India moves to block new nicotine pouch formulations amid addiction risks

medicine.28/01/2010.photograph:pradeep gaur/mintSummaryIndia’s National Tobacco Control Programme has urged the rejection of licenses for manufacturing nicotine pouches, warning they could foster nicotine addiction among youth. Health officials stress that effective cessation methods should be prioritized as these products pose independent health risks.New Delhi: The National Tobacco Control Programme (NTCP) has recommended that India’s top drug advisory body reject licence applications for manufacturing, importing and marketing new nicotine pouch formulations in 2mg, 4mg and 6mg strengths, citing concerns that the small, tobacco-free, flavoured sachets could undermine the country’s efforts to curb nicotine use and protect public health, according to two government officials and a government document reviewed by Mint.The applications before India’s top drug advisory body, the Drugs Technical Advisory Board (DTAB), are for pouches containing different forms of nicotine, intended for smoking cessation and relief from withdrawal symptoms, amid concerns that they could encourage nicotine initiation and long-term addiction. The sachets are placed between the gum and lip to release nicotine and have gained popularity among young people.According to the document, various applications were received by the India’s apex drug controller—the Central Drugs Standard Control Organisation (CDSCO)—for grant of manufacturing/import and marketing of nicotine pouches in 2mg, 4mg and 6mg strengths containing different salts of nicotine such as nicotine ditartrate dihydrate, nicotine polacrilex, etc. for smoking cessation.“… TCD (Tobacco Control Division, under the health ministry) has emphasized that evidence-based cessation methods should be prioritized over nicotine pouches and recommended refraining from granting licenses for new nicotine formulations,” the document stated.Nicotine pouches contain no tobacco leaf and are marketed as “tobacco-free”, “modern” and “safer alternatives” to conventional tobacco products. They deliver nicotine through the gums without smoking or vaping and are promoted for smoking cessation and withdrawal relief. Flavoured variants, sleek packaging, influencer campaigns and aggressive digital marketing have raised concerns over their appeal to young people, much as with e-cigarettes.The Directorate General of Health Services (DGHS), under the health ministry, had asked the Drugs Controller General of India (DCGI) to ensure that all applications related to tobacco products or nicotine substances were discussed with the National Tobacco Control Programme.Subsequently, CDSCO informed DGHS and NTCP about the details of application for manufacturing, marketing and import and nicotine cases for the indication of smoking cessation and sought opinion on the same.In response, NTCP and health ministry wrote to the CDSCO stating that “these nicotine pouches are addictive, carry independent health risks, and are not effective cessation aids.”The communication further said, “Evidence-based cessation methods should be prioritized over nicotine pouches and recommended refraining from granting licenses for new nicotine formulations.”The latest DTAB meeting was held on 27 August in view of NTCP and the health ministry’s recommendation as DTAB has been examining how nicotine replacement products should be sold in India.Queries sent to the health ministry, DGHS, DCGI and nicotine pouches sellers Velo, Pouched India and ZeroSmoke on Saturday remained unanswered till press time.Health concernsThe development assumes significance given that nicotine significantly raises cardiovascular risks, with tobacco claiming 1.35 million lives every year in India. India has 268 million tobacco users, with the economic burden of treating tobacco-related illnesses accounting for ₹1.77 trillion annually.Mint earlier reported that nicotine pouches have emerged as a growing public health concern, with Indian manufacturers seeking approval to sell 6mg products—50% more potent than the current maximum—as therapeutic products under the nicotine replacement therapy (NRT) regime.Earlier in March, Mint reported about government plans to tighten rules on nicotine replacement products, including lozenges, by considering a mandate to restrict their sale strictly to licensed pharmacies and prohibit sales to minors.Nicotine treatment products such as nicotine gums, lozenges and patches in strengths of 2mg and 4mg are approved in India under the Drugs and Cosmetics Act, as they are used to reduce tobacco dependence. However, nicotine pouches are illegal under existing Indian drug laws and also violate the Food Safety and Standards Authority of India ban on nicotine in oral consumables. They also contain substances classified as poisons under the Poisons Act, 1919.Despite this, nicotine pouches are being largely imported and sold in the Indian market. The introduction of 6mg pouches has, however, raised concerns among public health experts.“Nicotine pouches should be considered very carefully, particularly given their potential for addiction and misuse. At the same time, the much larger public-health crisis of tobacco smoking cannot be overlooked. The enforcement of tobacco-control measures is often inconsistent and personality-driven. This must change. Tobacco-induced illness, including cancer, causes enormous mortality and morbidity, while passive smoking puts non-smokers at risk,” said Dr Alexander Thomas, a public health expert and founder-president of the Association of Healthcare Providers India.“Global evidence increasingly shows that nicotine pouches are being used not only by adult tobacco users, but also by adolescents and people with no history of conventional tobacco use. Their high nicotine content, discreet use and flavours can facilitate repeated use and nicotine dependence, while nicotine exposure also elevated cardiovascular risk concerns,” said Dr Prashant Kumar Singh, senior scientist at the Indian Council of Medical Research-National Institute of Cancer Prevention and Research (ICMR-NICPR).About the AuthorPriyanka SharmaPriyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.<br><br>Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.<br><br>Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.