Cough syrups go prescription-only: Why liquid medicines are facing scrutiny

India's Health Ministry has made cough syrups prescription-only and ordered tighter quality checks for all syrups. The move follows contamination-linked deaths and rising concern over misuse, addiction and unsafe self-medication.

In Short

• The Centre has ended the over-the-counter status of cough syrups in India
• Doctors warned over-the-counter access encouraged wrong doses and recreational misuse
• Experts said cough may signal asthma, infection or allergies needing diagnosis

The Union Health Ministry has introduced stricter quality checks for all syrups, including cough syrups, before they can be sold to patients. A new directive states that cough syrups can now be sold only with a doctor's prescription, ending their decades-long over-the-counter availability.

The decision comes after growing concerns over the safety and misuse of cough syrups, following several incidents in India and other countries where contaminated syrups were linked to deaths.

The new rule is not just about cough syrups, but about making sure that all liquid medicines are safe and are used properly.

The amendment removes the word "Syrups" from a category of medicines listed in Schedule K of the Drugs Rules, a move that effectively ends their over-the-counter availability and places them under stricter regulatory control.

WHY HAVE COUGH SYRUPS BEEN UNDER THE SPOTLIGHT?

The renewed scrutiny stems from a series of tragedies involving contaminated syrups containing toxic chemicals such as diethylene glycol (DEG) and ethylene glycol (EG), substances used in industrial solvents that can cause kidney failure, severe metabolic disturbances and even death.

Earlier this year, authorities in Madhya Pradesh launched an investigation after two children died in Shivpuri district following the consumption of medicines, including cough syrup. Samples were seized and sent for analysis.

In another incident in Rajasthan's Alwar district, five children lost their lives and several others fell ill after consuming medicines later found to contain harmful substances.

The episode raised fresh concerns about the quality and monitoring of liquid medicines.

These incidents came after India faced international scrutiny following reports linking Indian-made cough syrups to child deaths in countries such as The Gambia, Uzbekistan and Cameroon.

WHY THE LATEST GOVERNMENT NOTIFICATION MATTERS

Under the amended Drugs Rules, 1945, syrups will no longer be exempt from mandatory batch-wise testing by government laboratories.

Doctors say the decision was necessary because concerns surrounding syrups extend beyond contamination.

"It’s indeed a good initiative to include all syrup varieties, cough syrups included, under prescription medicines. Cough syrups have substances which might lead to drowsiness, addiction, or drug interaction in patients who do not seek medical advice before taking the medicines," said Dr Kuldeep Kumar Grover, Associate Director, Pulmonology and Critical Care, CK Birla Hospital, Gurugram.

He noted that over-the-counter availability often leads to improper dosage and even recreational misuse among teenagers and young adults.

"It is important to note that cough could be a symptom of other serious conditions like infections, asthma and allergies. Prescription-based access encourages proper evaluation, accurate treatment and safer medication use," he added.

COUGH DOES NOT ALWAYS NEED A SYRUP

People usually treat symptoms rather than understanding the disease behind them. Not every cough needs a cough syrup. First a doctor's intervention is required.

"Medicines should ideally be taken under a doctor's guidance because in medicine, we do not simply match a symptom to a drug. A cough does not automatically mean a cough syrup, and a fever does not automatically mean a fever medicine. Every symptom has an underlying cause, and our goal is to treat the disease rather than just suppress the symptoms," said Dr. Sanjay Wazir, Director, Pediatrics Department, Motherhood Hospital, Gurgaon.

According to him, not all coughs are the same. Some are caused by asthma and may worsen if suppressed. Productive coughs help clear mucus and often should not be stopped.

"In many cases, mild coughs do not require medication at all. Simple remedies such as honey, warm water and staying well-hydrated are often enough, and the body's immune system takes care of the problem over time. Cough suppressants are needed only when the cough is severe, exhausting or causing significant discomfort," he said.

He added that different cough syrups contain different ingredients and should not be viewed as harmless over-the-counter remedies.

MISUSE, ADDICTION AND ACCIDENTAL USE IN CHILDREN

Cough syrups and other liquid medicines have become a public health concern because of both contamination and misuse.

Dr. Mohsin Wali, Senior Consultant and Head of Preventive Cardiology at Pacific One Health and former Physician to the President of India, pointed out that some syrups contain ingredients such as codeine and dextromethorphan (DXM), which can cause dependence and are increasingly being misused.

"In some cases, codeine-containing syrups were used for non-medical purposes by young adults because of their morphine-like pleasurable effects, resulting in severe addiction. Some ingredients also have hallucinogenic effects and are misused," he said.

Dr. Wali also warned that some parents use cough syrups simply to make young children sleep because many formulations contain antihistamines that induce drowsiness.

"The problem is increasing day by day. To avoid overuse, misuse and addictive use, and to maintain the credibility of our pharmaceutical exports, such products should be brought under control and made available only on prescription," he said.

He added that the latest gazette notification was necessary to save lives and prevent abuse of these commonly used medicines.

"Despite their popularity, cough syrups have recently received attention for negative health effects attributed to their contamination. More rigorous quality control and regulatory procedures concerning their production and sale have positively impacted patient safety," said Dr. Tushar Tayal, Associate Director, Internal Medicine, CK Birla Hospital, Gurgaon.

However, he stressed that patients should understand that not every cough requires medication.

"Viral infections causing cough often resolve on their own, and there are no medications necessary other than drinking plenty of water and resting. Patients should use cough syrups only when recommended by a healthcare provider, particularly if a child, an elderly person or someone with pre-existing illnesses is taking them," Dr Tayal said.

The broader message behind the government's latest move highlights that medicines in syrup form, whether cough syrups or other formulations, should not be considered harmless household remedies.

Like all medicines, they need proper quality checks and should ideally be used under medical supervision.

This, of course, requires strengthening trust in India's pharmaceutical industry and imposing stricter oversight of syrups to prevent future tragedies.

After all, medicines are meant to heal, not become a source of harm.

- Ends