Customs Duty Exemption for 51 Rare Disease Medicine and Special Food

· Pembrolizumab (Keytruda) used in treatment of various cancers

· Duty Exemption for Parts and Raw Materials Extended by One year to 31 March, 2024 for manufacture of goods to be supplied in connection with the purposes of Off- shore Oil Exploration or Exploitation

· Machines used for Textile Industry Widened to Five New Categories including Shuttleless Looms– Exemption Valid till 31 March, 2025

· BCD exempted on Flat Panel Detector including Scintillators, Medical Grade Monitor and X-ray Tubes

· List 38 of Sl.No. 607B – List of Rare Disease for which all drugs, medicines or Food for special medical purpose exempted for personal use (Classified under Heading 9804)

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 or District Medical Officer/Civil Surgeon of the district. Drugs/Medicines generally attract basic customs duty of 10%, while some categories of life saving 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.

[Notification No. 17/2023-Customs dated 29 March, 2023]

Seeks to amend notification 50/2017-Customs dated 30.06.2017 to continue/provide BCD exemption on import of specific textile machineries parts & raw materials for manufacture of goods to be supplied in connection with the purposes of off-shore oil exploration or exploitation medicines of rare diseases and goods for use in the manufacture of X-ray machines