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India bans over-the-counter cough syrup purchase, makes doctor's prescription mandatory
WHO earlier expressed ‘deep concerns’ over the lack of drug safety regulations in India, after more than 20 children died following intake of contaminated cough syrups in Madhya Pradesh
- PUBLISHED: Tue 16 Jun 2026, 12:37 PM UPDATED: Tue 16 Jun 2026, 12:42 PM
In a bid to curb the misuse of cough syrups across India and to prevent incidents such as the death of children in a few states last year after consuming the syrup, the central government on Tuesday made it mandatory for buyers to have a doctor’s prescription before buying syrup-based medicines.
Consumers will now have to produce a valid prescription from a doctor while buying cough syrups and other syrup-based medicines.
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In October last year, the World Health Organisation (WHO) expressed its ‘deep concerns’ over the lack of drug safety regulations in India, after more than 20 children died following intake of contaminated cough syrups in Chhindwara district in Madhya Pradesh and even in parts of Rajasthan. The alerts related to three cough syrups manufactured in the country, including Coldrif, Respifresh TR and ReLife – which were identified as being substandard.
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Safety concerns have also been raised in India about the over-the-counter availability of cough and oral liquid medicines. The draft National Formulary of India 2026 urged the government not to allow the prescription or dispensing of cough and cold medicines to children below two, and even stop their being recommended for those under five, unless it was clinically necessary and supervised closely.
Toxic substances
A few brands of Indian cough syrups have over the years raised concerns across the world. About 90 deaths of children in The Gambia, Cameroon and Uzbekistan in 2023 were linked to Indian syrups contaminated with diethylene glycol (DEG).
There have been reports of toxic substances including diethylene glycol and ethylene glycol contaminating liquid oral formulations, resulting in serious ailments including renal and neurological toxicity, damaging the kidney and brain functions. DEG is a toxic industrial solvent used for break fluids and antifreeze.
Laboratory tests later revealed that the concentration of DEG in the samples were hundreds of times more than the permissible limits.
There are also fears that the growing tendency among many Indians to opt for self-medication or consuming syrups on the basis of non-medical advice leads to serious health problems for the young.
The Drugs Controller of India has inspected over 90 per cent of the 1,100 cough syrup manufacturers in the country and found there were a lot of compliance lapses. “We took serious actions on non-compliances, and our belief is that the rot of cough syrup manufacturing will be removed,” Drugs Controller General of India Rajeev Raghuvanshi, said at a global pharmaceutical quality summit in Mumbai in February.
Raghuvanshi said he wants to raise the standards of the Indian drugs regulator, bringing it on par with the US Food and Drug Administration.
