Basic Customs Duty and IGST
Exempted on Life Saving Medicines for Treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy imported for Personal Use
[Notification No.46/2021-Customs
Dated 30th September, 2021]
Seeks to implement GST Council recommendation on IGST on
imports related to Spinal Muscular Atrophy disease, etc,
as well Condition No. 102 pertaining to Services.
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
30th 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 personal use, namely: - |
|
|
|
|
|
|
(a) the life saving
drugs or medicines (including diagnostic test kits) specified in List 4; |
Nil |
- |
- |
|
|
|
(b) other life saving
drugs or medicines, |
Nil |
- |
16 |
|
|
|
(c)
life saving medicines for treatment of Spinal
Muscular Atrophy or Duchenne Muscular Dystrophy,
namely- |
Nil |
Nil |
16 |
|
|
|
(i)
Zolgensma
(Onasemnogene Abeparvovec) (ii)
Viltepso
(Viltolarsen) (iii)
any other medicine for treatment of
the said diseases |
|
|
|
(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 the Form as
applicable and specified 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 / 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 / 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.
This notification shall come into force on the 1st day of October, 2021.
[F.
No. 190354/206/2021-TRU]