Prescription Mandatory for Syrup Purchases: Government Tightens Regulations

Summary:
The government has amended the Drugs Rules, 1945 by removing “syrups” from the exempted medicines list under Schedule K, effectively ending over-the-counter sales of syrup-based medicines, including cough syrups, without a doctor’s prescription. The move is part of stricter regulatory oversight following safety concerns surrounding liquid medicines. Authorities have also proposed tighter restrictions on the use of cough and cold medicines in young children and strengthened quality testing requirements for syrup formulations due to risks linked to contaminants such as diethylene glycol (DEG) and ethylene glycol (EG). 

The central government has revised the Drugs Rules, 1945 by deleting the term “syrups” from the list of exempted medicines under Schedule K, indicating stricter regulation of syrup-based drug formulations. As a result, syrups, including cough medications, will no longer be available for over-the-counter purchase without a valid prescription from a registered medical practitioner.

The amendment was introduced through the Drugs (Fifth Amendment) Rules, 2026, issued by the Ministry of Health and Family Welfare. By removing “syrups” from Schedule K, the government has reduced the scope of exemptions previously granted to certain medicines under the regulatory framework.

Schedule K contains categories of medicines that are exempt from specific provisions related to their manufacture, sale, and distribution, provided certain conditions are met. These exemptions were originally intended to simplify access to particular medicines by relaxing some compliance requirements. With the latest revision, syrup-based products covered under this category will no longer enjoy those regulatory concessions.

The move comes amid heightened regulatory scrutiny of cough syrups and other liquid oral medicines following safety concerns in recent years. The government had already proposed tighter controls on the sale of cough syrups, including limiting their distribution through unlicensed rural practitioners and strengthening oversight of their availability.

Authorities have also focused on the safe use of such medicines in children. Under the draft National Formulary of India (NFI) 2026, cough and cold medications are not recommended for children below two years of age and should generally be avoided in children under five unless medically necessary and administered under close supervision. Increased monitoring has been driven by concerns over contamination in liquid medicines, including the presence of harmful substances such as diethylene glycol (DEG) and ethylene glycol (EG), which can cause severe kidney damage. In response, regulators have strengthened quality-testing requirements for both raw materials and finished syrup formulations.