India has banned over-the-counter sale of cough syrups, making a doctor's prescription mandatory for purchase, after the deaths of dozens of children at home and abroad linked to Indian-made medication triggered global scrutiny of its pharmaceutical industry.

The health ministry has amended rules to remove cough syrups from the list of medicines exempted from the requirement of a doctor’s prescription.

The amended rules have come into force with immediate effect.

Cough syrups manufactured in India have been blamed for the deaths of children in several countries. The WHO has flagged seven Indian-made syrups linked to nearly 300 deaths globally.

In the central Indian state of Madhya Pradesh, at least 22 children died last year after consuming what turned out to be contaminated cough syrup. The investigation into the incident pointed to failures in raw material sourcing and quality control and prompted the country’s drug regulator to form stricter regulations.

The syrup, made by a company in the southern state of Tamil Nadu, was found to contain 48.6 per cent of the toxic contaminant diethylene glycol, an industrial solvent linked to kidney failure that should not be found in medicine.

In the neighbouring state of Rajasthan, two children died after allegedly taking a locally-made Dextromethorphan syrup, a cough suppressant not meant for children. The incidents sparked widespread public outrage, leading to a government investigation.

Contaminated Indian-made syrups have been linked to the deaths of at least 141 children in The Gambia, Cameroon, and Uzbekistan since 2022, damaging the country’s reputation as one of the world’s biggest producers of pharmaceuticals.

In The Gambia alone, 70 children died in 2022 after consuming four cough syrups produced in India.

The WHO said that Uzbekistan’s health ministry found “unacceptable amounts” of diethylene glycol and ethylene glycol in the syrups imported from India.

Dr Anil Kumar J Nayak, head of the Indian Medical Association, said it was a positive development that syrups, particularly cough syrups, would no longer be available over-the-counter as they were causing serious issues.

“We welcome this gazette notification and congratulate the ministry,” he told the Press Trust of India, referring to the amended rules. “Selling these syrups over-the-counter was causing severe problems. Some people were using them for substance abuse. You could find two-three empty syrup bottles in almost any public toilet.”

“This was fuelling the drug trade,” he added. “Also, these syrups were sometimes given to children under three years old, putting their lives at serious risk.”