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National Policy for Rare Diseases

National Policy for Rare Diseases

In a significant move, the GST Council has announced that the Integrated Goods and Services Tax (IGST) on medicines and Food for Special Medical Purposes (FSMP) used for treating rare diseases enlisted under the National Policy for Rare Diseases, 2021, will be exempt when imported for personal use. This decision aims to alleviate the financial burden on patients and improve access to crucial treatments for rare diseases.

National Policy for Rare Diseases:

The Ministry of Health and Family Welfare introduced the National Policy for Rare Diseases (NPRD) in 2021 with the objective of providing comprehensive treatment options for patients affected by rare diseases. The policy encompasses various key features to address the challenges associated with rare diseases in India.

Promoting Indigenous Research and Local Production:

One of the key aims of the National Policy for Rare Diseases is to promote indigenous research and development, as well as local production of medicines. By encouraging research in rare diseases and facilitating local manufacturing, the policy aims to reduce dependency on expensive imported treatments and make them more affordable and accessible to patients.

Lowering Treatment Costs:

Another crucial aspect of the policy is to lower the cost of treatment for rare diseases. Rare diseases often require specialized and expensive treatments, placing a significant financial burden on patients and their families. The policy seeks to address this issue by exploring strategies to make treatment options more affordable, ensuring that patients can access the necessary care without enduring financial hardships.

Early Screening and Detection:

The National Policy for Rare Diseases emphasizes the importance of early screening and detection of rare diseases. Timely identification of rare diseases plays a crucial role in preventing their progression and reducing associated complications. By promoting early screening programs and raising awareness about the signs and symptoms of rare diseases, the policy aims to facilitate early intervention and improve health outcomes for affected individuals.

Centres of Excellence:

To provide specialized care for rare diseases, eight Centres of Excellence (CoEs) have been identified. These CoEs serve as dedicated facilities for the diagnosis, prevention, and treatment of rare diseases. They receive financial assistance for infrastructure development, including screening, tests, and treatment. This support enables them to offer comprehensive services and expertise to patients affected by rare diseases.

Categorization of Rare Diseases:

The rare diseases enlisted under the National Policy for Rare Diseases have been categorized into three groups. Group 1 comprises disorders amenable to one-time curative treatment. Group 2 includes diseases that require long-term/lifelong treatment, with relatively lower treatment costs and documented benefits. Group 3 encompasses diseases for which definitive treatment is available but presents challenges in patient selection due to high costs and lifelong therapy requirements.

GST Exemption for Imported Medicines:

The recent decision by the GST Council to exempt IGST on medicines and FSMP used for treating rare diseases imported for personal use is a significant step towards improving access to treatment. This exemption reduces the financial burden on patients who rely on imported medications for their rare diseases. It recognizes the unique challenges faced by individuals with rare diseases and aims to facilitate their access to life-saving treatments without additional tax implications.

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