New Delhi, June 16 (IANS). The central government on Tuesday amended the Drugs Rules, 1945, banning over-the-counter (OTC) sale of syrup-based medicines, including cough syrup, without a doctor’s prescription.
The decision comes after the government removed the word “syrup” from the category of medicines exempted under Schedule K, thereby making the regulatory oversight on such medicines more stringent.
The change has been notified under the Drugs (Fifth Amendment) Rules, 2026, which aims to ensure better control over the manufacturing, sale and distribution of syrup-based drugs.
‘Schedule-K’ of the Drugs Rules, 1945 contains categories of drugs which were exempted from certain provisions of the laws relating to their manufacture, sale and distribution subject to certain conditions. These exemptions were originally given to make medicines easily available to people in certain circumstances.
Before the amendment, there was a provision that cough syrup could be sold in villages with a population of less than 1,000 without complying with certain retail sales license rules. But now after this change, this discount will not be applicable on cough syrup.
Now the sale and distribution of cough syrup in such villages can be done only through duly licensed pharmacies. For this, it will be mandatory to follow the provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945.
Further, the Ministry of Health and Family Welfare said that this amendment has been made to strengthen the regulatory oversight on syrup-based medicines and to better align the rules with the existing public health and safety requirements.
According to the ministry, this step will promote responsible distribution and sale of cough syrup and ensure better adherence to regulatory standards across the country.
The Ministry has also advised cough syrup manufacturing companies, distributors and sellers to strictly comply with all licensing and regulatory requirements applicable under the Drugs and Cosmetics Act and Drugs Rules.
After this change, consumers will now have to produce a valid prescription issued by a registered medical specialist to purchase such medicines. This means that now a doctor’s prescription will be necessary to buy cough syrup.
–IANS
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