Central Govt notifies Customs Duty Exemption for all imported drugs and Food for Special Medical Purposes for personal use for treatment of all Rare Diseases [Read Notification]

In a major move, the central government has notified full customs duty exemption to all imported drugs and food for medical purposes for personal use, in treatment of all rare diseases.

The Central Government has given full exemption from 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 through a general exemption notification.

In order to avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Services District Medical Officer/Civil Surgeon of the district. Drugs/Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines attract concessional rate of 5% or Nil.

While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the Government has been receiving many representations  seeking  customs duty relief for drugs and medicines used in treatment of  other Rare Diseases. Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from ₹10 lakh to more than ₹1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight.

This exemption will result in substantial cost savings and provide much needed relief to the patients.

The Government has also fully exempted Pembrolizumab (Keytruda) used in treatment of various cancers from basic customs duty.

The Gazette Notification lists the following diseases as rare : –

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 malabsorption

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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