Cough syrups still being given to very young children; red warning for under-4s proposed
The proposed changes include a visual showing school-age children on the packaging, intended to make it clear that the medicine is meant for older children rather than infants and toddlers.
Despite the drug regulator’s guidelines, cough syrups continue to be administered to children under the age of four in India. The country's drug regulator is now considering a proposal to alter cough syrup labels to discourage their use in very young children. The adjustments would feature a visual depicting older children on the packaging to emphasize the medicine's intended use for school-aged children rather than infants and toddlers.
Additionally, a red warning stating: "WARNING: Cough syrup should not be used in children below 4 years of age" could be prominently displayed on the bottle label. This proposal has been submitted to the drugs consultative committee for review, aiming to modify Rule 96 of the Drugs Rules, 1945. The directorate general of health services (DGHS) issued an advisory last year urging caution when prescribing and dispensing cough and cold medicines for pediatric patients, particularly recommending against their use for children below two years of age.
However, despite these directives, there have been complaints alleging the continued prescription of cough syrups to infants below two years of age. An internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) recommended consulting the Indian Council of Medical Research (ICMR) on the feasibility of altering product labeling.
The ICMR, however, stated it is not currently engaged in any work related to cough syrup labeling. In June, the Union health ministry amended the drug rules to remove syrup-based medicines, including cough syrups, from the over-the-counter category, necessitating a doctor's prescription for purchase. This alteration, introduced through the Drugs (Fifth Amendment) Rules, 2026, brings syrup formulations under regulatory requirements previously exempted.
Written by urgent.news from Times of India's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
