In a major regulatory move aimed at improving drug safety and preventing the indiscriminate sale of liquid medicines, the Centre has made a doctor’s prescription mandatory for the purchase of syrup-based medicines, including cough syrups, through an amendment to the Drugs Rules, 1945.
The Ministry of Health and Family Welfare has notified the Drugs (Fifth Amendment) Rules, 2026, removing “syrups” from Schedule K of the Drugs Rules. The amendment took effect immediately after its publication in the Official Gazette on June 9. The change effectively ends the over-the-counter sale of syrup formulations that were previously exempt from certain regulatory provisions under Schedule K, bringing them under a stricter prescription-based regime.
What the amendment means
Schedule K contains a list of medicines exempted from specific provisions governing the manufacture, sale and distribution of drugs. The exemptions were originally intended to facilitate easier access to certain products under regulated conditions. With syrup formulations no longer included in the exempted category, pharmacies will now be required to obtain a valid prescription from a registered medical practitioner before dispensing such medicines. The government said the amendment is intended to improve monitoring of liquid oral medicines, curb misuse and strengthen accountability in the distribution chain.
Safety concerns behind the move
The decision comes amid growing concerns over the safety of cough syrups and other liquid oral formulations following a series of contamination incidents reported in India and abroad in recent years. Several countries had raised alarms over cough syrups contaminated with toxic substances such as diethylene glycol (DEG) and ethylene glycol (EG), chemicals known to cause severe kidney damage, organ failure and, in some cases, death, particularly among children.
In response, Indian regulators have introduced tighter quality-control measures, including mandatory testing of raw materials and finished products used in syrup manufacturing. Drug safety experts have also long advocated stricter controls on the sale of cough syrups, especially in areas where medicines are frequently purchased without professional medical advice.
Consultations before notification
According to the Health Ministry, the amendment follows a consultation process launched in December 2025, when draft rules proposing the change were placed in the public domain. Representatives from the pharmaceutical industry, pharmacists, medical professionals and consumer groups were invited to submit suggestions and objections. After reviewing the feedback, the government finalised the amendment. The proposal was also examined by the Drugs Technical Advisory Board (DTAB), the country’s apex statutory body on technical matters relating to drugs and cosmetics, before receiving final approval.
Contamination incidents triggered scrutiny
The regulatory tightening follows several serious incidents involving contaminated cough syrups. One of the most alarming cases occurred in September 2025, when at least 22 children reportedly died in Madhya Pradesh after consuming a contaminated cough syrup found to contain nearly 45% diethylene glycol (DEG), a toxic industrial solvent commonly used in brake fluid and antifreeze.
The syrup, marketed under the brand name Coldrif and manufactured by Sresan Pharmaceuticals in Tamil Nadu, was distributed across multiple districts of Madhya Pradesh. Laboratory tests later confirmed DEG levels far exceeding the permissible limit of 0.1% prescribed under pharmacopeial standards. Officials said the latest amendment forms part of broader efforts to strengthen drug regulation, improve patient safety and restore public confidence in the quality and distribution of medicines.