Experts criticise proposal to tag nicotine therapy as prescription drugs


A regulatory proposal to reclassify nicotine replacement therapy (NRT) products like chewing gum and patches as prescription-based drugs may hinder accessibility to people who want to quit smoking, experts have said.

The Drugs Technical Advisory Board (DTAB) has proposed including NRT under Schedule K of the Drugs and Cosmetics Act. It would lead to all formulations containing up to two to four milligrams of nicotine being sold on the prescription of an authorised medical professional and not over the counter (OTC). The proposal comes after the Health Ministry last year included NRT in the National List of Essential Medicines (NLEM), matching its policy goal of reducing tobacco use in the country by 30 per cent by 2025.

Putting NRT in prescription-based interventions may inadvertently hinder accessibility for smokers attempting to quit, particularly in remote areas, said Dr Chandrakant S Pandav, former head of department of community medicine, All India Institute of Medical Sciences, New Delhi.

“The geographical barrier, coupled with the necessity of routine doctor visits to renew prescriptions, can be discouraging for individuals seeking to quit smoking. The inconvenience and associated costs of these visits may deter smokers from pursuing NRT as a smoking cessation aid, ultimately hampering public health efforts to reduce smoking rates and related health risks,” he said.

According to research by Oxford University, NRT offers a 50 per cent higher success rate in quitting smoking compared to unassisted attempts. Research body Technavio suggests that the global smoking cessation and nicotine de-addiction market is estimated to grow at a compound annual growth rate of 12.59 per cent between 2022 and 2027.  

Pharmaceutical company Cipla is a leading player in the NRT segment with its Nicotex chewing gum. NRT is a first-line therapy for smoking cessation globally and it reduces the urge to smoke, said Puri.

“We believe in the importance of not only ensuring convenient access to such vital therapies, including the need for OTC accessibility, but also in-depth communications to support individuals in their quitting journey,” he said.

India has more than 100 million smokers and it has 20 per cent of global tobacco-related deaths, affecting families, livelihoods, and national productivity, according to the World Health Organization (WHO).

Dr Pandav said that instead of restricting access to NRT products, it’s important to acknowledge that they have a significantly lower health impact compared to cigarettes.

Studies by the US Food and Drug Administration have shown that the time taken for nicotine level in blood to peak due to NRT is slower than compared to smoking tobacco. 


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