The Centre has barred the over-the-counter sale of syrup medicines, including cough syrups, by making a doctor's prescription mandatory for their purchase. The development comes as authorities tighten oversight of liquid oral formulations following several contamination-linked deaths among children in recent years.

The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026, bringing syrup formulations under stricter regulatory control. The amendment has come into force with immediate effect following its publication in the Official Gazette.

Prescription mandatory for syrup medicines

Under the amendment, the word "syrups" has been removed from Schedule K of the Drugs Rules, 1945. Schedule K lists categories of medicines exempt from certain provisions governing the manufacture, sale and distribution of drugs under the Drugs and Cosmetics Act, 1940.

With the exemption withdrawn, consumers will now require a doctor's prescription to purchase syrup medicines, including cough syrups. However, lozenges, pills and tablets used for cough treatment continue to remain exempt under Schedule K.

The amendment follows a draft notification issued on December 29, 2025, inviting objections and suggestions from stakeholders and the public. The government said all comments received were considered before the final notification was issued after consultation with the Drugs Technical Advisory Board (DTAB), the country's highest statutory body on technical matters related to drugs.

The notification stated, "Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely."

The amendment further read, "In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word 'Syrups,' shall be omitted."

Move follows safety concerns over cough syrups

The decision comes amid heightened scrutiny of cough syrups and other liquid oral formulations following multiple incidents of contamination-linked deaths among children in India and abroad.

According to official sources, the amendment is aimed at enhancing traceability and regulatory supervision of syrup-based medicines while ensuring manufacturers and sellers comply with stricter licensing and quality-control requirements.

The issue was discussed at a meeting of the Drug Consultative Committee (DCC), the apex drug regulator's advisory body, after reports of deaths linked to contaminated cough syrups.

"DCC was apprised about the recent incidence due to contaminated cough syrup and it was proposed that the exemption provided under …Schedule K … in respect of syrups for cough may be deleted. DCC deliberated the matter and approved the proposal," the committee noted.

Health experts have also pointed to risks associated with inappropriate use of cough syrups among children. Certain formulations containing dextromethorphan are not recommended for young children and can lead to severe respiratory depression in vulnerable cases. The new requirement is expected to improve medical supervision before such medicines are consumed.

Series of contamination cases raised alarm

The latest policy shift comes months after at least 22 children reportedly died in Madhya Pradesh's Chhindwara district after consuming contaminated cough syrup.

Investigations found that the syrup involved in the case had been manufactured by a Tamil Nadu-based company and contained 48.6 per cent diethylene glycol (DEG), far above the maximum permissible limit of 0.1 per cent.

The incident was not isolated. In 2022, the World Health Organisation raised an alert after 70 children died in The Gambia and another 18 in Uzbekistan following the consumption of syrup formulations manufactured by Indian companies. The cases prompted the government to mandate laboratory testing of all syrup batches meant for export.

Earlier, at least 17 children died in Jammu and Kashmir's Ramnagar in 2020 after consuming a cough syrup that was later found to contain 34.97 per cent DEG. In 1998, another contamination incident in Gurugram was linked to the deaths of 33 children, while around 150 children were treated for acute kidney failure at Delhi's Kalawati Saran Children's Hospital.

Stricter oversight of syrup-based medicines

Officials said the amendment is expected to strengthen monitoring of syrup medicines across the supply chain and reduce the risk of misuse and contamination. By bringing all syrup formulations under prescription-based sale, authorities aim to improve patient safety and ensure greater accountability in the manufacture and distribution of these products.