Govt tightens sale of liquid medicines with high alcohol content

New Delhi: The Centre has tightened the sale of liquid medicines containing high levels of alcohol, moving them into the restricted category to curb misuse, according to a health ministry statement.

Oral liquid medicines containing more than 12% ethyl alcohol and sold in bottles larger than 30 ml have been moved to the restricted Schedule H1 category. The products include cough syrups, aromatic preparations such as tinctures of cardamom and ginger, tonics and other medicinal mixtures that were previously exempt from stricter sales controls under Schedule K.

With their inclusion under Schedule H1, these medicines can now be sold only against the prescription of a registered medical practitioner and supplied only through regulated pharmaceutical distribution chain, reducing the risk of diversion and misuse while preserving access for legitimate therapeutic use, the ministry said.

“In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol,” the gazette notification said.

The decision follows consultations with the Drugs Technical Advisory Board and requests from several state governments to curb the misuse of these products.

The ministry said some formulations contain alcohol concentrations of up to 80-90%, "making them susceptible to misuse for intoxication.”

A draft notification in this regard was released for public comments in October 2025, and no objections were received.

Pharmacies will have to maintain stricter sales records, while manufacturers and sellers will be required to obtain licences under the Drugs and Cosmetics Act, 1940.

Chemists and manufacturers have been given six months to comply with the new regulation before it officially starts.

The health ministry said that the initiative is “in line with the Government's continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health.”

The tightening also comes amid rapid expansion in India's pharmaceutical industry which is projected to cross $60 billion in 2026. The market is expected to nearly double to about $130 billion by 2030, prompting greater emphasis on compliance, traceability and responsible use of medicines.

“Alcohol-containing medicinal formulations have been part of clinical practice for decades, as ethyl alcohol serves as an effective solvent and preservative, helping maintain the stability and bioavailability of many active ingredients", said Dr Aijaz Ilmi, senior consultant, metabolic diseases, Pacific OneHealth Hospitals.

"However, preparations containing very high concentrations of alcohol warrant closer clinical oversight because of their higher potential for inappropriate use outside legitimate medical indications. These medicines should be prescribed only after a careful assessment of the patient's overall health, co-existing medical conditions, concurrent medications, and individual risk factors,” Ilmi said.

Bringing such products under Schedule H1 reinforces responsible prescribing and dispensing without compromising access for patients who genuinely require them, Ilmi said. “It also highlights the pharmacist's crucial role in ensuring regulatory compliance, preventing misuse, and maintaining appropriate dispensing records.”