|
DTAB recommends amendment of Schedule K to allow only unflavoured nicotine gums sold under exemption
|
|
Gireesh Babu, New Delhi
March 17 , 2026
|
|
|
The Drugs Technical Advisory Board (DTAB) has recommended amendment of Schedule K of the Drugs Rules, 1945 to restrict the over-the-counter sale of nicotine gums to unflavoured nicotine gums 2 mg, and to exclude nicotine lozenges 2 mg from the Schedule so that it should be sold under the provisions of sale license.
Marketing of nicotine replacement therapies (NRTs) by the tobacco industry may be restricted due to the significant conflict of interest, it recommended.
The DTAB, in its latest meeting held in February, 2026, was looking into a proposal to amend the entry no. 33 of the Schedule K, which currently exempts nicotine gum and lozenges containing upto 2 mg of nicotine from the provisions of sales license.
The Board, after deliberating the matter, recommended that the entry shall be amended to include only unflavoured nicotine gums 2 mg and not extended to any other form of NRTs.
This should also be based on conditions including that the sale to minors must be strictly prohibited and online accessibility to be closely monitored, and post-marketing surveillance should be conducted to monitor and report any adverse effect.
"Further, DTAB recommended that Nicotine lozenges 2 mg shall be excluded from Schedule K exemptions," added the minutes of the meeting held on February 16, 2026.
The Board also considered the recommendations of Indian Council of Medical Research (ICMR) and Tobacco Control Division (TCD), while discussing the matter.
Schedule K to the Drugs and Cosmetics Rules, 1945 lists the classes of drugs and the extent and conditions of exemption granted to these drugs from the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940. The Chapter IV of the Act pertains to manufacture, sale and distribution of drugs.
The NRT market in the country is a segment that is growing in low-double digits in the country and has players including Cipla, Rusan Pharma, among others in the country. ITC, owner of several major cigarette brands in the country, owns a nicotine gum brand Kwiknic.
According to a recent report published in the Grand View Research website, which offers end-to-end market research technology, India's NRT market was valued at $33.09 million in 2023, and is estimated to grow at a compound annual growth rate of 12.56% from 2024 to 2030.
It may be noted that the DTAB, in earlier meeting in 2024, backed a report from Indian Council of Medical Research (ICMR) suggesting that the NRTs should be available on prescription only and recommended the regulators to make amendments in the rules based on this.
The Board in its 89th meeting held on May 10, 2023, discussed the proposal and recommended to get comments and inputs from ICMR for further action on restricting Nicotine Replacement Therapies (NRTs) only through prescription. The Tobacco Control Division (TCD) opposed the proposal of including these therapies for Over-The-Counter (OTC) sales under Schedule K and has proposed that NRTs contain upto 2 mg or 4 mg only through prescription of authorised medical practitioners.
The matter was forwarded to ICMR on August 1, 2023 and the Council responded that though NRTs are efficacious there is a chance of abuse potential of OTC NRT among non-smokers and smokers. Accordingly, the Council recommended that all NRTs should be used under medical supervision and to be available on prescription only.
"DTAB deliberated the matter and agreed with the report of the ICMR. Further DTAB recommended to make appropriate amendments in the rules based on ICMR recommendations," concluded the meeting held earlier.
As per the existing provision under the particular entry in Schedule K, nicotine gum and lozenges containing upto 2 mg of nicotine are exempted from sale license and prescription of registered medical practitioner for retail sale. This provision was incorporated in the Schedule based on recommendation of ICMR.
The TCD proposed to take necessary action to place all formulations of nicotine containing upto 2 mg or 4 mg under the concerned schedule so that their supply is restricted and available only on the prescription of authorised medical practitioners, and not as OTC preparation.
The Board, in an earlier meeting held on November, 2018, agreed to amend the entry No.33 in Schedule K for providing exemption for all nicotine oral formulations containing 2 mg of nicotine and a draft notification was forwarded to the Centre for consideration.
However, the matter was later referred by the ministry of health to TCD for opinion on the draft amendment to include nicotine orally disintegrating strips along with nicotine gums and lozenges in the entry No.33 of Schedule K.
The TCD, after examining the proposal for amendment, said that some of the NRTs are already available as OTC and the proposed amendment envisages that all NRTs be made available through OTC sales, whereas, such a step may lead to increased access to NRTs for prospective quitters.
This poses certain risks such as the NRTs may be used by addicts for nicotine substitution in forced periods of abstinence, rather than as NRTs for quitting tobacco.
India has prohibited the e-Cigarettes and such devices by bringing in a separate legislation - The Prohibition of Electronic Cigarettes (Production, Manufacture, Import, Export, Transport, Sale, Distribution, Storage and Advertisement) Act, 2019 but does not include any product licensed under the Drugs and Cosmetics Act, 1940. With any relaxation, the e-Cigarette industry might innovate and bring products, it opined.
|
|
|
|
|
|
|
|
TOPICS
|
The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
|
|
|
|
|