New Delhi: The government has amended the Drugs Rules, 1945 (Fifth Amendment), removing an exemption that allowed the sale of cough syrups in small villages without compliance with certain retail licensing requirements, according to an official statement Tuesday.
The amendment was notified through a notification and involves the omission of the word ‘syrup’ from Schedule K of the Drugs Rules, 1945, according to the statement from the Ministry of Health and Family Welfare.
Schedule K provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it for specified categories of drugs, it said.
Before the amendment, the provision allowed cough syrups to be sold in villages with a population of less than 1,000 without requiring compliance with certain retail sale licensing norms. With the latest change, the exemption will no longer apply to cough syrups.
Now, the sale and dispensing of cough syrups in such villages will now have to be carried out only through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
In addition, the Health Ministry said the amendment has been introduced to strengthen regulatory oversight of syrup formulations and align the exemption framework with current public health and safety requirements.
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According to the ministry, the measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.
Moreover, the ministry advised manufacturers, distributors and retailers dealing in cough syrups to ensure strict adherence to all applicable licensing and regulatory requirements under the Drugs and Cosmetics Act and the Drugs Rules.
As a result, consumers will now need a valid prescription from a registered medical practitioner to purchase such medications.
