India’s Policy for Rare Disease Treatment Mired in Legal Gridlock

An Indian health policy initiative meant to provide funding to rare disease patients has struggled to gain approval from the country’s administration, according to a publication from DNA India.

First proposed by the national government of India in 2017, the National Policy for Treatment of Rare Diseases is intended to provide what is often much needed financial assistance to Indian nationals affected by a rare health condition.

Rare Disease in India

Before the details of policy can be discussed, it’s important to have a broad understanding of the Indian health environment.

Though a largely modernized and technologically advanced country, there are many parts of India where access to regular travel or much needed health services can be limited. In these unusually insular communities, “rare” medical conditions can occur at much higher rates. Estimates vary considerably, but experts believe somewhere between 5 and 8% of Indians are living with a rare disease. Though this number may sound alarming on its own, in reality the figure may actually be even higher due to the prevalence of individuals who are poorly integrated into the state health system.

The National Policy for Treatment of Rare Diseases

The National Policy for Treatment of Rare Diseases (or NPTRD) is the official name of the policy initiative that was first handed to the National Health Mission (NHM) for consideration in 2017. The National Health Mission is an arm of the larger Ministry of Health and Family Welfare, tasked with providing and improving medical care to under-served areas of the country.

Early drafts of the NPTRD allotted roughly $14.5 million to the new program. This money was to be supplementary, however – for every 4 parts paid by the NHM through the NPTRD, the local state government was expected to pay 6 parts. That means most of the money dispensed to rare disease patients would come from their own local government.

In early 2018, the first draft of the NPTRD was published with the expectation that the NHM implement the initiative by September of the same year. In December, however, a last-minute committee was formed by the Ministry of Health to “draft a revised policy.”

Squabbles arose over particulars of the policy’s execution. Suddenly, politicians were concerned over the allocation of such funding for so-called “tertiary diseases” (chronic conditions that are managed, not cured). It seems the implication was that treatment of “primary” (diseases that could be prevented, e.g. measles) and “secondary” conditions (diseases that can be detected early and limited with treatment) were within the purview of the NHM while treatment of “tertiary” conditions was not. Simply put, some in the government didn’t want to spend money on conditions that couldn’t be cured outright.

A general lack of consensus seems to characterize the current debate over the NPTRD. Politicians and taxpayers alike aren’t sure where state funding should end and NPTRD support begin. Under current language, applicants for NPTRD funding must be approved by their local state’s technical committee and then nominated to the NHM – even then, however, there is no binding legal language requiring the NHM to dispense the money. All approvals would be at the discretion of NPTRD and NHM officials.

The sustained delays preventing the NPTRD’s taking effect will undoubtedly impact India’s rare disease community. Patients like Pritesh, an anonymous 26-year-old from Gujarat with mucopolysaccharidosis II (MPS II), could die while politicians wrestle with legal concerns.

According to Shashank Tyagi, the secretary and national coordinator for India’s Lysosomal Storage Disorders Support Society, fewer than 50 doctors in India specialize in rare disease treatment. Since there may be as many as 80,000,000 living in India with a rare disease, each rare disease doctor could be responsible for over 1.5 million patients. The startling figure highlights the serious need for India to improve medical infrastructure around the country – especially for rare diseases in rural areas.

What challenges exist in developing countries that might make fighting rare disease even harder? Do you think “tertiary” conditions should be treated with less urgency than primary or secondary conditions? Share your thoughts with Patient Worthy!

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