NEW DELHI, July 10 (Xinhua) -- India's federal health ministry, in a bid to prevent the misuse of medicinal products with high alcohol content, has tightened rules saying these products can no longer be sold as freely as before and instead will now require licenses and a doctor's prescription, officials said Friday
According to an official notification, all formulations containing more than 12 percent ethyl alcohol, in quantities exceeding 30 ml, would no longer be covered under the exemption provided to them under Schedule K.
According to the ministry, the amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a registered medical practitioner and stricter record-keeping.
"The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain," the statement further reads. "It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use."
The health ministry stated that the initiative was in line with the government's continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health. ■