Lok Sabha Question No. 5591 (UNSTARRED), answered on 2026-03-27
Subject: Impact of Nicotine Replacement Therapy
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Appalanaidu Kalisetti

## GOVERNMENTOFINDIA MINISTRY OFHEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO.5591 TO BE ANSWERED ON 27 TH MARCH, 2026

## IMPACTOFNICOTINE REPLACEMENT THERAPY

## 5591. SHRI APPALANAIDU KALISETTI:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) the current availability of Nicotine Replacement Therapy (NRT) products including the number and types of formulations approved and marketed along with their price range in the country, brand-wise and State/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 number who purchased NRT through private channels, year-wise since 2019;
- (d) whether any assessment has been conducted regarding the effectiveness and quitsuccess rates of NRT and key findings, if so, the details thereof; and
- (e) whether the Government is considering adopting alternate cessation-support techniques, in addition to NRT, to improve quit outcomes and if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILYWELFARE (SHRI PRATAPRAO 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 issued by State Licensing Authority (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 ceiling prices of scheduled formulation 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 products are as under:-

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

(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 tobacco users who tried to quit, 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 behavioral interventions.

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