In re Becton Dickinson India Pvt Ltd (CAAR Delhi)
Summary: The Customs Authority for Advance Rulings (CAAR), New Delhi held that the BD ViperTM LT System imported by Becton Dickinson India Pvt. Ltd. is classifiable under Customs Tariff Item 9031 49 00 and not under CTI 9027 50 90 or 9027 89 90. The automated real-time PCR-based system is used with in-vitro diagnostic assays for extraction, amplification and detection of nucleic acids, particularly high-risk HPV DNA in cervical cancer screening. The applicant sought classification under Heading 9027 as an instrument for chemical analysis, whereas the jurisdictional Commissionerate proposed Heading 9031.
CAAR observed that the system does not measure the composition, concentration, quantity or other property of the specimen presented to it. Instead, it processes the specimen through lysis, DNA extraction, purification and amplification, creates a fluorescent signal, compares that signal with a predetermined criterion and ultimately reports a positive or negative result. The Authority characterised this function as “checking” rather than physical or chemical analysis. Accordingly, Heading 9027 was held inapplicable.
CAAR also rejected the applicant’s reliance on the HSN Explanatory Note covering instruments used in clinical laboratories for in-vitro diagnostic testing. It noted that the CDSCO import licence described the BD ViperTM LT System as being used “in conjunction” with appropriate IVD assays. The Authority further held that classification under the Customs Tariff is governed by the terms of the Tariff and that characterisation as a medical device under another enactment is not determinative of customs classification.
