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To strengthen regulatory control over the sale of high-alcohol content medicines without a prescription, the Center has introduced new rules stipulating that all oral preparations containing more than 12 percent ethyl alcohol now require a prescription and must be sold in licensed retail outlets.
Changes in Regulation
The Ministry of Health of the Union announced in an official notification that oral compositions with an ethyl alcohol concentration above 12%, packaged in bottles or containers exceeding 30 milliliters (ml), will be included in Appendix H1 of the Drugs and Cosmetics Rules of 1945. Appendix H1 falls under the category of prescription drugs requiring strict control, including mandatory sales record keeping and prescription storage by pharmacies.
Furthermore, the ministry stated that such compositions will no longer fall under Appendix K of the same Rules, which exempts certain medicines from norms regulating production and distribution, allowing them to be sold without a prescription. Consequently, pharmacies are also required to possess a valid retail sales license to dispense these oral forms.
Implementation Timeline and Reasons
The new rules will take effect six months after publication in the gazette, meaning by January 2027. This step followed reports from several drug control agencies indicating instances of abuse and stockpiling of oral preparations with high concentrations of ethyl alcohol for intoxication purposes.
Ethyl alcohol is used in various oral forms as a solvent for active ingredients and as a preservative to maintain stability and microbiological control. The Ministry noted that some medicines, including cardamom and ginger tinctures and other aromatic preparations, were previously exempted from licensing requirements under Appendix K.
The ministry added, 'Some of these compositions contain a high concentration of ethyl alcohol, in some cases up to 80–90 percent by volume (v/v), making them susceptible to abuse for intoxicating purposes.' According to a senior official from the state licensing body, medications such as oral tinctures used for digestive aids and syrups previously did not fall under standard licensing requirements for allopathic drugs.
Exploitation of Loopholes and Reaction
However, this official also reported that some manufacturers in rural and small towns exploited this loophole by producing tinctures with very high alcohol content but only a negligible amount of ginger or cardamom. Industry experts and informed officials stated that this step had been discussed for a long time.
A draft notification of this change was released last October following recommendations from both the Drug Consultative Committee (DCC) and the Technical Advisory Board on Drugs (DTAB) of the Central Drugs Standard Control Organization (CDSCO). Discussions accelerated after the death of over 20 children in Chhindwara, Madhya Pradesh, after consuming cough syrups like Coldrif, which were found to be contaminated with industrial solvents. As the aforementioned official quoted, 'as a result, the word 'syrups' was removed from Appendix K of the Drugs and Cosmetics Rules. The new amendment excludes oral compositions with high alcohol content from open sale.'
Rishi Agrawal, co-founder and CEO of the compliance firm TeamLease RegTech, emphasized that the six-month implementation period should be viewed as an opportunity to review compliance systems, distribution practices, and internal controls, rather than just a transition period. He added that a balanced approach protects legitimate patient access while strengthening safeguards against diversion and misuse. In his words, 'the impact goes beyond licensing or labeling for the industry. It means greater accountability across the entire pharmaceutical supply chain, from manufacturers and distributors to pharmacies, through stricter record-keeping, prescription dispensing, and enhanced traceability.'
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