India has moved to restrict the sale of cough syrups strictly to licensed pharmacies, particularly in rural areas, putting an end to over-the-counter sales through general retail outlets. The decision comes as the country’s drug regulators have been under growing pressure to tighten oversight following child deaths connected to contaminated medicines.
Previously, certain cough syrups were included on an exemption list under India’s drug regulations, which allowed them to be sold as common household remedies without the stricter requirements that apply to other medications. This meant vendors holding limited retail licenses — often operating in small towns or villages with populations of no more than 1,000 and no nearby pharmacy — were permitted to sell these products. Customers frequently purchased the syrups without a prescription, sometimes from stores that had nothing to do with pharmaceuticals.
As of a government notification dated June 15, cough syrups have been removed from that exemption list. Pills, tablets, and lozenges will continue to be covered under the relaxed rules.
India’s Health Ministry issued a statement explaining the change: “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.”
The ministry added: “The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.”
A health ministry official, speaking without attribution, noted that in urban areas, cough syrups were already required to be sold through registered pharmacies under existing rules.
India’s pharmaceutical industry, which is largely made up of smaller manufacturers and is projected to reach a value of $130 billion by 2030, has faced mounting criticism over quality control in recent years. Since 2022, cough syrups manufactured in India have been connected to the deaths of more than 140 children in Africa and Central Asia, dealing a significant blow to the country’s standing as the so-called “pharmacy of the world.”
Last October, a syrup called Coldrif, made by Sresan Pharmaceutical, was linked to the deaths of 24 children. The country’s drug regulatory agency reported in February that it had completed inspections of nearly 90% of cough syrup manufacturers and had taken action against those found to be out of compliance.
Tushar Tayal, a doctor at CK Birla Hospital in Gurgaon, voiced support for the new policy. “We have seen people with chronic cough resorting to self-medication,” he said, noting that the latest action is necessary in light of ongoing safety and quality concerns.
