Month: December 2025
Quota Allocation of Drug Substance for Product Development Studies
123. Recall Alert (Class-I) – Drug Products (Human) Substandard – Gligit Baltistan.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.
| DRAP Alert No | No II/S/12-25-123 |
| Action Date | 18 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drugs, Water & Food Testing Laboratory, Government of Gilgit Baltistan informed that the samples of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Remarks | Manufacturers |
| 1. | Glitric Tablets Each prolonged release tablet contains: Glyceryl Trinitrate …………… 2.6 mg (Reg. # 119607) | 25H261 & 25H262 | Batch # 25H261 The sample has been declared “Substandard” on the basis of Assay & Dissolution Test. Batch # 25H262 The sample has been declared “Substandard” on the basis of Assay Test. | M/s Linta Pharmaceuticals. Plot # 03, Street S-5, National Industrial Zone, Rawat, Islamabad. (DML # 000810) |
| 2. | Betahist Tablet Each Tablet contains: Betahistine DiHydrochloride … 16 mg (Reg. 091595) | 25H249 | The sample has been declared “Substandard” on the basis of Physical description. (Tablets found with softening, cracking, rough orange peel texture, easily break, and become powder when pressed with fingers). |
| Risk Statement: | The identified quality defects in Glyceryl Trinitrate prolonged-release tablets (Glitric 2.6 mg), including failure of assay and dissolution, and the severe physical instability observed in Betahistine tablets (Betahist 16 mg) may result in therapeutic failure and unpredictable dosing. Glyceryl Trinitrate is a critical cardiovascular medicine with a sensitive therapeutic window, and inadequate dosing may precipitate angina or serious ischemic events, particularlyinelderly patients and those with ischemic heart disease. Betahistine defects may lead to loss of efficacy in patients suffering from vertigo and balance disorders. The public most likely to be affected includes chronic cardiovascular and vestibular disorder patients, especially the elderly and comorbid populations. |
| 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. |
122. Rapid Alert – Falsified / Spurious / Unregistered Tramadol Tablets.
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED TRAMADOL TABLETS
| DRAP Alert No | No I/S/12-25-122 |
| Action Date | 18 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 samples of following drug products sent by National Task Force (NTF), have been declared ‘spurious/falsified/unregistered’ as under: |
The product identification details are as under: –
| S# | Product Name | Batch No. | Manufacturer | Remarks |
| 1. | Tablet TAMOL-X 225 mg Each tablet contains: Tramadol HCl …. 225 mg | TM004 | M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825) | ‘Unregistered (Falsified)’ Tablet Tamol X 225 mg is not registered with DRAP. |
| 2. | Tramaking 250 mg Tablets Each tablet contains: Tramadol HCl …. 250 mg | TRD379 | M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825) | ‘Unregistered (Falsified)’ Tablet Tramaking 250mg is not registered with DRAP. |
| 3. | Namadol – 225 mg Tablets Each tablet contains: Tramadol HCl … 225 mg | TRD2025 | M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825) | ‘Spurious & Falsified (unregistered)’ Tablet Namadol 225mg is not registered with DRAP & does not contain the Active Pharmaceutical Ingredient (Tramadol HCl) as claimed on the label claim. |
| Risk Statement | The above-mentioned products, namely Tablet TAMOL-X 225 mg, Tramaking 250 mg Tablets, and Namadol 225 mg Tablets, have been identified as unregistered, spurious, and falsified therapeutic goods and are therefore not evaluated or approved by DRAP for safety, quality, or efficacy. Laboratory findings indicate that Namadol 225 mg Tablets do not contain the declared Active Pharmaceutical Ingredient (Tramadol HCl), while the remaining products are unregistered and illegally manufactured/marketed, posing a serious public-health risk. Consumption of such products may result in therapeutic failure, uncontrolled pain, withdrawal symptoms, unexpected toxicity, overdose, respiratory depression, or other serious adverse drug reactions, particularly due to uncertain composition, strength, and quality. The population most likely to be affected includes patients suffering from moderate to severe pain, individuals with chronic pain conditions, post-operative patients, and persons misusing or dependent on opioid analgesics, as well as elderly patients and those with comorbidities (hepatic, renal, or respiratory disorders). Healthcare professionals, pharmacies, and distributors handling these products are also at risk of legal and regulatory consequences. Immediate removal of the products from the supply chain is essential to prevent potential harm to public health. |
| 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. |
120. Recall Alert (Class-I) – Drug Products (Human) Substandard by DTL Punjab.
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.
| DRAP Alert No | No II/S/12-25-120 |
| Action Date | 16 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories, Punjab informed that the sample of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876) | DX029, DX039, DX040, DX041, DX033, DX031, DX045, DX042, DX044, DX046, DX047, DX048, DX049, DX050, DX051, DX053, DX052, DX060, DX059. | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The sample is declared as “Adulterated” as per section 3 (iv) of The Drugs Act 1976. |
| 2. | Injection Ame-Pin Each 2ml contains: Tramadol HCI… 100 mg (Reg. # 065943) | TD-042 | M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604) | The sample “Sub-Standard” on the basis “Particulate contamination” visible particles” as per BP. |
| Risk Statement: | The use of Injection Neudex (Dexamethasone) declared as adulterated, and Injection Ame-Pin (Tramadol) found sub-standard due to visible particulate contamination, poses a serious risk to patient safety, particularly among critically ill patients, surgical patients, emergency care recipients, elderly individuals, and those with compromised immunity. Administration of adulterated or contaminated injectable products may result in treatment failure, severe allergic reactions, embolism, infections, organ toxicity, or even fatal outcomes. Healthcare professionals and patients are therefore urged to immediately discontinue use of the affected batches to prevent any potential adverse health consequences. |
| 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. |
119. Recall Alert (Class-II) – Drug Products (Human) Substandard -DTL Punjab
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.
| DRAP Alert No | No II/S/12-25-119 |
| Action Date | 16 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories, Punjab informed that the sample of below mentioned drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Tablet Ascard 75 mg Each Enteric Coated Tablet Contains: Acetylsalicylic Acid (Aspirin BP) ….75mg (Reg. # 016600) | AR034L | M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000537) | The sample is declared as “sub-standard” on the basis of Test for Related Substances (Impurity C: Salicylic Acid). |
| 2. | Sachet PREVASMA Each Sachet Contains: Montelukast Sodium USP eq. to Montelukast …………………………….. 4.0 mg (Reg. # 074838) | 033 | M/s MKB Pharmaceuticals (Pvt) Ltd. 66-Hayatabad Industrial Estate Jamrud Road Peshawar. (DML # 000617) | The sample is declared as “sub-standard” on the basis of Test for Impurities i.e. Organic Impurities. |
| Risk Statement: | The use of the above-mentioned sub-standard therapeutic goods may pose a potential risk to public health, particularly among patients requiring regular and long-term therapy. Tablet Ascard 75 mg is commonly prescribed for cardio-protective purposes, especially in patients with ischemic heart disease, history of stroke, hypertension, and diabetes, where the presence of excess Salicylic Acid impurity may increase the risk of gastro-intestinal irritation, bleeding tendencies, and hypersensitivity reactions. Similarly, Sachet PREVASMA (Montelukast 4 mg) is primarily used in children and patients with asthma and allergic conditions, and the presence of organic impurities beyond specified limits may lead to reduced therapeutic efficacy, unexpected adverse reactions, or worsening of respiratory symptoms. Therefore, children, elderly patients, cardiac patients, asthmatics, and individuals on chronic medication represent the population most likely to be affected, and immediate regulatory action including recall, market monitoring, and patient safety communication is warranted to mitigate potential health risks. |
| 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. |
Decisions of the 110th Meeting of the Medical Device Board (MDB) held on 26-11-2025 & 27-11-2025 (Manual Applications – Part II)
Tender for Conducting a National Pharmaceutical Pricing Survey
121. Rapid Alert- Falsified SIMULECT (Basiliximab) for injection identified in the WHO African and European Regions.
Rapid Alert
CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS
| DRAP Alert No | No I/S/12-25-121 |
| Action Date | 10 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 | This WHO Medical Product Alert refers to falsified SIMULECT 20mg (basiliximab) for injection – batch number SFYD2. The falsified product has been detected in Rwanda, Bulgaria, and Türkiye, and was reported to WHO in December 2024 and November 2025. In Pakistan, SIMULECT 20 mg (Reg. # 025218) is supplied as a powder vial with or without a water for injection (solvent) ampoule for reconstitution, by Novartis Pharma (Pakistan) Limited (Importer), and is administered either as an intravenous infusion or as an injection, usually in a hospital setting. The genuine manufacturer also identified several visual discrepancies on the packaging & Batch number. The falsified product shows batch number SFYD2, which is not a valid batch number for SIMULECT. A sample of the falsified product was forensically tested by the genuine manufacturer and found to contain no active pharmaceutical ingredients; instead, it contained ascorbic acid. Any SIMULECT product with batch number SFYD2 should be considered falsified. The falsified product label displays the National Drug Code NDC 0078-0331-84. While the National Drug Code (NDC) is a unique identifier for medicines marketed in the United States of America, the label contains other discrepancies compared to genuine SIMULECT packaging. · The genuine product lists the ingredient dose in milligrams using “mg,” while the falsified product uses “MG”. · The genuine product lists the country of manufacture as “Product of France” while the falsified product lists the country of manufacture as “Product of Switzerland or France”. |
| Risk Statement | TThis falsified product should be considered unsafe, and its use may pose severe and potentially life-threatening risks to patients, including: • Therapeutic failure leading to organ rejection. • Inadequate or excessive immune suppression, increasing vulnerability to opportunistic infections. • Life-threatening allergic or toxic reactions from unknown or harmful ingredients. • Risk of infection from unsterile injections. It is important to detect and remove any falsified SIMULECT from circulation to prevent harm to patients. |
| 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. |
118. Recall Alert (Class-I) – DTLs Punjab declared Substandard products (Human)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB
| DRAP Alert No | No I/S/12-25-118 |
| Action Date | 08 December, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories Punjab informed that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | AOTILAS 120 ML SUSPENSION Each mL Contains: Domperidone ………. 1 mg (Reg. # 112505) | S8B05 | M/s Astellas Pharmaceutical (Pvt) Ltd. 15-C Industrial Estate Hayatabad Peshawar. (DML # 000677) | The sample is “Substandard” as it contains the impurity “Diethylene Glycol” above the permissible limit. |
| 2. | Injection. Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876) | DX032, DX034, DX035 & DX036 | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The sample is declared as “Adulterated” as per section 3 (iv) of The Drugs Act 1976. |
| Risk Statement: | The substandard quality of AOTILAS 120 mL Suspension containing Diethylene Glycol (DEG) above the permissible limit, and the adulterated status of Neudex Injection (Dexamethasone) pose a severe and immediate threat to public health. The populations most likely to be affected include infants, children, elderly patients, pregnant women, and critically ill patients who are prescribed these medicines for gastrointestinal disorders, inflammation, allergic reactions, and emergency medical conditions. Exposure to Diethylene Glycol is highly toxic and may cause acute kidney failure, neurological damage, metabolic acidosis, and death, especially in pediatric patients. The use of an adulterated injectable corticosteroid significantly increases the risk of systemic toxicity, treatment failure, severe infections, shock, and fatal outcomes. Continued availability or use of these products may lead to rapid deterioration of patient health, mass poisoning incidents, irreversible organ damage, and loss of life, representing a highest-level public health emergency requiring immediate recall and strict regulatory enforcement. |
| 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. |