Lok Sabha Question No. 1148 (UNSTARRED), answered on 2025-02-10
Subject: Reduction of Import Duties/Taxes on Life-Saving Drugs
Ministry: FINANCE
Asked by: Shri Dharambir Singh, Smt. Kriti Devi Debbarman, Shri Biplab Kumar Deb, Shri Ravindra Shukla Alias Ravi Kishan, Shri Tejasvi Surya, Shri Dineshbhai Makwana, Shri Yogender Chandolia, Shri Lumbaram Choudhary, Dr. Hemant Vishnu Savara, Shri Bidyut Baran Mahato

## GOVERNMENT OF INDIA MINISTRY OF FINANCE DEPARTMENT OF REVENUE LOK SABHA UNSTARRED QUESTION NO.1148

## TO BE ANSWERED ON MONDAY, FEBRUARY 10, 2025

## REDUCTION OF IMPORT DUTIES/TAXES ON LIFE-SAVING DRUGS

## 1148. SHRI BIPLAB KUMAR DEB:

SHRI DINESHBHAI MAKWANA:

DR. HEMANT VISHNU SAVARA:

SHRI LUMBA RAM:

SHRI YOGENDER CHANDOLIA:

SHRI TEJASVI SURYA:

SHRI BIDYUT BARAN MAHATO:

SMT. KRITI DEVI DEBBARMAN:

SHRI DHARAMBIR SINGH:

SHRI RAVINDRA SHUKLA ALIAS RAVI KISHAN: :

Will the Minister of FINANCE be pleased to state:

- (a) whether the Government has taken any steps to reduce import duties or taxes on lifesaving drugs for Rare diseases and if so, the details thereof;
- (b) whether there is a GST exemption in case of such imports; and
- (c) the detailed process to utilize such exemptions?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF FINANCE

- (a) and (b): (i) All drugs, medicines and Food for Special Medical Purposes (FSMP) used for the treatment  of  rare  diseases  listed  in  Annexure  'A'  are  exempted  from  basic  customs  duty  and IGST, when imported by
1. individuals for personal use
2. by Centres of Excellence listed in Annexure B, or any person or institution recommended by any of the Centre of Excellence.
- (ii) In  Union  Budget  2025-26,  life-saving  drugs  or  medicines  at  Annexure  'C'  for  rare diseases have been added to List 4 of notification No. 50/2017-Customs, which attracts Nil Basic customs duty.

(c): The procedure prescribed under notification No. 50/2017-Customs is as follows:

(i) For  personal  imports,  the  individual  has  to  furnish  a  form  (attached  as  Annexure  'D') certified by 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  before  Deputy  Commissioner  of  Customs  or  the Assistant  Commissioner  of  Customs  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) For imports by any person or institution, there has to be recommendation by any of the Centre of Excellence listed in Annexure 'B', certifying that the person (by name) for whom the drugs or medicines  [Drugs, Medicines or Food for Special Medical Purposes (FSMP)] are being imported, is suffering from a rare disease (to be specified by name) and requires these drugs or medicines  [Drugs, Medicines or Food for Special Medical Purposes (FSMP)] for the treatment of said rare disease.

*******

## Annexure A

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 Multisysteminflammatory 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. A typical Hemolytic Uremic Syndrome.

## Annexure B

| (1)   | AIIMS, New Delhi                                                   |
|-------|--------------------------------------------------------------------|
| (2)   | Centre for Human Genetics, Bengaluru                               |
| (3)   | Institute of Post Graduate Medical Education and Research, Kolkata |
| (4)   | King Edward Memorial Hospital, Mumbai                              |
| (5)   | Maulana Azad Medical College, New Delhi                            |
| (6)   | Nizam Institute of Medical Sciences, Secundarabad                  |
| (7)   | PGIMR, Chandigarh                                                  |
| (8)   | Sanjay Gandhi Post Graduate Institute of Medical Science, Lucknow. |

1. Onasemnogene abeparvovec
2. Risdiplam
3. Spesolimab
4. Velaglucerase Alpha
5. Agalsidase Alfa
6. Rurioctocog Alpha Pegol
7. Idursulphatase
8. Alglucosidase Alfa
9. Laronidase
10. Olipudase Alfa
11. Agalsidase Beta
12. Imiglucerase

## Annexure C

## Annexure D

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 38and 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