National Policy of Rare Disease, 2021 has been approved by the Union Health Minister Harsh Vardhan which aims to lower the high cost of treatment for rare diseases, with an increased focus on indigenous research and local production of medicines, an official statement said on Saturday.
Under the scheme of Rashtriya Arogya Nidhi, a provision for financial support up to Rs 20 lakh is proposed for the treatment of those rare diseases that require a one-time treatment (diseases listed under Group 1 in the rare disease policy).
“Beneficiaries for such financial assistance will not be limited to BPL families, but the benefit will be extended to about 40 percent of the population who are eligible under the Pradhan Mantri Jan Arogya Yojana,” the health ministry said in the statement.
The policy also envisages a crowdfunding mechanism in which corporates and individuals will be encouraged to extend financial support through a robust IT platform for the treatment of rare diseases.
The financial support for the treatment of rare diseases is proposed under the Umbrella Scheme of Rashtriya Arogya Nidhi (RAN) and not under the Ayushman Bharat PMJAY, it stated.
“Union Health Minister Harsh Vardhan approved the ‘National Policy for Rare Disease’ 2021′ on March 30,” the ministry said.
“The Rare Diseases Policy aims to lower the high cost of treatment for rare diseases with an increased focus on indigenous research with the help of a national consortium to be set up with the Department of Health Research, Ministry of Health and Welfare as convenor,” it said.
Collected Funds will be utilized by Centres of Excellence (CoEs) for the treatment of all three categories of rare diseases as the first charge and then the balance financial resources could also be used for research, the statement said.
The policy also talks about the creation of a national hospital-based registry of rare diseases so that adequate data is available for the definition of such diseases and for research and development related to rare diseases within the country, it said.
It also focuses on early screening and prevention through primary and secondary health care infrastructure such as Health and Wellness Centres and District Early Intervention Centres (DEICs) and through counseling for high-risk patients, the ministry said.
The screening will also be supported by Nidan Kendras set up by the Department of Biotechnology.
The Draft policy for Rare Diseases was put in the public domain on January 13, 2020, on which comments/views were invited from stakeholders, the general public, organizations and states and Union territories. All the comments received were examined in depth by an expert committee constituted by the health ministry.
The policy aims to strengthen tertiary health care facilities for prevention and treatment of rare diseases through designating eight health facilities as ‘Centres of Excellence and these will also be provided one-time financial support of up to Rs 5 crore for up-gradation of diagnostics facilities, it said.
The field of rare diseases is very complex and heterogeneous, and the prevention, treatment and management of rare diseases have multiple challenges.
There are also fundamental challenges in the research and development for the majority of rare diseases as relatively little is known about the pathophysiology or the natural history of these diseases, particularly in the Indian context, the statement said.
Rare diseases are also difficult to research upon as the patient pool is very small and it often results in inadequate clinical experience. Availability and accessibility to medicines are also important to reduce morbidity and mortality associated with a rare disease. Despite progress in recent years, there is a need to augment effective and safe treatment for rare diseases.
Various high courts and Supreme Court have also raised concern about the policy because of the high cost of the treatment of rare diseases,the statement added.