Mumbai: The Central Drugs Standard Control Organisation (CDSCO) has mandated stricter labelling rules for solvent manufacturers in response to the contaminated cough syrup tragedies that killed at least 25 children in Madhya Pradesh in Oct. The new guidelines, issued to state FDAs are to prevent industrial chemicals from entering the medicinal supply chain.The earlier deaths were linked to the presence of toxic diethylene glycol (DEG) in the syrups. DEG is an industrial solvent that is poisonous if consumed. It can make its way into medicinal syrups in place of safe pharmaceutical solvents like glycerin or propylene glycol, which are common and non-toxic ingredients.A state FDA official said that while most manufacturers already distinguish between pharmaceutical and industrial-grade solvents, the new mandatory labelling rules will eliminate any ambiguity. “The revised guidelines will help manufacturers at every stage correctly identify the product,” the official said. The rules call for a clear mention of what the product is, its uses, chemical names, and manufacturer information.
