New Delhi, July 22 (ANI): The U.S. Food and Drug Administration’s recent authorization of modified-risk claims for certain non-combustible nicotine products has added to the global debate over strategies to reduce tobacco-related harm.
For India, the key question is whether the country’s research institutions should conduct an independent evaluation of the emerging evidence, tailored to India’s public health and regulatory environment.
Research from countries including Sweden, the United Kingdom, Japan, and Norway has documented declines in cigarette smoking alongside increased use of non-combustible nicotine alternatives. In the United States, the FDA permits modified-risk claims only after scientific evaluation.
While experts caution against directly adopting another country’s regulatory model, they argue that the growing body of international research merits an objective review by Indian scientists rather than being accepted or rejected on ideological grounds.
The Indian Council of Medical Research (ICMR), the country’s premier biomedical research institution and the government’s principal scientific adviser on health, has long guided national policy on issues ranging from infectious diseases to clinical research. Experts say the organization is well-positioned to conduct an independent assessment of emerging evidence on tobacco and nicotine products.
Padma Shri awardee Dr. Mohsin Wali, senior consultant at Sir Ganga Ram Hospital in New Delhi, said India has a strong record of evaluating international scientific evidence and adapting it to domestic needs.
“India has a track record of scrutinising global evidence critically and tailoring it to domestic priorities. ICMR exemplifies this pragmatic approach: in COVID-19 diagnostic validation, gene therapy development and clinical trials, and Good Clinical Practice, it has aligned its structures with internationally accepted benchmarks, including those of the U.S. FDA and ICH. This method enabled India to adopt proven technical practices while calibrating them to the national context. A similar assessment of the U.S. trajectory in tobacco governance is now worth pursuing. Over several decades, cigarette smoking and overall tobacco consumption have declined substantially in the United States, while India continues to face a large and, in some segments, growing challenge. Studying that divergence could inform strategies suited to India’s distinct landscape,” he said.
India has one of the world’s largest populations of tobacco users, with nearly 267 million consumers. Tobacco-related diseases remain a leading cause of cancer, cardiovascular disease, and respiratory illness. Public health experts continue to stress that preventing tobacco use and supporting complete cessation should remain the foundation of tobacco-control efforts.
However, they note that millions of adult users struggle to quit despite repeated attempts, prompting discussion about evidence-based alternatives for adult smokers.
Padma Shri awardee Dr. Chandrakant S. Pandav, former professor and head of the Centre for Community Medicine at the All India Institute of Medical Sciences (AIIMS), New Delhi, said concerns about youth nicotine use should be carefully evaluated alongside available evidence.
“The strongest objection is that such a discussion will spur youth uptake. U.S. figures counter that concern. The record shows that as the FDA authorised modified-risk claims for adults, overall youth tobacco use fell from 23.3% in 2019 to 7.5% in 2025 — the third consecutive annual decline. Youth e-cigarette consumption dropped to 5.2%, its lowest in a decade. Cigarette smoking among teenagers stands at 1.4%, and use of oral products, the category authorised for adults, was 1.7%. Calibrated governance combined with sustained public health messaging can curb youth uptake while pathways for grown users away from combustible tobacco are evaluated. Protecting young people and providing alternatives for adult consumers are not incompatible goals.”
Pandav added that calling for an independent scientific review does not imply adopting another country’s regulatory framework or endorsing any specific product.
“It means enabling Indian researchers to examine the data rigorously, its strengths, limitations, long-term outcomes and population-level effects, and determine what relevance, if any, it holds within India’s epidemiological and regulatory environment,” he said.
The article argues that science has consistently guided India’s public health policies, including its response to the COVID-19 pandemic, clinical research standards, and vaccine development.
It concludes that tobacco and nicotine policy should be evaluated with the same scientific rigor, with decisions driven by evidence from both Indian and international research rather than ideology, given the country’s substantial tobacco-related disease burden. (ANI)
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