Amendment to Notification No. 61/94-Customs (N.T.) dated 21.11.1994

Amendment to Notification No. 61/94-Customs (N.T.) dated 21.11.1994 vide Notification No. 17/2023-Customs Dated: 29^th March, 2023

GOVERNMENT OF INDIA
MINISTRY OF FINANCE
(DEPARTMENT OF REVENUE)

Notification No. 17/2023-Customs Dated: 29^th March, 2023

G.S.R. 228(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), notification No. 50/2017-Customs, dated the 30^th 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,

I. in the Table, –

(1) against S. No. 167A, in column (3), for the entry, the entry “Drugs, Medicines or Food for Special Medical Purposes (FSMP) used for treatment of rare diseases” shall be substituted;

(2) against S. No. 403, in column (3), for the figures “2023”, the figures “2024” shall be substituted;

(3) for S. No. 460 and the entries relating thereto, the following S. Nos. and
entries shall be substituted with effect from 1^st April, 2023, namely: –

(1)	(2)	(3)	(4)	(5)	(6)
“460.	8446, 8448	The following goods (other than old and used) for use in the textile industry, namely: – (i) Shuttleless Rapier Looms (above 650 rpm); (ii) Shuttleless Waterjet Looms (above 800 rpm); (iii) Shuttleless Airjet Looms (above 1000 rpm); (iv) Parts and components for use in manufacturing of shuttleless looms: Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	Nil   Nil   Nil   Nil	–   –   –   –	–   –   –   9
460A.	8446	The following weaving machines (other than old and used), for use in the textile industry, namely: – (i) Carbon Fabric Weaving Rapier Looms; (ii) Biaxial and multiaxial weaving machines for manufacturing technical textiles; (iii) 3-D and block weaving machines for manufacturing technical textiles: Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	5%	–	–
460B.	8447	The following knitting machines (other than old and used), for use in the textile industry, namely: – (i) Flat Knitting Machines (11 revolutions per minute or minimum speed of 0.3 Mts per sec); (ii) Warp Knitting Machines (Minimum working width of 60″ and minimum speed of 500 RPM); (iii) Raschel Knitting Machines (Minimum working width of 60″ and minimum speed of 500 RPM); (iv) Knitting machines for spacer fabrics: Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	5%	–	–
460C.	84	The following goods (other than old and used), for use in the textile industry, namely: – (i) Industrial sewing machine (tariff heading 8452); (ii) Laser garment panel cutter (tariff item 8456 11 00); (iii) Whole garment making machine (knitted) (chapter 84); (iv Ink Jet printing machines (tariff item 8443 39 10): Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	5% 5% 5% 5%	– – – –	– – – –
460D.	84	Machinery (other than old and used) for manufacture of non-wovens textiles, namely: – (i) Complete production lines for the production of following non-wovens, up to rolled good preparation and packing, namely: (a) Needle punched non- wovens (b) Chemically bonded non-wovens (c) Thermally bonded non-wovens (d) Stitch bond non-wovens (e) Spun laced (hydro entangled) non-wovens (f) Melt blown non-wovens (g) Spun bond melt blown (SMS) non-wovens (ii) Machinery for finishing of all non-wovens; (iii) Machinery for converting non-wovens into made-ups: Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	5%	–	–
460E.	84, or any chapter	Parts and components (other than old and used) for use in manufacturing of textile machineries (falling under tariff headings 8444, 8445, 8446, 8447, 8448, 8449, 8451, 8452):Provided that nothing contained in this S. No. shall have effect after the 31st March, 2025.	5%	–	9”;

(4)against S. No. 563A, in column (3), in entry (ii), after item (g) and entries relating thereto, the following items and the entries relating thereto shall be inserted with effect from 1^st April, 2023, namely: –

“(h) Flat Panel Detector, including Scintillators (9022 90 90);

(i) X-ray Tube (9022 30 00)”;

(5) against S. No. 564, in column (3), after item (g), the following items and the entries relating thereto shall be inserted with effect from 1^st April, 2023, namely: –

“(h) Medical Grade Monitor (8528 59 00);

(i) Flat Panel Detector, including Scintillators (9022 90 90);

(j) X-ray Tube (9022 30 00)”;

(6) after S. No. 607A and the entries relating thereto, the following S. No. and entries shall be inserted, namely: –

(1)	(2)	(3)	(4)	(5)	(6)
“607B.	9804	Drugs, Medicines or Food for Special Medical Purposes (FSMP) used for treatment of rare diseases specified in List 38.	Nil	–	115”;

II. in the ANNEXURE,

(1) in Condition No. 112, for the words “drugs or medicines” at both places, the words “Drugs, Medicines or Food for Special Medical Purposes (FSMP)” shall be substituted;

(2) after Condition No. 114, the following Condition No. shall be inserted, namely: –

“115.

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 for Drugs/Medicines/FSMP used for treatment of Rare Diseases covered under S. No.607B of the Table. Certificate No ……………. of ………….. (year) Certified that the medicine………………………….. (name of the Drug/Medicine/FSMP) to be used for the treatment of ………… (patient name), is a Drug/Medicine/ Food for Special Medical Purposes (FSMP) used specifically for treatment of rare disease specified in List 38 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.

III. (1) in List 4, after item number 111 and the entries relating thereto, the following entry shall be inserted, namely: –

“(112) Pembrolizumab (Keytruda)”;

(2) after List 37 and the entries relating thereto, the following list and entries shall be inserted, namely: –

“List 38 (See S. No. 607B of the Table)

1. Lysosomal Storage Disorders (LSDs)

2. Adrenoleukodystrophy

3. Severe Combined Immunodeficiency (SCID)

4. Chronic Granulomatous disease

5. Wiskot Aldrich Syndrome

6. Osteopetrosis

7. Fanconi Anemia

8. Laron’s Syndrome

9. Tyrosinemia

10. Glycogen storage disorders (GSD) I, III and IV due to poor metabolic control, multiple liver adenomas, or high risk for Hepatocellular carcinoma, or condition of substantial cirrhosis or liver dysfunction, or progressive liver failure

11. Maple Syrup Urine Disease (MSUD)

12. Urea cycle disorders

13. Organic acidemias

14. Autosomal recessive Polycystic Kidney Disease

15. Autosomal dominant Polycystic Kidney Disease

16. Phenylketonuria (PKU)

17. Non-PKU hyperphenylalaninemia conditions

18. Homocystinuria

19. Urea Cycle Enzyme defects

20. Glutaric Aciduria type 1 and 2

21. Methyl Malonic Acidemia

22. Propionic Acidemia

23. Isovaleric Acidemia

24. Leucine sensitive hypoglycemia

25. Galactosemia

26. Glucose galactose malabsorbtion

27. Severe Food protein allergy

28. GH deficiency

29. Prader Willi Syndrome

30. Turner syndrome

31. Noonan syndrome

32. Acidemias, mitochondrial disorders

33. Acute Intermittent Porphyria

34. Wilson’s Disease

35. Congenital Adrenal Hyperplasia

36. Neonatal onset Multisystem inflammatory Disease (NoMID)

37. Gaucher Disease Type I and III

38. Hurler Syndrome [Mucopolysaccharisosis (MPS) Type I]

39. Hunter syndrome (MPS II)

40. Pompe Disease

41. Fabry Disease

42. MPS IVA

43. MPS VI

44. Cystic Fibrosis.

45. Duchenne Muscular Dystrophy

46. Spinal Muscular Atrophy

47. Wolman Disease

48. Hypophosphatasia

49. Neuronal ceroid lipofuschinosis

50. Hypophosphatic Rickets

51. Atypical Hemolytic Uremic Syndrome”.

2. Save as otherwise provided, this notification shall come into force on 30^th March, 2023.

[F. No. 334/05/2023-TRU]

(Amreeta Titus)
Deputy Secretary

Note: The principal notification No. 50/2017-Customs, dated the 30^th 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 June, 2017 and was last amended vide notification No. 16/2023-Customs, dated the 3^rd March, 2023, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 170(E), dated the 3^rd March, 2023.