Key Summary
- The decision follows reports of contamination-linked deaths of children in India and several countries.
- The latest amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines.
- The health ministry said they have consulted the Drugs Technical Advisory Board before amending rules.
India has amended rules to prohibit the sale of cough syrups without a doctor's prescription, amid growing safety concerns over their unchecked use.
It has also restricted cough syrup sales to licensed pharmacies, especially in villages.
The move follows a draft notification issued by the government in December last year seeking objections and suggestions from stakeholders.
The health ministry said the comments received from the public had been considered before finalising the amendment, and they have consulted the Drugs Technical Advisory Board (DTAB).
The latest government notification has removed cough syrups from the exemption list, while allowing pills, tablets and lozenges to remain on it.
The decision comes following reports of contamination-linked deaths of children in India and several countries.
The World Health Organisation (WHO) had last year issued an alert against three contaminated cough syrups in India, following the death of over 20 children.
The latest amendment is expected to enhance traceability and regulatory supervision of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality-control requirements.
The All India Organisation of Chemists and Druggists (AIOCD) has welcomed the health ministry's notification.
