Falsified and Unregistered Sugar XL Capsules
|DRAP Alert No||No II/S/06-23-26|
|Action Date||19th June 2023|
|Target Audience||1. Regulatory Field Force|
2. Pharmacists and Chemists at Distribution, Pharmacies, and Medical Stores
3. General Public
|Problem Statement||Federal Inspector of Drugs Karachi took the sample of Sugar XL capsules and sent it to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Unregistered under the Drugs Act 1976. |
The product detail as under: –
Therapeutic Goods Affected:-
|Sr||Product Name||Batch #||Manufactured by||Remarks|
|1||Sugar XL Capsules|
Registration No.: Nil
Mfg. Date: Nil
Exp. date: use within 5 years
|Nil||M/s. Naz Homoeo Pharmacy, Karachi||Glibenclamide has been identified on an assay test (3.34mg) which is an allopathic drug and the sample is not registered with DRAP. Hence the sample is declared as “Un-registered Drug Product.”|
|Risk Statement:||The Claimed Product is Homoeopathic with some quantity of an allopathic ingredient Glibenclamide which is an oral hypoglycemic drug used to treat type 2 diabetes. As the product is unregistered this infers that the quality and safety attributes of the product are not accepted and approved by DRAP.|
Unregistered products containing Glibenclamide may cause adverse reactions including variation in blood glucose level which may lead to hypoglycemic conditions and the patient may get faint.
|Action Initiated||The Regulatory Field Force has been directed to increase surveillance throughout the supply chain to confiscate the 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 supplier of such products should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) to ensure the removal of this product.|
|Advice for Healthcare Professionals||-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of the above-mentioned products.|
-Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using 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 not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product 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.