Officials on Friday expressed concerns about an imported solvent widely utilized in the food and pharmaceutical industries being mixed with an industrial-grade chemical containing ‘poisonous impurities,’ to increase its quantity and profitability. Officials believe that it could lead to organ failure and fatalities among consumers.
Thanks to the swift action of the Drug Regulatory Authority of Pakistan (DRAP), no harmful incidents related to medicine consumption have been reported so far. Officials added that DRAP had recalled cough syrup and the raw material used in its production after discovering toxic contaminants during laboratory testing.
Officials fear that industrial-grade propylene glycol (PEG) is being mixed with pharmaceutical- and food-grade PEG, a solvent that is widely used in the production of carbonated drinks, cough syrups, and food products.
Smaller pharmaceutical businesses and the food industry in Pakistan are receiving this mixture, which may contain harmful contaminants including Ethylene Glycol (EG) and Diethylene Glycol (DEG).
Experts in the pharmaceutical sector pointed out that propylene glycol is a commonly used solvent in the food and pharmaceutical industries. Imported PEG of the pharmaceutical and food grades, with permissible limits of impurities EG and DEG, costs around Rs 3,000– Rs 4,000.
However, local food and pharmaceutical industries are receiving Rs. 800 to Rs. 1,000 from certain individuals. According to experts, this kind of pricing is not possible unless it is combined with industrial-grade PEG, which can include hazardous contaminants.
A cough syrup manufactured by a pharmaceutical company in Peshawar was recalled by the Drug Regulatory Authority after the Central Drug Testing Laboratory (CDL) of DRAP found that the syrup contained more than 25% ethylene glycol (EG). Poisonous contaminants were also discovered by the DRAP in the solvent, which was imported from Thailand.
According to an official of DRAP, “We have alerted the entire field force of the DRAP to start sampling of the Propylene Glycol imported from Dow Chemicals, Thailand and not to let it be used for manufacturing of therapeutic goods before it is found safe for human consumption.”
DRAP decided not to permit certain chemicals to enter Pakistan without testing at entry points after discovering ‘poisonous impurities’ in raw materials imported from Thailand for cough syrup production.
Talking to a local media outlet, a DRAP official said,
We have requested the Customs authorities to provide us with a list of importers of Propylene Glycol, Glycerin, and Sorbitol, which are used in therapeutic goods as solvents. DRAP needs to test these solvents at entry points in Pakistan to detect the presence of any toxic impurities and contaminants before the distribution in Pakistan, to apprehend any alarming situation.
In a letter to Customs authorities, the DRAP mentioned that Propylene Glycol, Glycerin, and Sorbitol, commonly used in various industries, also serve as solvents in the manufacturing of therapeutic goods.
The DRAP brought to light the possibility that these excipients, as previously reported by other countries, are contaminated with extremely dangerous levels of ethylene glycol (EG) and diethylene glycol (DEG).
“DEG and EG in higher than the permissible limits may lead to severe health injury. Incidents of severe health injury/deaths of children were reported in 2022 in Gambia and Indonesia due to consumption of cough syrup containing glycerin contaminated with aforesaid impurities,” the DRAP letter further said.
DRAP underlined the need for an extensive list of raw material suppliers, including Pakistani importers of sorbitol, glycerin, and propylene glycol. To carry out necessary sampling at Pakistani entrance points and discover any harmful impurities or pollutants in time for distribution, the DRAP needs this information.
The purpose is to avert potential worrying circumstances connected to these chemicals in Pakistan, as mentioned in the DRAP letter.
Regarding the necessary information sharing and deciding on the sample processes at customs ports, DRAP officials stated that they had asked Customs authorities to designate a focal person.