India is shutting the door on nicotine pouches. Photo credit: Bengt Wiberg, Pixabay.
India’s nicotine pouch market has been growing. The government wants to stop it.
India’s Ministry of Health and Family Welfare issued a letter directing state authorities to take enforcement action against unauthorized nicotine pouches as products such as ZYN and White Fox become increasingly available through online sellers and brick-and-mortar tobacco retailers.
The September 19 directive marks a significant escalation in India’s response to a category that is rapidly expanding internationally but remains unapproved in one of Asia’s largest tobacco markets. The Health Ministry wrote in the letter that the “availability of oral nicotine pouches through online and offline channels in the country” has increased, according to media reports.
“Nicotine exposure is of particular concern among children,” the ministry said.
States were instructed to “initiate appropriate enforcement action in accordance with the law, in the interest of public health and the protection of children.” The directive cited provisions of India’s drug laws that authorize authorities to search for and seize unauthorized products and to prosecute those selling them.
Pouches aren’t being singled out. India has taken a restrictive approach to the next generation of nicotine products.
The country banned e-cigarettes in 2019 while allowing certain nicotine-replacement products, including approved gums, lozenges, and patches. Nicotine pouches currently sold in India have not received the regulatory approvals required by Indian authorities.
Despite that, the products are reaching consumers.
A government study published in June described nicotine pouches as “a largely unregulated public health concern” and found that use was prevalent among people ages 18 to 40. Products identified in the Indian market included ZYN and Swedish Smokeless Solutions’ White Fox.
The study also documented pouch sales across both online and offline channels, highlighting the difficulty Indian authorities face in controlling a category that can be easily transported and sold through e-commerce and conventional tobacco retailers.
Government officials noted that some products are being smuggled into the country. Philip Morris states it has zero tolerance for illegal trade, while Swedish Smokeless advises consumers to purchase authentic products from authorized retailers.
India’s latest enforcement action comes as regulators are also seeking to block efforts to establish a formal pathway for nicotine pouches.
At its August 27 meeting, India’s Drugs Technical Advisory Board (DTAB) considered applications from the Central Drugs Standard Control Organization for permission to manufacture, import, and market nicotine pouches containing 2 mg, 4 mg, and 6 mg of nicotine.
According to the official meeting minutes, the products contained nicotine salts, including nicotine dihydrate ditartrate and nicotine polacrilex, and were proposed for smoking cessation and for relief of nicotine withdrawal symptoms.
The applications were referred to India’s National Tobacco Control Programme (NTCP).
The NTCP told the board that nicotine pouches “are addictive, pose independent health risks, and have not been established as effective smoking-cessation aids.” It recommended prioritizing evidence-based tobacco-cessation interventions over approving new nicotine pouch formulations.
The board went further.
After considering nicotine products already approved by Indian regulators and the objective of tobacco cessation, the DTAB “recommended that no new nicotine formulation be approved henceforth in the public interest.”
That recommendation could pose a significant barrier to companies seeking to establish a legal nicotine pouch market in India. It also highlights an important distinction in the country’s approach to nicotine.
India’s regulatory framework already permits certain pharmaceutical nicotine products. Previous DTAB decisions have classified nicotine gum, lozenges, and other oral formulations as “cessation” products.
The current government position instead focuses on whether additional nicotine formulations should be authorized and whether nicotine pouches already reaching Indian consumers have the authorizations required under the country’s drug laws.
That distinction has already reached the courts.
Earlier this year, Indian regulators found that duty-free shops at Mumbai’s international airport, operated by an Adani Group joint venture, had improperly stocked and sold nicotine pouches. Adani challenged the decision, arguing, among other things, that goods sold in duty-free stores in international departure areas fell outside the scope of certain domestic laws.
The Bombay High Court rejected that argument, ruling that duty-free stores operating within India are not immune from domestic law. Adani has denied wrongdoing. The court also said the company remained free to make representations to the government on nicotine pouches.
The dispute revealed how deeply nicotine pouches had penetrated the Indian market before regulators intensified their response. It also comes as pouch manufacturers increasingly look beyond established markets in the United States and Europe.
Across Asia, regulatory approaches remain fragmented. Some countries prohibit or tightly restrict emerging nicotine products, while others are developing regulatory frameworks that distinguish among combustible cigarettes, heated tobacco products, vapor products, and oral nicotine products.
India is moving in the opposite direction.
The Health Ministry is now asking state authorities to identify products already on the market and to use existing law to remove them. At the same time, the country’s principal technical advisory body on drugs has recommended closing the door to approval of new nicotine formulations.
For nicotine pouch manufacturers eyeing India’s enormous population as a potential future market, those two developments convey essentially the same message. India is not opening the door to nicotine pouches. For now, it is trying to shut it.