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Exemption for Rare Diseases drugs

  • March 31, 2023
  • Posted by: OptimizeIAS Team
  • Category: DPN Topics
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Exemption for Rare Diseases drugs

Subject : Science and tech / Governance

Concept :

  • The Union government declared that all the drugs and food for special medical purposes imported for personal use for the treatment of all rare diseases listed under the National Policy for Rare Diseases, 2021 will be fully exempted from basic customs duty.
  • The Union government has further fully exempted pembrolizumab (Keytruda), used for treating various types of cancers, from basic customs duty.
  • Drugs or medicines usually attract basic customs duty of 10%, while some categories of life-saving drugs/vaccines attract a concessional rate of 5% or nil.
  • As per the announcements by the government, exemptions are already available for certain drugs for the treatment of spinal muscular atrophy or Duchenne muscular dystrophy.
  • Since the drugs or special foods used for treating a few diseases are expensive and often need to be imported, the exemption will help reduce the cost and provide much-needed relief to the patients.

What are ‘rare diseases?

  • These are often serious, chronic, and life-threatening conditions.
  • WHO defines a rare disease as an often-debilitating lifelong disease or disorder with a prevalence of 1 or less, per 1000 population.
  • However, different countries have their own definitions.
  • A disease or disorder is defined as rare in India when it affects fewer than 1 in 2500 individuals.
  • There may be as many as 7,000 rare diseases, individual diseases may be rare, and the total number of people with a rare disease is large.
  • Examples: Lysosomal Storage Disorders (LSD), Gaucher disease, Pompe disease, cystic fibrosis, muscular dystrophy, spina bifida, haemophilia, MPS 1 and 2, and Fabry disease.

Treatment:

  • About 95% of rare diseases have no approved treatment even when a correct diagnosis is made.
  • Rare diseases are also called ‘orphan diseases’ and drugs to treat them are called “orphan drugs” because of the expensive nature of available drugs.

About National Policy of Rare Diseases (NPRD):

  • The National Policy of Rare Diseases (NPRD) was notified in March 2021.
  • Aim:
    • To increase focus on indigenous research and local production of medicines.
    • To lower the cost of treatment of rare diseases.
    • To screen and detect rare diseases early at early stages, which will in turn help in their prevention.
  • Categorization: The policy has categorized rare diseases into three groups:
    • Group 1: Disorders amenable to one-time curative treatment.
    • Group 2: Those requiring long-term or lifelong treatment.
    • Group 3: Diseases for which definitive treatment is available but challenges are to make an optimal patient selection for benefit, very high cost, and lifelong therapy.
  • Financial Support:
  • Provision for financial support of up to Rs.50 lakhs to the patients suffering from any category of Rare Diseases and for treatment in any of the Centre of Excellence (CoE) mentioned in NPRD-2021, outside the Umbrella Scheme of RashtriyaArogaya Nidhi.

Rashtriya Arogya Nidhi

  • The Scheme provides financial assistance to patients, living below the poverty line (BPL) and who are suffering from major life-threatening diseases, to receive medical treatment at any of the super speciality Government hospitals/institutes.
Exemption for Rare Diseases drugs Science and tech
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