Indian government exempts import duty on rare disease drugs

New Delhi: The Central government on Thursday announced exemption on basic customs duty on all drugs and food for special medical purposes imported for personal use for treatment of all rare diseases. The union government has also exempted Pembrolizumab (Keytruda), a drug used in treatment of various cancers, from basic customs duty.

Drugs and medicines generally attract basic customs duty of 10 per cent, while some categories of life saving drugs and vaccines attract a concessional rate of 5 per cent or no duty.

The Finance Ministry said 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 or Civil Surgeon of the district.

A rare disease is a health condition of low prevalence that affects a small number of people compared with other prevalent diseases in the general population. It is estimated that globally around 6000 to 8000 rare diseases exist with new rare diseases being reported in the medical literature regularly. However, 80% of all rare disease patients are affected by approximately 350 rare diseases. Rare diseases include genetic diseases, rare cancers, infectious tropical diseases and degenerative diseases. 80% of rare diseases are genetic in origin, hence, disproportionately impact children. So far about 450 rare diseases have been recorded in India.

Rare diseases are, in most cases, serious, chronic, debilitating and life threatening illnesses, often requiring long-term and specialised treatments/management. In addition, they often result in some form of handicap, sometimes extremely severe. Moreover, they disproportionately impact children: Cystic Fibrosis, Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Wolman Disease, Hypophosphatasia, Neuronal ceroid lipofuscinosis are some of the disorders for which the cost of treatment is very high and in many cases need long term follow up

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 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, said the ministry.