Buying A Cough Syrup? You'll Now Need A Doctor's Prescription As Centre Tightens Drug Safety Norms

New Delhi: In a significant move aimed at strengthening drug safety and curbing the unrestricted sale of liquid medicines, the Central Government has made a doctor's prescription mandatory for the purchase of syrup-based medicines, including cough syrups, by amending the Drugs Rules, 1945.

The Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, under which the word "syrups" has been removed from Schedule K of the Drugs Rules, 1945. The amendment came into force immediately upon its publication in the Official Gazette on June 9.

The decision effectively ends the over-the-counter (OTC) sale of syrup formulations that earlier enjoyed regulatory exemptions under Schedule K, bringing them under stricter oversight and prescription-based dispensing.

What has changed?

Schedule K of the Drugs Rules, 1945, lists categories of medicines that are exempt from certain provisions related to the manufacture, sale and distribution of drugs. These exemptions were introduced to facilitate easier public access to specific products such as antiseptics, antacids and contraceptives under defined conditions.

With the latest amendment, syrup-based formulations have been removed from this exempted category. As a result, pharmacies will no longer be permitted to sell such medicines without a valid prescription from a registered medical practitioner.

The move is intended to strengthen monitoring of liquid oral medicines and prevent misuse while ensuring greater accountability across the supply chain.

Triggered by safety concerns

The regulatory tightening comes against the backdrop of heightened global scrutiny of cough syrups and other liquid oral formulations following a series of contamination incidents reported in recent years.

Several countries had flagged concerns over cough syrups found to contain toxic substances such as diethylene glycol (DEG) and ethylene glycol (EG), chemicals that can cause severe kidney injury, organ failure and even death, particularly among children.

The incidents prompted Indian regulators to introduce stricter quality control measures, including mandatory testing of raw materials and finished products used in syrup manufacturing.

Drug safety experts have repeatedly stressed the need for tighter controls on the sale and distribution of cough syrups, especially in rural and semi-urban areas where medicines are often purchased without medical consultation.

According to the Health Ministry, the amendment follows an extensive consultation process initiated in December 2025 when draft rules proposing the change were placed in the public domain.

Stakeholders, including pharmaceutical companies, pharmacists, medical professionals and consumer groups, were invited to submit objections and suggestions. After examining the feedback received, the government finalised the amendment.

The proposal was also reviewed by the Drugs Technical Advisory Board (DTAB), the country's highest statutory body on technical matters related to drugs and cosmetics, before being notified.

The past cases

In September 2025, at least 22 children had died in Madhya Pradesh after consuming a contaminated cough syrup found to contain nearly 45% diethylene glycol (DEG), a toxic industrial solvent used in brake fluid and antifreeze. The concentration is hundreds of times above the permissible limit of 0.1% set by pharmacopeial safety standards.

The syrup, branded Coldrif, was manufactured by Sresan Pharmaceuticals in Tamil Nadu and distributed across several districts of Madhya Pradesh. Laboratory tests had confirmed the dangerously high DEG levels.

Over the years, DEG in Indian-made cough syrups has claimed dozens of young lives. In 2023, Indian syrups tainted with DEG were linked to the deaths of 70 children in The Gambia and 18 in Uzbekistan.

Between December 2019 and January 2020, at least 12 children under five had died in Jammu allegedly from cough syrup, with activists suggesting the number of casualties might have been higher. In the past, there's also been abuse of cough syrups containing codeine, a mild opioid that can produce euphoria in high doses and lead to dependence and is not advised for young children.

Focus on children's safety

The move also aligns with the government's broader efforts to regulate the use of cough and cold medications among children.

As part of the draft National Formulary of India (NFI) 2026, authorities have proposed that cough and cold medicines should not be prescribed or dispensed to children below the age of two years. The draft further states that such medicines are generally not recommended for children under five unless there is a clear clinical necessity and close medical supervision.

Public health experts have long cautioned against the indiscriminate use of cough syrups in young children, citing limited therapeutic benefits and potential safety risks.

The latest amendment is part of a series of regulatory measures undertaken by the government to enhance the safety, quality and traceability of medicines manufactured and sold in India.

Stricter controls over syrup formulations will help prevent the circulation of unsafe products.

With the removal of syrups from Schedule K, the government has regulated liquid medicines, particularly those widely used by children.