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Government of India
Ministry of Finance
Department of Revenue
(Central Board of Excise and Customs)
Circular No. 28/2016-Cus
New Delhi, dated the 14th June, 2016
To,
All Chief Commissioners of Customs / Customs (Preventive),
All Chief Commissioners of Customs and Central Excise,
All Commissioners of Customs / Customs (Preventive),
All Commissioners of Customs and Central Excise.
Sir/Madam,
Subject: Single Window Project – Simplification of procedure in SWIFT
for clearance of consignments related to drugs & cosmetics reg.
Kind reference is invited to Board’s
Circular No. 03/2016 dated 03.02.2016
and
Circular No. 10/2016 dated 15.03.2016 regarding the Indian Customs Single
Window. Central Board of Excise and Customs (CBEC) has operationalised the
‘Indian Customs Single Window Project’ to facilitate trade from 01st April 2016
at all EDI locations throughout India. As a result the importers and exporters
electronically lodge their Customs clearance documents at a single point only
with the Customs. The required permission, if any, from Partner Government
Agencies (PGAs) such as Animal Quarantine, Plant Quarantine, Drug Controller,
Food Safety and Standards Authority of India, Textile Committee etc. is obtained
online without the importer/exporter having to separately approach these
agencies. This has been made possible through a common, seamlessly integrated IT
systems utilized by all regulatory agencies, logistics service providers and the
importers/exporters. The Single Window Interface for Trade (SWIFT) thus provides
the importers/exporters a single point interface for clearance of import and
export goods thereby reducing dwell time and cost of doing business.
2. Since its implementation, reports have been received highlighting problems
faced by trade in relation to the import of drugs, cosmetics and medical
equipment. The Board has examined these issues and in consultation with the Drug
Controller General of India the following decisions have been taken to simplify
the procedure for clearance of such goods:
Items that are Chemicals and Not drugs
2.1 Several items falling under different Customs Tariff Heads which have
been mapped in SWIFT as requiring clearance from Assistant Drug Controller’s
(ADC) office are chemicals and not drugs. These are being routed for ADC’s
clearance by virtue of the Customs Tariff Heads under which they are declared,
and the ADC’s office routinely declares them as “out of scope”. In this regard,
a list of such items have been prepared and published on the ICEGATE website as
part of PGA Exemption Category (PEC).
Importers of such goods should identify their items on this PEC list and
include them as part of the integrated Declaration in order to avoid unnecessary
references to the ADC. If any more items deserve to be part of the PEC list,
importers/ Customs Brokers may bring it to the notice of the respective
Commissioners. The Board has already established a Working Group to examine all
such items. The PEC will be duly updated after holding consultations in the
Working Group and with the approval of the concerned PGAs (DCGI – in case of
drugs and cosmetics items).
Dual Use Items & Excipients
2.2 Several items falling under different Customs Tariff Heads which have
been mapped in SWIFT as requiring clearance from Assistant Drug Controller’s
(ADC) office have dual use (use for medicinal and non-medicinal purposes) and
excipients (an inactive substance that can serve as the vehicle or medium for a
drug or other active substance). A large number of importers are importing them
for purposes other than drugs or medicinal use. Presently, for the clearance of
dual use items, the importers have to first seek a permit from Deputy Drug
Controller’s office and then to obtain an NOC from ADC office. To simplify the
clearance of dual use items, it has been decided in consultation with the DCGI
that items that are not pharmaceutical grade or items that do not contain any
Active Pharmaceutical Ingredients (API) need not be referred to the ADC for NoC.
Therefore, in respect of the category of dual-use items or excipients, in the
Integrated Declaration, the items will normally not be referred to the ADC
clearance if the importers or their Customs Brokers declare as follows:
(i) While providing the item details, it must be declared that the item is
not pharmaceutical grade and does not contain any Active Pharmaceutical
Ingredient.
(ii) The ‘intended end use/ purpose of import’ that is declared as part of
item details should not be for human or veterinary medicinal purposes.
Risk-based testing & procedure for drawing of samples
2.3 Samples will be drawn for testing of products based on risk. In this
regard, the DCGI has already outlined the criteria for risk-based testing under
which intervention for inspection and sampling by ADC officers will be
significantly reduced. Further, the procedure for drawing of samples for drugs
has been streamlined. Customs officers may carry out the inspection of all
drug/cosmetics consignments. They shall forward copies of authenticated labels
of consignments for verification by the ADCs office. In cases where the
consignments have to be opened for the drawing of product samples, an officer
from the ADC’s office shall draw the samples. The ADC’s office reserve the right
to inspect any drugs/cosmetics consignment.
2.4 It was reported that in respect of import of drugs & cosmetics items, the
ADC’s office draws samples for testing irrespective of whether the same batch to
which the item belongs has undergone testing in previous consignments.
Considering that this causes unnecessary hardship to the importer, it has been
decided that if the product sample from a particular batch has been tested, and
based on that sample, the consignment/item has been granted NOC by ADC’s office,
then a product sample shall not be drawn again for subsequent consignments/items
pertaining to the same batch for the purposes of giving NOC.
Letters of Guarantee and Undertakings
2.5 For different situations of clearance, the DCGI requires the importer to
present letters of declarations, undertaking and letters of guarantee in formats
prescribed in its Guidance Document. It was decided that wherever the text of
these declarations, undertakings, and letters of guarantee are provided as part
of the integrated declaration and digitally signed by the declarant, the
importer may not produce separate hardcopies of the same declarations
undertakings and letters of guarantee. These shall be subsumed as part of the
Integrated Declaration.
Mapping ADC’s office to ICES locations
2.6 Drugs, cosmetics, medical devices, non-critical diagnostics, dual use
items, feed grade items etc, which require ADC clearance shall be imported only
at the ports notified by CDSCO/DCGI. However, if consignments landed from vessel
or aircrafts at a notified port are subsequently transshipped to another Customs
location, the consignment will be referred for regulatory clearance purposes to
the nearest ADC for clearance. For this purpose, when SWIFT was launched, all
ICES locations were already mapped in the system to the nearest ADC’s office for
routing the consignments for ADC’s clearance. Commissioners of Customs may
report to the Board in case there are any problems with the mapping.
3. For implementation of the above decisions, DG (Systems) shall introduce
necessary qualifiers in respect of the existing data fields in the Integrated
Declaration. in regard to information required by ADC relating to supporting
documents, CBEC is carrying out necessary upgrades to its IT infrastructure.
Access by ADC’s office to data fields or images of supporting documents and
labels etc will be enabled once the CBEC IT infrastructure is upgraded.
4. Commissioners of Customs may kindly issue public notices to bring to the
notice of the Trade the above changes. Importers and Customs Brokers may be
advised to correctly declare all information in the Integrated Declaration
including product details required by for Single Window and their intended
end-use, especially since their declaration will determine how the consignments
are handled in respect of regulatory clearances.
5. Any problems faced by field formations pertaining to above may kindly be
reported to Single Window Project team, CBEC.
F.No.450/147/2015-Cus-IV
(Zubair Riaz)
Director (Customs)
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