Government of India
Ministry of Finance
Department of Revenue
(Central Board of Indirect Taxes & Customs)
Tariff Unit
To.
All Pi incipal Chief Commissioners/Chief Commissioners of Customs/Customs (Preventive),
All Pi incipal Chief Commissioners/Chief Commissioners of Customs and Central Tax
All Principal Commissioners/ Commissioners of Customs/Customs (Preventive)
All Principal Commissioners/Commissioners of Customs and Central Tax
Sir,
Subject: Clarification on Electro-Chemiluminescence Immunoassay kits-Reg.
In relation to the benefit of exemption of duties accorded to Chemiluminescence Immuno Assay (CLIA) kits, the Board is in receipt of representations seeking a clarification on whether Electro chemiluminescence Immuno Assay (ECLIA) kits are covered under the ambit of CLIA diagnostic kits.
2. The relevant entries and the notifications are as below:
a) Serial no 167(A) of Notification 50/2017(Cus) read with Serial no 57 of List 4
b) Serial no. 180 to Schedule I of Notification 01/2017(Integrated Tax-Rate), read with Serial no 178 to List 1
The notifications against the said serial numbers specify 'CLIA diagnostic kits'. However, there is no specific mention of ECLIA diagnostic kits.
3. The matter was examined in consultation with the Ministry of Health and Family Welfare(MoHFW). The significant points on which a clarification was sought from MoHFW and the response received are tabulated below:
1
2
I. Label Chemical Directly Involved in the Light Emission Reaction
ii. Enzyme Catalyzed Light Emission Reaction
iii. Redox Reaction Mediated Light Emission Reaction (ECLIA).
3
4
Both use the concept of chemiluminescence tor detection.
Both techniques rely on the concept of antigen-antibody binding.
Both are mainly used for disease diagnostics based on analyte detection
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6
4. The above clarifications from MoHFW clearly elaborate the various aspects of CLIA and ECLIA kits, It is advised that field formations take into account the above clarifications and make reasonable decisions on the assessment of the CLIA and ECLIA kits.
Hindi version follows.
Varun Koundinya
STO (Tariff Unit)
Customs Policy Wing