|DRAP Alert No||NoI/S/07-22-18|
|Action Date||5th August, 2022|
|Target Audience||1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores|
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
3. General Public
|Product(s) Affected||Product Name: GLUCANTIME (Meglumine Antimoniate)|
Purported to be Manufactured By: TILLOTTS PHARMA AG, Switzerland
Batch No. 1119-078
Manufacturing Date: December-2019,
Expiry Date: November-2022
|Problem Statement||Suspected falsified GLUCANTIME (Meglumine Antimoniate) has been found in in the market of Quetta, Pakistan. World Health Organization, Regulation and Safety Unit, has informed regarding the availability of falsified GLUCANTIME (Meglumine Antimoniate) purported to be manufactured by the TILLOTTS PHARMA AG, Switzerland .|
The stated manufacturer listed on the falsified product TILLOTTS PHARMA AG, Switzerland has confirmed that they do NOT manufactured this product and neither they sub-contract the manufacturing, nor distribute these products anywhere in the world.
The following discrepancies can be identified in this falsified product:-
• The outer packaging has English and French labeling but contains visible spelling mistakes and questionable information
• Medicine – spelt “medecine”
• Use of a Gmail email address for manufacturers contact
• Statement that the product is an over the counter medicine.
Pictures of Falsified GLUCANTIME (Meglumine Antimoniate) can be viewed on this link.
|Action to be taken||-All Pharmacists and chemists working at distributions and Pharmacies are required to be alert and immediately inform the DRAP upon the presence of this falsified product in the market or any information related to the supply of this falsified product.|
-Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.
-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective eradication of falsified product(s) and initiation of relevant legal proceedings.
|Advice for Healthcare Professionals||-DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. |
-Adverse reactions or quality problems experienced with the use of this product may 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||-If anyone posses this falsified product, it is advised to not use this product9s) and shall immediately inform the DRAP. |
-Consumers are also advised to contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.