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Centre plans tighter rules on nicotine lozenges, may mandate pharmacy-only sales
Mint.The proposal follows recommendations by the Drugs Technical Advisory Board (DTAB) at a meeting held in February. The board also called for a strict ban on sales to minors and closer monitoring of online platforms to prevent easy access.In India, NRT products including nicotine gums and lozenges are regulated as drugs under the Drugs and Cosmetics Act as they are used to reduce tobacco dependence.
However, under a special exemption in Schedule K, nicotine gums and lozenges containing 2 mg of nicotine can be sold without a drug sale licence.According to the meeting minutes reviewed by Mint, the board was also informed about recommendations from the Indian Council of Medical Research (ICMR) and the Tobacco Control Division (TCD). After deliberation, DTAB recommended amending entry 33 of Schedule K so that the exemption applies only to unflavoured 2 mg nicotine gums, and not to any other NRT products.The board also recommended that sales to minors be strictly prohibited, online access be closely monitored, and post-marketing surveillance be conducted to track adverse effects.
It further suggested restricting the marketing of NRT products by tobacco companies due to potential conflicts of interest, as per the document.“Further, DTAB recommended that nicotine lozenges 2 mg shall be excluded from Schedule K exemptions,” the document added.“The board has recommended narrowing these exemptions significantly. Under the new plan only unflavoured 2mg nicotine gums will continue to be exempt from a sale license.
All 2mg nicotine lozenges will now require a formal drug sale license. This move effectively pulls lozenges, which often come in attractive flavours, off general store shelves and places them behind the pharmacy
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21.05 / 09:47
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