Experts not in favour of nicotine replacement therapies being reclassified as prescription drugs

New Delhi: Nicotine replacement therapies are safe and empower individuals to quit smoking, a group of doctors have said while expressing concern over the proposal to reclassify them as prescription drugs.

Experts feel the move to reclassify them as prescription drugs will limit their accessibility to those seeking to stop tobacco consumption.

The Drugs Technical Advisory Board (DTAB) under the Central Drugs Standard Control Organisation (CDSCO) has proposed to place nicotine replacement therapies under Schedule K of the Drugs and Cosmetics Rules so that in future they would be available only on the prescription of authorised medical practitioners and not as over-the-counter preparation.

Nicotine polacrilex gums, lozenges and transdermal patches are used for nicotine replacement therapies (NRT).

NRT offers a 50 per cent higher probability of quitting smoking compared to attempting to quit without it, and it is both safe and readily available without the need for a prescription, experts have said.

Dr Chandrakant S Pandav, former head of the Department of Community Medicine at the AIIMS-New Delhi, stressed the need for improved access to tobacco cessation methods in India and said tobacco use afflicts 28.6 per cent of adults in the country, with a particularly significant impact on 42 per cent of men and 14.2 per cent of women.

"Challenges continue to exist in challenging geographic locations and rural areas, highlighting the importance of making NRT accessible over the counter," Dr Pandav said, adding that "easier access to NRT without prescriptions empowers individuals to quit smoking".

Nicotine is the primary addictive component in cigarettes. NRT serves as a temporary replacement for a small quantity of nicotine, controlling cravings, alleviating withdrawal symptoms and facilitating the transition to tobacco abstinence, he said.

Unlike cigarettes, NRT provides a gradual and very small increase in blood nicotine levels, which discourages misuse. The aim of NRT is to enable people to quit smoking with the help of nicotine delivery systems with reduced addictiveness, Dr Pandav stated.

Dr Sajeela Maini of the Sir Ganga Ram Hospital in New Delhi said, "In my years of practice in smoking cessation, I have found that nicotine replacement therapy is the mainstay of smoking cessation therapy. Substituting cigarettes with a nicotine product works the best. It is most effective in reducing the urges, and withdrawals of quitting the stick. Tobacco dependence is a mind-body addiction."

She stressed on the need to address both the physiology and psychology of addiction in proper perspective, it to be effective.

Pharmacotherapy, per se, has a supportive role in reducing the urges and withdrawals of quitting and making the process less discomforting, Dr Maini said.

"To ensure the success of our smoking cessation endeavours, we should concentrate on enhanced access to NRT. Tobacco addiction is one of the most widespread addictions in the world. In fact, we need a multi-pronged approach to arrest this menace. Tobacco cessation is still in its infancy in India. We need to educate the public pro-actively about scientifically-backed options like NRT to assist them in quitting smoking and thus prevent them from developing tobaccosis - spectrum of diseases caused by smoking and chewing of tobacco," she said.

Dr Pandav also pointed to Indian trials conducted in 2023 such as the one in Odisha, which demonstrated the efficacy of NRT in halting smokeless tobacco use.

Another study in Bengaluru in the same year highlighted the effectiveness of combining NRT with behavioural counselling in reducing cigarette smoking, he said.

At the 89th Drugs Technical Advisory Board meeting held in May 2023, there was a proposal to amend Schedule K of the Drugs and Cosmetics Rules, 1945.  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 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," Dr Maini said.