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NPPA asks manufacturers to submit data on certain dosage forms of nicotine to fix ceiling prices
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Gireesh Babu, New Delhi
January 18 , 2025
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The National Pharmaceutical Pricing Authority (NPPA) has called for data from the manufacturers of specific forms of scheduled formulations of nicotine, used for nicotine replacement therapy, as part of fixing the ceiling prices of these products.
The data has been sought from the manufacturers and marketing firms on nicotine (for nicotine replacement therapy) 2 mg and 4 mg strengths in the form of mouth dissolving strips, tablets and oral inhalers.
All manufacturers and marketing companies who have these formulations in their portfolio were requested to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) in value terms for the month of October, 2023 in a format provided by the Authority.
The MAT sales, excluding taxes, for the month of October, 2023, to be submitted has been explained as the total sales during November 2022 to October 2023.
"The information may be furnished positively within 7 days from the issue of this OM (Office Memorandum) for taking appropriate action for fixation of ceiling prices pursuant to the issue of Revised Schedule-I of DPCO, 2013," said the Authority in the OM issued with copy to apex pharma associations including IDMA, IPA, OPPI, FOPE, FICCI, ASSOCHAM, among others for information and necessary action.
It may be noted that NRT formulations were included in the National List of Essential Medicine (NLEM), 2022 for the first time and with the revision of Schedule I of the Drugs Prices Control Order (DPCO), 2013 with the NLEM, these formulations were also added into the list of Schedule I.
Experts say that the inclusion of NRT into NLEM has brought in recognition of these treatments including paving way for them to be covered under insurance and other medical reimbursement schemes.
The pricing authority has already fixed the ceiling prices of nicotine (for NRT) in 2 mg and 4 mg strengths in the form of gum, lozenge, and oral dosage form of pastilles.
As per the updated price list released by the NPPA on May 15, 2024, nicotine lozenge 2 mg is priced at Rs. 7.92 per lozenge and 4 mg at Rs. 9.75 per lozenge; nicotine gum 2 mg at Rs. 8.59 per gum and 4 mg at Rs. 10.64 per gum; nicotine oral dosage forms 2 mg pastille at Rs. 7.12 per pastille, and 4 mg at Rs. 7.83 per pastille.
On the regulatory side, the attempts are to keep the NRTs within the ambit of prescription drugs, even though there have been demands to bring them into over-the-counter category.
The Drugs Technical Advisory Board (DTAB) last year considered a 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.
However, the board 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.
While it was observed that under Schedule K, nicotine gum and lozenges containing upto 2 mg of nicotine were exempted from sale license and prescription of registered medical practitioner for retail sale, 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, 2024.
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