The Central Government has made the rules for sale and control of oral medicines containing more than 12% ethyl alcohol strict by amending the Drugs Rules, 1945. Now all oral medicines containing more than 12% ethyl alcohol, if sold in bottles or packs larger than 30 ml, will be placed under Schedule H1. This means that such medicines will not be sold without a doctor’s prescription. Records of the sale of these medicines will also have to be maintained, as It is necessary for Schedule H1 medicines.
Earlier people used to buy such oral medicines even without doctor’s prescription. But this will not happen now. Let us tell you what is this new rule? What changes will happen if this happens?
What is Schedule H1?
Schedule H1 is a list of medicines whose sale is closely monitored. These medicines can be purchased only on the prescription of a registered doctor. The medical store also has to keep the records of their sales safe. Actually, the Center has approved the amendment in the Drugs Rules 1945.
Why did the government take this decision?
There is a possibility of misuse of some oral medicines containing high alcohol. The new rule will increase monitoring on the sale of such medicines. This will help in preventing misuse of medicines and ensuring the safety of patients. This amendment will come into effect 6 months after its publication in the Gazette, i.e. it will be valid from January next year.
This change will be applicable only to oral medicines sold in packaging larger than 30 ml and containing more than 12% ethyl alcohol. The government had earlier sought suggestions from the people on this proposal, but after not receiving any objection or suggestion, it was finalized.
Why is alcohol mixed?
According to reports, it is necessary to add alcohol (Ethanol) to many oral medicines like syrups, tonics and some drops. Let us tell you why this is done?
To mix the medicine (Solvent)- Actually, many medicinal elements do not dissolve properly in water. Whereas with the help of ethanol it helps in dissolving these medicines and at this rate the medicine gets prepared normally.
To keep the medicine safe- Many medicines cause growth of bacteria, fungus or other microorganisms. To prevent these from growing, alcohol is added to some oral medicines. In this way the shelf life of the medicine increases.
Better absorb- The active nutrients in some medicines are better absorbed by the body in the presence of alcohol. In this way their effect can be achieved more effectively.
To extract herbal extract- Ethanol is used to extract active ingredients from many plants in Ayurvedic and herbal tinctures. Due to this, medicinal properties are obtained in a better way.
Leave a Reply