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,

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 1st April, 2023, namely: -
 

(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 1st 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 1st 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: -
 

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 30th March, 2023.

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

(Amreeta Titus)
Deputy Secretary

Note: The principal notification No. 50/2017-Customs, dated the 30th 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 30th June, 2017 and was last amended vide notification No. 16/2023-Customs, dated the 3rd 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 3rd March, 2023.