No sale of syrups without doctor's prescription; here's what govt did

The Centre has amended the Drugs Rules, 1945 and removed 'syrups' from a category under Schedule K, amid tighter oversight of cough syrups and drug safety

The Centre has amended the Drugs Rules, 1945, removing the word “syrups” from a category of exempted drugs listed under Schedule K, signalling tighter regulatory oversight of syrup-based formulations. This effectively means that over-the-counter sale of syrups, including cough syrups, without a doctor's prescription will now be prohibited. 

The Ministry of Health and Family Welfare notified the change through the Drugs (Fifth Amendment) Rules, 2026. Under the notification, the government has omitted the word “syrups” from Schedule K, narrowing the list of medicines eligible for exemptions under the rules.

What is Schedule K?

 

Schedule K under the Drugs Rules, 1945 lists categories of drugs that are exempt from certain provisions governing manufacture, sale and distribution, subject to specified conditions. 

 

These exemptions were introduced to allow easier access to certain categories of medicines under specified circumstances by easing some compliance requirements. 

With the removal of “syrups” from the exempted category, syrup formulations covered under that provision will no longer receive the same regulatory relaxation available earlier.

Why cough syrups have come under focus

The amendment comes amid growing regulatory attention on cough and oral liquid medicines following safety concerns in recent years. 

The government had earlier proposed stricter rules for cough syrup sales, including restricting their availability through unlicensed village pharmacists and tightening conditions around distribution. 

Separately, authorities have moved to strengthen safeguards around paediatric use of such medicines. 

As part of the draft National Formulary of India (NFI) 2026, the Centre proposed that cough and cold medicines should not be prescribed or dispensed to children below two years and are generally not recommended for children under five unless clinically necessary and closely supervised. 

The increased scrutiny follows concerns over contamination in liquid oral formulations and reports involving toxic substances such as diethylene glycol (DEG) and ethylene glycol (EG), both of which can cause serious kidney injury. 

Regulatory agencies have since tightened testing requirements for raw materials and finished products, particularly for ingredients used in syrup formulations.