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  • 01 April, 2023

  • 5 Min Read

Duty Exemptions for Rare Disease medicine

Duty Exemptions for Rare Disease medicine

  • The National Policy for Rare Diseases 2021 lists all the rare diseases that must be treated, and the Central Government has granted complete exemption from basic customs duty on all pharmaceuticals and food imported for personal use.


  • The individual importer must present a certificate from the district's medical officer or civil surgeon, or the central or state director of health services, to be eligible for this exemption.
  • The standard customs duty for medicinal products is 10%, although several categories of life-saving medicines and vaccines are subject to a concessionary rate of 5% or NIL.
  • Pembrolizumab (Keytruda), which is used to treat some types of cancers, has also been completely exempted from basic customs duties by the government.
  • The Central Board of Indirect Taxes and Customs (CBIC) has authorised the exemption by changing "Drugs or Medicines" to "Drugs, Medicines or Food for Special Medical Purposes (FSMP)".

What is a Rare Disease

  • The World Health Organization (WHO) classifies a condition as a rare disease if it has a prevalence of 1 or less per 1000 people and is a lifelong illness or disorder.
  • Hemangiomas, Hirschsprung disease, Gaucher disease, etc., are a few examples of rare disorders.
  • Rare diseases include inherited malignancies, autoimmune conditions, congenital abnormalities, Hirschsprung's disease, Gaucher disease, cystic fibrosis, muscular dystrophies, and Lysosomal Storage Disorders, according to the Organization for Rare Diseases India (LSDs)

Rare Diseases Policy

  • The Ministry of Health & Family Welfare's Department of Health Research will serve as the convenor of a National Consortium that will be established as part of the Rare Diseases Policy to put more emphasis on indigenous research and minimise the high cost of treating rare diseases.
  • Treatment for uncommon diseases will be less expensive thanks to increased emphasis on research and development and local drug production.
  • The policy also calls for the establishment of a national registry of rare diseases, based in hospitals, to provide sufficient information for defining rare diseases and for domestic research and development on rare diseases.
  • The Policy also emphasises early screening and prevention through primary and secondary health care infrastructure, including Health and Wellness Centers and District Early Intervention Centers (DEICs), as well as through counselling for the parents of children at high risk.
  • Nidan Kendras, which was established by the Department of Biotechnology, will also facilitate screening.
  • By designating eight healthcare facilities as Centers of Excellence (CoEs) and providing these CoEs with one-time financial support of up to Rs 5 crores for the upgradation of diagnostics facilities, the policy also aims to strengthen the tertiary healthcare facilities for the prevention and treatment of rare diseases.

Obstacle to handle rare diseases

  • In areas where pharmaceuticals are available, they are prohibitively expensive, putting a tremendous strain on resources, and the government has not been able to give these for free.
  • Only a few diseases have been labelled as "rare" in India due to the absence of epidemiological data on the prevalence of these conditions.
  • The use of ambiguous terminology and inconsistent definitions can lead to misunderstandings and discrepancies, which can have an impact on both research and development and patient access to care.
  • Fewer than 5% of patients have access to therapies, but 95% do not have any approved treatments, and less than 1 in 10 patients receive disease-specific care.

National Policy for Rare Diseases 2021

  • With the purpose of treating people with rare diseases, the government developed the National Policy for Rare Diseases (NPRD), 2021 in March 2021. The following are the key components of the NPRD, 2021:
  • Group 1, Group 2, and Group 3 are the three categories into which the rare diseases have been divided.
  • Category 1: Diseases that can be cured with a single treatment.
  • Category 2: Disorders with relatively lower costs and benefits of therapy have been established in the literature and require annual or more frequent surveillance. These diseases require long-term/lifelong treatment.
  • Category 3: Conditions for which there is a permanent cure, but choosing the right patient is difficult due to factors including high cost and lifelong treatment.
  • There is a provision for patients with any category of rare diseases who choose to receive treatment at any of the Centers of Excellence (CoE) listed in NPRD-2021 outside of the scope of the Rashtriya Arogaya Nidhi umbrella scheme to receive financial assistance of up to Rs. 50 lakhs.
  • The patient from the neighbourhood can go to the closest Center of Excellence to get assessed and apply for benefits to receive financial aid for the treatment of a rare disease.
  • For the diagnosis, prevention, and treatment of uncommon diseases, eight (08) Centres of Excellence (CoEs) have been identified.

For the creation of infrastructure for screening, testing, and treatment, the Centers of Excellence will receive one-time grants totaling a maximum of Rs. 5 crore each.

Source: The Hindu

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