Parliament Question: Impact of Nicotine Replacement Therapy

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO.5591 TOBE ANSWERED ON27TH MARCH, 2026 IMPACTOFNICOTINE REPLACEMENTTHERAPY

5591.SHRIAPPALANAIDU KALISETTI:

Will the Minister of HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) the current availability of Nicotine Replacement Therapy (NRT) products including the numberandtypes of formulationsapproved andmarketedalong with theirprice range inthe country,brand-wise andState/UT-wise;

(b) whether NRT products are accessible in public health facilities under the National Tobacco Control Programme and the status of stock availability, procurement and distribution in Government hospitals and cessation centres during the last five years, if so, the details thereof;

(c) the number of individuals who have used NRT by Government programmes and estimated numberwho purchased NRTthrough private channels,year-wise since 2019;

(d) whether anyassessment hasbeenconductedregardingthe effectiveness andquit- success ratesof NRTandkeyfindings, if so, the detailsthereof; and

(e) whether the Government is considering adopting alternate cessation-support techniques, in additiontoNRT,toimprove quit outcomesandif so,the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILYWELFARE (SHRIPRATAPRAO JADHAV)

(a): The Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare has approved Nicotine Replacement Therapy (NRT) products such as Nicotine Transdermal patch, Nicotine Polacrilex Gum, Nicotine Polacrilex Lozenges and Nicotine Polacrilex Orally disintegrating stripes for using as aid for smoking cessation. The Nicotine formulations containing up to 2 mg of nicotine are exempted from requirement of sale license issuedby StateLicensingAuthority (SLA).The prices of drugs are regulated as per provisions of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) across the country. The National Pharmaceutical Pricing Authority (NPPA) under Department of Pharmaceuticals fixes ceilingprices of scheduledformulation listed in Schedule-I of DPCO, 2013. Since Nicotine is listed in Schedule-I of DPCO, 2013, NPPA has fixed ceiling price for NRT products which is applicable to all scheduled formulation (whether branded or generic) sold across the country to all the States/UTs. The fixed ceiling prices of the NRT

productsare asunder:- S.No Medicines Strength Unit CeilingPrice(in ₹) 1 Nicotine (for nicotine Lozenge 2mg 1 8.06 replacement therapy) Lozenges 2 Nicotine (for nicotine Gum 2mg 1Gum 8.74 replacement therapy) 3 Nicotine (for nicotine Gum 4mg 1Gum 10.83 replacement therapy) 4 Nicotine (for nicotine Lozenge 4mg 1 9.92 replacement therapy) Lozenges 5 Nicotine (for nicotine Oral Dosage forms 1Pastille 7.24 replacement therapy) 2mgPastille 6 Nicotine (for nicotine Oral Dosage forms 1Pastille 7.97 replacement therapy) 4mgPastille

(b) to (d): The Tobacco Cessation Centers offer comprehensive cessation services by way of counselling and pharmacological interventions wherein NRT is provided free of cost. As per Global Adult Tobacco Survey (GATS), 2016–17, 4.1% of smokers and 3.2% of smokeless tobaccousers who triedtoquit,used pharmacotherapy, including NRT.

(e): The National Tobacco Control Program (NTCP) provides evidence-based cessation support (pharmacological and behavioral therapy) to strengthen tobacco-dependence treatment. It also aims to boost tobacco cessation by enhancing counseling services through tobacco cessation centers, National Quitline services, and building capacity of healthcare providers to offer behavioralinterventions.

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