To prevent the misuse of certain alcohol-containing medicines, the government has brought them under Schedule H1. Here’s everything patients need to know about the new rules.
Published: July 10, 2026, 11:38 PM IST
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The government has banned several high concentration cough syrups in India. Representational image
In a move to tighten the sale of high-alcohol medicines, the Centre has decided to include oral medicines containing more than 12 per cent ethyl alcohol and sold in bottles exceeding 30 ml under Schedule H1 of the Drugs Rules, 1945.
The government says the move is designed to reduce the misuse of these medicines while allowing patients to obtain them through a doctor’s prescription.
What is the new rule?
The Government of India has introduced stricter regulations for high-alcohol medicinal syrups and tonics. Products containing more than 12 per cent alcohol by volume will now require a doctor’s prescription to help prevent misuse and protect public health.
The new rule issued by the Ministry of Health and Family Welfare strengthens the regulation of alcohol-containing oral medicines.
As per the new rule, medicinal syrups, tonics, tinctures, and other oral formulations containing more than 12 per cent ethyl alcohol (v/v) and sold in packs larger than 30 ml are now classified as prescription-only medicines. Meanwhile, these medicines cannot be sold over the counter, and a valid prescription from a registered medical practitioner is mandatory before a pharmacy can dispense them.
It further said that pharmacies must maintain records and comply with the stricter requirements that apply to prescription medicines, helping regulators monitor their sale and reduce misuse.
What is Schedule H1?
Introduced in 2013, Schedule H1 covers a group of prescription medicines that are subject to stricter regulations under the Drugs and Cosmetics Rules, 1945. The category was created to prevent the misuse of antibiotics and habit-forming drugs.
Some of the key features of Schedule H1 state that these medicines can only be sold on the prescription of a Registered Medical Practitioner (RMP). Over-the-counter (OTC) sale is prohibited. Another feature states that every Schedule H1 medicine must carry the following warning inside a red-bordered box :
Schedule H1 Drug – Warning:
It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Some of the Schedule H1 medicines include Third- and fourth-generation antibiotics, certain anti-tuberculosis (anti-TB) medicines, habit-forming or high-risk medicines, and other drugs notified by the government from time to time.
Why is alcohol in medicines in the first place?
Alcohol, usually in the form of ethanol, is added to certain medicines for pharmaceutical reasons. It helps maintain the medicine’s stability and effectiveness rather than producing any intoxicating effect.
It is important to understand the reason for the use of alcohol in medicines. Firstly, it acts as a solvent, as many active pharmaceutical ingredients, herbal extracts, essential oils, and flavoring agents do not dissolve well in water. It also helps preserve the medicine, as Alcohol inhibits the growth of bacteria, fungi, and other microorganisms, helping to extend the shelf life of liquid medicines such as syrups, tinctures, and tonics.
It helps improve chemical stability, as some active ingredients degrade quickly in water alone. Ethanol helps stabilise these ingredients, allowing the medicine to remain effective throughout its shelf life. In Ayurvedic, Unani, homeopathic, and herbal medicines, alcohol is often used to extract medicinal compounds from plants more efficiently than water.
It helps to improve absorption and also improve the solubility of the active ingredient, which may help the body absorb it more effectively. Alcohol can help dissolve flavoring agents and reduce bitterness in some liquid medicines, making them easier to consume.
What will this mean for consumers?
The government’s new prescription requirement for high-alcohol oral medicines will change how consumers purchase and use certain syrups and tonics. Now, a doctor’s prescription is required for oral medicines containing more than 12 per cent ethyl alcohol (v/v) (as specified under the new regulatory proposal).
This also means consumers will no longer be able to buy these products over the counter. However, routine cough syrups and common medicines will not be automatically affected. Under the new rule, pharmacists must verify prescriptions before dispensing these medicines and comply with Schedule H1 record-keeping requirements.
It will ensure better patient safety, as a doctor’s evaluation helps ensure the medicine is appropriate, the dosage, and potential side effects. Better patient safety. A doctor’s evaluation helps ensure the medicine is appropriate, dosage, and potential side effects.
