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Alcohol-Based Drugs: The central government has tightened regulations regarding the sale and manufacture of medicinal drugs containing more than 12% ethyl alcohol. Such drugs will no longer be manufactured or purchased in the normal manner.

Rules for alcohol-containing medications

Alcohol-Based Drugs: If you too buy medicines from medical stores without consulting a doctor, then this news is important for you. The central government has tightened the rules regarding the sale and manufacture of medicinal drugs containing more than 12 percent ethyl alcohol. Now, such medicines will neither be manufactured in the usual way nor will they be easily purchased from medical stores. The government has included these drugs in Schedule H1 of the Drugs Rules 1945, bringing them under the licensing regime under the Drugs and Cosmetics Act 1940.

This means that they will now only be sold on prescription from a registered doctor, and medical stores will be required to maintain records of each sale. According to the Ministry of Health, this decision was taken to prevent the misuse of medicinal drugs that contain high amounts of ethyl alcohol.

Which medicines will the new rule apply to?

The new rule applies to oral medicinal formulations containing more than 12 percent ethyl alcohol and sold in packs larger than 30 milliliters. These include certain tinctures and herbal liquid preparations made from cardamom, ginger, and other aromatic substances. These products were exempt from licensing under the Schedule to the Drugs Rules. Taking advantage of this exemption, some products were using 60 to 90 percent ethyl alcohol, increasing the risk of misuse.  

What will change now after the government's strictness?

Following the government's new amendment, all such drugs can only be manufactured and sold with a license. They have also been placed under Schedule H1. This will directly impact the drug's availability; only with a registered doctor's prescription, medical stores will be required to maintain records of all sales, these drugs will only be supplied through licensed pharmaceutical chains, and they cannot be manufactured or distributed without the regulations' authorization. The government has also clarified that the rule will come into effect six months after the notification is published in the gazette, so that manufacturers and sellers can make their arrangements in accordance with the new rules.

Why did the government take strict action?

According to the Ministry of Health, some tinctures made from ingredients like cardamom and ginger were originally prepared for medicinal purposes. They have been used for various medical needs, including digestive problems. However, investigations revealed that some products contained 80 to 90 percent ethyl alcohol, leading to their use as an alternative to alcohol. In light of this, the government has decided to amend regulations and place these products under stricter supervision.