India’s fight against tobacco needs strength

Subject: Science and technology

Section: Health

Context:

The health ministry of India has proposed to place nicotine replacement therapies (NRT) under Schedule K so that in future they would be available only on the prescription of authorised medical practitioners and not as over-the-counter (OTC) preparation.

89th Drug Technical Advisory Board (DTAB) meeting:

Nicotine polacrilex gums, lozenges and transdermal patches are used for NRT.
At the 89th Drugs Technical Advisory Board meeting held in May 2023, there was a proposal to amend Schedule K.
The idea is to place all formulations of nicotine containing up to 2mg-4mg under prescription of authorized medical practitioners and not as over the counter (OTC) preparation.

Consequences of putting NRT under prescription drugs:

It will limit the product accessibility to prospective tobacco quitters and will also slow down the efforts of the government on tobacco de-addiction.
It will hinder ease of access, thereby going against the intent of National List of Essential Medicines 2022, in which oral dosage forms of 2mg and 4mg were recently included by the health ministry.
At the 81st DTAB meeting in 2018, the committee agreed to amend entry no 33 in Schedule K for providing exemption for all nicotine oral formulations containing 2mg of nicotine.

Impact of tobacco in India:

India has over a 100 million smokers and accounts for over a fifth of the world’s tobacco-related deaths.
Tobacco-related cancers accounted for 27 per cent of the country’s cancer burden in 2020, according to Indian Council of Medical Research (ICMR).
One of the significant goals of the health policy of India is relative reduction in prevalence of current tobacco use by 30 per cent by 2025.

Nicotine Replacement Therapies (NRTs):

NRT is a WHO-approved therapy for smoking cessation.
This was first available in the United States as an over-the-counter (OTC) product in 1996 (patch and gum), with approval of the lozenge and mini-lozenge in 2002 and 2010.
Since then, nicotine gums (2mg and 4mg) have been granted OTC status worldwide including in Australia, Canada, Germany, Sweden, Switzerland, Norway, Colombia, Iceland, Denmark, New Zealand, Austria, Italy based on its excellent safety and the confidence that patients / consumers can self-medicate responsibly.
Nicotine lozenges and transdermal patches are available OTC in the US and the United Kingdom.

Drugs and Cosmetics Rules 1940:

The Drugs and Cosmetics Rules, 1940 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940.
These rules classify drugs under given schedules and present guidelines for the storage, sale, display and prescription of each schedule.
Schedule K: Contains various substances and drugs and their corresponding regulation.
Schedule M: Contains various regulations for manufacturing, premises, waste disposal and equipment.