2019(12)LCX0100(AAAR)
AAAR-KARNATAKA
Strides Emerging Markets Ltd
decided on 03/12/2019
KARNATAKA APPELLATE AUTHORITY
FOR ADVANCE RULING
6TH FLOOR, VANIJYA TERIGE KARYALAYA KALIDASA ROAD,
GANDHINAGAR, BANGALORE-560009.
(Constituted under Section 99 of the Karnataka Goods and Services Tax Act, 2017
vide Government of Karnataka Order No FD 47 CSL 2017, Bengaluru, dated
25-04-2018)
BEFORE THE BENCH OF
Shri. D.P.NAGENDRA KUMAR,
Member
Shri. M.S. SRIKAR, Member
ORDER NO.KAR/AAAR/04/2018-19
DATED:03.12.2019.
PROCEEDINGS
(Under Section 101 of the Central Goods and Service Tax
Act, 2017 and the Karnataka Goods and Services Tax Act, 2017)
Name and address of the appellant |
M/s Strides Emerging Markets Ltd, Strides house, Bilekanahally, Bannerghatta Road, Bengaluru 560076 |
GSTIN or User ID | 29AARCS5667DIZO |
Advance Ruling Order against which appeal is filed | Advance Ruling No KAR ADRG 18/2019 Dated 07.08.2019 |
Date of filing appeal | 03.10.2019 |
Represented by | Mr. Abhi Paresh, Chartered Accountant |
Jurisdictional Authority - Centre | Commissioner of Central Tax, South Commissionerate |
Jurisdictional Authority-State | LGSTO—25, Bengaluru |
Whether payment of fees for filing appeal is discharged. If yes, the amount and challan details. | Yes. Payment of Rs. 20,000/- made vide Challan CIN SBIN19102900006212 dated 01.10.2019 |
At the outset, we would like to
make it clear that the provisions of both the Central Goods and Services Tax
Act, 2017 and the Karnataka Goods and Services Tax Act, 2017 (hereinafter
referred to as CGST Act, 2017 and KGST Act, 2017) are the same except for
certain provisions. Therefore, unless a mention is specifically made to such
dissimilar provisions, a reference to the CGST Act would also mean a reference
to the corresponding similar provisions under the KGST Act.
The present appeal has been filed under Section 100 of the CGST Act, 2017 and
the KGST Act, 2017 by M/s Strides Emerging Markets Ltd (hereinafter referred to
as ‘Appellant’) against the Advance Ruling No. KAR ADRG 18/2019 dated 07.08.2019
pronounced by the Karnataka Authority for Advance Ruling.
Brief facts of the case:
1. The Appellant is a pharmaceutical company engaged in the development and
manufacture of generic and IP led niche pharmaceutical products. The Appellant
is registered as a 100% Export Oriented Unit (EOU) in Karnataka.
2. The Appellant has developed a new product “Nicotine Polacrilex Lozenge” (NPL)
which is purportedly used for therapeutic purpose tor nicotine consumption
cessation The product is available in dosages of 2 mg and 4 mg depending on the
power of the medicine and the manner of intake of NPL is mentioned on the usage
manual which is kept inside the NPL packets.
3. The primary ingredient in NPL is nicotine which is mixed with various other
ingredients to add colour, flavor, etc and the target customer base of NPL is
addicted smokers who wish to give up or reduce the smoking habit When a person
uses tobacco products, there are various harmful chemicals which go inside the
human body in addition to nicotine which cause life threatening diseases.
4. The primary effect of nicotine in tobacco products is its stimulant effect
which acts as a contributing factor to the addictive properties of tobacco
smoking In other words, the presence of nicotine in tobacco contributes towards
addiction of a particular person to smoke tobacco However, in NPL, the primary
ingredient nicotine is present in a non-harmful quantity. NPL when taken in
prescribed quantum, provides the body with adequate nicotine intake However,
there is gradual decline in the dependency of the body on nicotine Given this,
the harmful effects of smoking tobacco are nullified by taking NPL.
5. The following entries in the GST rate Notification No.01/2017-CT(R)/IT(R)
dated 28.06.2017 prompted the Appellant to seek a ruling before the Karnataka
Authority for Advance Ruling:
S.No. |
Chapter Heading/ Sub Heading/ Tariff Item |
Description of goods |
Rate |
Schedule-II |
|||
63 |
3004 |
Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale, including Ayurvedic, Unani, homoeopathic siddha or Bio-chemic systems medicaments, put up for retail sale |
12% |
Schedule III |
|||
41 |
30 |
Nicotine polacrilex gum |
18% |
6. In view of the above entries
in the GST rate notification, the appellant filed an application on 16.05 2018
before the Karnataka Authority for Advance Ruling under Section 97 of CGST/KGST
Act,2017 read with Rule 104 of CGST / KGST Rules, 2017 in form GST ARA-01,
seeking a ruling on the following question
“What is the appropriate classification of Nicotine Polacriliex Lozenge
(hereinafter referred to as “NCT”) manufactured by the Company and rate of tax
applicable thereupon under Notification 012017-Central Tax (Rate) dated
28.06.2017?”
7. On examination of the issue, the Karnataka Authority for Advance Ruling (AAR),
vide Advance Ruling No ADRG 18/2019 dated 7th August 2019 (hereinafter referred
to as ‘Impugned Order) held that the Chapter Notes and Explanatory Notes to
Chapter 30 specifically excluded “Preparations, such as tablets, chewing gums or
patches (transdermal systems), intended to assist smokers to stop smoking
(heading 21.06 or 38.024), Therefore, the product NCT is not covered under SI No
63 of Schedule II of Notification No 01/2017-CT (R) dt 28.06.2017. Further, the
AAR held that the product cannot be classified under Chapter 21.06 which deals
with food preparations not elsewhere specified or included since the instant
product basically consists of nicotine which is not edible / food preparation.
Therefore, the AAR held that the only alternative left for the classification of
the instant product is Chapter Heading 38.24 Accordingly, the AAR gave the
following ruling:
“The instant product. Nicotine Polacriliex Lozenge, is rightly classifiable
under the heading 38.24. Accordingly, the product is covered under serial number
97 of Schedule III to Notification No. 01/2017 -Central Tax (Rate) dated
28.06.2017 and attracts GS T at the rate of 18% (9% CGSST, 9% SGST)”
8. Being aggrieved by the above-mentioned Ruling of the Authority, an appeal was
preferred before Appellate Authority for Advance Ruling under section 100 of the
CGST Act, 2017 / KGST Act, 2017 on 03.10 2019 on following grounds
8.1 The Chapter Heading 3004 covers all medicaments which consists of mixed or
unmixed products for therapeutic or prophylactic use, put up in measured doses;
that in the instant case, NPL is used for therapeutic or prophylactic purposes
in measured dosage of 2mg / 4mg and results in
Providing relief to the patient against tobacco abuse
Safeguards the patient against life harming diseases such as chronic obstructive
pulmonary disease, heart disease, diabetes, cancers, etc and harm to the
reproductive system in women.
8.2 They contended that the product manufactured is not covered by the exclusion
from chapter 30 as stated under Chapter Note 1(b) to Chapter 30 The entry at
Chapter Note 1(b) to Chapter 30 states that preparations, such as tablets,
chewing gum or patches (transdermal systems) intended to assist smokers to stop
smoking, are excluded from Chapter 30; that the product manufactured by the
appellant is a lozenge which does not fall under the above category and hence
the product manufactured is not excluded from Chapter 30. They submitted that
the product manufactured by the Appellant has many more medicinal benefits and
is not limited to assist the consumer to stop smoking, that the restriction
under Chapter Note 1(b) is not absolute since “Nicotine Polacrilex Gum” is
specifically included under Tariff head 3004 49 90. Given the same, the
restriction under Chapter Note 1(b) is not binding and applicable in the present
case.
8.3. They submitted that the term ‘such as’ used in the entry at clause 1(b) of
Chapter Notes to Chapter 30 is a specific term which restricts the scope of the
entry and is to be interpreted to mean that only the items included under the
said entry would be covered They submitted that the product manufactured has
therapeutic uses and is hence classifiable under Chapter 30 and is subject to
GST at 12%; that the product is a ‘lozenge’ but not a gum which is used for
therapeutic or prophylactic purpose of nicotine consumption cessation that
safeguards the patient against life harming diseases such as chronic obstructive
pulmonary disease, heart disease, diabetes, etc and therefore it is a medicament
in true sense and can be classified under Chapter Heading 3004 at 12% GST in
terms of entry no. 63 of Schedule II of Notification No 01/2017-CT (R). They
submitted that the product NPL cannot be excluded from heading 3004 because the
primary purpose of NPL is to provide therapeutic or prophylactic treatment for
addicted smokers to safeguard from life harming diseases as a medicament but not
just assist smokers to stop smoking.
8.4 They further submitted that as per the general rules for classification of
goods, specific entry needs to be given preference over a generic entry, that
given the same, the AAR order which seeks to classify the said product which has
therapeutic uses and approved by the regulatory body viz. Drug Controller as a
medicine, under the generic heading viz. residuary heading, is illegal and
deserves to be set aside.
PERSONAL HEARING: -
9. The appellant was called for a personal hearing on 21.10.2019 and was
represented by Shri Abhi Paresh, Chartered Accountant who reiterated the
submissions made in the grounds of appeal. He also submitted that the product
NPL is a lozenge and not gum; that the product is a medicament which helps
people having a history of smoking abuse to give up smoking and also treats the
connected health problems associated with smoking abuse. He stated that although
the Chapter Note 1(b) to Chapter 30 specifically excludes preparations such as
tablets, chewing gums and patches from the purview of the Chapter 30, the fact
that Schedule III to GST Notification No 01/2017 - Central Tax (Rate) dated 28
06 2017 specifically mentions Nicotine Polacrilex Gum under Chapter 30 is
evident that the GST rate notification has overridden the Chapter Note He also
submitted that in trade parlance the Nicotine chewable tablets and gum arc
medicinal products. On a specific query from the Bench regarding the chemical
composition of the product Nicotine Polacrilex Lozenge, he agreed to submit the
extract of the pharmacopeia and the Drug Controllers approval for the said
product within a week’s time.
9.1. In their additional submissions made vide letter dated 31.10.2019, the
appellant made the following submissions;
9.2. They submitted that. Nicotine Polacrilex Lozenge manufactured by them is a
medicinal product classifiable under Chapter 30 of the GST Tariff and subject to
12% GST rate under Chapter 3004 by virtue of Notification 11/2017-Central tax
(rate) dated 1-7-2017 [Entry 63]; that, composition certificate issued by head
of Quality Assurance, clearly states that NPL is medically approved, has
therapeutic uses since it forms part of the Nicotine replacement therapy
recommended by WHO and USFDA; that, composition certificate issued for NPL
states that NPL has US Pharmacopeia standards; that, NPL is a drug approved
under the Drugs and Cosmetics Act 1940 and Rules 1945 They submitted that the
definition of a drug as per Section 2(b) the said act includes
(i) all medicines for internal or external use of human beings or animals and
all substances intended to be used for or in the diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or animals,
including preparations applied on human body for the purpose of repelling
insects like mosquitoes,
(ii) such substances (other than food) intended to affect the structure or any
function of the human body or intended to be used for the destruction of vermin
or insects which cause disease in human beings or animals, as may be specified
from time to time by the Central Government by notification in the Official
Gazette,
(iii) all substances intended for use as components of a drug including empty
gelatin capsules; and
(iv) such devices* intended for internal or external use in the diagnosis,
treatment, mitigation or prevention of disease or disorder in human beings or
animals, as may be specified from time to time by the Central Government by
notification in the Official Gazette, after consultation with the Board
9.3. They submitted that, from the above definition it is clear that NPL is
certified as a drug and is a Medicine and hence deserves classification under
Chapter 3004; that, NPL is a product having therapeutic uses, that, since NPL
has therapeutic uses, it qualifies as a medicament under Tariff Head 3004 and
thereby would not fit into the exclusion under clause (b) to Note 1 to chapter
30. That the said exclusion is for “preparations in general” and does not apply
where the said product qualifies as a medicament and hence deserves treatment as
a pharmaceutical product, that considering that “Nicotine Polacrilex Gum” is
specifically included under Tariff item 3004 49.90, the interpretation that
medicaments helping smokers to quit smoking be covered under the above chapter
note would render the said Tariff’ item “redundant”; that NCL being a medicament
would not be covered under the exclusion provided under Chapter Note 1(b) to
Chapter 30 and would fall under Tariff item 3004 49 90 “Other” and be subject to
12% GST rate They submitted copies of the composition certificates and
certificate of analysis of the product “Nicotine Polacrilex Lozenge”
DISCUSSION & FINDINGS: -
10. We have gone through the records of the case and taken into consideration
the submissions made by the Appellant in their grounds of appeal and at the time
of the personal hearing.
11. The Appellant in their additional written submissions dated 31 10.2019 had
sought for another opportunity to be heard in person. However, we are not
inclined to grant another personal hearing as the issue has been argued at
length during the hearing on 21st October 2019 and detailed written submissions
have also been made in their grounds of appeal as well as in their additional
submissions. We are of the view that another hearing would not bring forth any
fresh facts or evidences which have a bearing on this matter and hence we are
not inclined to grant another opportunity for hearing but proceed to decide the
case on the basis of the submissions made and documents placed on record.
12. Before we proceed with the main issue of classification of the product
Nicotine Polacrilex Lozenge, we find that there has been a delay in filing the
present appeal. The order of the Authority of Advance Ruling dated 07.08.2019
was admittedly received by the appellant on 7th August 2019. The appeal was
filed before this Appellate Authority on 3rd October 2019 after a period of 57
days from the date of receipt of the order of the AAR.
13. The provisions of Section 100(2) of the CGST Act mandates that an appeal
should be filed within 30 days from the date of communication of the advance
ruling order that is sought to be challenged. However, in terms of the proviso
to Section 100(2) of the said Act, the Appellate Authority is empowered to allow
the appeal to be presented within a further period of 30 days if it is satisfied
that the appellant was prevented by sufficient cause from presenting the appeal
within the initial period of 30 days.
14. In the instant case, the appeal filed against the Advance Ruling order dated
07 08.2019 is evidently belated by 57 days. The appellant, however, has not
explained the reason for the delay in filing the appeal. Be that as it may, in
the interest of justice, and considering the fact that the delay is within the
condonable powers of this Authority, we are inclined to suo moto condone the
delay in filing this appeal and proceed with a decision on the merits of this
case
15 Coming to the issue at hand, the appellant approached the Authority for
Advance Ruling with the question regarding the classification of the product
“Nicotine Polacrilex Lozenge” and the applicable rate of tax The Authority for
Advance Ruling gave a ruling that the impugned product is classifiable under
Chapter heading 38.24 attracting GST at the rate of 18% in terms of SI.No 97 of
Schedule III of Notification No 01/2017-IT (R) dt 28.06.2017. This decision was
given in view of the specific exclusion contained in Chapter Note 1(b) to
Chapter 30 to preparations, such as tablets, chewing gum or patches (transdermal
systems), intended to assist smokers to stop smoking. Since the impugned product
is primarily meant to assist smokers to stop smoking, the Authority held that
the product cannot be classified under Chapter 30 as a medicament and classified
the same under chapter heading 38.24.
16. Aggrieved by the said ruling, the appellant is before us in appeal. In order
to decide on the classification of the product “Nicotine Polacrilex Lozenge” we
shall start by summarizing in general terms our understanding about tobacco and
nicotine addiction. We understand that the nicotine in tobacco is an important
pan of cigarette addiction. When a smoker stops smoking, the nicotine levels
drop quickly This drop can cause withdrawal symptoms such as erasing tobacco,
nervousness, irritability, headache, weight gain, and difficulty in
concentrating. Nicotine Polacrilex Lozenge is a nicotine replacement therapy
that reduces withdrawal symptoms, including nicotine craving, associated with
quitting smoking. Nicotine Polacrilex lozenges offer smokers who are trying to
quit and ex-smokers, quick relief from cravings that are a part of nicotine
withdrawal. Nicotine Polacrilex Lozenge comes in the form of a small,
candy-like, tablet in different flavors. When a nicotine lozenge is placed in
the mouth and allowed to dissolve over the course of 20 to 30 minutes, nicotine
is absorbed into the bloodstream, relieving the short-term cravings to smoke.
17. As seen from the documents submitted by the Appellant, the active ingredient
in the product “Nicotine Polacrilex Lozenge” is Nicotine Polacrilex USP. The US
Pharmacopeia describes Nicotine Polacrilex as a nicotine bound ion-exchange
resin which is prepared from methacrylic acid and divinylbenzene. This nicotine
containing resin contains not less than 95% and not more than 115% of the
labelled amount of nicotine. This is blended with inactive ingredients and
delivered in the form of tablets, chewing gum, lozenges or transdermal patches.
In the instant case, the Nicotine Polacrilex 2mg and 4mg Lozenge contains the
active ingredient Nicotine Polacrilex USP and inactive ingredients like
Aspartame (sweetner). Colloidal anhydrous silica (glidant). Flavor modulator.
Flavour peppermint, menthol (all flavoring agents), Hydroxy propyl methyl
cellulose (release modifier/binder), magnesium stearate (lubricant), sodium
bicarbonate (stabilizer/release modifier). Sorbitol, Mannitol (sweetner/diluent),
tartrazine. Brilliant blue FCF (colorant) and Xanthan Gum (Release
modifier/binder). This product is licensed by the Drugs Control Department.
18. Having seen the composition of the product, let us examine whether the
product can be considered as a medicament having therapeutic and prophylactic
uses. The word “medicament” has not been defined in the Customs Tariff Act or in
the Drug and Cosmetics Act. A common understanding and dictionary meaning of
medicament is a substance which treats illness and diseases. We find that
Nicotine Polacrilex is used as a stop smoking aid which reduces withdrawal
symptoms, including nicotine craving, associated with quitting smoking It is
pertinent to note that the use of Nicotine Polacrilex is indicated as merely an
“aid” to stop smoking and a drug which “reduces” withdrawal symptoms in those
who desire to quit smoking. It appears that the drug Nicotine Polacrilex does
not in any way “treat” the symptoms of nicotine cessation. For a drug to be a
medicament, it is essential that there should be a treatment of the illness or
disease. In the instant case, the product Nicotine Polacrilex Lozenge is only a
preparation which assists smokers to stop smoking It is a replacement therapy
for addicted smokers to wean them away from the smoking habit Use of Nicotine
Polacrilex lozenge will satisfy the nicotine craving of the smoker as measured
doses of nicotine are administered into the blood stream The Nicotine
replacement therapy ensures that the harmful effect of cigarette smoking is
minimized in a smoker who will gradually stop the smoking habit. The claim made
by the appellant that the impugned product is a medicament as it has therapeutic
and prophylactic value is not acceptable because the instant product merely
alters the mode of nicotine ingestion into the human anatomy. Smoking a
cigarette causes the human body to inhale not only the nicotine present in
tobacco smoke but also several harmful chemicals like tar, carbon monoxide,
radioactive compounds that are carcinogenic, etc. On the other hand, the
products like Nicotine Polacrilex lozenges used as a Nicotine Replacement aid,
allows the body to ingest only nicotine without any of the harmful chemicals
found in tobacco smoke. There is no therapeutic value in Nicotine Polacrilex
Lozenge other than that it is only an aid for cessation of smoking and helps to
reduce the withdrawal symptoms. Therefore, the Nicotine Polacrilex Lozenge
cannot be considered as a medicament
19. Coming to the classification of the product “Nicotine Polacrilex Lozenge’,
it is the case of the Appellant that the impugned products should be classified
under Chapter 30.04 as a Medicament. The Central Government, on the
recommendations of the GST Council, has issued Rate Notification Number
01/2017-CT (Rate) dated 28.06.2017 prescribing different rates of tax in
Schedules for specified goods. The Explanation to the Rate Notification No.
1/2017-Central Tax (Rate) dated 28.06.2017 states thus:
For the purposes of this Notification: ...
(iii) “Tariff item”, “sub-heading” “heading” and “Chapter” shall mean
respectively a tariff item, sub-heading, heading and chapter as specified m the
First Schedule to the Customs Tariff Act, 1975 (51 of 1975).
(iv) The rides for the interpretation of the First Schedule to the Customs
Tariff Act, 1975 (51 of 1975), including the Section and Chapter Notes and the
General Explanatory Notes of the First Schedule shall, so far as may be, apply
to the interpretation of this notification.
20. Therefore, while the Rate Notification under GST provides the rate of tax on
goods and services, in order to interpret these Rate Notifications for purposes
of levy of GST, one has to read the same along with the First Schedule of the
Customs Tariff Act, 1975 (including the Section and Chapter Notes and General
Explanatory Notes). The Customs Tariff is structured into Sections, Chapters and
sub-chapters, Headings and sub-headings.
21. Each Section and Chapter under the Tariff is accompanied by the notes known
as “Section Notes’ and Chapter Notes. These are given at the beginning of the
Section or Chapter respectively which governs the concerned Section or Chapter
as the case may be In the case of Section Notes, they are applicable to each
Chapter which is part of a specific section of the Tariff. Classification is to
be determined only based on description of the heading read with relevant
section or Chapter notes Since these notes are part of Tariff itself, these have
full statutory backing.
22. Various Tribunals have held that coverage of respective headings must be
determined in the light of the respective section and Chapter note. Hence in
this sense, the section and Chapter note have overriding force over the
respective headings and sub-headings In CC. v Sanghavi Swiss Refills P. Ltd.
(1997) 94 ELT 644 (CEGAT), it was held that section notes and Chapter notes,
being statutory in nature, have precedence over functional test of commercial
parlance for the purpose of classification.
23. Chapter 30 of the Customs Tariff’ Act, 1975 relates to “Pharmaceutical
products”. Chapter Note 1 to Chapter 30 lists out the goods which are excluded
from the purview of Chapter 30. As per Chapter Note 1(b), Chapter 30 does not
cover “preparations, such as tablets, chewing gum or patches (transdermal
systems) intended to assist smokers to stop smoking (heading 2106 or 3824)”
Therefore, any preparation which is intended to assist smokers to stop smoking
is excluded from the coverage of Chapter 30. The preparations may be in the form
of tablets, chewing gum or patches. In this case, the impugned product is in the
form of a Lozenge. Admittedly a lozenge is not a tablet or chewing gum or a
patch However, the use of the words “such as” in the Chapter Note 1(b) signifies
that it is only indicative and not exhaustive. The Hon’ble Supreme Court in Good
Year India Ltd v Collector of Customs 1997 (95) ELT 450 on the issue of
classification of ‘innci tube valves’ held that:
“...The words such as stainless steel, nickel monel, incoloy, hastelloy’ in
subheading (2) are only illustrative of the various metals from which valves can
be made but the said description is not exhaustive of the metals....”
Therefore, the term “such as’ used in Chapter Note 1(b) to Chapter 30
establishes that whatever goods are enumerated in the note are only
illustrations of a particular kind of goods and are not exhaustive of it and
cannot be construed restrictively By applying this well settled principle of
interpretation, it is clear that, the mention of preparations such as tablets,
chewing gum or patches referred to in Chapter Note 1(b) to Chapter 30, would
also cover within its purview ‘lozenges In the instant case, the product
Nicotine Polacrilex Lozenge is a preparation intended to assist smokers to stop
smoking and hence it clearly stands excluded from being classified under Chapter
30 of the Customs Tariff.
24. The appellant has made out an argument that the exclusions in Chapter Note
1(b) to Chapter 30 is for “preparations in general” and does not apply where the
said product qualifies as a medicament. They contend that since the Nicotine
Polacrilex Lozenge is a medicament, it deserves treatment as a pharmaceutical
product and hence it merits classification as a medicament under Chapter Heading
3004 As already mentioned in the aforesaid discussions, the impugned product is
merely an aid used in Nicotine Replacement Therapy to assist smokers to quit
smoking The impugned product assists in reducing the withdrawal symptoms. The
symptoms of nicotine withdrawal can be physical, mental and emotional The
withdrawal symptoms vary depending on how long and how many packs a day have
been smoked In Nicotine Replacement Therapy, the intensity of the withdrawal
symptoms (mainly a craving for nicotine) is reduced This is because the product
used in the Nicotine Replacement Therapy provides the person a small controlled
amount of nicotine without any of the other dangerous chemicals found in
cigarette smoke. This helps satisfy the craving for nicotine and reduces the
urge to smoke thereby helping the person manage the withdrawal symptoms As
already mentioned above, the product is not a medicament used to treat any
illness or disease It is only a preparation used to assist smokers to stop the
habit of smoking. No doubt the product is sold in measured doses of 2mg and 4mg
and is to be taken in a prescribed manner as indicated in the label However,
this fact will not categorize the product as a medicament classifiable under
Chapter 30 It may be noted that use of this substance for prolonged periods of
time may lead to a dependence on nicotine polacrilex. Therefore, the use of the
product in the manner prescribed is mainly to transfer the physiologic
dependence from ‘nicotine contained in tobacco’ to ‘nicotine bound in a
polacrilex’ Such transference minimizes the behavioral aspects associated with
cigarette smoking. Thus, the product is not a medicament for the treatment of
physiological conditions emanating from cigarette smoking but is a substance
containing nicotine used in Nicotine Replacement Therapy. Such stop smoking aids
cannot be classified under Chapter 30 in view of the exclusion given in Chapter
Note 1(b) to Chapter 30. In view of the aforesaid, we are not inclined to accept
this argument of the Appellant.
25. Having concluded that the product Nicotine Polacrilex lozenge is not
classifiable under Chapter 30, w’e move on to determine the Chapter under which
the product can be classified The Chapter Note 1(b) to Chapter 30, while
excluding from its purview preparations intended to assist smokers from smoking,
proposes to classify such preparations under either 21.06 (Food preparation not
elsewhere specified) or under 38.24 (Miscellaneous chemical products).Chapter 21
pertains to miscellaneous edible preparations and Chapter heading 21.06 covers
food preparations not elsewhere specified In this case, the impugned product
contains the active ingredient “Nicotine Polacrilex” which, as already stated
earlier, is a substance comprising of nicotine which is bound by a resin (Polacrilex).
Clearly, the combination of these ingredients cannot be considered as a food
preparation. Hence, Nicotine Polacrilex Lozenge is not classifiable under
Chapter Heading 21.06.
26. The other alternative chapter heading provided in Chapter Note 1(b) to
Chapter 30 for classifying preparations which assist smokers to stop smoking, is
Chapter Heading 38.24.Chapter 38 of the Customs Tariff Act relates to
“Miscellaneous chemical products” and the Chapter Heading 38 24 covers “Prepared
hinders for foundry moulds or cores; Chemical products and preparations of the
chemical or allied industries (including those consisting of mixtures of natural
products), not elsewhere specified or included.”
27. The active ingredient in “Nicotine Polacrilex Lozenge” is Nicotine which is
a natural alkaloid. Nicotine is bound to an ion-exchange resin (polymethacrilic
acid) and administered in the form of tablets, chewing gum, lozenge or patches
The chemical formulation of the nicotine bound to the resin polacrilexis such
that it provides the user of the product blood nicotine levels via buccal
absorption that will approximate those produced by the inhalation of tobacco
smoke. We find that the Nicotine Polacrilex Lozenge is a chemical preparation
and hence is more aptly classifiable under Chapter Heading 38.24 of the Customs
Tariff Act, 1975.
28. In the GST rate Notification No 01/2017-Central Tax (Rate) dated 28.06.2017,
the “Prepared hinders for foundry’ moulds or cores; Chemical products and
preparations of the chemical or allied industries (including those consisting of
mixtures of natural products), not elsewhere specified or included” falling
under Chapter Heading 38.24 are covered under entry SI.No 97 of Schedule III
with a GST rate of 18% (CGST 9% plus SGST 9%).
29. In view’ of the above we pass the following order
ORDER
We uphold the Order No.KAR ADRG 18/2019 dated 07/08/2019 passed by the Advance Ruling Authority and appeal filed by the appellant M/s. Strides Emerging Markets Ltd, stands dismissed on all accounts.
(D.P.NAGENDRAKUMAR)
Member Karnataka Appellate Authority
(MS SRIKAR)
Member Karnataka Appellate Authority
The Appellant
Copy to:
The Member (Central), Advance Ruling Authority, Karnataka.
The Member (State), Advance Ruling Authority, Karnataka.
The Commissioner of Central Tax, South Commissionerate
The Asst. Commissioner, LGSTO-25, Bengaluru.
Office Folder
Equivalent .