Quality control goes missing in children’s cough syrups

Strict quality control is essential during the production of propylene glycol and its raw materials to ensure purity and safety.

- DR P.S. VENKATESH RAO

In January of 2023, the WHO accused Indian cough syrups of causing the deaths of children in Gambia and Uzbekistan, defaming India, the Pharmacy to the world.

The controversy was about the presence of Diethylene glycol and Ethylene glycol as contaminants in Propylene Glycol, an excipient in cough syrups. The recent deaths of children in Rajasthan and Madhya Pradesh due to toxic cough syrups have again highlighted the danger of adulterated children’s cough syrups. Cough syrup samples collected from more than 100 pharma units in the country in mid-2024 failed quality tests, according to a government report, which highlighted that some had the same toxins that were found in the cough syrups that were linked to deaths of children in Gambia, Uzheki-stan, and Cameroon.

Excipients are inactive substances like colouring agents, preservatives, and fillers. Excipients contribute to the drug’s texture, taste, colour, and stability. Popular excipients in syrups include solvents like water, ethanol, and Propylene glycol, preservativessuch as parabensand sodium benzoate, stabilizers, sweeteners like sorbitol and. sucrose, artificial sweeteners like sucralose and aspartame, flavouringagents, colorants, and thickening agents like hydroxyethyl cellulose. Solvents are used to dissolve the Active Pharmaceutical Ingredients (APIs).