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DTAB backs ICMR's recommendation to keep NRTs as prescription only products
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Gireesh Babu, New Delhi
March 16 , 2024
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The Drugs Technical Advisory Board (DTAB) has backed a report from Indian Council of Medical Research (ICMR) suggesting that the nicotine replacement therapies (NRTs) should be available on prescription only and recommended the regulators to make amendments in the rules based on this.
The DTAB was considering the proposal to amend the Schedule K of the Drugs Rules, 1945 to include nicotine orally disintegrating strips along with nicotine gums and lozenges for exemption from the provision of sales license.
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 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 nonsmokers 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 in January, this year.
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.
The NRT market in the country is a segment that is growing in low-double digits in the country and has players including Cipla, Strides Consumer, Rusan Pharma, among others in the country.
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