners, pharmacists, and nursing staff, are advised to exercise heightened vigilance regarding the use and supply of Omnivisc 2% (HPMC) Ophthalmic Solution, Batch Nos. OMV190171 and OMV191171. They should immediately discontinue prescribing, dispensing, or administering these batches and ensure their removal from institutional and retail inventories. Patients who may have been exposed to these products should be clinically evaluated for signs of ocular infection or adverse reactions, particularly post-operative eye patients and contact lens users.
    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 ConsumersConsumers are strongly advised to immediately stop using Omnivisc 2% (HPMC) Ophthalmic Solution, particularly Batch Nos. OMV190171 and OMV191171, and to check product labels and batch numbers carefully. Any remaining stock should be isolated and returned to the point of purchase and not used further. Individuals who have already used these eye drops and experience symptoms such as eye redness, pain, discharge, blurred vision, sensitivity to light, or worsening of eye condition should seek immediate medical attention from an ophthalmologist. Patients who have recently undergone eye surgery, suffered eye trauma, or have underlying eye infections are at higher risk and should be especially vigilant. Consumers are also encouraged to report the product and any suspected adverse effects to the relevant health authority to help prevent further harm and protect public health.

    133. Recall Alert (Class-I) – Tablet BP-NORM (Substandard & Adulterated)

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    DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

    DRAP Alert NoNo I/S/01-26-133
    Action Date21 January, 2025.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Tablet. BP-NORM Atenolol … 50mg (Reg. # 071447)5968P485M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)The sample has been declared Substandard on the basis of failed assay of Atenolol, &Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (confirmed presence of an undeclared active ingredient i.e.  Ciprofloxacin HCl)
    Risk Statement:The use of BP-NORM (Atenolol 50 mg), Batch No. 5968P485, presents a serious risk to public health, particularly for patients with cardiovascular diseases such as hypertension, ischemic heart disease, arrhythmias, and the elderly who depend on consistent atenolol therapy. The product is substandard due to failed assay of atenolol, which may result in loss of therapeutic control, and is adulterated by the confirmed presence of an undeclared active ingredient, Ciprofloxacin HCl. This may expose patients to unintended antibiotic intake, leading to adverse reactions, drug interactions, and development of antimicrobial resistance, especially in vulnerable patients. Continued use of this batch may therefore cause significant harm, warranting immediate risk mitigation.
    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 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 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.

      Public Consultation: Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.

      Yasir Mahmood Drugs , ,

      The Drug Regulatory Authority of Pakistan (DRAP), Division of Biological Evaluation & Research, invites public comments on the draft “Guidance Document for Submission of Application on Form-5F (CTD) for Registration of Biological Products for Human Use – 2nd Edition.”

      This updated guidance aims to enhance clarity, align regulatory requirements with international standards, and introduce specific provisions for biosimilars, bulk/ready-to-fill biologicals, pharmacovigilance, stability, and comparability requirements. The document is intended to facilitate consistent, transparent, and efficient submission and review of registration applications for biological products.

      Stakeholders, including manufacturers, importers, healthcare professionals, academia, and the general public, are encouraged to review the draft and submit written comments, suggestions, or technical inputs at muneeb.cheema∂dra.gov.pk or muneebcheema∂hotmail.com within fifteen days of uploading of above document.

      Guidance-Document-Biological-Edition-2Download

      Invitation for Stakeholders’ Comments on Draft Amendments in the Bio-Study Rules, 2017

      Abdul Qadir Clinical Trials

      The Bio-Study Rules, 2017, notified vide S.R.O. 697(I)/2018 dated 05 June 2018, provide the regulatory framework for the conduct, oversight, and approval of clinical research in Pakistan. These Rules govern Clinical Trials and Bioavailability/Bioequivalence (BA/BE) studies, as well as the licensing and regulation of Clinical Trial Sites/Centres, Contract Research Organizations (CROs), BA/BE Study Centres, and Bioanalytical Laboratories.

      Since the promulgation of the Bio-Study Rules, 2017, significant advancements have taken place in international regulatory science, including revisions to the ICH-GCP guidelines, WHO Global Benchmarking Tool (WHO-GBT) recommendations, and regulatory practices adopted by reference regulatory authorities. In parallel, regulatory and operational experience gained during implementation of the Rules has highlighted the need to further streamline regulatory processes and reduce approval timelines, while ensuring continued compliance with ethical standards, subject safety, and data integrity.

      In view of the above, draft amendments are proposed to selected provisions of the Bio-Study Rules, 2017 with the following key objectives:

      i. Alignment with International Standards:

      • To harmonize the Rules with the latest ICH-GCP guidelines, WHO-GBT recommendations, and other internationally recognized regulatory standards.
      • To ensure consistency in terminology, definitions, and regulatory expectations in line with global best practices.

      ii. Reduction of Approval Timelines:

      • To enhance regulatory efficiency by minimizing procedural delays without compromising participant safety, scientific rigor, or ethical oversight.

      iii. Clarity in responsibilities of CSC/Chairman CSC:

      • To clearly designate and rationalize the roles, responsibilities, and decision-making powers of the Clinical Studies Committee (CSC) and the Director, Pharmacy Services / Chairman, CSC.
      • To empower the Director, Pharmacy Services / Chairman, CSC, to grant registration of Phase-IV Clinical Trials and BA/BE Studies, and to take regulatory decisions in clearly defined categories (including administrative matters, low-risk amendments, clarifications, and routine extensions), while reserving policy-level, complex, or high-risk matters for consideration and approval by the CSC.

      iv. Composition and Notification of the CSC:

      • To enhance the number of expert members in the CSC in order to optimally utilize multidisciplinary expertise for effective oversight of Clinical Trials and BA/BE studies.
      • Notification of the CSC by the Authority to ensure continuity and uninterrupted operational functioning of the Committee.

      The proposed amendments are expected to:

      • enhance regulatory predictability, clarity, and transparency;
      • reduce unnecessary administrative burden and approval timelines;
      • facilitate risk-based, proportionate, and efficient regulatory decision-making; and
      • strengthen Pakistan’s clinical research regulatory framework in alignment with international standards, thereby enhancing the country’s attractiveness for clinical research and innovation.

      Invitation for Comments

      All stakeholders, including sponsors, CROs, investigators, clinical trial sites, BA/BE study centres, ethics committees, academia, and other interested parties, are invited to review the draft amendments and submit their comments and suggestions or technical inputs at shafqat.hussain∂dra.gov.pk or akhtarabbas.khan∂yahoo.com within fifteen days of uploading of above document.

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      132. Recall Alert – Veterinary Products – Substandard by DTLs Punjab.

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      VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

      DRAP Alert NoNo I/S/01-26-132
      Action Date14 January, 2026.
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
      ·         Healthcare Professionals-Veterinarians
      ·         Farmers/consumers
      Problem / Issue Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product DetailsBatch #Manufacturer detailsRemarks
      1Injection, Actimec 10ml Ivermectin: 10 mg/ml (Reg # 034595)  AM-164M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)The sample is declared as “Sub-Standard” on the basis of Assay Test & Test for Related Substances.
      2MAC ROLD 1% 50ml Ivermectin: 10 mg/ml (Reg # 106810)YI-146M/s Haarlods Pharmaceuticals (Pvt) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921)The sample is declared as “Sub-Standard” on the basis of Assay Test, sterility test & Related Substances, while misbranded as per section 3(s)(vi) of the Drugs Act,1976. (Product does not contain Finished Drug Product Specifications)
      Risk Statement:The above veterinary ivermectin injectable products have been declared Sub-Standard due to failures in Assay, Related Substances, and Sterility tests, with one product also found misbranded for not meeting Finished Drug Product specifications. Use of such compromised injections may result in treatment failure, toxicity, infections, or adverse reactions in animals. The public most likely to be affected includes livestock farmers, dairy and meat producers, veterinarians, and animal handlers, as defective treatment can lead to animal illness, reduced productivity, economic losses, and potential downstream risks to milk and meat safety.
      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 VeterinarianThis 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 OwnersFarmers 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.