Import duty exempted on all drugs, food for special medical purposes for personal use to treat rare diseases

Drugs/Medicines generally attract basic customs duty of 10 percent, while some categories of life saving drugs/vaccines attract a concessional rate of 5 percent or Nil. "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," a finance ministry statement said.

The rare diseases whose Drugs, Medicines or Food for Special Medical Purposes (FSMP) are exempted from customs duty are Lysosomal Storage Disorders (LSDs), Adrenoleukodystrophy, Severe Combined Immunodeficiency (SCID), Chronic Granulomatous disease, Wiskot Aldrich Syndrome, Osteopetrosis, Fanconi Anemia, Laron's Syndrome, Tyrosinemia, 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, Maple Syrup Urine Disease (MSUD),Urea cycle disorders, Organic acidemias, Autosomal recessive Polycystic Kidney Disease, Autosomal dominant Polycystic Kidney Disease, Phenylketonuria (PKU), Non-PKU hyperphenylalaninemia conditions, Homocystinuria, Urea Cycle Enzyme defects, Glutaric Aciduria type 1 and 2, Methyl Malonic Acidemia, Propionic Acidemia, Isovaleric Acidemia, Leucine sensitive hypoglycemia, Galactosemia, Glucose galactose malabsorbtion, Severe Food protein allergy, GH deficiency, Prader Willi Syndrome, Turner syndrome, Noonan syndrome, Acidemias, mitochondrial disorders, Acute Intermittent Porphyria, Wilson's Disease, Congenital Adrenal Hyperplasia, Neonatal onset Multisystem inflammatory Disease (NoMID), Gaucher Disease Type I and III, Hurler Syndrome [Mucopolysaccharisosis (MPS) Type I], Hunter syndrome (MPS II), Pompe Disease, Fabry Disease, MPS IVA, MPS VI, Cystic Fibrosis., Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Wolman Disease, Hypophosphatasia, Neuronal ceroid lipofuschinosis, Hypophosphatic Rickets, Atypical Hemolytic Uremic Syndrome.

Food for Special Medical Purposes is a food formulation intended to provide nutritional support to persons who suffer from a specific disease, disorder or a medical condition, as a part of their dietary management. In order 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.

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. The ministry said it is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from Rs 10 lakh to more than Rs 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 ministry said.

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