Safety Alert of Risk of Sacroiliitis with Isotretinoin
Guidance Document for Submission of Applications on Form-5F (CTD) for Registration of Pharmaceutical Drug Products for Human Use
136. Rapid Alert – Spurious Tablet EFASTON – Batch # 51062
Rapid Alert
SPURIOUS (TABLET EFASTON 10mg) – Batch # 51062
| DRAP Alert No | No I/S/01-26-136 |
| Action Date | 23 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 Statement | The 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 Statement | Efaston® (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 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 Professionals | Healthcare 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 Consumers | Consumers 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. |
Training session for medical device stakeholders on the MDMC licensing and product registration portal
134. Recall Alert (Class-II) – CDL declared substandard – Henafim Paediatric Suspension
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.
| DRAP Alert No | No II/S/01-26-134 |
| Action Date | 14 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 Name | Batch | Manufacturers | Remarks |
| 1. | Henafim Paediatric Suspension Each 5ml contains: Paracetamol …. 120mg Chlorphineramine Maleate …. 1mg (Reg. # 078545) | 558 | M/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 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. |
135. Rapid Alert – Unregistered OMNIVISC 2% (Substandard & Misbranded)
Rapid Alert
Unregistered, Substandard /Misbranded – OMNIVISC 2%
| DRAP Alert No | No I/S/01-26-135 |
| Action Date | 21 January , 2026 |
| Target Audience | 1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores |
| Problem Statement | Drug 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 Name | Batch No. | Manufacturer | Remarks |
| 1. | Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL | OMV190171 | (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. |
| 2 | Omnivisc 2% (HPMC) Ophthalmic Solution USP, 5 mL | OMV191171 | (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 Statement | The 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 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 | Healthcare 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 Consumers | Consumers 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. |
Decisions of the 115th and 116th Meetings of the Medical Device Board (MDB) held on 01 & 07 Jan 2026 (Manual Applications – Part II)
Minutes of the 6th Meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC)
133. Recall Alert (Class-I) – Tablet BP-NORM (Substandard & Adulterated)
Recall Alert
DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.
| DRAP Alert No | No I/S/01-26-133 |
| Action Date | 21 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 Name | Batch No. | Manufacturers | Remarks |
| 1. | Tablet. BP-NORM Atenolol … 50mg (Reg. # 071447) | 5968P485 | M/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 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. |