Month: January 2024
Decisions of 63rd Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)
The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in 63rd meeting has deferred the following applications of registration/enlistment of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.
Recall Alert: Drug Product; IS-NS (0.9%) Infusion (Batch # B6-24) by ISIS Pharmaceutical & Chemical Works, Karachi
Recall Alert
| DRAP Alert No | No I/S/12-23-48 |
| Action Date | 2nd January, 2024 |
| Target Audience | · Healthcare Professionals particularly working in the critical care areas of hospitals including Physicians, Pharmacists, and Nurses. · Procurement Officers at Hospitals and Healthcare Institutions. · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores. |
| Problem / Issue | Federal Government Analyst, CDL Karachi has declared Batch No. B6-24 of product “IS-NS 0.9% INFUSION” as of Substandard quality. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufacturer |
|---|---|---|---|
| IS-NS 0.9% Infusion Reg.No 104066 | 0.9% Sodium Chloride | Batch No. B6-24 Mfg. Date: 08-23 Exp. date: 08-25 | M/s. ISIS Pharmaceutical & Chemical Works, Karachi |
| Risk Statement: | The use of substandard products based on assay tests may alter the dose and hamper the efficacy of the product leading to sub-therapeutic effects. |
| Action Initiated | -The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) has increase surveillance in the market to ensure the effective recall of defective products(s). -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 through phone at +92 51 910 73 17, 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 this 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. |