Source:
https://medicaldialogues.in/news/health/government-policies/mohfw-releases-national-policy-for-rare-diseases-check-out-salient-features-61970
https://medicaldialogues.in/news/health/government-policies/mohfw-releases-national-policy-for-rare-diseases-check-out-salient-features-61970
New Delhi: The government will provide a financial support of
up to Rs 15 lakh under its Rashtriya Arogaya Nidhi scheme for one-time
treatment of rare diseases, according to the much awaited draft Rare Diseases
Policy. Under the draft National Policy for Rare Diseases released, beneficiaries would not be limited to Below Poverty Line families, but will
also cover 40 per cent of the population eligible as per norms of the Ayushman
Bharat-Pradhan Mantri Jan Arogya Yojana for their treatment in government
tertiary hospitals only.
The Union Health Ministry intends to notify certain
medical institutes as Centers of Excellence for Rare Diseases. These include
AIIMS, New Delhi, Maulana Azad Medical College, New Delhi, Sanjay Gandhi Post
Graduate Institute of Medical Sciences, Lucknow, Post Graduate Institute of
Medical Education and Research, Chandigarh and four others. "The cost of
treatment of patient in these centres of excellence will be met out of
donations received through the online digital platform," according to the
draft policy. Also Read - Madhya Pradesh infant deaths: Govt orders suspension
of CMHO, Civil Surgeon The ministry has put up the draft policy on its website
and sought comments and suggestions over it by February 10. Rare diseases
categorised under Group 1, such as Lysosomal Storage Disorders (LSDs), immune
deficiency disorders, chronic granulomatous disease, osteopetrosis, Fabry's
disease and liver or kidney transplant, will be funded under the scheme. The
policy cited "resource constraints" to provide financial assistance
to rare diseases like Gaucher's disease, Spinal Muscular Atrophy, Hurler
Syndrome and Wolman disease that require lifelong treatment. "The
government will endeavour to create alternate funding mechanism through setting
up a digital platform for voluntary individual and corporate donors to
contribute to the treatment cost of patients of rare diseases," the draft
said. Rare diseases are severe and chronic illnesses and often
life-threatening. Patients suffering from rare diseases, especially Lysosomal
Storage Disorders (LSDs), often lead a very incapacitating life. There are
about 50 LSDs out of which only five have approved treatment options available
in India. The Ministry of Health had formulated a National Policy for Treatment
of Rare Diseases (NPTRD) in July, 2017. Implementation of the policy was,
however, faced with certain challenges.
A limiting factor in its implementation
was bringing states on board and lack of clarity on how much government could
support in terms of tertiary care. When the policy was shared with state
governments, issues such as cost effectiveness of interventions for rare
disease, the sharing of expenditure between central and state governments,
flexibility to state governments to accept the policy or change it according to
their situation, were raised. The policy had implementation challenges and
gaps, including the issue of cost effectiveness of supporting such health
interventions for resources limited situation, which made it not feasible to
implement. Given the challenges in implementing the policy, a decision was
taken to reframe the National Policy for Treatment of Rare Diseases and an
Expert Committee was constituted by the Ministry of Health in November 2018 to
review it. Pending reframing the policy, the earlier policy has been kept in
abeyance vide a non-statutory gazette notification dated December 18, 2018,
till the revised policy is issued or till further orders, whichever is earlier,
the draft document states. Holding that rare diseases place a major economic
burden on any country and especially in resource-constrained settings, the
draft policy states that at present very few pharmaceutical companies are
manufacturing drugs for rare diseases globally and there are no domestic
manufacturers in India. Due to high cost, the government has not been able to
provide these drugs for free. It is estimated that for a child weighing 10 kg,
the annual cost of treatment for some rare diseases may vary from Rs 10 lakh to
more than 1 crore per year, with drug dose and cost increasing with age. So
far, only about 450 diseases have been recorded in India from tertiary care
hospitals that are globally considered as rare diseases, according to the draft
policy.
The most commonly reported diseases include Haemophilia, Thalassemia,
Sickle-cell Anaemia and Primary Immuno Deficiency in children, auto-immune
diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung
disease, Gaucher's disease, Cystic Fibrosis, Hemangiomas and certain forms of
muscular dystrophies. Keeping in view the lack of availability of
epidemiological data on rare diseases, constraints on resources and competing
health priorities, the government is in the process of setting up a National
Registry for Rare Diseases at ICMR with the objective of creating a database of
various rare diseases. Steps have already been taken in this direction by ICMR.
Over a period of time, the registry is expected to yield enough information to
be able to arrive at a definition of rare diseases best suited to the country.
The
policy is attached @
