Cos seek nod to sell high-dose nicotine pouches, spark concern

With the government running awareness campaigns against tobacco use in the country, this has sparked concerns of nicotine initiation and long-term addiction.

The latest development pertains to Vcherish Pvt. Ltd, Harsh Nutricare Pvt. Ltd, Lyrus Life Sciences Pvt. Ltd, Fertin India Pvt. Ltd and Leaf Fibers Pvt. Ltd approaching the country’s apex drug regulator to manufacture and market oral nicotine pouches of dosage as high as 6mg.

In India, NRT products such as nicotine gums containing up to 2mg do not require a prescription. Above this level, it requires a doctor's supervision. Currently, 6mg nicotine pouches are not manufactured in India.

The Central Drugs Standard Control Organisation (CDSCO), on its part, is evaluating these proposals and has sought technical guidance from the health and family welfare’s ministry Tobacco Control Division on the companies' applications seeking to classify high-dosage nicotine pouches as smoking cessation aids under the nicotine replacement therapy framework.

Nicotine significantly escalates 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.

“Nicotine damages the cardiovascular system, regardless of how it is delivered into the body. It causes oxidative stress, harms the walls of blood vessels, promotes clotting, and accelerates the buildup of plaque," said Dr. Prashant Kumar Singh, senior scientist at Indian Council of Medical Research (ICMR)—National Institute of Cancer Prevention and Research (NICPR). "Furthermore, the liquid used in these devices often contains propylene glycol, which, when heated, produces formaldehyde and acetaldehyde, chemicals known to be toxic to the heart."

In India, NRT products, including nicotine gums and lozenges, are regulated as drugs under the Drugs and Cosmetics Act, given that they are shown as used for reducing tobacco dependence and classified as NRT under the Drugs and Cosmetics Act.

While the current NRT formats are approved in 2mg and 4mg strengths, the introduction of 6mg pouches has alarmed public health experts.

According to documents reviewed by Mint, while Vcherish and Lyrus Life Sciences have sought the drug regulator’s approval for Nicotine Polacrilex and Ditartrate Dihydrate formats in strengths ranging from 2mg to 6mg, Harsh Nutricare has sought a nod to Nicotine Ditartrate Dihydrate pouches. Fertin India plans to introduce a novel Oromucosal powder format for faster absorption, while Leaf Fibers is targeting high-dependence users with 4mg and 6 mg variants of nicotine pouches.

Experts say these pouches, while framed as tools to quit smoking, may actually serve as "initiation devices" for youth and non-smokers and warn that granting such approvals could open a pandora’s box of unregulated flavoured products in liquid, semi-solid, or powder forms that are difficult to monitor.

Experts also warn that neighbouring countries provide a cautionary trend, given the rapid spread of these products there and the fear of them entering the Indian market illegally. “The focus must shift toward scaling up access to evidence-based behavioral counseling, coupled with non-nicotine treatments like cytisine, varenicline, bupropion, if required," said Dr. Shalini Singh, director at ICMR—National Institute of Cancer Prevention and Research. "True health recovery requires quitting nicotine altogether, not just changing the delivery method."

While India's NRT market, valued at approximately $37.02 million (Vision Research Reports, 2023), is small compared to the $63 billion tobacco market in India (Data Bridge, 2024) and the $2 billion illegal e-cigarette market (IMARC Group), its potential to initiate new users remains alarming. Some of India's popular NRT brands are from pharmaceutical majors including Cipla, Glenmark Pharmaceuticals and Piramal Pharma.

The industry's rationale

The NRT industry does not agree with these concerns.

“Nicotine replacement therapy has been extensively studied to help curb withdrawal symptoms a person experiences while quitting. It is important to consult with healthcare providers and choose regulated NRT such as patches and gums to protect heart health while breaking free from tobacco," said Malavika Kaura Saxena, chief marketing officer at Rusan Pharma that manufactures the 2baconil brand of nicotine transdermal patches and nicotine gums. "Rusan Healthcare markets nicotine gums and patches, noting that these products deliver controlled, low-dose nicotine through oral absorption or transdermal delivery to ease quitting."

Queries sent on 25 December to the spokespersons of health and family welfare ministry and the Drugs Control General of India (DCGI), who heads the CDSCO, remained unanswered.

Queries emailed to Cipla and Piramal Pharma early 30 December also remained unanswered until press time, as were the queries emailed to Vcherish, Harsh Nutricare, Lyrus Life Sciences, Fertin India, and Leaf Fibers on Monday.

The legal point of view

The legal community seems to be divided on the matter.

Ashwin Sapra, partner (head - pharma & healthcare) at Cyril Amarchand Mangaldas, said that if strictly sold under doctor prescriptions, these pouches could be an effective aid in quitting smoking. “It would be unfair to categorize this as a backdoor attempt. It is a genuine attempt at getting clarity in an otherwise grey area of the law which needs to be reviewed, assessed and clarified with an open mind," he said.

But there are regulatory questions that the companies' proposals raise, says B. Shravanth Shanker, advocate-on-record at the Supreme Court of India. He noted that India’s nicotine regime consciously separates therapeutic replacement from recreational consumption.

“The scrutiny by the CDSCO must, therefore, turn on whether a higher dose pouch demonstrates a bona fide therapeutic justification, or whether it merely repackages nicotine for consumer use under the veneer of pharmaceutical legitimacy," Shanker said and cautioned that “classifying such pouches as drugs would confer a substantial tax and access advantage over cigarettes, incentives that Parliament has consistently sought to suppress."

A study, led by the ICMR-National Institute of Cancer Prevention and Research, published earlier this month in BMC Public Health, has sparked concern regarding nicotine. Analyzing data from 1.2 million participants, researchers found that nicotine triggers harmful effects regardless of the delivery method. The study revealed that e-cigarette users face a 53% higher risk of heart attacks compared to non-users. More importantly, former smokers who "switched" to nicotine devices, rather than quitting entirely, saw their heart attack risk spike by over 2.5 times. This evidence reinforces that nicotine acts as a direct cardiovascular toxin, causing arterial damage and blood clots.

Global norms on nicotine replacement

The US FDA regulates them as "tobacco products" but requires a separate, rigorous ‘drug’ approval process if they are to be marketed as cessation aids.

Australia strictly regulates these pouches as therapeutic goods; they cannot be legally purchased or imported without a valid prescription from a doctor.

The UK, on the other hand, follows general consumer safety regulations, though there is a push to move them under the same strict medicinal framework as other NRT products.

In the European Union, countries such as Belgium and the Netherlands have moved to ban nicotine pouches entirely due to the high risk of initiation among non-smokers.