Month: May 2026
Expression of Interest (Hiring of Legal Consultant)
27. Rapid Alert – Falsified IMFINZI Injection & ENHERTU 100mg
Rapid Alert
| FALSIFIED IMFINZI® (Durvalumab) Injection 500mg/10ml & FALSIFIED ENHERTU® 100 mg |
| DRAP Alert No | No I/S/05-26-27 |
| Action Date | 06 May, 2026 |
| Target Audience | Regulatory Field Force of DRAP and Provincial Drug Control Departments Healthcare Professionals Hospitals and Oncology Centers Consumers |
| Problem Statement | AstraZeneca Pakistan has notified DRAP regarding identification of suspected batches of falsified oncology products namely IMFINZI® (Durvalumab) Injection 500mg/10ml and ENHERTU® 100 mg, following authenticity queries raised by healthcare professionals from hospitals in Lahore, Pakistan. Investigations conducted by AstraZeneca and the respective manufacturers confirmed that the identified batches were not manufactured by the genuine manufacturers and are considered falsified products. The affected products and batches are as follows: |
| S # | Name of Product | Batch | Expiry Date | Purported Manufacturer | Remarks |
| 1 | IMFINZI® (Durvalumab) Injection 500mg/10ml | ASCB | 08-2028 | AstraZeneca, Sweden | Falsified |
| 2 | ENHERTU® 100 mg | DK1262 | 02-2026 | Daiichi Sankyo / AstraZeneca | Falsified |
| Investigation Findings: | IMFINZI® 500mg/10ml AstraZeneca Sweden Operations confirmed that batch number ASCB was never issued/manufactured by the company. Comparative assessment revealed packaging inconsistencies resembling products referenced in WHO Medical Product Alert No. 5/2024 concerning falsified IMFINZI®. The product is intended for intravenous administration and poses a significant risk to patient safety. ENHERTU® 100 mg Manufacturer confirmed that batch number DK1262 has never been produced. Visual examination identified multiple discrepancies in labeling, serial numbering, printing alignment, barcode formatting, and carton artwork compared with genuine packs. Packaging characteristics were inconsistent with approved manufacturer specifications. |
| Risk Statement | IMFINZI® (Durvalumab) is an oncology medicine used in treatment of various cancers, while ENHERTU® is indicated for HER2-positive malignancies. Use of falsified oncology products may result in: Therapeutic failure Disease progression Delay in life-saving cancer treatment Serious adverse reactions due to unknown composition Potential fatal consequences Since both products are administered intravenously, the public health risk associated with these falsified products is assessed as critical/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. |
Strategic Plan 2026-2030
Strategic Plan sets ambitions for us to achieve our strategic objectives that contribute towards ensuring availability of quality assured, safe and effective Therapeutic Goods (TGs) in Pakistan. We are committed to maximize opportunities of treatment for patients for the people of Pakistan.
Our Strategic planning is based our vision of enhancing Access to Medicine for all by contributing to advancement in the health care regulations in Pakistan
Minutes of the 356th Meeting of Registration Board (07th April 2026)
Decisions of 124th,125th,126th,127th Meeting of Medical Devices Board
Decision of 124th MDB Meeting
Decision of 125th MDB Meeting
Decision of 126th MDB Meeting
Decision of 127th MDB Meeting
26. Recall Alert (Human) – DTLs Punjab declared Substandard products
Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES |
| DRAP Alert No | No I/S/05-26-26 |
| Action Date | 04 May, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Drug Testing Laboratories (DTL) Punjab 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. | ZYOCAIN Gel Lignocaine Hydrochloride B.P 2% w/v (Reg # 012523) | G026 | M/s PharmaWise Laba. (Pvt.) Ltd. Formerty Fakma Pharma 25-41 QA Induatrial Estate, Lahore-Pakistan (DML # 000182) | The Sample is declared as “sub-standard” on the basis of Sterility Test. |
| 2. | Neocobal Injection 0.5/mg Each ml contains: Mecobalamin……..0.5mg (Reg # 071447) | S-3050 | M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564) | The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified). |
| 3. | Injection Neutroline 10 ml Water for injection 10ml (Reg # 096698) | L387 | M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576) | The Sample is declared as “sub-standard” on the basis of Endotoxin Test. |
| 4. | CARA-DOBA Injection Each 5mL ampoule contains Dobutamine HCL USP Eq to Dobutamine …. 250mg (Reg # 054987) | 25E004 | M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629) | The sample is sub-standard, on the basis “Physical description” and “Visible particulate matter” tests. |
| 5. | PAINSTOP Injection Each 3ml contains Diclofenac Sodium B.P………75mg (Reg # 023730) | PS-090, PS-091 | M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342) | The above sample is sub-standard on the basis “Physical Description-Visible Particulate matter”. |
| 6. | SENSOCAIN Injection Each ml contains: Bupivacaine Hydrochloride …. 5 mg (Reg # 047396) | 172K25 | M/s Brookes Pharma Private Limited 58-59 Sector 15 Korangi Industrial Area Karachi. (DML # 000275) | The sample is sub-standard on the basis of Sterility test. |
| 7. | Tablet Kadin 2 mg Each Tablet Contains Tizanidine (as Hydrochloride) … 2mg (Reg # 033347) | 570 | M/s FYNK Pharmaceuticals. 19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494) | The sample is declared as “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Paracetamol identified). |
| 8. | Infusion. GEE-SOL NS 1000ML Sodium Chloride 0.9% w/v (Reg # 080418) | 26A025 | M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817) | The sample is sub-standard, on the basis of Bacterial Endotoxins Test. |
| 9. | Infusion. GEE-SOL RL 500ml (Compound Sodium Lactate) (Reg # 080910) | 25MM264 | M/s Gallop Water Sciences, 404-Sundar Industrial Estate, Lahore. (DML # 000817) | The sample is sub-standard, on the basis of Bacterial Endotoxins Test. |
| Risk Statement: | The identified products present moderate to high public health risk, particularly because several are parenteral (injectable/infusion) preparations, which bypass natural body defenses. Failures in sterility and endotoxin tests (e.g., ZYOCAIN Gel, SENSOCAIN, Neutroline, GEE-SOL infusions) can lead to sepsis, pyrogenic reactions, or life-threatening infections, especially in hospitalized, immunocompromised, pediatric, and ICU patients, who are the most vulnerable. Products with visible particulate matter (CARA-DOBA, PAINSTOP) pose risks of embolism, inflammation, and organ damage. Adulterated medicines (Neocobal, Kadin) indicate serious quality breaches, potentially causing therapeutic failure, unexpected pharmacological effects, or toxicity, undermining clinician trust and treatment outcomes. The most likely affected population includes inpatients in public/private hospitals, emergency care recipients, and patients receiving IV therapy, where such products are commonly used. Overall, these defects reflect critical lapses in manufacturing quality systems, with the highest risk concentrated in injectables and infusions used in acute care settings. |
| 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. |
25. Recall Alert (Human) – CDL Declared Substandard products.
Recall Alert
| DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI |
| DRAP Alert No | No I/S/05-26-24 |
| Action Date | 04 May, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory Karachi informed that the samples of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Remarks |
| 1. | WAFIN Injection Each ampule contains: – Water for Injection …. 5ml (Reg # 066643) | 250101 | M/s Crest Pharmaceuticals. 43 Idustrial Triangle Kahuta Road. Islamabad (DML # 000694) | The sample has been declared “substandard” on the basis of sterility test. |
| 2. | Maverick 500 mg Injection Each vial contains: – Ceftriaxone Sodium eq. to Ceftriaxone …. 500 mg (Reg # 065444) | 250901 | The sample has been declared “substandard” on the basis of sterility test. |
| Risk Statement: | Both WAFIN Injection (Water for Injection 5 ml) and Maverick 500 mg Injection (Ceftriaxone Sodium) have been declared substandard due to sterility failure, posing a serious risk of microbial contamination that may lead to severe infections, including septicemia. The most likely affected population includes hospitalized patients, especially those in ICUs, immunocompromised individuals, pediatric and elderly patients, and those receiving intravenous antibiotic therapy. |
| 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. |
Career Opportunities in Drug Regulatory Authority of Pakistan
Applications are invited from citizens of Pakistan fulfilling the given conditions for appointment against the following positions in the Drug Regulatory Authority of Pakistan (DRAP). The details of requisite qualification, experience, age limit and regional/provincial quota and application procedure are given in following document:- (Syllabus is also given at the end)