By Timothy S. Donahue

Top Takeaways:

• Enforcement ordered: India’s Health Ministry has directed states to take action against unauthorized nicotine pouches being sold online and through brick-and-mortar retailers.
• Wide availability: A government-backed study found pouches available in seven of 10 cities surveyed and at 9% of tobacco points of sale, with researchers identifying hundreds of flavors.
• Regulatory resistance: India’s drug advisory board recommended that regulators approve no new nicotine formulations, including pouch applications submitted as smoking-cessation products.

India has nicotine pouches. It just doesn’t want them.

India’s Health Ministry has ordered states to crack down on unauthorized nicotine pouches as products such as ZYN and White Fox become increasingly available online and through tobacco retailers, despite lacking approval for sale in the country.

In a Sept. 19 advisory sent to states, the ministry cited increased “availability of oral nicotine pouches through online and offline channels in the country” and directed authorities to take enforcement action under existing law. “Nicotine exposure is of particular concern among children,” the ministry said.

The directive follows growing scrutiny of a category that has expanded rapidly internationally but is regulated very differently in India.

India’s Central Drugs Standard Control Organization regulates the import, manufacture, sale, and distribution of drugs under the Drugs and Cosmetics Act and its accompanying rules. Nicotine pouch products sold without the necessary authorization are considered unapproved drugs by Indian authorities.

The products have become increasingly easy to find. A study led by the Indian Council of Medical Research-National Institute of Cancer Prevention and Research and published in June found nicotine pouches in seven of the 10 Indian cities surveyed.

Researchers found the products at 9% of tobacco points of sale and identified availability on online platforms, in hookah shops, and through rapid-delivery services. The study identified 445 flavor variants and products with nicotine concentrations as high as 120 mg.

Researchers described the growing market as “a largely unregulated public health concern” and reported that consumption was concentrated among people ages 18 to 40. Brands identified in the Indian market included Philip Morris International’s ZYN and White Fox, which is owned by Swedish Smokeless Solutions.

The enforcement push also follows a high-profile dispute over nicotine pouch sales at Mumbai’s international airport.

Indian drug regulators determined earlier this year that duty-free shops operated by an Adani Group joint venture had improperly sold imported nicotine pouches without the required authorization. The shops stocked ZYN and White Fox products.

Adani challenged the government’s interpretation in court, arguing that duty-free operations in the airport’s international departure area should not be treated the same as domestic retail sales.

Indian authorities disagreed, maintaining that the products are unapproved drugs and cannot be legally sold without the required registrations and import licenses.

The broader regulatory environment could become even more restrictive.

At an Aug. 27 meeting, India’s Drugs Technical Advisory Board considered applications for permission to manufacture, import and market nicotine pouches containing 2 mg, 4 mg and 6 mg of nicotine.

The applications involved different nicotine salts and proposed marketing the products for smoking cessation and for relief of nicotine-withdrawal symptoms.

India’s National Tobacco Control Programme opposed the applications, telling the board that nicotine pouches are addictive, pose independent health risks, and have not been established as effective smoking-cessation products.

After considering the issue, the board recommended that “no new nicotine formulation be approved henceforth in the public interest.” That position draws a clear distinction between emerging nicotine products and nicotine-replacement therapies already authorized in India.

India permits approved nicotine gum, lozenges, and transdermal patches for smoking cessation. E-cigarettes, meanwhile, have been prohibited nationwide since 2019.

The Sept. 19 directive now places enforcement of India’s position on nicotine pouches squarely in the hands of state authorities. “Initiate appropriate enforcement action in accordance with the law, in the interest of public health and protection of children,” the Health Ministry told states.