Cough syrups to be sold only on doctor’s prescription as govt strengthens regulatory oversight
NEW DELLHI, JUNE 16 : In a move to introduce tighter regulatory control, the centre has issued a notification mandating that all syrups, including cough syrups, will need a doctor’s prescription before they are purchased.
Now, the over-the-counter (OTC) sale of these syrups will not be allowed.
The long-awaited decision comes after contaminated cough syrups were found to be linked to children’s deaths in India and abroad.
The Union Health and Family Welfare Ministry notified an amendment to the Drugs Rules, 1945, omitting the word “Syrup” from Schedule K of the Drug Rules, 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 made thereunder 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 said entry, this exemption will no longer be available for cough syrups.
Thus, 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 under it.
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 measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” officials said.
Welcoming the government’s decision, Dr Kuldeep Kumar Grover, Associate Director, Pulmonology and Critical Care, CK Birla Hospital, Gurugram, said including all syrup varieties, including cough syrups, under prescription medicines is a good step. “Cough syrups have substances which might lead to drowsiness and addiction in patients who do not seek medical advice before taking the medicines.”
“Being OTC drugs, there might be instances when they may be used for the wrong reasons, such as improper dosage administration and even for recreation in teens and young adults. It is important to note that a cough can be a symptom of other serious conditions, such as infections, asthma, and allergies. Prescription-based access encourages proper evaluation, accurate treatment, and safer medication use,” he added.
Centre mandates prescription for syrup medicines, including cough syrups, bars over-the-counter sale.
Eight arrested, 5,050 bottles of banned cough syrup seized in Bargarh
Advertisement
Dr (Prof) Mohsin Wali, Senior Consultant and Head of Preventive Cardiology at Pacific One Health, said that some African countries reported children’s death after consuming cough syrups, which contained industrial solvent, that caused kidney failure, severe metabolic acidosis and deaths in some cases.
“This brought a bad name to our country and resulted in the banning of some of these products,” he said.
The centre also advised manufacturers, distributors and retailers dealing with cough syrups to ensure strict adherence to the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The government took the step after a series of incidents rocked the country involving contaminated cough syrups, containing diethylene glycol (DEG) and ethylene glycol (EG), toxic industrial solvents used in antifreeze, paints, brake fluids, and plastics. These substances can be fatal even when taken in small amounts, especially for children.
Last year, as many as 20 children died in Madhya Pradesh and Rajasthan due to contaminated cough syrups, leading the World Health Organisation (WHO) to voice “deep concern” over gaps in India’s drug safety regulations.
India-made cough syrups came under global scanner after they were found to be linked to deaths of 70 children in The Gambia in 2022, 20 in Uzbekistan and 12 in Cameroon in 2023.
As India’s reputation as the “pharmacy of the world” suffered a severe blow, it was made mandatory for cough syrups intended for export to be tested at government-approved laboratories.
Describing the step as “significant,” Dr Meena J., Senior Consultant, Paediatrics and Neonatology, Aakash Healthcare, said many syrup medicines, especially cough and cold syrups, are often purchased without proper medical advice.
“Children are not small adults, and the wrong medicine or dose can sometimes do more harm than good. Making syrups prescription-only will encourage parents to consult a doctor before giving their children medicines. Sometimes it may mean an extra visit to the clinic, but the long-term benefit is safer and more appropriate treatment. This step can help reduce misuse, prevent medication errors, and improve child health safety across the country,” Dr Meena said.
-PTI
