Stricter regulation of nicotine replacement therapy: One step forward, two steps back approach

Dear Editor,

A series of regulations implemented by the Haryana government in India have had unintended consequences for the availability of nicotine replacement therapy (NRT) agents and the treatment of tobacco dependence. The government’s actions included a ban on manufacturing, storage, distribution, and sale of all tobacco-containing products, such as gutka, pan masala, flavored or scented tobacco, kharra, and other similar products. Additionally, nicotine was added to the list of poisons under the Haryana Poison Possession and Sales Rules. Consequently, anyone selling products containing nicotine must adhere to the same stringent regulations applied to substances already classified as poisons. These measures signify a well-intentioned but potentially counterproductive approach to public health. However, the notification did not provide a clear rationale for these changes. It seems that the decision was influenced by concerns that NRT agents have addiction potential and could be harmful, akin to other tobacco products.[1] This regulatory shift has led to the restricted availability of NRT agents in pharmacy shops. These agents were previously governed by Schedule K of the Drugs and Cosmetics Act of 1945, exempting nicotine gum and lozenges containing up to 2 mg of nicotine from the requirement of a sale license or a prescription from a registered medical practitioner.[2] Regrettably, it has become a deterrent for patients seeking treatment for nicotine dependence in a country with a high prevalence of tobacco users. The measures seem to be a result of prejudice against nicotine gums, which is a noncarcinogenic treatment modality with little to no dependence potential.[3] These regulations are also in direct conflict with India’s commitment as a member of the World Health Organization’s Framework Convention for Tobacco Control (FCTC). Article 14 of the FCTC recommends enhancing access to pharmaceutical treatment for tobacco dependence, which includes NRT. International commitments, such as the United Nations General Assembly’s Political Declaration on Noncommunicable Diseases in 2011 and the World Health Organization’s Global Action Plan in 2013, advocate for achieving 80% availability of essential medicines for noncommunicable diseases by 2025, including NRT. Furthermore, nicotine gums have been recently included in the National List of Essential Medicines in 2022.[4] These developments indicate a positive direction at the national level to address tobacco dependence but require better implication and coordination with states.

The National Tobacco Control Programme allocates funds for the purchase of cessation medications annually, but there is limited evidence of its implementation. Few studies have highlighted the poor availability of these agents in both public sector and private hospitals, including centers that provide tobacco cessation counseling or mental health services as well as pharmacy shops.[5,6] The NFHS 5 has also shown a higher use of tobacco (Males: 42.7%; Females: 10.7%) in the rural population than the urban population (Males: 28.8%; Females: 5.4%) of the country.[7] While some may take advantage of the online platforms to get NRT, poor patients will find it tough to get treatment in rural areas. Only wider availability of NRT and adequate awareness of its correct application can help to tackle tobacco use disorder. There have also been reports regarding increasing consumption of nicotine-based chewing gum, which has subsequently led to restricted sales of nicotine gum at medical stores. Despite concerns about addiction, no scientific basis for the ban has been offered, even for the low-dose 2 mg variant. Although the Drugs Technical Advisory Board has recommended making it a prescription-only drug, the complete ban on selling it at pharmacies fails to serve the interests of patients.[8]

In conclusion, the stricter regulation of NRT agents appears to be at odds with international commitments and hinders efforts to reduce tobacco dependence. Policymakers need to reconsider these regulations and adopt a more balanced approach that prioritizes public health and the needs of patients seeking assistance to quit tobacco.

Author’s contribution

Concept and design of paper: AG, EG, SC. Drafting the article: AG. Final editing and approval of the version to be published: EG, SC.

Source of funding

Nil.

Conflicts of interest

Nil.

Funding Statement

Nil.