This is an important step. The central government has tightened the rules for manufacturing and selling medicines containing more than 12% ethyl alcohol. Such medicines will no longer be easily purchased or manufactured from medical stores as before. The government has brought these medicines under the licensing system of ‘Drugs and Cosmetics Act, 1940’ and included them in ‘Schedule H1’ list of ‘Drugs Rules, 1945’.
This means that now these medicines can be sold only on the advice (prescription) of a registered doctor and the medical store will have to keep records of every sale. According to the Health Ministry, the purpose of this decision is to prevent misuse of medicines containing high ethyl alcohol.
To which medicines will this new rule apply?
The new rule will be applicable to those oral medicines which contain more than 12% ethyl alcohol and which are sold in packs larger than 30 ml. This includes some tinctures and herbal liquid medicines made from cardamom, ginger and other aromatic substances. Earlier, these products were exempted from licensing requirements under the ‘Drugs Rules’. Taking advantage of this exemption, the level of ethyl alcohol in some products was kept between 60% to 90%, due to which the concern of their misuse increased.
What will change after the government’s strict rules?
Under the government’s new changes, a license will be required to manufacture and sell such medicines. These have also been placed in ‘Schedule H1’. Its direct effect will be that these medicines will be available only on the advice of a registered doctor; The medical store must maintain records of every sale; Supply will be limited to licensed pharmaceutical channels only; And without regulatory approval they can neither be manufactured nor distributed. The government has clarified that this rule will come into effect six months after the publication of the notification in the ‘Official Gazette’, so that manufacturers and sellers can get time to adapt their work to the new rules.
Why did the government tighten the rules? According to the Health Ministry, some tinctures made from things like cardamom and ginger are mainly made for medicinal use. Although they have traditionally been used to treat digestive problems and other medical needs, tests have shown that some products contain ethyl alcohol levels of 80 to 90 percent, leading people to use them as an alternative to alcohol. Keeping this in mind, the government has decided to change the rules and bring these products under strict surveillance.