ISLAMABAD: A commonly used cough syrup has been recalled from the market on the direction of Drug Regulatory Authority of Pakistan (Drap) after it was learnt that stability data of the drug was out of specification.

The syrup manufactured by Ms Novartis is sold across the country and is commonly prescribed for cough. The company has advertised that it has been voluntarily recalling Sancos syrup of all doses from the market. It says the decision has been taken in line with the commitment to patients’ safety and ethical practices. It further says that the syrup was manufactured by a third party.

In its letter, the regulatory body said it was reported that the Sancos stability data was out of specification. As the product contained controlled drug, the company was directed to recall all the products from the jurisdiction of Islamabad. Moreover, the company was directed to submit a detailed report.

When contacted, Drap spokesperson Akhtar Abbas told Dawn that it was learnt during a random check in February that the syrup was out of specification.

“Initially the company claimed that the problem was in just a few batches. After that the company requested [Drap] to allow it to reduce the expiry duration of the syrup from three years to one and a half years.

“However, Drap directed the company to withdraw the syrup from the market,” he said.

“The company continuously resisted [the direction] but finally the problem has been settled and it has advertised that the syrup is being recalled,” he said.

The regulatory body claimed that some elements had started circulating the letters on the social media due to which a panic was created. “According to our information, now syrup is not being sold as medical stores and doctors have also learnt about the issue,” the spokesperson said.

Mr Abbas said there was issue of stability of syrup due to which there was a possibility of reduced shelf life of the syrup. While the company wanted to reduce the expiry duration of the syrup, Drap decided not to take the risk and directed the company to recall the syrup as controlled drug was involved in it, he said.

Published in Dawn, Aprill 10th, 2018