India's Central Drugs Standard Control Organisation (CDSCO) is reviewing a proposal to add a red warning and a school‑age pictorial to cough‑syrup bottles, a move aimed at stopping sales to children under four, the regulator said on July 12, 2026.
The proposal follows a Directorate General of Health Services advisory issued last October that cautioned against prescribing cough and cold medicines to children under two, yet a recent complaint filed in April 2026 highlighted that the practice had continued, the CDSCO’s technical committee noted.
In June 2026 the Ministry of Health and Family Welfare amended the Drugs Rules, removing syrup‑based medicines from the over‑the‑counter category; the Drugs (Fifth Amendment) Rules 2026 require a prescription for any syrup formulation, a change that was incorporated into the 1945 Rules through a June 9 notification.
The draft proposal was sent to the Drugs Consultative Committee (DCC) for consideration; the CDSCO had earlier consulted the Indian Council of Medical Research and a range of stakeholders, but ICMR confirmed it was not working on cough‑syrup labelling.
If the DCC approves the change, the Ministry will issue a final rule making the red warning mandatory and enforcing prescription‑only status for all cough‑syrup sales, a step that could curb the continued misuse of these medicines among India's most vulnerable children.