In re Illumina India Biotechnology Private Limited (CAAR Mumbai)
M/s. Illumina India Biotechnology Private Limited (having IEC No AAECI9143H and hereinafter referred to as ‘the applicant’, in short) filed an application (CAAR-1) for advance ruling before the Customs Authority for Advance Rulings, Mumbai (CAAR in short). The said application was received in the secretariat of the CAAR, Mumbai on 28.07.2023 along with its enclosures in terms of Section 28H (1) of the Customs Act, 1962 (hereinafter referred to as the ‘Act’ also). The applicant is seeking advance ruling on the classification of “Kits” referred as ‘the Products’ such as TruSeq Stranded mRNA, Nextera DNA CD Idx and NextSeq 1000/2000 reagent for imports through the Airport & Air Cargo Complex, Bangalore.
2. Applicant has stated as follows in their statement of relevant facts having a bearing on the question(s) raised enclosed with the CAAR-1 application:
Illumina India, which is a part of the Illumina group, is involved in the creation, manufacture and distribution of sequencing and array-based solutions for analysing genetic variation and function in various domains ranging from cancer research to agriculture. The Applicant is primarily engaged in import, distribution and sale of life science tools and integrated systems, reagents and DNA sequencing instruments. The key details such as general description, form, end usage and technical description of the Products as submitted by the applicant are discussed below.
TruSeq Stranded mRNA (`TruSeq’) with Illumina part no. 20020594 is a library preparation kit that comprises of: (A) reagents; and (B) buffers. These library preparations are essentially standard molecular biological reactions used for preparing sample materials for sequencing. The reagents present in the kit are used to break the external layer of the cell to extract messenger ribonucleic acid (`mRNA’) and Ribonucleic acid (`RNA’). Thereafter, mRNA and RNA are fragmented to prepare samples using the reagents. Subsequently, specialized adapters are added to both ends of the fragmented RNA/ mRNA to make the sample suitable for subsequent cluster generation and sequencing. Accordingly, the reagents play a key role in generating cluster RNA sequencing and thus, give TruSeq its essential character.
Nextera DNA CD Idx with Illumina part no. 20018708 is an index kit which comprises of an index plate with wells holding reagent containing Oligonucleotides compounds, and buffer solutions, which is present in a liquid state. The Index kit is used for whole-genome sequencing applications of DNA extracted from genetic materials. The Index kit can be used for extracting DNA amongst variety of species such as humans, rats, plant, bacteria, etc. In the DNA sequencing workflow, Index kit comes into the picture in cases where multiple samples are required to be prepared post library preparation. The Index kit allows multiple libraries to be pooled together and sequenced in the same run wherein, unique index sequences, or identifier are added to each library. Thus, the Index kit adds unique index to the samples during library preparation process to allow the instrument to read multiple samples. In the process of adding unique index to the sample, a reaction takes place between the Index kit and the samples. This reaction attributes the character of a reagent to the Index kit and plays a key role in its functioning. Thus, the essential character of the Index kit is that of a reagent.
NextSeq 1000/2000 reagent kit (`NextSeq reagent’) with Illumina part no. 20046811 contains (A) reagent in liquid state stored in cartridge (B) flow cell; and (C) resuspension buffer. An image of the various constituents of the kit is enclosed by the applicant below for easy reference.
(A) reagent in liquid state stored in cartridge and (B) flow cell (C) Resuspension Buffer
Post completion of the library preparation and indexing process, the NextSeq reagents are used for adding dye/ markers to the samples. The dye adds different colours to the samples. The different colours so added help in identification of the different profiles of the DNA or RNA in the resultant output of the sequencing process. Accordingly, the reagents play a key role in adding dye to the samples which helps in identification of different segments of the DNA and RNA strands used for generating sequencing data. Thus, the reagent gives the essential character to the kit.
Some of the common characteristics present in the Products which may potentially have a bearing on the classification are:
i. The Products are meant for laboratory research use and not for diagnostic purposes;
ii. They are presented in the form of kits;
iii. They are prepared laboratory reagents having no backing in the form of plastic, paper or other material impregnated or coated with reagent;
iv. They are meant solely for in vitro
On reviewing the classification of the Products, the Applicant is of the view that tariff item 3822 1990 of the First Schedule of the Customs Tariff Act, 1975 (`CTA’) would be most appropriate for the products.
3. The applicant further submits that the Products are kits which are used for the purpose of library preparation, indexing and adding dyes to the samples to study the different profiles of the RNA/ DNA strands.
The reagents carry out the following functions in the Product:
a. TruSeq — reagent is used for preparing samples such that they can be used for sequencing mRNA / RNA
b. Index kit — reagent is used for pooling multiple libraries so that multiple samples can be processed for sequencing
c. NextSeq reagents — reagent is used for adding dye/ marker to the samples for creating different profiles of RNA/ DNA strands
Accordingly, the reagents present in each of the kits play a critical role in the functioning of the Products providing essential character to the Products. Based on the nature, characteristics and functionality of the Products, CTH 3822 merits consideration to determine the appropriate classification of the Products:
