The Union Health Ministry has made a doctor’s prescription mandatory for purchasing all medicinal syrups, including cough syrups, by removing the term “syrup” from Schedule K of the Drugs Rules, 1945.
The decision follows the deaths of more than 300 children in several countries since 2022 due to contamination of India-made cough syrups with ethylene glycol (EG) and diethylene glycol (DEG).
Many over-the-counter cough syrups contain a combination of bronchodilators, antihistamines, and decongestants, which may cause harmful effects, especially in children.
The contamination incidents highlighted failures in manufacturing quality control, raw material testing, and regulatory oversight, rather than problems related to consumer access.
India has around three dozen State drug controllers, but enforcement remains weak because of a shortage of inspectors and inadequate regulatory capacity.
The World Health Organization (WHO) issued warnings in 2022 and 2023 regarding contaminated Indian cough syrups, raising concerns about India's pharmaceutical quality standards.