[TO BE PUBLISHED IN THE GAZETTE OF INDIA, EXTRAORDI NARY, PART II,SECTION 3, SUB-SECTION
(i)]
GOVERNMENT OF INDIA
MINISTRY OF FINANCE
(DEPARTMENT OF REVENUE)
NotificationNo.46/2021-Customs
New Delhi, the 30
th
September,2021
G.S.R.
(E)- In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act,
1962(52 of 1962) and sub-section (12) of section 3 of Customs Tariff Act, 1975 (51 of 1975), the Central Government,
on being satisfied that it is necessary in the public interest so to do, hereby makes the following further amendments in
the notification of the Government of India, in the Ministry of Finance (Department of Revenue), No.50/2017-Customs,
dated the 30th June, 2017, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section(i), vide
number G.S.R. 785(E), dated the 30
th
June, 2017, namely:-
In the said notification, -
(a)in the TABLE, for S. No. 607 and the entries relating thereto, the following S. No. and entries shall be substituted,
namely: -
(1) (2) (3) (4) (5) (6)
607. 9804 The following goods, imported for person al
use, namely: -
(a) the life saving drugs or medicines
(including diagnostic test kits) specified in
List 4;
(b) other life saving drugs or medicines,
(c) life saving medicines for treatment of
Spinal Muscular Atrophy or Duchenne
Muscular Dystrophy, namely-
(i)Zolgensma(OnasemnogeneAbeparv
ovec)
(ii) Viltepso (Viltolarsen)
(iii)any other medicine for treatment of
the said diseases
Nil
Nil
Nil
-
-
Nil
-
16
16;
(b) In the Annexure, -
(i) for Condition No. 16, the following condition shall be substituted, namely: -
16. If, -
(a) the goods are imported by an individual for personal use;
(b)it is certified in theForm as applicable andspecified below, by the Director General or Deputy
Director General or Assistant Director General, Health Services, New Delhi, Director of Health
Services of the State Government or the District Medical Officer/Civil Surgeon of the district, in
each individual case
(1) Form formedicines used for treatment of Spinal Muscular Atrophy/ Duchenne Muscular
Atrophy covered under sub-clause(iii) of clause (c) of S. No.607 of the Table.
Certificate No....
. of
...
.. (year)
Certified that the medicine
.(name of the medicine) to be used for the
treatment of
.............( patient name), is a life saving medicine used
specifically for Spinal Muscular Atrophy / Duchenne Muscular Atrophy and exemption
from the payment of customs duty and Integrated GST is recommended.
Signature with date of Director General /
Deputy Director General /
Assistant Director General,
Health Services, New Delhi or
Director of Health Services or
District Medical Officer/Civil Surgeon.
or
(2) Form for life saving drugs or medicines, not covered under (1) above, being imported
under clause (b) of S. No. 607 of the Table.
Certificate No....
. of
...
.. (year)
Certified that the drug / medicine
.(name of the drug / medicine) to be used
for the treatment of
.......( patient name), is a life saving drug / medicine
for
..( disease name) and exemption from the payment of customs duty is
recommended.
Signature with date of Director General /
Deputy Director General /
Assistant Director General,
Health Services, New Delhi or
Director of Health Services or
District Medical Officer/Civil Surgeon.
and
(c) the importer produces the said certificate to the Deputy Commissioner of Customs or the
Assistant Commissioner of Customs, as the case may be, at the time of clearance, or gives an
undertaking as acceptable to the Deputy Commissioner or the Assistant Commissioner to furnish
the said certificate within such period as may be specified by the Deputy Commissioner or the
Assistant Commissioner, failing which to pay duty leviable thereon.
(ii) in Condition No. 102, after item (iv), the following provisos and Explanation shall be inserted, namely: -
Provided that goods may, instead of being re-exported out of India in terms of condition at (iii) above, be given on
lease under a transaction covered by item 1(b) or 5 (f) of Schedule II of the Central Goods and Service Tax Act 2017,
by lessor to another lessee in India, in which case, -
(a) the original lessee shall give an intimation to the commissioner of customs and get his bond discharged;
(b) the new lessee shall, by execution of bond, in such form and for such sum, as may be specified by the Commissioner
of Customs, bind himself to comply with the conditions herein, as if he were the importer of the goods.
Provided further that in case of goods supplied by an SEZ unit to DTA under a transaction covered by item 1(b) or 5(f)
of Schedule II of the Central Goods and Services Tax Act, 2017, where SEZ unit is liable to pay integrated tax on such
transaction under the Integrated Goods and Services Tax Act, 2017, the lessee shall bind himself only with conditions
(ii), (iii) and (iv) above.
Explanation. - In case of goods supplied by an SEZ unit (lessor) to DTA under a transaction covered by item 1(b) or
5(f) of Schedule II of the Central Goods and Services Act, 2017, -
(a) the Commissioner of Customs or the Commissioner of Customs of the port of importation, wherever they
appear, shall mean the Specified Officer as defined in Special Economic Zone Rules, 2006;
(b) Re-export in item (iii) shall mean returning the goods to the lessor..
2. Thisnotificationshall come into force on the 1
st
day of October, 2021.
[F. No. 190354/206/2021-TRU]
(Rajeev Ranjan)
UnderSecretarytotheGovernmentofIndia
Note: - The principal notification No.50/2017-Customs, dated the 30
th
day of June, 2017 was published in the Gazette of
India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 785(E), dated the 30
th
day of June, 2017,
and last amended vide notification No. 44/2021-Customs, dated the 17
th
day of September, 2021 published in the
Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 640(E)., dated the 17
th
day of
September, 2021
