2024(07)LCX0432
Bharat Biotech Internal Limited
Versus
Commissioner of Customs
Customs Appeal No. 20910 of 2014 decided on 16-07-2024
CUSTOMS, EXCISE & SERVICE TAX APPELLATE TRIBUNAL
BANGALORE
Regional Bench COURT-2
Customs Appeal No. 20910 of 2014
[Arising out of the Order-in-Appeal No. 523 & 524/2013 dated 30.12.2013 passed by the Commissioner of Customs, Bangalore.]
M/s. Bharat Biotech Internal
Ltd,
Survey No.230, 231 & 235,
Yadaram Turkapallu,
Shameerpet,
Hyderbad– 500 078.
.....Appellant
VERSUS
Commissioner of Customs,
C.R. Building, P.B.No.5400
Queens Road,
Bangalore – 560 001.
….... Respondent
Appearance:
Ms. Gayatri Priya, Advocate Appeared for Appellant
Mr.K.A.Jathin, Authorized Representative for Respondent
Coram:
Hon'ble Mr. P.A. Augustian, Member (Judicial)
Hon'ble Mr. Pullela Nageswara Rao, Member (Technical)
FINAL ORDER No. 20579 of 2024
Date of Hearing: 18.01.2024
Date of Decision: 16.07.2024
Per: Pullela Nageswara Rao
M/s. Bharat
Biotech International Pvt Ltd, the appellant imported “Montanide ISA 206 VG”
vide two Bills of Entry No. 5434224 dated 12.12.2011 and 5629101 dated
02.01.2012 and paid Customs duty of Rs. 6,72,425/- and Rs. 10,78,722/-,
respectively, classifying the imported goods under CTH 38249090, as residuary
entry for chemical products not elsewhere mentioned, since the imported goods
are chemical product and mineral based Adjuvant of vegetable origin and cleared
the goods.
2. The Respondent, issued a Show Cause Notice proposing to classify the goods
under CTH 30023000 as “Vaccine for Veterinary Medicines” alleging that the
imported goods are animal vaccines. The Original Authority confirmed the demand
of Rs. 2,16,447/- with interest and penalty was dropped. Aggrieved with the
order, appellant filed an appeal before Commissioner (Appeals). Department has
filed an appeal before Commissioner (Appeals) against the dropping of penalty.
Commissioner (Appeals) confirmed the demand with interest and imposed penalty
under Section 114A of the Customs Act, 1962. Aggrieved by the order of the
Commissioner (Appeals) this appeal is filed before the Tribunal.
3. The appellant in the appeal contends that the Adjudicating Authority, held
that; though the goods were only an “Adjuvant” and does not qualify to be called
a vaccine either in terms of composition or function, since the imported item
gets formulated with vaccine and it acquires the qualities of a vaccine when
mixed with the vaccine, hence, it can be classified as a vaccine.
4. The Learned Counsel for the appellant contends that; on the sole ground on
which the classification has been determined is that the ‘Adjuvant’ gets
formulated with vaccine and enter into body of the animal as vaccine and
therefore the functional parameters are to act as a vaccine; Department has not
disputed that the imported goods are Adjuvants and not vaccines and they are
only added to the vaccines to increase the body’s immune response to the
Vaccine; the technical bulletin on the imported goods mentioned that the vaccine
can be prepared by mixing the imported goods with an antigenic media, which
produces anti bodies in the body; hence, the imported goods are merely raw
materials/ingredients for certain vaccines and cannot be administrated as
vaccines directly to any animal; Tariff item 30023000 under which revenue seeks
classification of imported goods and Chapter heading 3002 does not include
components or parts of raw materials that form part of the products mentioned in
the CTH entry and no such inclusions are mentioned therein; hence, Tariff item
30023000, which reads as ‘Vaccine for veterinary medicines” does not include
elements in the vaccine and it is against the General Rules of interpretation of
classification; giving the raw material a characteristic of final product for
classification, when such raw material cannot be used directly as a product
under Tariff item is improper and not sustainable in law. Further, the Learned
Counsel submits that the difference between the Adjuvant and Vaccine is that
Adjuvant is a carrier of the medicine for effective function of the vaccine,
whereas the vaccine is administered for the immunity.
5. The Learned Counsel contends that; Commissioner (Appeals) classified the
goods under CTH 3002 on the grounds that rule 3(b) of the general rules of
interpretation is applicable. This rule is applicable when the goods imported
consists of mixture of composite goods; the imported goods being “Adjuvant” has
no mixture or composite within it which is a vaccine; Commissioner (Appeals)
finding that the predominant use of the product shall be considered for
classification and since predominant use is in vaccine it has to be classified
as a vaccine is highly erroneous; the imported goods without being processed any
further cannot be used as a vaccine; the predominant use or end use for the
product is not relevant criteria for classification as held in the case of
Glaxo Laboratories (India Ltd) Vs Union of India, 1985 (21) ELT 72
(Tri.-Bombay); the Hon’ble Court while placing reliance on the decisions of
the Apex Court in the case of Dunlop India Limited Vs Union of India AIR 1977
SC 571 held that;
14. “…..the end use of an article is absolutely irrelevant for the purpose of its classification under the tariff entry, where there is no reference to the end use of the article in the entry itself, it shall be judged on the basis of its nature at the time of its importation. Its ultimate use is not relevant.”
6. The Learned Counsel further submits that it is well settled principle of law that the classification of goods is a matter of chargeability and the burden to prove is clearly on the Revenue. In case the Department intends to classify the goods under a particular heading or sub-heading different from that claimed by the appellant, the Department is required to adduce proper evidence for the discharge of the burden of proof. In the present case the department has failed to produce any documentary evidence to show that the product can be used as a vaccine as such for animals. The Learned Counsel relied on the following cases laws:-
i. HPL Chemicals Ltd Vs. CCEx, Chandigarh 2006 (197) ELT 324
ii. Hero Motorcorp Ltd Vs. CC (NS-1) Raigad 2022 (379) ELT 214 (Tri- Mumbai)
7. Further the Learned Counsel
contends that since the goods imported by no stretch of imagination can be
directly placed under vaccines and the department itself admitted they are not
vaccines by themselves, they are only “Adjuvant”, where there is no specific
entry for Adjuvants even under common parlance the importer does not treat the
“Adjuvant” as vaccines and the department also does not treat the “Adjuvant” as
vaccine, therefore allegation of wilful misdeclaration and suppression of facts
is unsustainable.
8. The Learned Counsel contends that equal penalty alleging suppression and
wilful misstatement is not warranted in cases involving classification disputes
and this issue is no more res integra and they relied on the following case
laws:-
i. Abraham J Tarakan Vs. CCE, Cochin 2007 (210) ELT 112 (tri-Bang)
ii. CC Import Nhava Sheva Vs. Vodafone Essar Gujarat Ltd 2020 (373) ELT 421 (Tri-Mum)
9. The Learned Authorised
Representative (AR) for the Revenue has reiterated the finding in the impugned
order.
10. Heard both sides and perused the records. We find in this case the dispute
is with the regard to the classification of the imported goods “Montanide ISA
206 (VG)”. The importer has claimed classification under CTH 38249090, whereas
department has proposed and classification under CTH 30023000 as “Vaccine for
veterinary medicine”. In this regard the purpose of Adjuvants and types are as
below:
ADJUVANTS is an agent that modifies the effect of agents. Immunologic adjuvants are added to vaccines to stimulate the immune system's response to the target antigen, but do not in themselves confer immunity. Although immunological adjuvants have traditionally been viewed as substances that aid the immune response to antigen, adjuvants have also evolved as substances that can aid in stabilizing formulations of antigens, especially for vaccines administered for animal health.
Mechanisms of adjuvants:
Adjuvants are needed to improve the routing and adaptive immune responses to antigens. This reaction is mediated by two main types of lymphocytes, B and T cells. Adjuvants can apply their effects through different mechanisms. Some adjuvants, such as alum, function as delivery systems by generating depots that trap antigens at the injection site, providing slow release in order to continue the stimulation of the immune system.
Types of adjuvants:
Inorganic compounds: alum, aluminum hydroxide, aluminum phosphate, calcium phosphate hydroxide
Mineral oil: paraffin oil
Bacterial products: killed bacteria Bordetella pertussis, Mycobacterium bovis, toxoids
Nonbacterial organics: squalene, thimerosal
Delivery systems: detergents (Quil A)
Cytokines: IL-1, IL-2, IL-12
Combination: Freund's complete adjuvant, Freund's incomplete adjuvant
Alum is the most commonly used adjuvant in human vaccination. It is found in numerous vaccines, including diphtheria-tetanus-pertussis, human papillomavirus, and hepatitis vaccines
11. The above adjuvants are to be
classified as per the material composition in the respective Tariff heading. The
appellant imports different “Adjuvants”, based on their composition, they are
being classified, accordingly. We find that the item imported is “Immunological
Adjuvant” used in the preparation of vaccines for human and animals.
Immunological Adjuvant was classified by the Department under Tariff Item
30023000 as “Vaccine for veterinary medicine” as against the appellants
declaration under Tariff Item 38249090 as chemical products not elsewhere
mentioned even though the imported goods are injectable mineral oil and
emulsifier obtained from mannitol and purified oleic acid of vegetable origin.
Further, we find the Adjuvants are of different types and they are used for the
purpose of enhancing the immune response in the Immunological vaccines
administered for humans and animals.
12. Considering the above, we find that to classify Adjuvant as a vaccine by the
Department is incorrect and not legally tenable. Therefore, the confirmation of
demand with interest is legally not sustainable, hence it needs to be set aside.
Further we find that the imposition of penalty under Section 114A of the Customs
Act. 1962 is also not sustainable as there is no misdeclaration or suppression
of facts as all the details are submitted at the time of filing the bill of
entry.
13. In view of the above discussion and in the facts and circumstances of the
case, the appeal is allowed setting aside the impugned Order.
(Order Pronounced in Open court on 16.07.2024)
(P.A. Augustian)
Member (Judicial)
(Pullela Nageswara Rao)
Member (Technical)