Source: The post Regulatory and Health Issues of Alcoholic Tinctures has been created, based on the article “Getting drunk, on homoeopathy” published in “The Hindu” on 28th January 2025
UPSC Syllabus Topic: GS Paper2- Governance-Issues relating to development and management of Social Sector/Services relating to Health,
Context: The article discusses the public health risks of alcoholic tinctures marketed as homeopathic remedies in India. It highlights regulatory challenges, weak enforcement, and legal hurdles, emphasizing the harm to health and revenue, especially with high alcohol content in such products.
For detailed information on Methanol poisoning deaths due to Spurious alcohol in India read this article here
What is the Issue with Alcoholic Tinctures in India?
- High Alcohol Content: Homoeopathic tinctures contain up to 12% alcohol, significantly higher than “strong beer,” which has 7% alcohol. This makes them attractive substitutes for alcoholic beverages.
- Public Health Risk: Regular consumption of these tinctures can cause serious illnesses, such as alcoholic hepatitis. Unsuspecting consumers believe they are remedies without realizing their alcohol content.
- Deaths in Prohibition States: States like Bihar and Gujarat, which prohibit alcohol, reported deaths due to spurious tinctures.
- Regulatory Gap: Public health and alcohol taxation are State responsibilities, but States cannot regulate tinctures due to the Union’s Drugs and Cosmetics Act, 1940.
- Taxation Loophole: Medicinal alcohol is taxed at 18% (Union rate), much lower than State taxes on alcoholic beverages, causing revenue losses.
- Legal Challenges: Rule 106B (1994) limits tincture sales but faces prolonged litigation by the homoeopathy industry, delaying enforcement.
How Does the Constitution Regulate These Tinctures?
- State Role: Public health and alcohol taxation fall under State jurisdiction as per List II of Schedule VII.
- Union Exception: Entry 84 of List I allows the Union to tax alcohol meant for medicinal purposes.
- Pre-GST Era: Medicinal alcohol was taxed at 4% under the Medicinal and Toilet Preparations (Excise Duties) Act, 1955.
- Post-GST Confusion: The 101st Constitutional Amendment removed this exception. However, the Union now taxes medicinal alcohol at 18%, still lower than State taxes on alcoholic beverages.
- Concurrent List Conflict: Drugs are in the Concurrent List; States require presidential assent for amendments to the Union’s Drugs and Cosmetics Act, 1940.
What Attempt had been made to Regulate Tinctures?
- Rule 106B (1994): The Union government introduced Rule 106B under the Drugs and Cosmetics Rules, 1945, limiting retail tincture bottles to 30 ml with 12% alcohol and 100 ml bottles for hospitals.
- Industry Resistance: The homoeopathy industry opposed this rule, challenging it in courts, causing enforcement delays.
- Judicial Action:
- Delayed Enforcement: The Supreme Court transferred 13 cases against Rule 106B to itself in 2017. The matter remains unresolved.
- Bhagwati Medical Hall Judgment: The Court ruled that only the Union can regulate homoeopathic tinctures, frustrating State efforts.
For detailed information on Impacts of the SC ruling on alcohol regulation read this article here
What Should be Done?
- Amend Legal Framework: Allow States to regulate and tax homoeopathic tinctures, ensuring accountability under public health laws.
- Resolve Litigation: The Union should lay Rule 106B before Parliament for 30 days to settle ongoing lawsuits.
- Enhance Public Awareness: Labels must warn about health risks, similar to warnings on alcoholic beverages.
Question for practice:
Evaluate the impact of regulatory gaps and legal challenges on the public health and taxation of alcoholic tinctures in India.
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