India’s fight against tobacco needs strength

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. 

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 authorised medical practitioners and not as over the counter (OTC) preparation.

Any step undertaken to reclassify it as a prescription drug will limit the product accessibility to prospective tobacco quitters and will also slow down the efforts of the government on tobacco de-addiction. 

India has over a 100 million smokers and accounts for over a fifth of the world’s tobacco-related deaths. Families lose young adults and their future is ruined. Lives and livelihoods perish. The country loses productivity. This will also severely handicap our national campaigns ‘Make in India’ and ‘Atmanirbhar Bharat’.

Tobacco-related cancers accounted for 27 per cent of the country’s cancer burden in 2020, according to Indian Council of Medical Research (ICMR). 

But now ICMR endorsing the move to put small dosage of NRT under prescription will be counterproductive. 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.

That is why in 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. The committee realised the gravity of the situation and the necessity of looking into the convenience of patients for a tobacco-free society. 

But the 89th DTAB almost reversed the earlier decision. Under the current meeting it was stated that NRTs may be used by addicts for nicotine substitution in forced periods of abstinence, rather than quitting tobacco. But there is absolutely no substantial evidence that proves small dosage of NRT is habit-forming. 

The time taken for blood levels of nicotine to peak is much less for NRT as compared to smoking, which makes it less liable to abuse potential. Restricting supply of NRTs will not lead to the desired outcome of curbing tobacco addiction.

One of the significant cross-sectoral health goals under the health policy of India outlines is relative reduction in prevalence of current tobacco use by 30 per cent by 2025. This needs to be underlined. 

World No Tobacco Day on May 31, 2023 saw members of the parliament writing to Prime Minister Narendra Modi and Health Minister Mansukh Mandaviya seeking to make tobacco control laws stricter. They include Rajya Sabha MP Vandana Chavan, Amol Kolhe, Lok Sabha MP from Shirur; Supriya Sule, Lok Sabha MP from Baramati; Shriniwas Patil, Lok Sabha MP from Satara; Pritam Munde, Lok Sabha MP from Beed and Ranjit Naik-Nimbalkar, Lok Sabha MP from Madha. The doctors' association Federation of All India Medical Association has written to the Prime Minister stating that tobacco use is one of the biggest public health threats in India, which not only leads to loss of lives but also has heavy social and economic costs for the public. 

Modi has also acknowledged the problem of tobacco addiction in his Mann Ki Baat broadcast.

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.

It will be more difficult to adopt NRT once it is placed under prescription as it will serve as an additional barrier requiring the smoker to visit the registered medical practitioner. Many of the tobacco users might go underground and not report, phobic to the rigmarole of obtaining a prescription and then using NRT. 

While cigarettes are not banned and openly available in India, the proposal to make NRT available only by prescription seems deleterious. In order to meet the objective of reduced tobacco use, the government should make all forms of NRT available OTC, including those containing up to 2mg of nicotine.

Wider and easy availability of NRT over the counters will help us reduce tobacco use by 30 per cent by 2025. India has become a global leader in spreading awareness around the deadly effects of tobacco consumption. NRT in OTC will save families and help the country.

Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth.

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