Context

• A recent judgment of the Supreme Court of India in Bhagwati Medical Hall vs Central Drugs Standard Control Organisation has reignited debate on a pressing public health issue: the regulation of alcoholic tinctures marketed as homeopathic remedies.
• The judgment highlights the complex regulatory architecture, economic implications, and public health hazards associated with these products.
• Despite sporadic attempts to address the issue, regulatory hurdles and industry resistance have left state governments grappling with an impossible challenge.

The Complexity of Regulatory Framework Governing Alcoholic Tinctures in India

• Constitutional Provisions and Division of Powers
  • The governance of alcoholic tinctures is shaped by multiple entries in the Constitution's Seventh Schedule, which allocates legislative authority between the Union and state governments.
  • According to Schedule VII, states have the exclusive power to legislate on public health and the taxation of alcohol under List II (State List).
  • This makes states the primary authority responsible for public health measures and alcohol-related laws within their territories.
  • However, an exception exists: alcohol meant for medicinal purposes falls under Entry 84 of List I (Union List), granting the Union government the authority to regulate its taxation.
  • This constitutional division creates a regulatory grey area.
  • While the states are tasked with ensuring public health, they have limited powers to regulate medicinal alcohol due to the Union’s jurisdiction over its taxation and standards.
  • This dual control creates a situation where neither authority can fully address the issue.
• Concurrent Jurisdiction Over Drugs
  • Drugs, including homeopathic products, fall under the Concurrent List (List III), which allows both the Union and state governments to legislate.
  • However, the Drugs and Cosmetics Act, 1940, a central legislation, lays down the quality standards for homeopathic drugs, including alcoholic tinctures.
  • This Act prevents states from unilaterally amending provisions or introducing stricter regulations without presidential assent.
  • As a result, states have limited scope to address local public health concerns arising from the misuse of these tinctures.
• Quality Regulation and Taxation Loopholes
  • The regulatory complexity has allowed manufacturers of homeopathic alcoholic tinctures to largely escape oversight.
  • Unlike alcoholic beverages, which are subject to rigorous quality checks and taxation by state excise departments, these tinctures operate under the more lenient framework of medicinal alcohol.
  • Manufacturers have exploited these loopholes to produce and market tinctures with alcohol content as high as 12%, which is legally permissible under the Drugs and Cosmetics Act.
  • In contrast, popular alcoholic beverages such as ‘strong beer’ contain only 7% alcohol by volume.
  • This disparity not only makes tinctures an attractive alternative for those seeking intoxication but also undermines the efforts of state governments to regulate alcohol consumption.

Challenges in Regulating Alcoholic Tinctures

• Industry Lawfare
  • Efforts to regulate alcoholic tinctures have been consistently thwarted by the homeopathic industry's aggressive legal strategies.
  • After the Union government introduced Rule 106B to the Drugs and Cosmetics Rules, 1945 in 1994—capping the alcohol content at 12% and limiting retail bottle sizes—the industry mounted a legal challenge.
  • Over two decades, these lawsuits questioned the rule's constitutionality, its scientific basis, and procedural lapses in its enactment.
• Regulatory Hurdles and Systematic Inefficiencies
  • Although the Supreme Court and multiple High Courts upheld the rule, subsequent litigation targeted technical flaws, such as the failure to table the rule in Parliament.
  • Despite the simplicity of resolving this issue, placing the rule before Parliament for 30 days, the Union government chose prolonged litigation delaying enforcement.
  • By 2017, the Supreme Court consolidated these cases, but the matter remains unresolved.
  • These delays highlight systemic inefficiencies that jeopardize public health.

Broader Implications of Alcoholic Tinctures

• Revenue Concerns
  • Revenue losses arise when consumers opt for these low-tax tinctures over higher-taxed alcoholic beverages.
  • More alarmingly, states like Gujarat and Bihar, which prohibit the sale of alcoholic beverages, report fatalities linked to the consumption of spurious homeopathic tinctures.
  • Such incidents undermine state-level alcohol prohibition policies, creating a public health crisis.
• Health Concerns
  • Unsuspecting consumers, often unaware of the alcohol content in these tinctures, may develop severe conditions like alcoholic hepatitis.
  • Doctors have observed a worrying trend of patients exhibiting symptoms typically associated with chronic alcohol consumption after using these so-called remedies.
  • The industry's labelling and marketing practices do little to inform consumers of the potential harm.

The Way Forward

• Comprehensive Overhaul of Laws Governing Medicinal Alcohol
  • The persistent legal battles and regulatory inertia underscore the need for a comprehensive overhaul of laws governing medicinal alcohol.
  • The Union government must prioritise the public health implications of alcoholic tinctures, especially as other countries consider mandatory cancer warnings on alcoholic beverages.
  • Beyond addressing taxation disparities, it is essential to scrutinise the use of alcohol in traditional medicine systems like homeopathy and Ayurveda.
• Striking a Balance
  • At a time when the efficacy of these remedies is increasingly questioned, allowing them to cause harm is unacceptable.
  • Policymakers must strike a balance between respecting cultural practices and safeguarding public health.
  • Regulatory clarity, scientific evaluation, and robust enforcement mechanisms are imperative to curbing the misuse of alcoholic tinctures.

Conclusion

• The regulation of alcoholic tinctures in India exemplifies the challenges of balancing federalism, public health, and industry interests.
• The Supreme Court's judgment in the Bhagwati Medical Hall case serves as a reminder of the urgent need for coordinated action.
• Addressing this issue requires not only legal reforms but also a paradigm shift in how public health and consumer protection are prioritized in policymaking.