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Make nicotine gum and lozenges prescription drugs: Delhi govt to drug regulator

Currently, the 2mg gums and lozenges are allowed to be sold over the counter and are available even at cigarette kiosks in the city

delhi Updated: Dec 13, 2017 12:45 IST
Anonna Dutt
Low-dose nicotine gum and lozenges – containing up to 2mg nicotine – are labelled under the schedule ‘K’ of the Drugs and Cosmetics Act and sold over-the-counter as a tobacco-cessation aid.
Low-dose nicotine gum and lozenges – containing up to 2mg nicotine – are labelled under the schedule ‘K’ of the Drugs and Cosmetics Act and sold over-the-counter as a tobacco-cessation aid.(File Photo/LiveMint)

The Delhi government has written to the Drug Controller General of India (DGCI) asking to include nicotine gum and lozenges in the category of drugs that are sold only on a doctor’s prescription.

“Higher-dose variants of nicotine gum and lozenges containing up to 4mg of nicotine should be sold only on prescription, but these are available over-the-counter at most places,” Delhi’s state tobacco control officer Dr SK Arora said.

Low-dose nicotine gum and lozenges – containing up to 2mg nicotine – are labelled under the schedule ‘K’ of the Drugs and Cosmetics Act and sold over-the-counter as a tobacco-cessation aid. They are also available at several cigarette kiosks.

“The easily availability of nicotine-replacement products threaten to make them gateways to nicotine addiction for young people,” Arora added.

In India, 199 million people use tobacco, of which 100 million smoke it in the form of bidi, cigarette and hookah, among others.

“There’s the additional danger of people who are trying to quit tobacco use getting addicted to another form of nicotine. Unregulated sale can also lead to nicotine poisoning that may causes seizures and respiratory depression, leading to death,” Dr Arora said.

Using nicotine replacement therapies such as gums, lozenges, nasal sprays and patches increase a person’s chances of quit smoking by 50-70%, according to the meta-analysis of 150 studies by Cochrane.

“In Haryana, the sale of these nicotine products is completely banned but this is not acceptable as the state should not prevent people from accessing nicotine replacement therapy, if they need it,” Dr Arora said.

Drug inspectors cannot take action against people selling these, even if they’re being sold to children, as these are not scheduled drugs currently.

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