Government exempts customs duty on drugs for rare diseases
Drugs for over 51 additional diseases will be now exempt from customs duty. The move could reduce the costs of highly priced drugs by 5-10%.
The government has fully exempt basic customs duty on all drugs and food for Special Medical Purposes imported for personal use for treatment of all rare diseases listed under the National Policy for Rare Diseases 2021, with effect from 30 March 2023.
Drugs for over 51 additional diseases will be now exempt from customs duty. The move could reduce the costs of highly priced drugs, often used for a long period of time, by 5-10%.
The government mentioned it is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases varies from Rs10 lakh to over Rs1 crore per year with treatment being lifelong and drug dose and cost increasing with age and weight.
The Ministry of Finance said, “This exemption will result in substantial cost savings and provide much needed relief to the patients.”
To avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Services or District Medical Officer/Civil Surgeon of the district.
Exemptions were already there on specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy. The Government has also fully exempted Pembrolizumab (Keytruda) used in treatment of various cancers from basic customs duty.
The diseases that are covered now under exemption are:
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
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