DRAP launches countrywide investigation to identify importer who provided the raw material, says official
- Propylene Glycol was imported by local firm from Thailand
- “Today we have ordered recall of Delorvin Syrup,” says DRAP.
- DRAP suspects industrial grade material added to raw material.
ISLAMABAD: Following the detection of “poisonous impurities,” the Drug Regulatory Authority of Pakistan (DRAP) 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 testing at the Central Drug Testing Lab (CDL) Karachi, the publication quoted officials as saying.
The raw material, Propylene Glycol was imported by a local firm from Thailand and supplied to different pharmaceutical companies throughout the country for manufacturing of cough syrups, which are high in demand these days due to the outbreak of influenza and other respiratory illnesses in the country, DRAP officials added.
“Today we have ordered recall of Delorvin Syrup, and Propylene Glycol, a raw material used in the manufacturing of cough syrup. During testing, poisonous amount of two lethal impurities i.e. Ethylene Glycol (EG) and Diethylene Glycol (EG) were detected in the cough syrup and the raw material used in it”, a senior DRAP official told The News.
In addition to recalling the cough syrup and raw material used in the manufacturing of the syrup, DRAP officials launched a countrywide investigation to identify the importer who provided the raw material to different pharmaceutical companies and ascertain the companies which used the “substandard” raw material.
Propylene Glycol is used as an excipient or non-active pharmaceutical ingredient in manufacturing of syrups, especially cough syrups, experts said, adding that some companies try to use industrial-grade Propylene Glycol, which was not safe for human consumption as it carried “poisonous levels” of Ethylene Glycol and Diethylene Glycol.
Hundreds of children have so far died in many countries after some Indian companies exported cough syrups containing poisonous impurities, including EG and DEG, while a few weeks back, some cough syrups manufactured by a Lahore-based pharmaceutical company were also detected by the World Health Organization (WHO) in Maldives and some other countries of the world.
DRAP official claimed that a pharmaceutical firm itself approached the drug regulatory authority to get the cough syrup tested for poisonous impurities and when the prepared batch of the cough syrup and raw material was tested at the CDL Karachi, it was found to be substandard, containing poisonous impurities.
To a query, DRAP’s senior official said every pharmaceutical company was supposed to test all the active as well as non-active raw materials for impurities for the safety of patients adding that DRAP was also starting “risk-based sampling and testing” of raw materials being imported in the country. Asked why criminal proceedings were not being launched against the manufacturers and importers, the DRAP official said some of the companies would be prosecuted as they were found involved in criminal activities.
“Here in this fresh case, we suspect that some middle man imported raw material from an authentic source in Thailand but later added industrial grade material in it to increase its quantity and provided it to the manufacturers. We are not only recalling the raw material imported by this middle man but are also going to lodge a criminal case if any wrongdoing was proved after investigations,” the official added.
