Circular No. 10/2022
F.No. 524/18/2017-STO(TU)
Government of India
Ministry of Finance
Department of Revenue
(Central Board of Indirect Taxes & Customs)
Tariff Unit
North Block, New Delhi
Dated: 25.07.2022
To,
All
Principal Chief Commissioners/Chief Commissioners of Customs/Customs (Preventive),
All
Principal 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
Response from MOHFW
Chemiluminescence immunoassay (CLIA) is
la widely used detection method which
combines the highly-sensitive
chemiluminescence assay with highly-
specific Immune response and affinity of
antibodies. In CLIA diagnostic kits,
chemiluminescence technique is combined
with immunochemical reactions. CLIA Kits
are designed to detect the
chemiluminescence reactions. In CLIA the
label, i.e. the true "indicator" of the analytic
reaction, is a luminescent molecule.
S.No
1. How is a CLIA diagnostic kit
defined?
What are the different
parameters that need to fulfilled to be
considered
as a CLIA diagnostic kit?
Clarification sought
Cireular No. 10/2022
S.No.
Whether CLIA is a generic term thatCLIA have different label systems according
ncludes other technologies such asto the difference of physical chemistry
ECLIA cte.
Clarification sought Response from MOHFW
mechanism of the light emission which are
.If yes, what are the other technologies mention below :
that are considercd to be included
within CLIA
i. Label Chemical Directly Involved in the
Light Emission Reaction
i. Enzyme Catalyzed Light Emission
Reaction
ii. Redox Reaction Mediated Light
Emission Reaction (ECLIA).
Whether an ECLIA diagnostic kit that isCLIA
imported can also be used as a CLIA
diagnostic kit.
ECLIA
immunoassay)
and
(Electrochemiluminescence
both, are advanced methods of Immunof
diagnostics based on the concept of
antibody-antigen binding. CLIA uses a
chemical
chemiluminescence following antibody-
antigen binding while ECLIA uses an
electrochemical
chemiluminescence
immunoassay technique. Both techniques are
rapid, specific and similar in following
points
reaction to generate
5. What are the parameters on the basis of
which it is concluded that CLIA and
ECLIA are one and the same.
reaction
generate
the
to
signals
in
Both use the concept
o
chemiluminescence for detection.
Both techniques rely on the concept ot
antigen-antibody binding.
Both are mainly used tfor
disease
diagnostics based on analyte detection.
6 Whether CLIA and ECLIA kits can be Chemiluminescence lmmuno assay (CLIA)
is a self suflicient kit which provides
asensitive, high throughput alternative to
conventional colorimetrie methodologies. In
Chemiluminescence Immuno assay (CLIA).
the luminescence is produced as a result of
chemical
reaction where as in Electro
Chemiluninescencelmmunoassay (ECLIA).
theluminescenee
is produced
as a result of
electrochemical reaction. The CLIA and
ECLIA canaccommodate many
immunoasay principles while providing
superior performance and theapplications,
uses of both the techniques are same. Hence
both CLIA and ECLIA are one and the
same.
considered
the same and if the
Cxemption granted
to CLIA can be
extended to ECLIA.
Circular No. 10/2022
The above clarifications from MotIFW 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
