India is home to nearly 270 million tobacco users and accounts for roughly one-fifth of all tobacco-related deaths worldwide. Every day, approximately 3,500 Indians die from diseases caused by smoking and chewing tobacco. Against this grim arithmetic, one would expect the government to throw open every available exit door for those desperate to quit. Instead, New Delhi appears to be bolting one shut. In a recommendation that could reshape India’s tobacco cessation landscape, the Drugs Technical Advisory Board (DTAB) ~ meeting in February 2026 ~ has proposed that nicotine lozenges be stripped of their over-the-counter (OTC) exemption under Schedule K of the Drugs and Cosmetics Rules.
If enacted, lozenges containing 2 mg of nicotine would no longer be available at general stores or online platforms; they would be confined to licensed pharmacies and, potentially, require a prescription. The exemption would survive only for unflavoured 2 mg nicotine gums. The Board has further recommended a strict prohibition on sales to minors, tighter surveillance of online platforms, post-marketing tracking of adverse effects, and restrictions on tobacco companies marketing nicotine replacement therapy (NRT) products. The proposal did not materialise in a vacuum. It deserves to be understood on its own terms before it is challenged.
The state’s concern is anchored in a legitimate fear ~ that products designed to help people quit tobacco are being repurposed to initiate or sustain nicotine addiction, particularly among the young. India banned e-cigarettes, heated tobacco products, and nicotine pouches precisely because the tobacco industry has a documented history of repackaging addiction in attractive, youth-friendly formats. Flavoured nicotine lozenges, critics argue, risk becoming the next vector: discreet, pleasant-tasting, and available without a pharmacist’s oversight at every neighbourhood store. The DTAB’s caution is not plucked from thin air. At the 89th DTAB meeting in 2023, members noted that NRT products could be misused for nicotine substitution during forced periods of abstinence ~ on flights, in offices, at hospitals ~ rather than as genuine cessation aids.
Research presented by the Indian Council of Medical Research and the Tobacco Control Division reinforced these apprehensions. Globally, the tobacco industry has attempted to exploit NRT licensing pathways to slip novel nicotine products into markets through regulatory side doors. India has seen applications to include nicotine strips and pouches under the same Schedule K exemption that was originally carved out for cessation gums. If the exemption becomes a loophole, the argument goes, it must be narrowed. There is also the question of regulatory coherence. India prohibits e-cigarettes under a sweeping 2019 law. Allowing flavoured nicotine lozenges unrestricted OTC access while banning vapes creates an inconsistency that weakens the overall tobacco control architecture.
A government that claims zero tolerance for novel nicotine products cannot simultaneously permit their pharmacy-free distribution under a different label. These are defensible positions. But defensible is not the same as wise. Strip away the regulatory elegance and look at the ground reality. India has roughly one tobacco cessation centre for every two million people. Rural areas, where 43 per cent of men use tobacco and culturally embedded smokeless forms dominate daily life, are dramatically underserved. The national quit ratio ~ the proportion of lifetime users who have successfully stopped ~ hovers at just 21 per cent.
In a country where seven out of ten patients walking into a rural outpatient department in Rajasthan are tobacco users, and where community health workers plead not for lectures but for medicines, restricting access to one of the few affordable pharmacological aids available is a peculiar act of self-sabotage. Consider the journey of a daily bidi smoker in a village in eastern Uttar Pradesh or rural Odisha. He earns a modest wage. He knows tobacco is harming him ~ the warnings on packets have done their work. He wants to quit. Under the current dispensation, he can walk into a shop and buy a strip of nicotine lozenges for a few rupees. No prescription, no pharmacist, no bus ride to the district hospital.
The lozenge does not cure him overnight, but it dulls the craving long enough to get through a difficult day. That frictionless access is not a design flaw. It is the entire point. Now imagine the same man under the proposed regime. The nearest licensed pharmacy may be ten or fifteen kilometres away. If a prescription is required, the nearest qualified medical practitioner could be further still. The hassle is not trivial ~ it is prohibitive. Research consistently shows that even small barriers to cessation aids cause significant drop-off in quit attempts. The man does not fill out a complaint form; he simply lights another bidi. The lozenge, meanwhile, sits locked behind a pharmacist’s counter that he will never visit. The irony is sharp enough to draw blood.
Cigarettes and bidis remain available at every pan shop, roadside stall, and railway platform in the country. No prescription is needed. No pharmacist supervises the transaction. No online monitoring tracks the sale. A product that kills is sold with fewer restrictions than a product that helps people stop dying. The economics compound the injustice. A recent analysis published in BMJ Global Health estimates that tobacco cessation could economically uplift over 20 million Indian households. The poorest rural families spend 6.6 per cent of their monthly per-capita expenditure on tobacco. Money freed from addiction flows into food, education, and healthcare. Every barrier placed between a tobacco user and a cessation tool is, in economic terms, a barrier placed between a family and a pathway out of poverty.
The concern about minors accessing nicotine products is genuine. But the proposed solution ~ restricting all adult access ~ is disproportionate. India already has laws prohibiting the sale of tobacco products to minors under the Cigarettes and Other Tobacco Products Act (COTPA) and the Juvenile Justice Act. These laws are poorly enforced: surveys show that 45 per cent of young cigarette buyers are not even asked their age. The failure is one of implementation, not of insufficient legislation. Restricting NRT access to combat youth nicotine use is the regulatory equivalent of banning bandages because some teenagers might use them unnecessarily.
It treats the symptom while ignoring the structural deficit ~ which is the near-total absence of effective age verification at the point of sale for any nicotine or tobacco product in India. Moreover, there is no substantive evidence that low-dose nicotine gums and lozenges are a significant gateway to tobacco addiction among minors. The real gateways ~ bidis at one rupee a stick, flavoured gutka in shiny sachets, peer pressure in school corridors ~ remain largely unaddressed by this policy move. Policy need not be binary. Between unfettered access and pharmacy-only restriction lies a range of pragmatic options that protect youth without abandoning adult quitters.
First, enforce age-gating at the point of sale, not product-gating for all consumers. India should invest in stricter age verification mechanisms for all nicotine and tobacco products ~ including cigarettes and bidis ~ rather than restricting cessation products alone. Digital age verification at online platforms, already recommended by DTAB, should be implemented as a standalone measure without pulling lozenges off general store shelves. Second, retain OTC status for unflavoured, low-dose lozenges alongside gums. The distinction between a 2 mg gum and a 2 mg lozenge is pharmacologically negligible. If the gum is safe enough for open sale, the lozenge is too.
Restrict flavoured variants if the concern is youth appeal, but do not punish the unflavoured cessation tool that a 55-year-old bidi smoker in Chhattisgarh relies on. Third, mandate pharmacist-assisted sales without requiring a prescription. The Australian model is instructive: nicotine products are available at pharmacies with a pharmacist consultation but without a doctor’s prescription. This adds a layer of professional guidance without creating the access barrier of a prescription. India could pilot this in urban areas while maintaining broader OTC access in districts with low pharmacy density. Fourth, decouple cessation policy from tobacco industry regulation.
The DTAB’s recommendation to restrict NRT marketing by tobacco companies is sensible and should proceed independently. Preventing the industry from co-opting cessation products does not require making those products harder for consumers to obtain. These are two separate problems that demand two separate solutions. Fifth, invest massively in cessation infrastructure before restricting access channels. India’s 600 tobacco cessation centres are woefully inadequate for a population of 270 million users. Before narrowing the retail channels through which cessation aids reach people, the government must widen the clinical and counselling infrastructure that can absorb the redirected demand.
To restrict supply without building capacity is to create a cessation desert. India’s tobacco control journey has been marked by laudable ambition ~ from COTPA to the e-cigarette ban to graphic health warnings that now cover 85 per cent of cigarette packaging. But ambition without coherence produces paradox. A country that puts a quit line number on every cigarette pack cannot simultaneously make it harder for the person who calls that number to access the one affordable pharmacological tool within reach. The DTAB’s instincts are not wrong.
The tobacco industry does exploit regulatory gaps. Youth protection is non-negotiable. Post-marketing surveillance is overdue. But the instrument must be proportionate to the threat. When the collateral damage of a regulation falls disproportionately on the rural poor, the undereducated, and the genuinely addicted ~ the very populations that bear the heaviest burden of tobacco disease ~ the regulation needs recalibration, not just implementation. India does not lack tobacco users who want to quit. It lacks a system that makes quitting easy. This policy, in its current form, makes it harder. That is not tobacco control. It is our own goal.
(The writer has been in a Tobacco Cessation consortium roundtable at World Health Assembly, Berlin under the Chairmanship of DG, WHO. He writes on public health policy and regulatory design in emerging economies)