LAHORE: The Drugs Regulatory Authority of Pakistan (DRAP) has once again raised a drug impurity alert about a chemical being used as an anti-freezing agent in various medicines, especially cough syrups, which may damage kidneys. This is the second alert of its kind, the earlier one being in October.
While issuing a fresh advisory to the pharmaceutical companies on Wednesday, DRAP has directed to ensure testing of solvents – glycerine, propylene glycol & sorbitol – used in oral preparations for the presence of any lethal/toxic impurities namely Di Ethylene Glycol (DEG) & Ethylene Glycol (EG). The DRAP, in an earlier advisory on October 21st, had even advised recalling at once the product(s), if any, reported out of specifications after conducting test/analysis on already-manufactured batches, otherwise strict regulatory action would be taken.
Since oral preparations (cough syrups) have a massive consumption, any DEG contamination is a striking whistle to take immediate action. While DRAP was necessitated to issue a second drug impurity alert within two months speaks volumes about the scale of damage it might have caused during this period.
The widely used solvent in pharmaceutical products such as sorbitol, glycerin and propylene glycol (PG) has the potential and tendency to be mixed or contaminated with DEG. The established clinical features of DEG poisoning are identified as neurotoxic, hepatotoxic and nephrotoxic. The dot of elevated cerebrospinal fluid protein concentrations in victims of DEG may easily be connected with the obvious kidney injury. DEG converts into hydroxy ethoxy acetic acid and promotes acidosis, which sharply attacks kidney cells responsible for filtration and thereafter creatinine is increased in blood to challenge the biochemical balance throughout the body and brain. In the past, di ethylene glycol has caused deaths on a large scale in various countries, while a renowned company’s toothpaste containing DEG also led to the spread of various diseases.
As per DRAP’s advisory, it received several responses from different pharmaceutical manufacturers and their associations explaining the unavailability of testing facilities for these impurities and requested extending time to develop the requisite testing provisions.
In this regard, it is to inform that Central Drugs Laboratory (CDL) Karachi has the facility for testing the above-mentioned impurities. Therefore, DRAP advised all these stakeholders including pharmaceutical manufacturers and regulators to ensure that while purchasing these solvents, they must ensure that the supplier/vendor of these solvents had performed the test for specific impurity that included the limit test for DEG and EG of all the batches present in the consignment.
The firms shall also be responsible for impurity testing of the solvents like glycerin, sorbitol and propylene glycol on each and every batch either by acquiring their in-house facility or from Central Drugs Laboratory, DRAP Karachi on payment of the requisite fee. Such testing shall not render the firm any regulatory action and will be limited to preventing the use of adulterated solvents in manufacturing. The Federal Inspectors of Drugs are advised to conduct risk-based sampling of the above solvents for testing by the CDL, Karachi for the presence of any impurity.
While hailing DRAP’s advisory on drug impurity, Drug Lawyers’ Forum Chairman Noor Mahar said these steps will help save lives as the properties of Di Ethylene Glycol’s are similar to glycerin. Therefore, it is used as a cheaper substitute. If it enters the body in excess, it affects the kidneys and causes many other diseases. The cough syrups, containing this chemical, have highest over the counter sale in Pakistan.
Noor Mahar said that there are no formal laws in Pakistan for testing these hazardous elements. However, DRAP’s notice will ensure tests on all batches of glycerine, sorbitol and propylene glycol before purchase by the pharmaceutical companies.
