India's National Tobacco Control Programme has recommended that the country's top drug regulator reject licence applications for manufacturing, importing and marketing nicotine pouches in 2mg, 4mg and 6mg strengths.

The recommendation, reported by Mint on 6 September based on two government officials and a government document, was submitted to the Central Drugs Standard Control Organisation (CDSCO). Officials cited concerns that the flavoured, tobacco-free sachets could undermine India's tobacco control efforts and pose a youth-initiation risk.

This is a pre-emptive block: India is stopping pouches at the regulatory door rather than banning an existing market.

Who applied and what they wanted

At least five companies approached CDSCO seeking approval to manufacture and market pouches in India, according to earlier Mint reporting from 31 December 2025. The applicants included:

• Vcherish Pvt. Ltd
• Harsh Nutricare Pvt. Ltd
• Lyrus Life Sciences Pvt. Ltd
• Fertin India Pvt. Ltd
• Leaf Fibers Pvt. Ltd

Some framed their applications as nicotine replacement therapy (NRT) under India's Drugs and Cosmetics Act. That classification matters: in India, NRT products such as gums up to 2mg are regulated as drugs, and 2mg and 4mg strengths are already approved for other formats. The companies sought approval for pouches up to 6mg — a strength not previously manufactured in India.

CDSCO sought technical guidance from the health ministry's Tobacco Control Division. The NTCP recommendation is the result of that consultation.

Why officials rejected the NRT framing

Health officials argue that nicotine pouches are unproven as cessation aids and that their flavours and digital marketing make them an initiation risk rather than a quit tool. The Mint report quotes officials stressing that "effective cessation methods should be prioritized as these products pose independent health risks."

India has 268 million tobacco users and banned e-cigarettes outright in 2019. Pouches occupy a legal grey area: The Hindu explained on 8 September that COTPA (the Cigarettes and Other Tobacco Products Act) does not clearly cover tobacco-free nicotine pouches, and the 2019 vape ban does not cover them either. Their status as food or drugs under Indian law remains unsettled.

A separate court case concerns pouches sold at Mumbai duty-free (operated by Adani).

What this means

India is now the clearest recent example of a major market closing itself to nicotine pouches at the licensing stage. The NRT-classification strategy that companies tried — positioning high-strength pouches as medical products — is visibly dead on arrival.

For manufacturers eyeing India's scale, the NTCP recommendation signals that the regulatory path is shut, and the legal grey area is narrowing toward a de facto ban.

SOURCES:
Mint: India moves to block new nicotine pouch formulations amid addiction risks
The Hindu: Are nicotine pouches beyond the law? Explained
Mint: Cos seek nod to sell high-dose nicotine pouches, spark concern

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