Centre Bans Over-The-Counter Sale Of Syrup, Doctor's Prescription Mandatory: Here's Why It Matters

The Union Ministry of Health and Family Welfare (MoHFW) has issued a notification to ban the sale of over-the-counter cough syrups. The new rule makes a doctor's prescription mandatory for purchasing a cough syrup from pharmacies across the country. 

The Ministry notified the amendment to the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026, which removed the word 'syrups' from the Schedule K of the Rules, 1945 (Serial No. 7, Entry 7). With this amendment into effect, cough syrups cannot be sold over-the-counter as well as in villages with populations below 1,000 persons. 

What is Schedule K?

Schedule K of the Drug and Cosmetic Rules, 1945, provides exemptions from certain provisions under the Drugs and Cosmetics Act, 1945. The Schedule lists the specific classes of drugs exempted from the licensing, manufacturing, and distribution regulations. With the omission of 'syrups' from this schedule, a doctor's prescription is now mandatory for over-the-counter sales.

Health Ministry Bans OTC Sale of Cough Syrups: Why It Matters

The government has made it mandatory that cough syrups will not be sold over the counter without a valid doctor's prescription to tigthen regulations governing the sale of cough syrups and to promote responsible distribution and sale of cough syrups to ensure public health and safety.

This ban comes in the wake of deaths of children due to contaminated cough syrups. Another main concern is illegal supply and distribution of substances in cough syrups. The government aims to curb tragic fatalities linked to toxic contamination of cough syrups and illegal trafficking.

2025 Madhya Pradesh Cough Syrup-linked Deaths of Chidlren

In 2025, cough syrups contaminated with diethylene glycol caused deaths of 24 children in Rajasthan and Madhya Pradesh. These cough syrups were from the domestic batches of 'Coldrif' manufactured by Sresan Pharmaceuticals. Following investigations, the World Health Organisation (WHO) issued an official Medical Product Alert.

Illegal Drug Trafficking of Codeine-based Cough Syrups

Many common cough syrups also contain codeine (a Schedule H drug) and dextromethorphan, ingredients that possess opioid or hallucinogenic properties. In a major anti-narcotic operation in Noida, police have managed to seize illegal trafficking of codeine-based cough syrup worth Rs 7.25 lakh. Preliminary investigation revealed that each 5 ml dose of the seized cough syrup contained 10 mg of Codeine Phosphate.

In another major drug bust, Assam's Cachar police seized 21,600 bottles of illegal codeine-based syrup along the NH-27 near Puticherra Toll Gate. Earlier in 2023, The Anti-Narcotics Cell of Mumbai Police had busted an interstate drug smuggling racket and seized codeine-based cough syrups worth Rs 35 lakh. Another instance of illegal drug trade had surfaced in Patna in 2025 when police raided the Ramkrishna Nagar area and seized around 30,000 bottles of codeine-based cough syrup worth Rs 50 lakh.