New Delhi, June 16 (IANS). The government has amended the Drugs Rules, 1945 (Fifth Amendment), removing the exemption that allowed cough syrups to be sold in small villages without complying with certain retail licensing norms. This information was given in an official statement issued by the Ministry of Health and Family Welfare on Tuesday.
According to the statement, this amendment has been implemented through notification. Under this, the word ‘syrup’ has been removed from Schedule-K of the Drugs Rules, 1945.
According to the statement, certain categories of drugs in Schedule-K are exempted from certain provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder.
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 new system, this discount will not be applicable on cough syrup.
Now, sale and distribution of cough syrup in such villages can be done only through duly licensed pharmacies. For this, all the provisions of the Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945 will have to be followed.
The Health Ministry said that this amendment has been made with the aim of strengthening the regulatory oversight on syrup-based medicines and bringing the rules in line with the existing public health and safety requirements.
According to the ministry, this step will promote responsible distribution and sale of cough syrups and ensure better compliance with regulatory standards across the country.
Apart from this, the Ministry has advised the cough syrup manufacturing companies, distributors and sellers to strictly comply with all the 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. That means cough syrup will now be available only under prescribed rules and through licensed medical stores.
–IANS
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