ISLAMABAD: Alarmed by reports of deaths in Indonesia linked to the consumption of cough syrup, the Drug Regulatory Authority of Pakistan (Drap) has directed all pharmaceutical companies to get their syrups and medicines tested for lethal and toxic impurities.
At present, Pakistan does not have any law which makes testing for the impurities in raw materials and finished medicine products mandatory.
It may be noted that a global alert has already been issued over four cough syrups after the World Health Organisation (WHO) warned they could be linked to the deaths of children.
The WHO identified the medicines as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Drap says such testing will prevent use of adulterated solvent in manufacturing
According to a document available with Dawn, Drap advised these companies to test solvents, such as glycerine, propylene glycol and sorbitol, used in oral preparations for the presence of any impurities such as diethyline glycol (DEG) and ethylene glycol (EG).
The document stated that different pharmaceutical manufacturers and their associates were expressing the unavailability of testing facilities to test the impurities at present and were seeking time to develop the requisite testing capacities.
Drap informed companies that the Central Drug Laboratory (CDL) in Karachi had the facility for testing the impurities and suggested the companies get their raw material tested from CDL.
“Pharmaceutical companies/manufacturers have been further directed that, while purchasing solvents, they must ensure that the suppliers of raw materials had performed tests for DEG and EG of all batches present in the consignment,” as per the document.
“The companies shall also be responsible for impurity testing of the solvents on each and every batch either by acquiring their in-house facility or from CDL on [a] payment of [a] fee. Such testing shall not render the firm for any regulatory action and will be limited to prevent the use of adulterated solvent in the manufacturing,” the document stated.
Moreover, federal inspectors of drugs have been advised to conduct risk-based sampling of the solvents in syrups.
Drug Lawyers Forum President Noor Mehar, while talking to Dawn, said, “a number of deaths have been reported” in Indonesia and The Gambia.
“It has been revealed that the syrups or raw materials were prepared by Indian companies. In Pakistan, the pharma companies import raw materials and use them without testing, so chances of impurities cannot be avoided,” he said.
Replying to a question, he said the DEG was used in cough syrups for anti-freezing and to ensure the mixing of different components.
“As DEG is cheaper than glycerine, some companies use DEG instead of glycerine, but if it is added in greater quantities, it can result in various ailments, including kidney failure,” he said, adding that since 1938, thousands of deaths have been reported due to the presence of DEG in cough syrups.
“It is unfortunate that there is no law to ensure the testing of the raw material [by the pharma companies]. We appreciate that the Drap has directed the companies to get their raw materials and finished products tested,” Mr Mehar said.
Ministry of National Health Services (NHS) spokesperson Sajid Shah told Dawn that DEG and EG were used in most solutions, such as cough and fever syrups, and antibiotic suspensions.
In July this year, Health Minister Abdul Qadir Patel had taken notice of allegations of the use of toxic anaesthesia in the Pakistan Institute of Medical Sciences (Pims) and announced that criminal proceedings would be started against the management of the hospital. However, it emerged that the death was reported due to some other reason.
It is worth mentioning that a few years back, on the directions of Drap, a commonly used cough syrup had been recalled from the shelves. The company had advertised that it had been voluntarily recalling the syrup of all doses and the decision was taken in line with the commitment to patient safety and ethical practices.
PMC branch in Gilgit-Baltistan
The Pakistan Medical Commission established its branch in Gilgit to facilitate the health professionals of the area.
The federal health ministry spokesperson said that doctors used to travel almost 14 hours to reach Islamabad to renew their licences and for other issues.
“Now all the issues related to health professionals will be addressed there. Minister Health Abdul Qadir Patel had to go to Gilgit on Wednesday to inaugurate the office, but [his] flight was cancelled,” he said.
Published in Dawn, December 15th, 2022