Doctor's prescription now mandatory for all 'syrups,' including cough
What's the story
The central government has tightened regulations on the sale of syrups, including cough syrups, by amending the Drugs Rules, 1945. The amendment was notified by the Ministry of Health and Family Welfare on June 9 through the Drugs (Fifth Amendment) Rules, 2026. The change removes "syrups" from Schedule K, a list of exempted drugs under certain conditions. This means that the over-the-counter selling of syrups, including cough syrups, without a doctor's prescription will now be banned.
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Union Ministry of Health and Family Welfare issues notification which brings into effect that all 'Syrups', including cough syrups will no longer be available over the counter. A prescription by a doctor will be required for the purchase of 'Syrups'. pic.twitter.com/k0jsP25EqJ
— ANI (@ANI) June 16, 2026
Prescription requirement
Prescription mandatory for syrup purchases
The amendment now mandates that consumers must have a doctor's prescription to buy syrups from pharmacies. This effectively ends their over-the-counter availability and brings them under stricter regulatory control. The change is expected to impact routine purchases of cough and other medicinal syrups, which were previously available without medical authorization.
Safety concerns
Addressing safety concerns in syrup formulations
The move comes amid growing safety concerns over cough and oral liquid medicines in recent years. There have been issues with contamination in liquid oral formulations and dangerous substances like diethylene glycol (DEG) and ethylene glycol (EG), which can cause severe kidney damage. In light of these concerns, regulatory agencies have tightened testing requirements for raw materials and finished products used in syrup formulations.
Pediatric guidelines
Proposed rules for cough syrups
The government has also proposed stricter rules for the sale of cough syrups, including their availability through unlicensed village pharmacists. Under the draft National Formulary of India (NFI) 2026, it has been proposed that cough and cold medicines should not be prescribed or dispensed to children below two years. They are generally not recommended for children under five unless clinically necessary and closely supervised.