Drugs for rare diseases
Why in news? 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 are now fully exempted from basic customs duty, the Union government declared through a general exemption notification.
- The Centre has also fully exempted pembrolizumab (Keytruda), used in treatment of various cancers, from basic customs duty.
- In order to get this exemption, the individual importer has to produce a certificate from the Central or State Director of 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.
- According to a government release, while exemptions are already in place for certain drugs for treatment of spinal muscular atrophy or Duchenne muscular dystrophy, it has been receiving many representations seeking customs duty relief for drugs and medicines used in treatment of other rare diseases.
- 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 over Rs.1 crore per year, with treatment being lifelong and drug dose and cost increasing with age and weight.
What is the rare disease ?
- Rare disease are often serious , chronic and life threatening conditions. WHO defines a rare disease as often lifelong disease or disorder with prevalence of 1 or less, per 1000 population .
- India formulated a National Policy on Rare Diseases (NPRD) in 2017, but it lacked clarity on disease coverage, patient eligibility, and cost-sharing. The revised policy was released in March 2021
- India does not have a standard definition of rare diseases, it is difficult to arrive at their exact prevalence.
- Epidemiological data for rare diseases is collated by the National Registry for Rare Diseases, maintained by the Indian Council of Medical Research (ICMR).