The syrup has caused poisonings and deaths worldwide in recent years due to ethylene glycol (EG) and diethylene glycol (DEG) poisoning during its low-cost production process.
The global market for over-the-counter cough, cold and allergy medicines for children will be worth an estimated $2.5 billion by 2022, according to research firm Euromonitor. They usually contain the active ingredient acetaminophen (also known as acetaminophen) to reduce fever and syrups made from glycerol or propylene glycol that are safe, sweet and easy to take.
At the end of last year, the world recorded hundreds of deaths or intoxications of children after the use of cough syrup from the largest pharmaceutical company in the world, India. In The Gambia, health authorities discovered that imported cough syrup was contaminated with a highly toxic substance, ethylene glycol (EG) and diethylene glycol (DEG). Both are a byproduct of the propylene glycol syrup manufacturing process, said Dr. Chaitanya Kumar Koduri, MD, US Pharmacopeia (USP).
According to Koduri, pharmaceutical companies often need to purify propylene glycol to get rid of all the toxicity if they want to use it in cough medicine. International standards allow the amount of EG and DEG in the drug after purification to not exceed 0.1%, which corresponds to 0.1 grams per 100 ml of syrup.
Components have similar properties. But while propylene glycol is not toxic, DEG and EG are extremely harmful. According to pathologists, when ingested, it leads to kidney failure and death if not treated quickly. The lethal dose depends on the user’s weight. Children are more at risk than adults.
Several deaths have occurred in the past year due to parents accidentally giving their children more cough syrup than prescribed. However, experts say the responsibility still lies with the manufacturer.
In the past, pharmaceutical companies replaced propylene glycol with pure DEG or EG to save costs. In chemical sites, EG and DEG are less than half of propylene glycol.
According to Koduri, pharmaceutical companies often need to purify propylene glycol to get rid of all the toxicity if they want to use it in cough medicine. International standards allow the amount of EG and DEG in the drug after purification to not exceed 0.1%, which corresponds to 0.1 grams per 100 ml of syrup.
Components have similar properties. But while propylene glycol is not toxic, DEG and EG are extremely harmful. According to pathologists, when ingested, it leads to kidney failure and death if not treated quickly. The lethal dose depends on the user’s weight. Children are more at risk than adults.
Several deaths have occurred in the past year due to parents accidentally giving their children more cough syrup than prescribed. However, experts say the responsibility still lies with the manufacturer.
In the past, pharmaceutical companies replaced propylene glycol with pure DEG or EG to save costs. In chemical sites, EG and DEG are less than half of propylene glycol.
In 1990, around 90 children in Haiti and over 200 children in Bangladesh died from DEG in acetaminophen syrup. Recently, Panama, India and Nigeria have also reported deaths following the use of oral cough and fever remedies.
After the incident, the World Health Organization (WHO) tightened its drug safety guidelines, asking manufacturers to test their finished products more carefully. However, the formulation and application of laws depends on the country, at the time of production and consumption.
Recent incidents involving cough medicine have affected the dark side of India’s pharmaceutical industry, which has around 10,000 factories run by 3,000 companies. The industry moves around US$ 50 billion annually, accounting for 20% of the global supply and 40% of the supply of generic drugs in the United States.
Indeed, the “medicine cabinet of the world” is no stranger to scandal. In 2022, the US Food and Drug Administration issued an import alert against four major Indian companies. These notifications are usually issued after a shipment is found to be of low quality during foreign inspections.
According to Dinesh Singh Thakur, a public health activist, low costs and poor quality control are the long-term downsides for the industry. These are the factors that have driven the billion dollar industry to grow rapidly over the last few decades. In the book The Truth Pill: The Myth of Drug Regulation in India, Mr. Thakur and attorney Prashant Reddy have documented at least five cases of substandard drugs entering the market, causing many deaths since the 1970s.
