national policy for rare diseases: Govt exempts import duty on drugs, food needed for special medical purposes

national policy for rare diseases: Govt exempts import duty on drugs, food needed for special medical purposes


The government on Thrusday exempted basic customs duty on all drugs and food for special medical purposes imported for personal use for treatment of rare diseases, stated a government press release.

The import duty waiver will come into effect from April 1.

Also, the government has exempted Pembrolizumab (Keytruda), used in treatment of various cancers, from basic customs duty.

Drugs/Medicines generally attract basic customs duty of 10 per cent, while some categories of life saving drugs/vaccines attract a concessional rate of 5 per cent 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 statement by finance ministry said.

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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