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High-alcohol formulations to require licence, prescription as Centre amends rules
The health ministry has ended the Schedule K exemption for high-alcohol medicinal formulations, bringing them under Schedule H1 to curb misuse and addiction.
The Union ministry of health and family welfare has brought medicinal products containing ethyl alcohol under stricter regulatory oversight by removing their licensing exemption under Schedule K and placing them under Schedule H1 to check misuse and addiction.
“In a significant step towards strengthening regulatory oversight and preventing misuse of medicinal products with high alcohol content, the Ministry of Health and Family Welfare has removed the existing exemption (under Schedule K) from licensing requirements for formulations containing ethyl alcohol,” the health ministry said in a statement.
Certain medicinal products, including tinctures of cardamom, ginger and other aromatic preparations, have been exempted from licensing requirements under Schedule K of the Drugs Rules, 1945. Some of these formulations contain high concentrations of ethyl alcohol, in certain cases up to 80–90% v/v, making them susceptible to misuse for intoxication.
According to people in the health ministry, complaints were also received from certain state governments in this regard. “These medicinal products are largely tinctures used to create digestive aids, etc., which were earlier exempted from the standard licensing requirements for allopathic medicines. A section of manufacturers in villages and small cities, we learnt, was making use of this loophole and manufacturing tinctures with very high alcohol content and a hint of ginger or cardamom. They were selling them in high-volume bottles. The government, therefore, felt the need to regulate this category as well,” said a senior official, requesting anonymity.
The official explained that these products were not Ayurvedic, Unani, Siddha or Homoeopathic products, as those are already regulated under the AYUSH rules. “As per their rules, there is a cap of 16% on Ayurvedic, Unani and Siddha medicines and up to 12% on Homoeopathic medicines. The ones we are talking about are tinctures meant for aiding digestion, etc.”
To address this concern, the government has mandated that all formulations containing more than 12% v/v ethyl alcohol, in quantities exceeding 30 mL, will no longer be covered under the exemption provided to them under Schedule K. Consequently, such products will be required to obtain the requisite licences under the Drugs and Cosmetics Act, 1940.
The decision to amend the rules was made after detailed consultations with the Drugs Technical Advisory Board.
The amendment also shifts these products to Schedule H1 of the Drugs Rules, 1945, which mandates sale against the prescription of a registered medical practitioner and stricter record-keeping. The record of all sales made under Schedule H1 needs to be duly maintained and preserved for at least three years.
“The amendment is expected to strengthen regulatory oversight over those medicinal products containing alcohol, ensuring their supply only through the regulated pharmaceutical supply chain. It will significantly reduce the possibility of diversion and misuse while ensuring their continued availability for legitimate therapeutic use,” said the health ministry in a statement.
“The initiative is in line with the government’s continued efforts to strengthen the regulatory framework for drugs, promote the rational and responsible use of medicinal products and safeguard public health,” it added.
