Anti-Cold Fixed Drug Combination : Prohibition
The Central Drugs Standard Control Organisation (CDSCO) in India has prohibited the use of an anti-cold fixed drug combination in children below four years of age.
- Combination products, also known as fixed dose drug combinations (FDCs), are combinations of two or more active drugs in a single dosage form.
- The Food and Drug Administration, USA defines a combination product as ‘a product composed of any combination of a drug and a device or a biological product and a device or a drug and a biological product or a drug, device, and a biological product.
- The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory body for cosmetics, pharmaceuticals, and medical devices. It’s responsible for overseeing the import, manufacture, sale, and distribution of medical devices in the country.