Month: February 2022
Area Requirement for Manufacturing Site for Alternative Medicines and Health Products
Drug Product Recall: Disprin Tablets (Batch # 2BN1080) by M/s. Reckitt Benckiser Pakistan Ltd, Karachi
DRAP launched Online Import Export System (OIES) to regulate import and export of therapeutics goods across the country.
In line with the vision of Prime Minister of Pakistan, and to facilitate the therapeutic goods’ industry for ease of business and provision of conducive environment for compliance to regulatory requirement, Drug Regulatory Authority of Pakistan (DRAP) has introduced an electronic application management system which will enable applicants and regulators to communicate electronically for management of import and export information of therapeutic goods. Online Import / Export Application System (OIES) is accessible through the official website of DRAP under E-Services. A guidance document on operational features of the online Import / Export Application System is also available to assist applicants for submission of information. This system will also enable applicants to view / maintain all submissions related to import & export to DRAP through an individualized dashboard for each user.
Drug Product Recall: Cefim DS 200mg/5ml Suspension (Batch#141865) by M/S Hilton Pharma (Pvt.) Ltd., Karachi
Drug Product Recall: Cefim 100mg/5ml Suspension (Batch#134774) , M/S Hilton Pharma (Pvt.) Ltd., Karachi
CDL Karachi has declared the batch No. 134774 of product “Cefim Suspension” as substandard and spurious.