RARE
DISEASES – SCIENCE
News: Drugs for rare diseases get customs
duty relief
What's
in the news?
●
The Central Government has given full
exemption from basic customs duty on 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 through a general exemption
notification.
Key
takeaways:
●
In order to avail this exemption, the
individual importer has to produce a certificate from Central or State Director
Health Services or District Medical Officer/Civil Surgeon of the district.
●
Drugs/Medicines generally attract basic
customs duty of 10%, while some categories of lifesaving drugs/vaccines attract
concessional rate of 5% or Nil.
What
is Rare Disease?
●
WHO defines a rare disease as a lifelong
disease or disorder that often highly weakens an individual. It has a prevalence of 1 or less per 1000
population.
●
However, every country has its own
definition for rare diseases.
●
The US defines rare diseases as a disease
or condition that affects fewer than 200,000 patients in the country.
National
Policy for Rare Diseases, 2021:
Categorisation: The
policy categorizes rare diseases into three groups as follows.
●
Group
1:
Disorders amenable to one-time curative
treatment.
●
Group
2:
Diseases 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.
●
The government has identified eight Centres of Excellence for the
treatment of rare diseases.
●
National Policy for Rare Diseases, 2021
provides for the National Consortium for
Research and Development on therapeutics for Rare Diseases with an expanded
mandate to include research & development, technology transfer and
indigenization of therapeutics for rare diseases.
Government
Support:
●
The government will provide financial
support of up to Rs. 20 lakh under
the umbrella scheme of Rashtriya Arogya Nidhi for treatment of those rare
diseases listed under group 1.
●
Moreover, beneficiaries for such financial
assistance would not be limited to BPL families. About 40% of the population,
eligible under Pradhan Mantri Jan Arogya Yojana, will also be eligible for
assistance.
●
Further, for group 2, the state governments can consider supporting specific
patients. It includes a rare disease that can be managed with special diets
or hormonal supplements or other relatively low-cost interventions (Diseases
listed under group 2).
●
Voluntary
Crowdfunding: The government has said that it will
assist in voluntary crowd-funding for the treatment of group 3. It is because it will be difficult to fully finance the
treatment of high-cost rare diseases of group 3.
Criticisms:
●
Though the document specifies increasing
the government support for treating patients with a rare disease from ₹15 lakh
to ₹20 lakh - caregivers say this doesn’t
reflect the actual costs of treatment.
●
It is argued that the new policy offers no
support to patients awaiting treatment since the earlier National Policy for
Treatment of Rare Diseases 2017 was kept in abeyance.
●
Concerns have been raised about the new
policy not considering group 3 patients, who require lifelong treatment
support.
●
It has been demanded that at least two centers
in every state need to be identified as a center of excellence to help the
patients avoid the time and cost of moving out.
Go
back to basics:
Rashtriya
Arogya Nidhi scheme:
●
It provides
financial assistance to patients living below the poverty line and who are
suffering from major life-threatening diseases, to receive medical treatment.