Alcohol Based Drug: If you also buy medicines from a medical store without doctor’s advice, 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 can neither be made in the normal way as before nor can they be purchased easily from medical stores. The government has included these medicines in Schedule H1 of the Drugs Rules 1945, bringing them under the licensing regime under the Drugs and Cosmetics Act 1940.
This means that now they will be sold only on the prescription of a registered doctor and the medical store will also have to keep records of every sale. According to the Health Ministry, this decision has been taken to prevent misuse of those medicinal drugs which contain high quantity of ethyl alcohol.
On which medicines will the new rule apply?
The new rule will be applicable to those oral medicinal formulations which contain more than 12 percent ethyl alcohol and which are sold in packs larger than 30 ml. These also include some tinctures and herbal liquid preparations prepared from cardamom, ginger and other aromatic substances. These products came under the category exempted from license under the Schedule of Drugs Rules. Taking advantage of this exemption, 60 to 90 percent ethyl alcohol was being used in some products, due to which the possibility of their misuse had increased.
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What will change now after the government’s strictness?
After the new amendment of the government, all such medicines can be manufactured and sold only after taking license. Also, they have been placed under Schedule H1. Its direct effect will be that medicines will be available only on the prescription of a registered doctor, medical stores will have to keep records of every sale, these medicines will be supplied only through licensed pharmaceutical chains and they cannot be manufactured and distributed without the permission of the rules. The government has also clarified that the rules will come into force after 6 months of publishing the notification in the Gazette, so that manufacturers and sellers can make their arrangements as per the new rules.
Why did the government take strict action?
According to the Health Ministry, some tinctures made from substances like cardamom and ginger are originally prepared for medicinal use. They have been used for other medical needs including digestive problems, however, investigation revealed that the ethyl alcohol content in some products was 80 to 90 percent, due to which they started being used as an alternative to alcohol. Keeping this in view, the government has decided to bring these products under strict monitoring by changing the rules.
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