NEW DELHI: The Centre plans to tighten rules governing the sale of nicotine lozenges, moving them from general store counters to regulated pharmacy shelves to curb easy access among minors and non-smokers.
The move would remove 2mg nicotine lozenges from the exemption under Schedule K of the Drugs Rules, 1945, which currently allows certain nicotine replacement therapy (NRT) products to be sold without a drug sale licence. As a result, retailers would require a formal licence to sell nicotine lozenges, according to two officials and documents reviewed by Mint.
The proposal follows recommendations by the Drugs Technical Advisory Board (DTAB) at a meeting held in February. The board also called for a strict ban on sales to minors and closer monitoring of online platforms to prevent easy access.
In India, NRT products including nicotine gums and lozenges are regulated as drugs under the Drugs and Cosmetics Act as they are used to reduce tobacco dependence. However, under a special exemption in Schedule K, nicotine gums and lozenges containing 2 mg of nicotine can be sold without a drug sale licence.
According to the meeting minutes reviewed by Mint, the board was also informed about recommendations from the Indian Council of Medical Research (ICMR) and the Tobacco Control Division (TCD). After deliberation, DTAB recommended amending entry 33 of Schedule K so that the exemption applies only to unflavoured 2 mg nicotine gums, and not to any other NRT products.
The board also recommended that sales to minors be strictly prohibited, online access be closely monitored, and post-marketing surveillance be conducted to track adverse effects. It further suggested restricting the marketing of NRT products by tobacco companies due to potential conflicts of interest, as per the document.
“Further, DTAB recommended that nicotine lozenges 2 mg shall be excluded from Schedule K exemptions,” the document added.
“The board has recommended narrowing these exemptions significantly. Under the new plan only unflavoured 2mg nicotine gums will continue to be exempt from a sale license. All 2mg nicotine lozenges will now require a formal drug sale license. This move effectively pulls lozenges, which often come in attractive flavours, off general store shelves and places them behind the pharmacy counter,” said one of the two officials cited above.
“Until now, under a special exemption in Schedule K of the Drugs Rules, 1945, nicotine gums and lozenges containing 2mg of nicotine did not require a sale license. This meant that any grocery store, kiosk, or online platform could sell these products without the oversight applied to medicines. While originally intended to make it easier for smokers to quit, this ease of access has sparked fears that non-smokers and minors are using them as a recreational "gateway" to nicotine,” said the official familiar with the matter.
Queries sent to the health ministry spokesperson remained unanswered till press time.
The development assumes significance given that 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.
While the Indian NRT market is comparatively smaller at around $37.02 million as compared to the $62 billion tobacco market and $2 billion illegal e-cigarette market; its potential to initiate users is alarming.
Public health experts have long warned about youth exposure to nicotine products.
“Nicotine exposure during adolescence impairs brain development, reduces impulse control, worsens anxiety and depression, and may increase the risk of chronic diseases including cancer and heart disease,” said Dr. Shalini Singh, director of the Indian Council of Medical Research’s National Institute of Cancer Prevention and Research, adding that as of December 2024, over 50 countries had adopted policies regulating or banning flavoured nicotine products.
“Global evidence is unambiguous that flavours are not incidental to nicotine products rather they are the industry's most deliberate and effective tool for creating a new generation of addicts,” Singh said.
The World Health Organization has also warned that tobacco companies are targeting children and young people with flavoured nicotine products, said Dr Prashant Kumar Singh, senior scientist at the ICMR-National Institute of Cancer Prevention and Research.