Government’s big decision: Now medicines with high alcohol content will not be available without doctor’s prescription, new rules implemented

New Delhi, July 10. The Central Government has tightened the rules regarding the sale and distribution of medicinal formulations (medicines) containing high amounts of ethyl alcohol (Ethanol). Now medicines containing more than 12 percent ethyl alcohol and available in packs larger than 30 ml can be sold only on the prescription of a registered doctor. Besides, it will also be mandatory to obtain license for their manufacture and sale.

According to the Ministry of Health and Family Welfare, this decision has been taken to prevent misuse of such medicines for addictive purposes and to ensure their safe availability to the needy patients.

Why was this decision taken?

The ministry said that some medicines like cardamom, ginger and other aromatic medicinal tinctures earlier had license exemption under Schedule K. But due to the presence of 80 to 90 percent ethyl alcohol in them, the possibility of their misuse was increasing. Many state governments had also expressed concern to the Center in this regard.

What have changed in the new rules?

Under the new amendment of the government:

• Medicines containing more than 12% ethyl alcohol and in packs larger than 30 ml will no longer get Schedule K exemption.
• License will be mandatory for the manufacture and sale of these products.
• These medicines are included in Schedule H1 of the Drugs Rules, 1945.
• Now they will be sold only on doctor’s prescription.
• The medical store will also have to maintain detailed records of the sale of these medicines.

What will be the benefit?

The Health Ministry says that the new rules will strengthen monitoring and control of alcohol-containing medicines. This will prevent their misuse, while genuine patients will continue to get medicines as per their need. This amendment has been implemented through the Gazette notification of the Ministry of Health and Family Welfare and is being considered an important step towards making the drug regulatory system of the country more effective and public health friendly.