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 Servicesor District Medical Officer/Civil Surgeon of the district.Drugs/Medicines generally attractbasic 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 willresult in substantial cost savings and provide much needed relief to the patients. 

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

Related Notifications - 

Notification No. 17/2023 - Dated: 29-3-2023

Notification No. 18/2023 - Dated: 29-3-2023

Customs duty exemption for imported drugs and FSMP enables duty-free personal imports for treatment of listed rare diseases. Full exemption from basic customs duty applies to all imported drugs and Food for Special Medical Purposes for personal use to treat diseases listed under the National Policy for Rare Diseases 2021, effected by general exemption notifications. Eligible importers must produce a certificate from the Central or State Director of Health Services or the District Medical Officer/Civil Surgeon. The measure extends prior limited exemptions for specific rare-disease therapies and separately exempts pembrolizumab by notification.