DRAP recalls syrup after ‘poisonous impurities’ found

• Propylene glycol was imported by a local company from Thailand
• “Today we ordered the recall of Delorvin syrup,” says DRAP.
• DRAP suspects industrial grade material added to the raw material.

ISLAMABAD: After detecting “poisonous impurities”, the Drug Regulatory Authority of Pakistan (DRAP) has recalled a cough syrup and imported raw material used in it, The news reported on Thursday.

The “poisonous impurities” were detected in the cough syrup during tests at the Central Drug Testing Lab (CDL) in Karachi, the report said, according to officials.

The raw material, propylene glycol was imported by a local company from Thailand and supplied to various pharmaceutical companies across the country to make cough syrups, which are in high demand these days due to the epidemic of influenza and other respiratory diseases in the country. DRAP executives added.

“Today we ordered the recall of Delorvin syrup and propylene glycol, a raw material used in the manufacture of cough syrup. During the tests, poisonous amount of two deadly impurities namely ethylene glycol (EG) and diethylene glycol (EG) was detected in the cough syrup and raw material used in it,” said a senior DRAP official. The news.

Besides recalling the cough syrup and the raw material used to make the syrup, DRAP officials have launched a nationwide investigation to trace the importer who supplied the raw material to various pharmaceutical companies and ascertain the companies who used the “inferior” raw material.

Propylene glycol is used as an excipient or inactive pharmaceutical ingredient in making syrups, particularly cough syrups, experts said, adding that some companies were trying to use industrial-grade propylene glycol, which was unsafe for human consumption as it carried “poisonous levels” of ethylene glycol. and Diethylene Glycol.

Hundreds of children have died so far in several countries after some Indian companies exported cough syrups containing poisonous impurities including EG and DEG, while a few weeks ago, some cough syrups manufactured by a Lahore-based pharmaceutical company were also identified by the World Health Organization (WHO) in the Maldives and some other countries in the world.

The DRAP official claimed that a pharmaceutical company approached the drug regulator itself to test the cough syrup for poisonous impurities and when the prepared batch of the cough syrup and raw material was tested at CDL Karachi, it was found to be inferior. quality, contained poisonous impurities.

To a question, the senior DRAP official said that every pharmaceutical company is supposed to check all active and inactive raw materials for impurities for patient safety, adding that DRAP is also starting “risk-based sampling and testing” of raw materials . imported into the country. Asked why criminal proceedings were not initiated against the manufacturers and importers, the DRAP official said some of the companies would be prosecuted as they were found to be involved in criminal activities.

“Here, in this new case, we suspect that a middleman imported raw material from an authentic source in Thailand, but later added industrial grade material to increase its quantity and supplied it to manufacturers. We are not only recalling the raw material imported by this middleman but will also file a criminal case if any violation is found after investigations,” the official added.