New Delhi, March 4 Amid growing public debate on nicotine products, public health experts and clinicians have urged policymakers to consider allowing nicotine gums up to 4 mg under prescription regulations, as is the practice in most developed nations, to make them more accessible to smokers who want to quit.
Nicotine gums – available globally in 2 mg and 4 mg strengths – have been used for over three decades as evidence-based smoking cessation aids, endorsed by the World Health Organization (WHO) and included in the WHO Essential Medicines List.
Until one and a half years ago, nicotine gums up to 4 mg were sold over the counter (OTC) under Schedule K drugs in India.
Unlike nicotine pouches or novel delivery formats, gums are medicinal products, regulated under the Drugs and Cosmetics Act, 1940, and designed to help dependent smokers quit combustible tobacco – the single largest preventable cause of death in India.
Dr. Meenakshi N, Family Physician, Public Health Specialist & Clinical Researcher, Apollo Hospital in Noida, UP, said, "It is critical to separate fear from facts. Nicotine gums are not initiation products; they are therapeutic tools. Extensive global evidence shows that regulated NRT delivers controlled nicotine without exposure to tar, carbon monoxide or the 7,000 toxic chemicals present in cigarettes."
According to Cochrane Reviews (2021), nicotine replacement therapy increases long-term smoking quit rates by 50-70 per cent compared to unaided attempts.
Also, WHO's 2024 Tobacco Cessation Guidelines reaffirm that both 2mg and 4mg nicotine gums are first-line treatments, with the 4mg dose recommended for smokers with higher nicotine dependence.
Importantly, global safety data show no meaningful increase in cardiovascular events associated with therapeutic NRT use, even among patients with heart disease, when used as directed by the US FDA.
In India, nicotine gums fall under Schedule K exemptions of the Drugs and Cosmetics Rules, intended to improve access to essential public health interventions.
The Drugs Technical Advisory Board (DTAB) has repeatedly acknowledged the low abuse potential of oral NRTs, retaining 2mg gum as OTC and noting no conclusive evidence of widespread misuse of higher-dose gums when used therapeutically.
Dr. Rajesh Madan, Senior Consultant Cardiologist, Max Hospital, Dwarka, noted, "Nicotine itself is not risk-free, but the harm profile of medicinal nicotine is dramatically lower than smoking. The real danger lies in denying dependent smokers access to effective cessation tools, especially in low-resource settings."
India is home to over 100 million smokers (GATS-2, Ministry of Health, 2022), and evidence shows that nearly 98 per cent of quit attempts fail without pharmacological support.
Prescription-only barriers disproportionately affect rural and low-income populations, directly conflicting with the National Tobacco Control Programme (NTCP) and Article 21 of the Constitution, which guarantees the right to health, according to a section of experts.
More than 100 countries, including the United States, the United Kingdom, Canada, Australia and most of the European Union, allow both 2mg and 4mg nicotine gums as OTC products. None has reported any increased youth initiation attributable to medicinal gum availability.
R Benjamin, Behaviour Therapist, Psychologist at Shambhave Wellness, Gurgaon, Haryana, added, "The global lesson is clear: easier access to regulated NRT reduces smoking prevalence. Restricting therapeutic doses does not protect youth; it only prolongs tobacco addiction among adults."
Public health experts cautioned that policy decisions must be guided by comparative risk, not absolute fear.
Cigarettes kill 1.35 million Indians every year, while NRT remains among the safest pharmacological interventions in modern medicine.
As India works toward SDG 3.4 and tobacco-related mortality reduction, experts say the focus should remain on evidence-based cessation, strict enforcement against non-therapeutic nicotine products, and clear regulatory differentiation, not conflation.