SUPREME COURT OF INDIA
S.H. KAPADIA & B. SUDERSHAN REDDY
M/s. Span Diagnostics LtdPETITIONER
versus
Commissioner of Central Excise, SuratRESPONDENT
Appeal (civil) 1076-1080 of 2002
Decided on 30/04/2007
WITH
Civil Appeal No.5322 of 2002
M/s. J. Mitra & Co. Ltd.Appellant
Versus
Commissioner of Central Excise, Delhi Respondent
AND
Civil Appeal Nos.1953-54 of 2003
Commissioner of Central Excise, New Delhi Appellant
Versus
M/s. J. Mitra & Co. Ltd. & another Respondents
CULTURE OF MICRO-ORGANISM - CLASSIFICATION OF BIOTECH PRODUCTS - [Central Excise Tariff Act, Chapter Heading 30.02, Chapter Heading 30.05] - The court discussed the classification of monoclonal antibodies (MABs) under Chapter Sub-heading 3002.00 and Chapter Heading 30.05 of the Central Excise Tariff Act. The court held that MABs are classified as 'cultures of micro-organisms' under Chapter Heading 30.02 and not as 'pharmaceutical products' under Chapter Heading 30.05. The court emphasized that the width of the Heading under CETA cannot be expanded by reading Note 3(e) to Chapter 30 and concluded that MAB is a 'culture of micro-organism' and falls specifically under Chapter Heading 30.02 of CETA. The court also highlighted that the HSN Explanatory Note to Chapter Heading 30.06 corresponding to Chapter Heading 30.05 of CETA shows that MAB is excluded from Chapter Heading 30.05. The court classified the six items under Chapter Heading 30.02 of CETA and answered the civil appeal in favor of the assessee.
Fact of the Case:
The court addressed the classification of biotech products, specifically monoclonal antibodies (MABs), under the Central Excise Tariff Act. The dispute arose from the classification of MABs under Chapter Sub-heading 3002.00 and Chapter Heading 30.05 of the Central Excise Tariff Act.
Finding of the Court:
The court found that MABs are classified as 'cultures of micro-organisms' under Chapter Heading 30.02 and not as 'pharmaceutical products' under Chapter Heading 30.05. The court emphasized that the width of the Heading under CETA cannot be expanded by reading Note 3(e) to Chapter 30 and concluded that MAB is a 'culture of micro-organism' and falls specifically under Chapter Heading 30.02 of CETA.
Issues: The main issue was whether MABs should be classified under Chapter Heading 30.05 on account of Note No.3(e) to Chapter 30 of CETA, even though MAB is a 'culture of micro-organism' falling under CSH 3002.00 (Chapter Heading 30.02).
Ratio Decidendi: The court held that MAB is a 'culture of micro-organism' and falls specifically under Chapter Heading 30.02 of CETA. The court emphasized that MAB is not a sera of human or animal origin, not a vegetable extract, and not a plant extract, and therefore, it cannot fall under Chapter Heading 30.05 of CETA. The court also highlighted that the HSN Explanatory Note to Chapter Heading 30.06 corresponding to Chapter Heading 30.05 of CETA shows that MAB is excluded from Chapter Heading 30.05.
Final Decision: The court classified the six items under Chapter Heading 30.02 of CETA and answered the civil appeal in favor of the assessee.
JUDGMENT
Kapadia, J.
From the impugned judgment dated 1.1.2002 delivered by the Customs, Excise and Gold (Control) Appellate Tribunal (CEGAT, for short), New Delhi, vide Appeal No.E/1644 and 1645 of 2000-C, C.A. No.5322 of 2002 and C.A. No.1953-54 of 2003 have been iled by the assessees and by the Department respectively. For the sake of convenience and clarity we proceed to decide each of the following civil appeals serially.
C.A.No.5322/2002 filed by M/s. J. Mitra & Co.Ltd. (Assessee) In this civil appeal we are concerned with the classification of biotech products.
The said assessee was engaged in the manufacture of blood-grouping reagents and diagnostic and laboratory reagents. It had obtained registration on 10.9.99 for the manufacture and clearances of the following products:
(1)Anti-A Mono Clonal
(2)Anti-B Mono Clonal
(3)Anti-Decoders Mono Clonal
(4)Anti-Decoders Mono Clonal
(5)Anti-Decoders 1gM Mono Clonal
(6)Anti-Decoders 1gG Mono Clonal
The above six items are called Monoclonal Antibodies (for short, MABs). They were classified by the assessee under Chapter Sub-heading 3002.00 (Chapter Heading 30.02) of Central Excise Tariff Act (for short, CETA) whereas the Department classified the MABs under CSH 3005.90 (Chapter Heading 30.05) of CETA.
The assessee classified MABs as "cultures of micro-organisms" whereas the Department classified the said MABs as "pharmaceutical products, not elsewhere specified or included".
The CEGAT (Tribunal), vide the impugned judgment, upheld the classification of MABs under CSH 3005.90 of CETA as claimed by the Department, hence this civil appeal is filed by the assessee.
For the sake of convenience, we quote hereinbelow Chapter Note 3 in Chapter 30 of the CETA concerning pharmaceutical products which reads as under:
"CHAPTER 30
PHARMACEUTICAL PRODUCTS
Notes :
1. and
2. xxxxxxxxx
3. Heading No.30.05 applies only to the following, which are to be classified in that heading and in no other heading of this Schedule:-
(a) to (d) xxxxxxxxx
(e) Blood grouping reagents;
(f) to (h)xxxxxxxxx"
We quote hereinbelow Chapter Heading 30.02 and CSH 3002.00 of CETA which read as under:
"CHAPTER 30
PHARMACEUTICAL PRODUCTS
Notes : 1. to 5. xxxxxxxxx
Heading Sub-heading Description of goodsRate of
No.No.duty
(1)(2)(3)(4)
30.023002.00Antisera and other blood
fractions; Vaccines, Toxins,
Cultures of micro-organisms
(including ferments but
excluding yeasts) and similar
products
We quote hereinbelow Chapter Heading 30.05 in entirety of CETA which reads as under:
"CHAPTER 30
PHARMACEUTICAL PRODUCTS
Notes : 1. to 5. xxxxxxxxx
Heading Sub-heading Description of goodsRate of
No.No.duty
(1)(2)(3)(4)
30.05Pharmaceutical goods, not
elsewhere specified
3005.10Chemical contraceptivesNil
3005.20Dental cements and other dental 15%
fillings
3005.90Others15%
We also quote hereinbelow relevant extracts of Chapter Note No.2 in Chapter 30 of HSN (Second Edition) which read as follows:
"CHAPTER 30
PHARMACEUTICAL PRODUCTS
Chapter Notes.
1.xxxxxxxxx
2. For the purposes of heading No.30.02, the expression "modified immunological products" applies only to monoclonal antibodies (MABs), antibody fragments, antibody conjugates and antibody fragment conjugates."
We also quote hereinbelow Chapter Heading 30.02 in entirety from the said HSN which reads as under:
"30.02 HUMAN BLOOD; ANIMAL BLOOD PREPARED FOR THERAPEUTIC, PROPHYLACTIC OR DIAGNOSTIC USES; ANTISERA AND OTHER BLOOD FRCTIONS AND MODIFIED IMUNOLOGICAL PRODUCTS, WHETHER OR NOT OBTAINED BY MEANS OF BIOTECHNOLOGICAL PROCESSES; VACCINES, TOXINS, CULTURES OF MICRO-ORGANISMS (EXCLUDING YEASTS) AND SIMILAR PRODUCTS.
3002.10 Antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes
3002.20 Vaccines for human medicine
3002.30 Vaccines for veterinary medicine
3002.90 Other
This heading covers:
(A) Human blood (e.g., human blood in sealed ampoules).
(B) Animal blood prepared for therapeutic, prophylactic or diagnostic uses
Animal blood not prepared for suc
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