Year: 2026
Notification (S.R.O. 515(l)/2026)
Invitation to bid (For the supply of chemicals, glassware, reference standards/USP standards/CRMs and columns)
Decisions of the 123rd meeting of the Medical Devices Board (MDB) held on 25-02-2026 (Manual Applications Part-II)
Tender for Provision of Record Management Services
Draft Therapeutic Goods (Import and Export) Rules 2026 (For Comments)
Note:- “comments may be forwarded to the Authority either through email at director.legal∂dra.gov.pk or by post to the official postal address of DRAP within fourteen days of the publication of the Notification.”
17. Volunatry Recall. Osilex-D (Glitz Pharma)
Recall Alert
| VOLUNTARY RECALL OF DRUG PRODUCT |
| DRAP Alert No | No II/V/03-26-14 |
| Action Date | 11 March, 2026. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | M/s Glitz Pharma, 205, Muhammadi Plaza, College Road, Rawalpindi – Pakistan (Plant: Plot No. 265, Industrial Triangle Kahuta Road, Islamabad) has informed the Drug Regulatory Authority of Pakistan (DRAP) regarding voluntary recall of the following drug product due to quality defect observed during ongoing stability studies. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch | Manufacturers | Mfg. & exp. date |
| 1. | Osilex D Manufacturing Date: August 2025 Expiry Date: July 2027. | T22125 | M/s Glitz Pharma Plot No 265 Industrial Triangle Kahuta Road Islamabad. (DML # 000571) | The firm has initiated recall of the above-mentioned batch after observing changes in physical appearance during stability studies which do not comply with approved quality specifications. |
| Risk Statement: | The affected batch of Osilex D Tablet exhibited changes in physical appearance during stability studies. Although no adverse event has been reported, deviation from approved quality specifications may potentially compromise product quality, safety, and efficacy. The recall is being conducted as a precautionary measure to safeguard public health and ensure regulatory compliance. | |
| Action Initiated | The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market. | |
| Advice for Healthcare Professionals | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link. Further information of reporting problems to DRAP is available on this link. | |
| Advice for Pharmacies/Medical stores: – | All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). | |
| 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. |
Stakeholders are invited to comment on Draft Post-registration variation guidelines for pharmaceutical and biological products (3rd Edition)
This is the draft for 3rd Edition of the Post-registration variation guidleines. This document is intended to provide information for submission of post registration variation application by the registrations / marketing authorization holders of drug products and includes categories of variations and the required documentation & procedures for submission of an application for a particular variation. Keeping in view of the decisions of the Registration Board, the following changes have been incorporated in this edition:
- Changes in Labelling & Prescribing Information and/or SmPC
- Standardization of formulation in accordance with the innovator’s product/ approvals of reference regulatory authorities/ pharmacopeias.
- Change in packaging design/color scheme of packaging material
- Grant of additional pack size for locally manufactured products (non-essential drugs) (except injectables and ophthalmic preparations)
- Change in registration Status from finished import to bulk labelled primary pack import local secondary packing.
- Change in registration status from finished import to ready-to-fill bulk/ bulk concentrate import local processing.
Call for Stakeholder Input
DRAP invites healthcare professionals, pharmaceutical manufacturers, researchers, policymakers, and the public to review the draft guideline and provide constructive feedback. Your expertise will ensure the framework is robust, transparent, and aligned with international best practices.
Submit Feedback: Email comments to sanakanwal2010∂gmail.com by 26th March, 2026.
Deadline for Feedback: 26th March, 2026
16. Recall Alert (Human) – CDL Karachi declared substandard products.
Recall Alert
| DRUG PRODUCT DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI. |
| DRAP Alert No | No II/S/03-26-14 |
| Action Date | 11 March, 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. | Santochlor ophthalmic Solution Chloramphenicol 5mg/ml (Reg # 021605) | D-330 | M/s Sante (Pvt) Ltd. A/97 S.I.T.E Super Highway Karachi. (DML # 000702) | The sample has been declared “substandard” on the basis of assay test. |
| 2. | Ciprozat Tablet Ciprofloxacin 500mg/ per tablet (Reg # 031221) | 2421 | M/s Hizat Pharmaceutical Industry. 170 Industrial Estate Jamrud Road Peshawar. (DML # 000315) | The sample has been declared “substandard” on the basis of dissolution test. |
| Risk Statement: | The above-mentioned batches of Santochlor Ophthalmic Solution (Chloramphenicol 5mg/ml) and Ciprozat Tablet (Ciprofloxacin 500mg) have been declared Substandard based on failure of assay and dissolution tests respectively. Substandard ophthalmic chloramphenicol may result in inadequate treatment of bacterial eye infections, leading to prolonged infection, worsening inflammation, or potential complications affecting vision. Substandard ciprofloxacin tablets may cause reduced therapeutic response in bacterial infections, increasing the risk of treatment failure, antimicrobial resistance, and disease progression. The most likely affected population includes patients suffering from eye infections and individuals being treated for bacterial infections, particularly those requiring timely and effective antibiotic therapy. Healthcare professionals are advised to discontinue use of the affected batches and ensure availability of quality-assured alternatives. |
| 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. |
15. Recall Alert (Veterinary) – DTLs Punjab declared substandard products.
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/03-26-15 |
| Action Date | 11 March, 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 Micrise-1% 10 ml Each ml contains: Ivermectin …. 10 mg (Reg # 111206) | MR-087 | M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934) | The sample is declared as “sub-standard” on the basis of Assay Test and Chromatographic Purity Test |
| 2. | Injection Wormec 1% 10 ml Each ml contains: Ivermectin …. 10 mg (Reg # 020802) | V00845 | M/s Nawan Laboratories (Pvt) Ltd. 136 Sector 15 Korangi Industrial Area Karachi. (DML # 000442) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test. |
| Risk Statement: | The above-mentioned batches of Ivermectin Injection 1% (10 ml) have been declared Sub-Standard based on failure of Assay and Chromatographic Purity tests, indicating possible incorrect potency and/or presence of unacceptable impurities. Substandard veterinary ivermectin may lead to treatment failure in parasitic infections, persistent worm burden, development of drug resistance, and potential toxicity in animals. The most likely affected population includes livestock (cattle, sheep, goats) and other animals treated for internal and external parasites, particularly in farm settings where mass deworming is practiced. |
| 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. |