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ISLAMABAD: The Drug Regulatory Authority of Pakistan (Drap) has directed a pharmaceutical company to recall a syrup, which is given to children to treat fever, from the market and has advised the health professionals not to prescribe it.
The direction has been giving after getting a report from the federal government analyst Central Drugs Laboratory (CDL), Karachi, that the medicine — Barpon 100mg/5ml — has been found substandard.
However, representative of the manufacturing company, JASM Pharmaceutical (Pvt) Ltd, Risalpur, has announced the decision to challenge the Drap move, claiming that the syrup could not be declared substandard as company also got it tested before dispatching it to market.
The Drap document, seen by Dawn, said the batch (No. 202), having manufacturing date of July 2023 and expiry date of June 2025, has been found substandard. It stated that Barpon infusion contains ibuprofen, a medicine used to treat mild to moderate pain and fever (high temperature).
Company to challenge decision, claims product tested before dispatch
The administration of substandard products may lead to complications, as well as an increased risk of failure of therapy. The age-profile of patients is important and young patients especially are at risk, according to the document.
“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 are hereby advised to immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/company,” it stated.
However, JASM’s Director Mohammad Khalid told Dawn that the company was ISO-9001 certified (for having quality management system) and it tests raw material and also finished products.
“We give medicines of our company to our own children. We will challenge Drap’s decision as we tested both the raw material and finished product from a lab,” Mr Khalid said.
Published in Dawn, March 18th, 2024
