Context: According to a report released by the Central Drugs Standard Control Organisation (CDSCO), the nation’s top drug regulator, at least five batches of cough and allergic rhinitis syrups from two Indian manufacturers have been found to contain higher than permissible levels of contaminants – diethylene glycol and ethylene glycol.
About Ethylene glycol and Di Ethylene Glycol (DEG)
Ethylene glycol and Di Ethylene Glycol (DEG) are colourless, odourless, sweetish-tasting substances that are mostly used for industrial purposes ranging from antifreeze formulations to brake fluids, paints, plastics etc. The pharmaceutical grade can be used for medicines and consumer products in the quantity that is recommended.
Note: According to the WHO, the accepted safety level for ethylene glycol and diethylene glycol is no more than 0.10%.
** The two contaminants are known to be toxic in humans and can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, and acute kidney injury that may result in death especially in children.
About Central Drugs Standard Control Organisation(CDSCO)
Work under: Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
Headquarter: New Delhi
- It is assigned duties under Drugs and Cosmetics Act, 1940.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
- Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Note: The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that controls the prices of pharmaceutical drugs in India.