India’s drug regulator is moving towards a more cautious approach to new nicotine products, with the Drugs Technical Advisory Board (DTAB) recommending that no new nicotine formulation be approved “henceforth” in the public interest.
The recommendation by the country’s highest statutory decision-making and advisory body on technical matters related to drugs, cosmetics, and medical devices comes at a time when nicotine pouches are becoming increasingly visible in India, including through online platforms and other informal channels.
Health officials said such a suggestion was made at the DTAB meeting on August 27, after the board considered applications received by the Central Drugs Standard Control Organisation (CDSCO) seeking permission to manufacture, import and market nicotine pouches in 2 mg, 4 mg and 6 mg strengths.
The products contain different nicotine salts and were proposed for smoking cessation and relief from nicotine-withdrawal symptoms.
The National Tobacco Control Programme (NTCP), which examined the proposal, told DTAB that nicotine pouches are addictive, pose independent health risks and have not been established as effective smoking-cessation aids. It recommended that licences for new nicotine formulations should not be granted and that evidence-based tobacco-cessation methods should be prioritised.
DTAB accepted this line of reasoning and recommended that no new nicotine formulation be approved. A recent ICMR-National Institute of Cancer Prevention and Research (ICMR-NICPR) study too had raised concerns about their availability and use, particularly among younger people and working men.
The recommendation does not mean that every nicotine product currently available will immediately disappear.
It is aimed at preventing the approval of new nicotine formulations. Existing products and their regulatory status will continue to be governed by the rules and approvals applicable to them.
This distinction is important because nicotine is also used in approved nicotine-replacement therapies (NRTs), such as nicotine gums and lozenges, which are intended to help smokers quit.
In February this year, DTAB had already recommended tightening the rules around these products. It proposed that the Schedule K exemption for nicotine gums and lozenges be limited to unflavoured 2 mg nicotine gum.
It also called for 2 mg nicotine lozenges to be removed from the exemption, meaning they would require a sale licence. The board also called for restrictions on sales to minors, closer monitoring of online availability and post-marketing surveillance.
Nicotine pouches are small sachets placed between the gum and lip. They do not contain tobacco leaf but deliver nicotine through the mouth.
Their discreet form, flavours and online availability have raised concerns among public health researchers. The ICMR-NICPR study had reported that the products were available in seven of 10 cities surveyed, with about 9% of points of sale found to be selling them. The study also found products being sold through e-commerce platforms, hookah shops and other channels.
The concern is not simply whether the products contain tobacco. Nicotine itself is addictive, and the emergence of products that can be used discreetly may create another route of nicotine exposure, particularly among people who may not otherwise use tobacco.
The ICMR-NICPR study raised concerns that oral nicotine pouches outside approved nicotine-replacement products fall within the country's drug regulatory framework and that their availability through online and other channels could make enforcement difficult.
