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Exemption From Custom Duties For Drugs Treating Rare Diseases


The centre recently announced the full exemption of custom duty for drugs, food imported for treatment of rare diseases.


GS-II: Social Justice (Health related issues, Governance and Government Policies, Issues Arising Out of Design & Implementation of Policies)

Dimensions of the Article:

  1. Key points
  2. What is a rare disease?
  3. Provisions of the National Rare Disease Policy 2021
  4. Criticisms of the National Rare Disease Policy 2021
  5. Conclusion

Key points:

  • Recently, The central government provided full exemption from basic customs duty for all drugs and food imported for treatment of rare diseases listed under the National Policy for Rare Diseases (and anti-cancer drug Pembrolizumab).
  • It is a significant step towards its endeavour to address issues relating to the public’s welfare.
  • How to avail:
    • To avail thus exemption, the individual importer must produce a certificate from specified authorities.
  • Custom duties for medicines:
    • Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines get concessions or exemptions.
  • Exemption of custom duties:
    • The exemption has already been provided to specified drugs for the treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy.
  • Significance:
    • Treatment: While some of these diseases do not have any described treatment methodologies,
    • Underreporting of cases:
      • It is estimated that between 7,000-8,000 conditions; 450 of them have been reported from hospitals in India.
    • Cost of drugs: Wherever treatment exists, the drugs have to be imported and costs are prohibitive, putting it out of the reach of most people.
      • The NPRD estimates 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 costs increasing with age and weight.
      • The duty exemption will lead to substantial savings for patients.

What is a rare disease?

A rare disease, also referred to as an orphan disease, is any disease that affects a small percentage of the population.

  • Most rare diseases are genetic, and are present throughout a person’s entire life, even if symptoms do not immediately appear.


  • Rare diseases are characterised by a wide diversity of symptoms and signs that vary not only from disease to disease but also from patient to patient suffering from the same disease. Relatively common symptoms can hide underlying rare diseases, leading to misdiagnosis.
  • Most rare diseases are genetic, and are present throughout a person’s entire life, even if symptoms do not immediately appear.
  • Haemophilia,
  • Thalassemia,
  • Sickle-cell anaemia,
  • Auto-immune diseases,
  • Pompe disease,
  • Hirschsprung disease,
  • Gaucher’s disease,
  • Cystic Fibrosis,
  • Hemangiomas and
  • Certain forms of muscular dystrophies

Are some of the most common rare diseases recorded in India.


While there is no universally accepted definition of rare diseases, countries typically arrive at their own descriptions, taking into consideration disease prevalence, its severity and the existence of alternative therapeutic options.

In the US, for instance, a rare disease is defined as a condition that affects fewer than 200,000 people.

The same definition is used by the National Organisation for Rare Disorders (NORD).

Concerns and challenges:

  • Rare diseases pose a significant challenge to health care systems because of the difficulty in collecting epidemiological data, which in turn impedes the process of arriving at a disease burden, calculating cost estimations and making correct and timely diagnoses, among other problems.
  • Many cases of rare diseases may be serious, chronic and life-threatening. In some cases, the affected individuals, mostly children, may also suffer from some form of a handicap.
  • As per the 2017 report, over 50 per cent of new cases are reported in children and these diseases are responsible for 35 per cent of deaths in those below the age of one, 10 per cent of deaths between the ages of one and five, and 12 per cent between five and 15.

Provisions of the National Rare Disease Policy 2021

  • Patients of rare diseases will be eligible for a one-tome treatment under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY).
  • Financial support up to Rs20 lakh under the Umbrella Scheme of Rashtriya Arogaya Nidhi shall be provided by the central government for treatment of those rare diseases that require a one-time treatment (diseases listed under Group 1) for their treatment in Government tertiary hospitals only. – (NOT be limited to below poverty line (BPL) families, but extended to about 40% of the population as eligible under the norms of Pradhan Mantri Jan Arogya Yojana (PMJAY))
  • The policy has categorised rare diseases in three groups:
  • Disorders amenable to one-time curative treatment;
  • Those requiring long term or lifelong treatment; and
  • Diseases for which definitive treatment is available but challenges are to make optimal patient selection for benefit.
  • The government has said that it will also assist in voluntary crowd-funding for treatment as it will be difficult to fully finance treatment of high-cost rare diseases.

Criticisms of the National Rare Disease Policy 2021

  • Though the document specifies increasing the government support for treating patients with a ‘rare disease’— from Rs 15 lakh to Rs 20 lakh — caregivers say this doesn’t reflect actual costs of treatment.
  • The Policy leaves patients with Group 3 rare diseases to fend for themselves due to the absence of a sustainable funding support.
  • What the policy doesn’t capture is that these are diseases that last a lifetime adding up to a huge amount of expenditure and many of the patients who can’t afford such treatment will be unable to even make it to the prescribed tertiary hospitals for treatment.


  • The NPRD underlining the magnitude of the disease, stressed on the need to judiciously use the available scarce resources considering the demand.
  • Towards achieving the goal of affordable health care, the government must ensure that its directions are followed in full, besides staying the course to innovate solutions for this category of patients.

-Source: The Hindu 

February 2024