Acting on the directive from the Delhi High Court, Ministry of Health has drafted a national policy for the treatment of 450 Rare Diseases. A policy was considered necessary after Writ petitions were filled in the Delhi high court regarding free treatment of such diseases.
Though there is no official definition of a Rare Disease in India, it refers to the diseases that affect a small percentage of the population. Treatment of such diseases are not easily available, and if available, the costs of are seldom affordable.
Haemophilia, Thalassemia, Sickle cell anaemia and Primary Immuno Deficiency in children, Lysosomal storage disorders such as Pompe disease and Gaucher’s disease are some of the rare diseases found in India.
In the US, rare diseases have been classified as the ones which affect fewer than 2 lakh people. In the UK, it is also known as Orphaned Disease because pharmaceutical companies are not interested in adopting them to develop drugs to treat them.
The policy recognizes rare diseases under three categories:-
- Diseases requiring one-time curative treatment [Osteopetrosis, Tyrosinemia, and Fabry’s disease, and immune deficiency disorders]
- Diseases that demand a long-term treatment, but the cost of treatment is low [Phenylketonuria, Galactosemia]
- Diseases which need a long-term treatment with higher costs.
Central government will provide an assistance of Rs 15 lakh to patients suffering from rare diseases that comes under category 1. The treatment will be made available to beneficiaries of the Rashtriya Arogya Nidhi scheme and will be limited to the beneficiaries of Pradhan Mantri Jan Arogya Yojana
For the diseases under Cateogary 2 and 3, the government is devising to set up a digital platform where it will invite voluntary and corporate donations in order to gather the funds.
The Government is planning to notify certain medical institutes like New Delhi’s AIIMS, Chandigarh’s Post Graduate Institute of Medical Education and Research, Lucknow’s Sanjay Gandhi Post Graduate Institute of Medical Sciences, and four others as the Centres of Excellence for Rare diseases.
According to the policy, Indian Council of Medical Research (ICMR) will maintain a registry of rare diseases.
Moreover, the scheme only covers certain treatable diseases under category 1. Due to lack of adequate resources no financial assistance will be given to treat rare diseases that require lifelong treatment. These diseases include Gaucher’s Disease, Hurler Syndrome, Wolman Disease, among others. Treatment for some of these diseases may vary from ₹10 Lakhs to more than ₹1 crore per year.
In 2017, the Government had approved a national policy for the Rare Diseases, but it was scrapped later that year in the month of December because of failure in allocation of funds.
In 2018, the Government returned with another policy, but the policy was under the umbrella of the Rashtriya Arogya Nidhi (RAN). The RAN 1997 scheme catered only to the people living below the poverty line and promised them treatment under the Arogya Nidhi Fund in the super speciality medical institutes which have now been branded as the Centres of Excellence for the Rare Diseases in the present draft.
However, the government received criticism for the inclusion of the policy under RAN since it only catered to the BPL population, unlike the previous one that had no such eligibility bar.
Hence, the Union Government, after much reviewing, has come up with a little different policy, that would not be limited to BPL population. The present scheme will also accommodate beneficiaries under Ayushman Bharat which covers over forty percent of the population.
India has over 72 million of people suffering from Rare diseases and yet it is still waiting for a proper definition to be announced for these diseases. As these diseases are neglected by pharmaceutical companies because of their low economic value, the Government must incentivize drug manufacturing companies to produce medicines for such diseases.