The health ministry of India has proposed to take place nicotine replacement therapies (NRT) under Schedule K so that in future they would be available only on the prescription of authorized medical practitioners, and not as Over the Counter (OTC) preparation. Nicotine Polacrilex Gums, lozenges and transdermal patches are used for NRT.
At the 89th DTAB meeting held in May 2023, there was a proposal to amend Schedule K. The idea was to place all formulations of nicotine, containing up to 2mg or 4mg under the prescription of authorised medical practitioners and not as an 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 haplessly homes over 100 million smokers and this pitifully accounts for over one-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 severely handicap our national drive – Make in India and Atmanirbhar Bharat.
Tobacco-related cancers accounted for 27 per cent of the country’s cancer burden in 2020, according to the Indian Council of Medical Research (ICMR). But now, ICMR endorsing the move to put a small dosage of NRT under prescription will be counterproductive. It will hinder ease of access, thereby going against the intent of NLEM 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 an 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. During 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 a small dosage of NRT is habit-forming. The time taken for blood levels of nicotine to peak is much lesser for NRT as compared to smoking, which makes it less liable to abuse potential. Restricting the supply of NRTs will not lead to desired the outcome of curbing tobacco addiction.
One of the significant cross-sectoral health goals under the Health Policy of India outlines a relative reduction in the prevalence of current tobacco use by 30% by 2025. This needs to be underlined. Last World No Tobacco Day on May 31, saw MPs 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 (FAIMA) 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.
Prime Minister Narendra Modi said in his Mann ki Baat broadcast, “We all know that tobacco addiction is very harmful to human health and coming out of this addiction is also very difficult. People who consume tobacco in any form suffer problems like cancer, diabetes, blood pressure, among others. For youth, it can have a drastic impact on mental growth.”
NRT is a WHO-approved therapy for smoking cessation. This was first available in the US as an OTC product in 1996 (patch and gum), with approval of the lozenge and mini lozenge in 2002 and 2010. Since then, nicotine gums 2 & 4mg have been granted OTC status worldwide including in Australia, Canada, Germany, Sweden, Switzerland, Norway, Colombia, Iceland, Denmark, New Zealand, Austria, Italy etc. based on their excellent safety and the confidence that patients/consumers can self-medicate responsibly.
Nicotine lozenges and transdermal patches are OTC in US and UK. 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 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 are 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% by 2025, as targeted by the Prime Minister. India has become a global leader in spreading awareness about the deadly effects of tobacco consumption.
Let’s not go backtrack to tobacco misery and reverse our own good work. NRT in OTC will save families and help the country.
