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Rachel V Thomas

India Ends OTC Sale of Cough Syrups, Doctor's Prescription Now Mandatory

<span>India</span>’s Union Ministry of Health and Family Welfare has issued a notification ending the over-the-counter (OTC) sale of all syrups, including <span>cough syrups</span>.

Under the new rules, a doctor's prescription will now be required to purchase cough syrups across the country.

“Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder,” the notification said.

<h2>Why Are the Rules Being Amended?</h2>

The amendment comes months after contaminated cough syrups were linked to the deaths of 22 children in Madhya Pradesh and Rajasthan, raising fresh concerns over the safety and regulation of commonly used liquid medicines.

Following the incident last year, health authorities in India had banned three cough syrups <span>Coldrif</span>, Respifresh TR and ReLife after traces of diethylene glycol (<span>DEG</span>) were detected in the products. The Coldrif contamination was linked to the deaths of 22 children in the country.

“The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements,” the notification said.

“The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” it added.

<strong>Also read: </strong><a href="https://www.healthandme.com/nutrition/introducing-eggs-before-age-one-may-lower-allergy-risk-by-17-study-article-154537394" data-type="tilCustomLink">Introducing Eggs Before Age One May Lower Allergy Risk by 17%, Says Study</a>

 <h2>Experts Welcome Move To Restrict Cough Syrup Sales</h2>

Dr Kuldeep Kumar Grover, Associate Director, Pulmonology and Critical Care, CK Birla Hospital, Gurugram called it a 

"a good initiative to include all syrup varieties, cough syrups included, under prescription medicines". 

Cough syrups have substances that might lead to drowsiness, addiction, or drug interaction in patients who do not seek medical advice before taking the medicines.

"It is important to note that a 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," Grover said.

Dr. (Prof.) Mohsin Wali, former Physician to the President of India, said cough syrups and similar formulations often contain suppressants such as codeine and dextromethorphan (DXM), along with other solvents.

Dr. Wali, Senior Consultant and Head of Preventive Cardiology at Pacific One Health, recalled previous incidents in which contaminated Indian-made cough syrups were linked to deaths in Gambia and other African countries.

"Industrial-grade solvents were detected in some of these products, leading to kidney failure, severe metabolic acidosis, and, in some cases, death," he said.

According to Dr. Wali, the new notification will help curb the overuse, misuse, and addictive use of cough syrups while improving patient safety. 

The Ministry notified an amendment to the Drugs Rules, 1945, through <span>Gazette Notification</span> G.S.R. 927(E) dated December 29, 2025, published in the Gazette of India Extraordinary, Part II, Section 3, Sub-section (i), dated December 30, 2025. 

The amendment omits the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the heading “Class of Drugs.”

Schedule K of the Drugs Rules, 1945, provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it for specified classes of drugs.

Before this amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions.

With the omission of the word “Syrup” from the entry, this exemption will no longer apply to cough syrups.

Manufacturers, distributors, and retailers dealing with cough syrups have been advised to ensure strict compliance with the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.

Last year, India formally prohibited the use of certain commonly available OTC cough and cold medicines in children below the age of four.

The policy move, notified through a gazette notification, banned a fixed-dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride—two ingredients commonly found in pediatric cough syrups.

The decision followed growing global concerns over the safety of these medicines in very young children, with India joining several countries that have introduced stricter regulations.

Countries including the United States, Canada, and the United Kingdom had previously issued guidelines or warnings regarding the use of OTC cough and cold medicines in young children.

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India’s Union Ministry of Health and Family Welfare has issued a notification ending the over-the-counter (OTC) sale of all syrups, including cough syrups.Under the new rules, a doctor's prescription will now be required to purchase cough syrups across the country.“Consequently, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder,” the notification said.Why Are the Rules Being Amended?The amendment comes months after contaminated cough syrups were linked to the deaths of 22 children in Madhya Pradesh and Rajasthan, raising fresh concerns over the safety and regulation of commonly used liquid medicines.Following the incident last year, health authorities in India had banned three cough syrups Coldrif, Respifresh TR and ReLife after traces of diethylene glycol (DEG) were detected in the products. The Coldrif contamination was linked to the deaths of 22 children in the country.“The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements,” the notification said.“The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” it added.Also read: Introducing Eggs Before Age One May Lower Allergy Risk by 17%, Says Study Experts Welcome Move To Restrict Cough Syrup SalesDr Kuldeep Kumar Grover, Associate Director, Pulmonology and Critical Care, CK Birla Hospital, Gurugram called it a "a good initiative to include all syrup varieties, cough syrups included, under prescription medicines". Cough syrups have substances that might lead to drowsiness, addiction, or drug interaction in patients who do not seek medical advice before taking the medicines. "It is important to note that a 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," Grover said.Dr. (Prof.) Mohsin Wali, former Physician to the President of India, said cough syrups and similar formulations often contain suppressants such as codeine and dextromethorphan (DXM), along with other solvents.Dr. Wali, Senior Consultant and Head of Preventive Cardiology at Pacific One Health, recalled previous incidents in which contaminated Indian-made cough syrups were linked to deaths in Gambia and other African countries."Industrial-grade solvents were detected in some of these products, leading to kidney failure, severe metabolic acidosis, and, in some cases, death," he said.According to Dr. Wali, the new notification will help curb the overuse, misuse, and addictive use of cough syrups while improving patient safety. What Did The Notification Say?The Ministry notified an amendment to the Drugs Rules, 1945, through Gazette Notification G.S.R. 927(E) dated December 29, 2025, published in the Gazette of India Extraordinary, Part II, Section 3, Sub-section (i), dated December 30, 2025. The amendment omits the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the heading “Class of Drugs.”Schedule K of the Drugs Rules, 1945, provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it for specified classes of drugs.Before this amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions.  With the omission of the word “Syrup” from the entry, this exemption will no longer apply to cough syrups.Manufacturers, distributors, and retailers dealing with cough syrups have been advised to ensure strict compliance with the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.Ban On Pediatric Cough SyrupsLast year, India formally prohibited the use of certain commonly available OTC cough and cold medicines in children below the age of four.The policy move, notified through a gazette notification, banned a fixed-dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride—two ingredients commonly found in pediatric cough syrups.The decision followed growing global concerns over the safety of these medicines in very young children, with India joining several countries that have introduced stricter regulations.Countries including the United States, Canada, and the United Kingdom had previously issued guidelines or warnings regarding the use of OTC cough and cold medicines in young children.

india ends otc sale of cough syrups, doctor's prescription now mandatory

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