The World Health Organisation (WHO) has recently expressed concerns about the production of substandard cough syrups in India, which are reportedly linked to 300 child deaths. These products are found to contain high levels of harmful diethylene glycol and ethylene glycol, bringing significant health risks along with them. The WHO has consequently issued an alert for seven such syrups produced in the country. In response, India’s Drugs Controller General has now made it mandatory for all cough syrups to undergo testing in designated labs before they are exported.
Understanding Ethylene Glycol and Diethylene Glycol
Ethylene glycol and diethylene glycol are toxic types of alcohol that have a slightly sweet taste. These substances can contaminate cough syrups, particularly those containing paracetamol. While paracetamol in syrup form is good and safe for treating infections in children due to its fever-reducing properties, these glycols are adulterants that are sometimes illegally used as solvents in liquid drugs as an alternative to non-toxic solvents like glycerin or propylene glycol, primarily to save production costs.
A lethal dose for oral consumption is typically around 1,000-1,500 milligrams per kilogram of body weight. Toxicity can also occur with smaller doses if they are consumed continuously over several days or weeks. Large quantities need to be taken in before the symptoms of contamination manifest themselves.
Besides their use in antifreeze, ethylene glycol is utilized as an ingredient in hydraulic fluids, printing inks, and paint solvents. Similarly, diethylene glycol is employed in the industrial preparation of antifreeze, brake fluid, cigarettes, and certain dyes.
Risks Associated with Substandard Cough Syrups
Substandard cough syrups pose serious health hazards as they might contain high levels of diethylene glycol and ethylene glycol, which can inflict damage to the kidneys. Other concerns include unscientific combinations of chemical components in these products that can potentially interact with each other and cause harm.
Furthermore, these substandard syrups might also lack therapeutic relevance, implying that they may not effectively treat the root cause of the cough. Some of them, especially those containing codeine, can become addictive and even fatal for children if consumed. They could also lead to side effects like drowsiness, dizziness, blurred vision, nausea, and difficulty in articulating, indicating potential harm.
Regulations Related to Drugs in India
The regulation of drugs and cosmetics in India primarily falls under the purview of The Drugs and Cosmetics Act, 1940 and Rules 1945. This act provides regulatory guidelines for manufacturing licenses for Ayurvedic, Siddha, Unani medicines, among others. It makes it mandatory for manufacturers to comply with the Good Manufacturing Practices (GMP) and provide proof of safety and effectiveness.
The Central Drugs Standard Control Organisation (CDSCO) is the central authority responsible for controlling the import of drugs, approving new drugs, and overseeing clinical trials. Additionally, certain licenses are approved by this authority as the Central Licence Approving Authority.
Other major bodies involved in the regulation of drugs and pharmaceuticals in India include the Ministry of Health and Family Welfare, Ministry of Chemicals and Fertilizers, Ministry of Commerce, Ministry of Science and Technology, Ministry of Environment, Directorate General of Health Services (DGHS), and the Indian Council of Medical Research (ICMR). Furthermore, the National Pharmaceutical Pricing Authority (NPPA) which enforces the Drugs (Prices Control) Order (DPCO) 2013, and the Council of Scientific and Industrial Research (CSIR) Laboratories also have important roles to play in this sector.