Srinagar, Jun 16: Strengthening vigil of pharmaceutical sales and curb misuse of drugs, the Union Ministry of Health and Family Welfare on Tuesday amended the Drugs (Fifth Amendment) Rules, 2026, removing the word “Syrups” from Schedule K of the Drugs Rules, 1945.
This effectively ends the over-the-counter (OTC) availability of all syrup-based medications, including common cough syrups.
A series of incidents involving contaminated cough syrups containing toxic chemicals such as diethylene glycol (DEG) and ethylene glycol has been noted in India over the past. One of the earliest major cases occurred in 2019-20 in the Ramnagar area of Udhampur. Atleast 9-12 children died after consuming the cough syrup Coldbest-PC.
This prompted recalls and investigations into pharmaceutical quality control.
The issue resurfaced in 2022-23, when Indian-manufactured cough syrups were linked to the deaths of dozens of children in countries including the Gambia and Uzbekistan.
The compromised quality and safety practices in manufacturing, supply-chain oversight, and regulatory enforcement have led Health Ministry to relook at the cough syrup manufacturing and dispensing practices.
The new notification was published in the official gazette on Tuesday, June 16, and is effective immediately.
It mandates that for any purchase a syrup formulations from licensed pharmacies, a doctor’s prescription is now required.
Earlier, exemptions under Schedule K allowed the sale of cough syrups and other liquid medicines without prescriptions.
This was permitted in small villages with populations under 1000.
That exemption for cough syrups has now been withdrawn across the country.
This change could have particularly meaningful effects in J&K, where unregulated access to some pharma drugs, especially codeine-based cough syrups, has long been suspected as a gateway to drug addiction crisis.
J&K has one of the highest rates of substance abuse in India.
Although pharmaceutical opioids like codeine are a very small proportion of the addiction pie-chart, it contributes as a primary drug of abuse for starters, mostly in their teens, experts believe.
Illegal sale of prescription drugs and OTC medicines is believed to be fueling the problem.
The amendment is meant to enhance regulatory control of cough syrups and align their sale with contemporary public health and safety standards.
The cough syrups have been in focus over the past few years, and the reckless prescription norms were highlighted recently when many children lost lives in Madhya Pradesh.
In addition, there are broader issues of self-medication and abuse of cough syrups across country.
The Union Health Ministry has advised manufacturers, distributors, and retailers to ensure strict compliance with licensing and regulatory requirements under the amended rules.
Now, requiring prescriptions for purchase of any cough syrup could disrupt casual purchases from local chemists, and improve monitoring of supply-chains, especially in rural and semi-urban areas.
Documented prescriptions may help authorities track patterns and reduce diversion.
In addition, the amendments will encourage proper medical consultation rather than self-medication.
This could help in reducing risks of dependency, overdose, or contamination.
