New Delhi: A proposal by the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator, to classify all nicotine replacement therapies (NRT) — treatments aimed at helping people stop the use of tobacco — as prescription drugs has now been endorsed by the Indian Council of Medical Research (ICMR), ThePrint has learnt.
NRTs give tobacco users nicotine in the form of gum, patches, sprays, inhalers, or lozenges, but without the other harmful chemicals present in tobacco and are generally indicated for people with severe nicotine dependence.
Several studies show that these therapies raise the success rate of quitting tobacco by 50 percent or more.
In India, according to the existing rules under the Schedule K of the Drugs and Cosmetics Rules, 1945, nicotine gum and lozenges contain up to 2mg of nicotine and do not require a prescription from a doctor for retail sale.
However, NTR products such as nicotine patches, which usually contain 7, 14 or 21 mg nicotine, can be bought only with a prescription by a doctor, as under current norms.
Since 2018, the Drug Technical Advisory Board (DTAB) under the CDSCO has been mulling a proposal to place all NRTs under schedule K, citing the risk of its abuse and misuse by tobacco users.
In 2023, the matter was referred to the ICMR for its view and in a DTAB meeting held this year, the CDSCO committee noted that the top health research agency has agreed that while “NRTs are efficacious, there is a chance of abuse potential of over-the-counter NRTs among non-smokers and smokers”.
“Accordingly, (the) ICMR has recommended that all NRTs should be used under medical supervision and to be available on prescription only,” the DTAB has said. ThePrint has a copy of the minutes of the DTAB meeting.
“.. DTAB (has now) recommended to make appropriate amendments in the rules based on (the) ICMR recommendations,” the minutes said.
This latest decision by the drug regulator may have a significant ramification for a country like India. According to the World Health Organization (WHO), tobacco — a major risk factor for many chronic diseases, including cancer, lung disease, cardiovascular disease and stroke — is one of the leading causes of death and disease in India and accounts for nearly 1.35 million deaths every year.
India is also the second-largest consumer and producer of tobacco and nearly 267 million people (15 years and above) and 29 percent of all adults are users of tobacco, according to the Global Adult Tobacco Survey India, 2016-17.
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Specialists divided
The planned move, however, has evoked mixed reactions among experts with some stressing that it may limit the accessibility of NRTs for those who need it, while others supporting the decision by the CDSCO and the ICMR.
Dr Arjun Singh, a surgical oncologist with the premier cancer hospital Tata Memorial Centre in Mumbai pointed out that historically, the tobacco industry has always seen a huge market potential and has been investing big in alternative sources of nicotine delivery (often termed as harm reduction) through measures such as nicotine gums and e-cigarettes.
In most large-scale trials, the efficacy of NRTs has been shown to be equivalent and at best, better in the short term when the participants are still being monitored in the study. But several studies have also shown that “quitters” ended up using both NRTs and smoking or chewing tobacco together, Singh said.
“The long-term role of such replacement has never been strongly proven and, therefore, making these nicotine gums and lozenges a product that needs a license is definitely a positive step towards reducing its abuse. Nicotine will still keep the pharmacological dependence going, irrespective of dosage. The true aim of a cessation tool should not be to create an alternative but to help through targeted education and counseling,” Singh underlined.
He also suggested that if sale of NRTs is to be through prescription only, it should be done from licensed tobacco cessation clinics and not by any medical practitioner.
Head and neck surgical oncologist Dr Aditya Joshipura, who works with HCG Cancer Centre in Bengaluru, also welcomed the move saying it is a significant step towards ensuring responsible use and patient safety.
But few other experts like tobacco cessation specialist Dr Rakesh Gupta, president of Rajasthan Cancer Foundation, underscored that the CDSCO and ICMR should first present evidence on why certain NRT products were earlier available over the counter in India and what evidence is there now to restrict their usage under prescription.
Gupta also opined that while 2 mg NRT products should be allowed to stay over the counter to help those who can’t run to the hospital every time to get a prescription, the 4mg oral NRTs, NRT patches and sprays should be made available only on a prescription.
Further, he said that in his cohort of over 1,000 patients who were treated by him for tobacco dependence, the use of 2 mg NRT — gums or lozenges — was an effective tool to help individuals quit, including those used to smoking, or using smokeless tobacco. Majority of these people, Gupta said, were required to use NRT for about four to six weeks only.
“The keys to the proper use of 2 mg NRTs are to let patients titrate its use as per their needs after they quit (no tobacco use from the set quit date) and follow three instructions religiously — chewing slowly, stopping once the sense of satisfaction has come and not to take water for the next 30 minutes,” he said.
Oncology researcher Dr Ravi Mehrotra, too, underlined that clinical trials have shown that behavioral counseling along with NRT in the form of drugs and nicotine lozenge or patches are beneficial for cessation.
Quitting tobacco is very difficult and accessibility to these aids needs to be facilitated at all costs, Mehrotra said.
(Edited by Zinnia Ray Chaudhuri)
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