DRAP cautions food authorities about imported toxic solvent

ISLAMABAD: An imported solvent widely used in pharmaceutical and food industry is reportedly being mixed with industrial grade chemical, containing ‘poisonous impurities’, to enhance its quantity and profitability, which may result in organ failure and deaths among consumers, officials feared on Friday.

Fortunately, no untoward incident due to the consumption of medicines has so far been reported as the Drug Regulatory Authority of Pakistan (DRAP) timely recalled a cough syrup and raw material used for its manufacturing after poisonous impurities were detected in them during laboratory analysis, they added.

But the authorities suspected that pharmaceutical and food grade Propylene Glycol (PEG), a solvent widely used for manufacturing of cough syrups, carbonated beverages and in the food industry, was being mixed with industrial grade PEG which may contain poisonous impurities including ‘Ethylene Glycol (EG) and Diethylene Glycol (DEG) and supplied to smaller pharmaceutical companies and food industry in Pakistan.

Pharmaceutical industry experts said Propylene Glycol is a solvent used widely in food and pharmaceutical industry. Pharmaceutical and food grade PEG having permissible limits of impurities EG and DEG costs between Rs3,000 to Rs4,000 from abroad but some people are supplying it at Rs800 to Rs1,000 to local food and pharmaceutical industries, which is not possible without mixing it with industrial grade PEG containing poisonous impurities, they claimed.

The drug regulatory authority had recalled a cough syrup, manufactured by a Peshawar-based pharmaceutical company after the Central Drug Testing Laboratory (CDL) of DRAP detected more than 25 percent of Ethylene Glycol (EG) in the syrup. The DRAP also found poisonous impurities in the solvent, which had been imported from Thailand.

“We have alerted the entire filed 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,” an official of the DRAP said.

But the officials were also worried about the use of Ethylene Glycol in manufacturing of carbonated drinks including colas as well as in various other food products, saying adulterated solvent used by some local companies could result in serious health consequences for the consumers.

“DRAP is also alerting food authorities to keep an eye over Propylene Glycol being used in the food industry and ensure that the solvent does not contain EG and DEG, which are lethal impurities,” the official added.

Following the detection of ‘poisonous impurities’ in raw material imported from Thailand for the preparations of cough syrups, the DRAP also decided to not let certain chemicals enter the country without their testing at points of entry into Pakistan, the official informed

“We have requested the Customs authorities to provide us 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 presence of any toxic impurities and contaminants before the distribution in Pakistan, to apprehend any alarming situation,” an official of the DRAP told ‘The News’.

In a letter to Customs authorities, the DRAP said Propylene Glycol, Glycerin, and Sorbitol are widely used in various industries in addition to their use in the manufacturing of therapeutic goods as a solvent. These excipients may be contaminated with highly toxic Ethylene Glycol (EG) and Diethylene Glycol (DEG) as been reported by many countries in the past.

“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.

It is, therefore, necessitated that a list of sources of these raw materials along with the details of importers of Propylene Glycol, Glycerin, and sorbitol in Pakistan be provided to the DRAP, so that necessary sampling may be conducted accordingly at the entry points in Pakistan to timely detect the presence of any toxic impurity/contaminants before the distribution in Pakistan to apprehend any alarming situation, the DRAP letter continued.

The DRAP officials said they have requested Customs authorities to nominate a focal person for requisite information sharing and mode of sampling at customs ports to safeguard public health.