Pharmaceutical firms directed to ensure medicine ingredients free of ‘poisonous substances’

ISLAMABAD: To prevent children from falling sick by consuming syrup medicines, the Drug Regulatory Authority of Pakistan (DRAP) has directed all the pharmaceutical companies of Pakistan to ensure the use of ‘pharmaceutical grade solvents (ingredients)’ purchased from qualified vendors and keep a close eye on the presence of toxic materials, which should not be present in the medicines’ raw material, officials told The News on Saturday.

Hundreds of children died in Gambia and Indonesia recently by consuming syrup medicines containing ingredients linked to acute kidney injuries (AKI), DRAP officials said. “But no such case has been reported in Pakistan yet due to enhanced surveillance and strict monitoring of the therapeutic goods’ manufacturing process,” the officials added.

“In Gambia and Indonesia, children died because they consumed cough syrups and other syrup medicines that contained ‘unacceptable amounts’ of Diethylene Glycol (DEG) and Ethylene Glycol (EG), which are poisonous chemicals. We have asked all the medicine manufacturers to ensure that all the raw materials they used for medicines manufacturing are free of these poisonous chemicals”, an official of the DRAP said.

World Health Organization (WHO) issued an alert earlier this month after it found an “unacceptable amount” of diethylene glycol and ethylene glycol in four Indian-made cough syrups linked to the 77 deaths in The Gambia.

Later, Indonesian health authorities also reported that the number of children, who have died in Indonesia from acute kidney injury (AKI) linked to harmful substances in medicinal syrups has risen to 133 from the previously reported 99 fatalities.

In order to prevent any untoward incident in Pakistan, especially in the winter season when consumption of cough syrups and other syrup medicines increases manifolds, the DRAP issued a ‘Drug Impurity Alert’ on Saturday, asking pharmaceutical companies to ensure that Glycerin, Propylene Glycol and Sorbitol used in the oral preparations are free of toxic impurities, especially diethylene glycol and ethylene glycol.

“Adulteration of these materials with highly toxic Diethylene Glycol (DEG) and Ethylene Glycol (EG) had been reported in many countries in past. DEG and EG are poisonous and may lead to severe health injury or death. Incidents of severe health injury/deaths of children as recently reported in Gambia and Indonesia due to consumption of cough syrup containing glycerin urges for an emergent need of vigilant monitoring of these possible contaminants”, the DRAP alert said.

It maintained that in this situation, it becomes essential to perform a test/analysis of raw material used in the preparations of therapeutic goods for the presence of any toxic impurity/contaminants, especially when used in oral dosage forms such as syrups/suspensions etc.

“It is the legal responsibility of all manufacturers of therapeutic goods to ensure before marketing that all the manufactured therapeutic goods are safe for consumption. Therefore, it is required that all manufacturers using these solvents must perform proper testing to detect DEG and EG contamination”, the alert said.

Strictly warning all the drug manufacturers not to use the solvents for the preparation of syrup medicines without testing them for the DEG and EG, the DRAP asked all the federal and provincial drug inspectors to carry out risk-based sampling of oral medicines, especially cough syrups containing the above-mentioned solvents and report to the QA and LT division of the DRAP on regular basis.

On the other hand, renowned pharmacist and President of the Pakistan Society of Health-System Pharmacists (PSHP) Abdul Latif Shaikh said the use of cough syrups should be discouraged by doctors and pharmacists as they have no therapeutic value and urged parents to give honey, lime water, steam and other traditional treatments for the control of cough.

“Cough syrups have no therapeutic value at all and their use should be discouraged. Unfortunately, cough syrups have become a major source of profits for national and multinational pharmaceutical firms in the world including Pakistan. Instead of using them, honey, lime, steam and several other proven traditional treatment options should be used to control and get rid of cough”, the PSHP President advised.