DTAB: Proposal to restrict Nicotine Replacement Therapies Sales to Prescription Only

This proposal, put forward by the Tobacco Control Division (TCD), has been under consideration by the Board.

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DTAB Drug Technical Advisory Board
DTAB

Last Updated on December 31, 2023 by The Health Master

Nicotine Replacement Therapies

The Drugs Technical Advisory Board (DTAB) has recently made a recommendation to seek comments and inputs from the Indian Council of Medical Research (ICMR) regarding the restriction of Nicotine Replacement Therapies (NRTs).

The proposal aims to limit the availability of NRTs containing up to 2 mg or 4 mg of nicotine by making them accessible only through prescriptions from authorized medical practitioners.

This proposal, put forward by the Tobacco Control Division (TCD), has been under consideration by the Board.

Background:

The Board had been reviewing a proposal to include all NRTs in Schedule K of the Drugs Rules, 1945, and allow their over-the-counter (OTC) availability. However, the TCD expressed concerns and objected to this proposal.

Existing Provision:

Currently, under the specific entry in Schedule K, nicotine gum and lozenges containing up to 2 mg of nicotine are exempted from the requirement of a sale license and prescription by a registered medical practitioner for retail sale.

This exemption was initially recommended by the ICMR and incorporated into the Schedule.

Proposed Action by the TCD:

The TCD has proposed taking necessary measures to include all nicotine formulations containing up to 2 mg or 4 mg in the relevant schedule.

This would restrict their supply and make them available only with a prescription from authorized medical practitioners, rather than as OTC preparations.

Previous Discussions:

In a previous meeting held in November 2018, the Board agreed to amend Entry No. 33 in Schedule K to provide an exemption for all nicotine oral formulations containing 2 mg of nicotine.

A draft notification was subsequently forwarded to the Centre for consideration. However, the Ministry of Health later referred the matter to the TCD for an opinion on the proposed amendment, specifically regarding the inclusion of nicotine orally disintegrating strips alongside nicotine gums and lozenges in Entry No. 33 of Schedule K.

Also read: Nicotine replacement therapy may become part of Essential Medicines List

TCD’s Opinion on the Amendment:

Upon examining the proposal for amendment, the TCD stated that some NRTs are already available as OTC products. The proposed amendment suggests making all NRTs accessible through OTC sales, but this could potentially increase access to NRTs for individuals who are not intending to quit tobacco.

Instead, there is a risk that these products could be used by nicotine addicts as substitutes during forced periods of abstinence.

It is important to note that the sale of e-cigarettes and similar devices has been prohibited in India under a separate legislation called The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage, and Advertisement) Act, 2019.

However, this legislation does not cover any product licensed under the Drugs and Cosmetics Act, 1940. Any relaxation in the regulation could potentially lead to innovations in the e-cigarette industry and the introduction of new products.

Market Overview:

The NRT market in India is experiencing growth in the low-double digits, and it includes various players such as Cipla, Strides Consumer, Rusan Pharma, among others.

Conclusion:

The DTAB has recommended seeking input from the ICMR on the proposal to restrict the sales of NRTs containing up to 2 mg or 4 mg of nicotine to prescription-only.

The aim is to address concerns regarding potential misuse and ensure that these therapies are used as intended for quitting tobacco.

The decision on this matter will have implications for the NRT market in India, which has been steadily growing.

DCC

DTAB

Technical Committee

Hathi Committee

Mashelkar Committee

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