In a move raising alarm among public health authorities, several Indian pharmaceutical companies are petitioning the nation's top drug regulator for permission to manufacture and sell high-dose oral nicotine pouches. These products, with a strength of 6mg of nicotine, would be 50% more potent than the current maximum allowed for over-the-counter nicotine replacement therapy (NRT) products in the country.
The Regulatory Push and Its Implications
According to official documents and sources, the companies—Vcherish Pvt. Ltd, Harsh Nutricare Pvt. Ltd, Lyrus Life Sciences Pvt. Ltd, Fertin India Pvt. Ltd, and Leaf Fibers Pvt. Ltd—have approached the Central Drugs Standard Control Organisation (CDSCO). They aim to market these 6mg pouches as therapeutic aids for smoking cessation under the NRT framework. Currently, NRT products like nicotine gums containing up to 2mg do not require a prescription in India, but anything above that level is supposed to be under medical supervision. No 6mg nicotine pouches are manufactured domestically at present.
The CDSCO is now evaluating these proposals and has sought technical guidance from the Tobacco Control Division of the Union health ministry. This development comes at a time when the government is actively running campaigns against tobacco use, which claims an estimated 1.35 million lives annually in India and places an economic burden of about ₹1.77 trillion each year for treating related illnesses.
Public Health Experts Sound the Alarm
Medical and public health specialists have expressed deep concern over the potential approval of such high-strength products. They argue that these pouches, while framed as quit-smoking tools, could easily become "initiation devices" for youth and non-smokers, leading to long-term nicotine addiction.
Dr. Prashant Kumar Singh, a senior scientist at ICMR's National Institute of Cancer Prevention and Research, emphasized the inherent dangers of nicotine. "Nicotine damages the cardiovascular system, regardless of how it is delivered into the body. It causes oxidative stress, harms the walls of blood vessels, promotes clotting, and accelerates the buildup of plaque," he stated.
Dr. Shalini Singh, Director at the same institute, advocated for a focus on evidence-based behavioral counseling and non-nicotine treatments. "True health recovery requires quitting nicotine altogether, not just changing the delivery method," she noted, warning against the potential for unregulated, flavoured products to flood the market if such approvals are granted.
Industry Rationale and Legal Ambiguity
The NRT industry defends the use of such products. Malavika Kaura Saxena, Chief Marketing Officer at Rusan Pharma, stated that regulated NRT like patches and gums deliver controlled, low-dose nicotine to help manage withdrawal symptoms and should be used under healthcare guidance.
The legal perspective on the matter appears divided. While some experts, like Ashwin Sapra of Cyril Amarchand Mangaldas, see it as a genuine attempt to clarify a grey area of law if strictly prescription-based, others urge extreme caution. B. Shravanth Shanker, an advocate-on-record at the Supreme Court, warned that classifying high-dose pouches as drugs could give them an unfair tax and access advantage over cigarettes, a incentive Parliament has historically sought to suppress.
The Indian NRT market, valued at around $37.02 million, is dwarfed by the massive tobacco and illegal e-cigarette markets. However, its potential to create new users remains a significant worry for policymakers as they deliberate on this critical public health issue.
