Print Friendly, PDF & Email

Rare Disease

Facts for Prelims (FFP)

Source: IE

Context: The Indian government has exempted all imported medicines and foods for personal use related to the management of 51 rare diseases (as listed in NPRD 2021) from basic customs duty.

  • The government has also fully exempted Pembrolizumab (Keytruda) used in the treatment of various types of cancer
About Rare diseasesInformation
DefinitionA rare disease (also called “Orphan” disease) is a condition that affects a small number of people compared to the general population— one or less than one per 1000 people (WHO); one or less than one in 2500 (India definition). There are 7,000 known rare diseases ( over 72% of them are genetic) with an estimated 300 million patients in the world.
Exampleslysosomal storage disorder, maple syrup urine disease, Severe food protein allergy, Wilson’s disease
Benefits of exemptionThe exemption will lead to substantial savings for patients with rare diseases, who are often unable to afford life-saving medicines due to prohibitive costs
ProcessPeople importing them have to obtain a certificate from the central or state director general of health services or district medical officer or civil surgeon. These certificates have to be provided to the customs officers at the time of clearance.
Challenges of rare diseasesPatients with rare diseases are disadvantaged by the lack of volumes that usually spur pharmacological companies into producing life-saving medicines
The magnitude of rare diseases in IndiaAn estimated 100 million people in India have some form of rare diseases
National Policy for Rare Diseases (NPRD), 2021Group 1: Disorders amenable to one-time curative treatment (financial support of up to Rs. 20 lakh under the umbrella scheme of Rashtriya Arogya Nidhi)

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.