Month: March 2023
Prequalification of panel hospitals
Minutes of 324th meeting of Registration Board held from 24th to 26th January, 2023
The Drug Registration Board convened its 324th meeting from 24th to 26th January, 2023 in the Committee Room of Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The minutes of meeting are hereby circulated for information of all stakeholders.
Recall Alert: Drug Product; Oscal-D Tablets (Batch # 6904) by M/s Aries Pharmaceuticals (Pvt) Ltd, Peshawar.
Recall Alert
| DRAP Alert No | NoI/S/02-23-14 |
| Action Date | 24th February 2023 |
| Target Audience | 1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Oscal-D Tablets Manufactured by: M/s. Aries Pharmaceuticals (Pvt) Ltd, Peshawar. Batch No. 6904 Manufacturing Date: 07-2022 Expiry Date: 07-2024 |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared the Batch No. 6904 of product “Oscal-D Tablets” as of substandard quality. |
| Risk Statement | Oscal-D Tablets may be used to treat conditions caused by low calcium levels such as osteoporosis, osteomalacia/rickets, hypoparathyroidism and latent tetany. Inaccurate use of the product may lead to adverse reactions including but not limited to irregular heartbeat, weakness, drowsiness, headache, dry mouth or a metallic taste in your mouth or muscle or bone pain. Impact of use of substandard product on basis of assay test may leads to low to no therapeutic effect etc. |
| Action Initiated | -The sole agent / registration holder has been directed to immediately recall the defected batch of product from the market. -All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / company. -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) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company. -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 | -Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product. -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist. |