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)
Syllabus:
Directive on the security of online portals and engagement with authorized personnel/consultants
The Drug Regulatory Authority of Pakistan (DRAP) is striving to fulfill its mission of ensuring the availability of safe, effective, and quality therapeutic goods through a transparent and efficient regulatory framework. In line with the Government’s “Digital Pakistan” vision, DRAP has successfully digitized all regulatory functions related to pharmaceuticals, biological drugs, and medical devices, streamlining processes to foster an environment conducive to the ease of doing business. The Alternative Medicine & Health Products online system will also be launched soon.
To facilitate stakeholders in navigating these digital advancements, the following key initiatives and directives are brought to your immediate attention:
- Comprehensive video tutorials and step-by-step user guides are available on the official DRAP website to assist stakeholders/applicants in navigating these online portals.
- To ensure clarity and regulatory predictability, DRAP has published detailed guidelines for various regulatory processes, ensuring that requirements are transparent and accessible to all.
- A Case Management System has been launched to streamline regulatory correspondence and planning of regulatory interactions, when required.
While DRAP has made every effort to simplify the regulatory interface, it has been observed that some stakeholders continue to rely on third-party consultancy services for processing their applications. DRAP strongly discourages the direct engagement of unauthorized consultants. Stakeholders are advised that the use of intermediaries can lead to complications regarding accountability and data integrity.
To safeguard your legitimate rights and business interests, please adhere to the following security protocols:
- Ensure that all login credentials for DRAP’s online platforms are kept secure and under the direct control of your authorized company personnel.
- Strictly limit or restrict access of outside consultants to your digital portals to prevent unauthorized data manipulation or privacy breaches.
- Regularly visit DRAP’s official website for regulatory updates and notifications.
The digitization of DRAP is intended to empower stakeholders by providing a direct and transparent link to the regulator. DRAP is actively collaborating with trade associations and health partners to conduct specialized training sessions. These programs are designed to promote a culture of compliance across the industry and to gather direct user feedback to continuously refine and improve the online systems. DRAP remains your partner in progress, committed to continuous improvement through direct engagement and technological innovation.
Circular for Implementation Plan of PIC/S Guide to Good Manufacturing Practice for Medicinal Products Part-l
Minutes of 355th Meeting of Registration Board
Minutes of 354th Meeting of Registration Board
24. Recall Alert – Veterinary Drug Products declared Substandard by DTL Punjab
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/04-26-24 |
| 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 | Provincial 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 Details | Batch | Manufacturer details | Remarks |
| 1 | Injection MAC ROLD 1% 10ml Ivermectin: 10 mg/ml (Reg # 106804) | YI-152 | M/s Haarolds Pharmaceuticals (Pvt.) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921) | The sample is declared as “misbranded” as per Section 3(s)(vi) of The Drugs Act 1976 and “SUB-STANDARD” on the basis of Assay Test and Test for Related Substances. |
| Risk Statement: | The use of this substandard and misbranded veterinary ivermectin injection may lead to ineffective parasite control, development of drug resistance, and potential toxicity in animals due to incorrect potency and presence of impurities. This can adversely affect animal health, productivity, and may pose indirect risks to public health through the food chain. Livestock animals (cattle, sheep, goats) treated for parasitic infections, particularly in commercial farming settings, and farmers relying on effective deworming for animal health and productivity. |
| 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. |