BACKGROUND AND IMPLEMENTATION CHALLENGES: To attract a new generation of tobacco and nicotine users, the tobacco industry has introduced emerging tobacco and nicotine products, such as e-cigarettes, heated tobacco products (HTPs), and oral nicotine pouches. These products have flavors and designs that are attractive to young people. State governments in India banned the sale of emerging products using prevailing drug laws, and this resulted in the central government passing a comprehensive national law prohibiting the manufacture, import, sale, advertisement, etc., of e-cigarettes, HTPs and similar products. However, despite the adoption of this comprehensive law, the products are readily available through online and offline stores due to implementation challenges. Further, the industry has launched efforts to introduce oral nicotine pouches and disintegrating strips as nicotine replacement therapies (NRTs), which are available as over-the-counter drugs.
INTERVENTION OR RESPONSE: The Drugs and Cosmetics Act, 1940 and the enabling Drugs and Cosmetics Rules, 1945, regulates the import, manufacture, distribution and sale of drugs and cosmetics in the country. Schedule K to the Rules exempts certain drugs from obtaining licenses, including nicotine gums and lozenges containing up to 2 mg of nicotine, and, therefore, the products may be sold over the counter.
RESULTS AND IMPACT: Government records were reviewed to determine which other products have applied for this exemption under Schedule K to the Rules. Based on this review, it was determined that the industry has attempted to exploit the NRT licensing process to place emerging nicotine products on the market.
CONCLUSIONS: The Indian Government, with support from CSOs, has recently taken positive steps to strengthen the implementation of laws regulating emerging tobacco and nicotine products. It is also closely monitoring industry efforts to introduce new-generation products disguised as NRTs. This is necessary to stay ahead of the industry's tactics as it attempts to evade regulation and continuously place new, addictive products on the market.