India's Tobacco Control Experts Advocate for Over-the-Counter Nicotine Replacement Therapy Access

Leading public health figures have endorsed maintaining unrestricted over-the-counter access to nicotine replacement therapies (NRTs) in all formulations and strengths, including 2 mg and 4 mg doses, as India confronts persistently low tobacco cessation outcomes.

At Respire-2026, a conference convened by the Asian Coalition for Health Empowerment (ACHE), health specialists stressed that expanding availability of evidence-based cessation aids represents a critical pathway to improving India's current quit success rate, which remains below 5%.

The intervention comes as policymakers draw on research from the Economic Advisory Council to the Prime Minister (EAC-PM), which released an analysis titled "Rise in Tobacco Consumption and Policy Implication: An Analysis of Household Consumption Expenditure Survey." This study documents the substantial financial toll of tobacco use, particularly affecting lower-income populations, and demonstrates how consumption reduction translates into tangible household economic gains.

Specialists underscored that cessation interventions must be available precisely when smokers commit to quitting, without procedural obstacles that could deter or postpone quit attempts.

Forum participants highlighted that maintaining OTC status for 2 mg and 4 mg NRTs—available as gums, lozenges, and other formats—would substantially broaden access beyond the constrained clinical systems currently operating under the National Tobacco Control Programme.

"The government's NRT framework has delivered meaningful public health results," said Dr. R.K. Sinha, President of the IMA South Delhi Chapter. "By preserving over-the-counter availability of 2 mg and 4 mg treatments, we ensure support reaches people at the critical moment they choose to stop smoking. This is how policy becomes effective in practice."

Global Evidence Supports Broader Access

International research consistently demonstrates NRT effectiveness in enhancing quit outcomes. Comprehensive systematic reviews show that 2 mg and 4 mg formulations raise quit success rates by 50–70% when compared to unaided cessation attempts.

Specialists cautioned, however, that inadequate access functions as a significant barrier in India, where cessation infrastructure remains nascent and behavioural counselling alone frequently proves insufficient.

"India's policy framework already acknowledges nicotine replacement's importance for cessation," noted Dr. Karl Fagerström, PhD, Professor Emeritus and Deputy Editor of Nicotine & Tobacco Research. "Scientific evidence spanning decades shows that disease stems from combustion byproducts and toxins, not nicotine itself. For cessation effectiveness, nicotine must be delivered at adequate concentrations to someone actively attempting to quit. This is precisely why 2 mg and 4 mg NRT doses appear on the WHO essential medicines list and why most OECD nations provide these dosages without prescription."

Regulatory Alignment and Accessibility

Experts emphasised that regulatory predictability and accessibility are fundamental to maximizing public health returns. They cautioned that constraining access to cessation medications could inadvertently impede progress in reducing tobacco prevalence.

"Public health policy must reflect clinical realities," stated Dr. Nimesh G. Desai, Former Director of IHBAS. "People attempting to quit need timely, practical assistance. Broadening access to validated treatments reinforces rather than undermines the cessation system."

"Effective regulation balances safety with accessibility," added Mr. Salim Veljee, Former Director of FDA Goa. "Widening OTC availability of 2 mg and 4 mg NRTs supports public health objectives while preserving regulatory safeguards."

Recommended Actions

Conference participants proposed several steps to advance national tobacco control:

• Maintain 2 mg and 4 mg NRTs as over-the-counter medications to increase uptake
• Increase cessation tool distribution alongside existing public health initiatives
• Ground policy decisions in scientific evidence, incorporate real-world usage data, and adopt international standards for nicotine replacement and alternative cessation products to effectively lower tobacco consumption

With India bearing a substantial tobacco disease burden alongside minimal quit rates, specialists concluded that expanding access to scientifically-validated cessation resources represents one of the fastest and most efficient interventions available. The EAC-PM's recent economic assessment, documenting tobacco's broader societal consequences, reinforces the urgency of developing accessible, effective, and evidence-informed cessation options.