Review on national policy of rare diseases, 2021

Abstract

In a country like India that already struggles to provide basic health facilities to its vast population, it becomes very difficult for people suffering from rare diseases to access treatment options. Currently, about 96 million people in India are living with a rare disease with almost no access to any kind of treatment. The National Policy of Rare Diseases was approved in 2017 but had limited impact as it faced a lot of implementation challenges. In the light of this, the policy was reframed after stakeholder's consultation and reviews from an expert committee. The reframed 'National Policy of Rare Diseases' was approved in March 2021. The study attempts to critically evaluate the policy in terms of its reach to the wider population and access to treatment for the most vulnerable population in India. An in-depth analysis reveals several limitations of the newly designed policy. The lack of availability of data to define the disease as per Indian standards, the absence of a framework for communication between the stakeholder institutions at all levels, and the lack of incentive to domestic drug manufacturers to invest funds into the research and development of the medicines for rare diseases severely limits our ability to deal with this public health concern. The Government needs to work towards developing a more holistic and empathetic policy to address the issues of lakhs of people suffering from rare diseases in India.