**Executive Summary**
This document is an answer to Unstarred Question No. 2426 in Lok Sabha, addressing the availability of Nicotine Replacement Therapy (NRT) products in India. The response, provided by the Minister of State in the Ministry of Health and Family Welfare, outlines the types of NRT products approved, price regulations, access through public health facilities, and government efforts to support tobacco cessation. The question was to be answered on February 13th, 2026.
**Key Points / Main Content**
* **NRT Product Availability and Approval:**
* The Central Drugs Standard Control Organization (CDSCO) has approved NRT products like Nicotine Transdermal patches, Nicotine Polacrilex Gum, Lozenges, and Orally disintegrating strips for smoking cessation.
* Nicotine formulations containing up to 2 mg of nicotine are exempt from sale license requirements from the State Licensing Authority (SLA).
* **Price Regulation:**
* Drug prices are regulated under the Drugs (Prices Control) Order, 2013 (DPCO, 2013).
* The National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for scheduled formulations listed in Schedule-I of DPCO, 2013, including Nicotine.
* Fixed ceiling prices for NRT products include:
* Nicotine Lozenge 2mg: ₹8.06
* Nicotine Gum 2mg: ₹8.74
* Nicotine Gum 4mg: ₹10.83
* Nicotine Lozenge 4mg: ₹9.92
* Oral Dosage forms 2mg Pastille: ₹7.24
* Oral Dosage forms 4mg Pastille: ₹7.97
* **Accessibility and Usage:**
* Tobacco Cessation Centers offer NRT free of cost as part of comprehensive cessation services.
* The Global Adult Tobacco Survey (GATS) 2016-17 indicates that 4.1% of smokers and 3.2% of smokeless tobacco users who tried to quit used pharmacotherapy, including NRT.
* **Government Initiatives:**
* The National Tobacco Control Program (NTCP) provides evidence-based cessation support (pharmacological and behavioral therapy).
* The NTCP aims to enhance counseling services through tobacco cessation centers, National Quitline services, and build healthcare provider capacity for behavioral interventions.
**Impact Analysis**
**Stakeholder: General Public / Smokers/Tobacco Users**
* **Impact:** Increased awareness and access to NRT products for smoking cessation. Availability of NRT at subsidized or free cost through government programs.
* **Action Required:** Utilize available NRT products and cessation support services provided by the government and healthcare facilities.
**Stakeholder: Ministry of Health and Family Welfare/CDSCO/NPPA**
* **Impact:** Continued regulation, approval, and pricing control of NRT products. Responsibility to support and expand tobacco cessation programs.
* **Action Required:** Maintain oversight of NRT product availability and pricing. Continue to implement and enhance the National Tobacco Control Program (NTCP).
**Stakeholder: Healthcare Providers/Tobacco Cessation Centers**
* **Impact:** Increased availability of resources and support for tobacco cessation interventions. Opportunity to enhance counseling services and provide behavioral interventions.
* **Action Required:** Offer NRT and counseling services through Tobacco Cessation Centers. Participate in capacity building programs for behavioral interventions.
Key Entities Referenced
Nicotine Replacement Therapy (NRT): Products used as an aid for smoking cessation
Drugs (Prices Control) Order, 2013 (DPCO, 2013): Order regulating the prices of drugs in India
National Pharmaceutical Pricing Authority (NPPA): Authority under Department of Pharmaceuticals that fixes ceiling prices of scheduled formulation
Central Drugs Standard Control Organization (CDSCO): Organization responsible for approving Nicotine Replacement Therapy (NRT) products
National Tobacco Control Program (NTCP): Program providing evidence-based cessation support to strengthen tobacco dependence treatment
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO.2426
TO BE ANSWERED ON13TH FEBRUARY,2026
AVAILABILITYOFNICOTINEREPLACEMENT THERAPYPRODUCTS
2426.SHRITANGELLAUDAYSRINIVAS:
Will the Minister of HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the current availabilityof Nicotine Replacement Therapyproductsincludingthe numberand
types of formulations approved and marketed along with price range, brand-wise in the
countryandState/UT-wise;
(b) whether NRT products are accessible in public health facilities under the National Tobacco
Control Programme and if so, the details of stock availability, procurement and distribution
inGovernment hospitals andtobaccocessation centresduring the last five years;
(c) the number of individuals who have used NRT through Government programmes and the
estimatednumberwho purchased NRTthrough private channels, year-wisesince 2019;
(d) whether anyassessment hasbeenconductedonthe effectiveness andquit-success rates
of NRTandif so, the keyfindingsthereof; and
(e) whether the Government isconsidering adoptionof alternative productsor cessation-
support techniques, in addition to NRT to strengthen tobacco-dependence treatment and
improve 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 ceilingprice 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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