Bengaluru: You can no longer buy cough syrup or any syrup-based medicine in India without a valid doctor’s prescription.
The move, notified by the Ministry of Health and Family Welfare on 16 June, was made to “strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements”, according to the government’s press release.
The change was made under the Drugs and Cosmetics Act 1940 and the Drugs Rules 1945.
The word syrup was removed from Schedule K of the Drugs Rules. “Prior to this amendment, Entry No. 13 of Schedule K permitted the sale of cough syrups in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing provisions,” the press release stated.
Dr Sivaranjini Santosh, the pediatrician widely known for her battle against mislabeled ORS drinks, lauded the “tough stance” taken by the ministry.
“Because of the over-the-counter sale of cough and cold syrups so many children and infants would have been hospitalised or even would have died because of overdosing,” she said in a post on X.
Also read: Cough syrup deaths—how contaminated Coldrif slipped past regulators
Syrup misuse
A 2024 study published in the Medical Journal Armed Forces India found that nearly 64 per cent of Indians self-medicate. Cough and cold were among the most common ailments treated without prescription.
The Indian cough syrup market was projected to rise from $262.5 million in 2024 to $743 million by 2035, at a CAGR of 9.92 per cent.
Dr. Kafeel Khan, a paediatrician told ThePrint that cough syrups are often nothing more than sedatives in disguise. “It’s not treatment, it is an illusion,” he said.
The concern regarding unsupervised cough syrup use was aggravated by the deaths of children in Madhya Pradesh and Rajasthan due to adulterated syrups.
The move by the ministry is widely seen as a response to the deaths.
Also read: Indians are obsessed with cough syrups. Are they really needed?
Implementation and incompetency
Many have criticised the move calling it a sign of “doctor-govt nexus”.
“Why should we pay Rs 700-1000 to a doctor for a cough syrup? Govt is punishing general public for their own failure and incompitency (sic),” one user said. Many have echoed this concern online.
Entrepreneur Shashikant Kore said the government was opting for an easy way out. “Instead of regulating quality of pharma products, govt is resorting to the easy way out with OTC ban,” he said on X.
Others have pointed out that requiring a prescription doesn’t tackle the risks of adulteration—the reason for the cough syrup deaths.
Many have also pointed out that the implementation of prescription checks in India are already abysmal, noting that even antibiotics are being sold over the counter.