NATIONAL POLICY FOR RARE DISEASES, 2021

S. Victoriya,

Government Law College, Vellore, Tamil Nadu

Introduction:

          In this 21st century, Healthy life is becoming an important and basic need of every individual in the world.  Many countries have exceeded in the field of Medicine. Even though India is the country with the Most Affordable Health Care. Thus, India has gained its reputation as the "World's Pharmacy" and "World's Health Hub". However, significant issues like the increasing cost of treatment for certain diseases, lack of infrastructure inadequate training for physical practitioners, etc.

To address the above issues, the Indian Government took a huge step in March 2021. This major step is called “National Policy for Rare Diseases 2021”. In that policy, there are several initiatives to refrain from the healthcare infrastructure. Especially in the field of rare diseases. This policy has many key provisions like definition and Criteria of rare diseases, classification of rare diseases, prioritization for the treatment of rare diseases and Centers of Excellence, etc, This article aims to examine the policy’s key provisions, advantages, disadvantages and suggestions.

Key Provisions:

           The prevention step towards a Healthy Nation taken by the Indian Government has the following key provisions.

1. Definition of Rare Diseases: According to this policy, a disease that affects 2500 individuals at the same time is defined as Rare Disease. It is the base of this policy. Every provision of this policy will be functional under this definition.

2. Criteria: The defined rare diseases are classified into 3 criteria under this policy.  These criteria are based on the seriousness of diseases, lack of treatment infrastructure and unpredictableness of diseases.

3. Creation of Register: Under this policy, a register should be created for the registration of rare diseases identified by various healthcare institutions in the nation. For the easy and immediate accessibility of healthcare data.

4. Centers of Excellence: This is the most important establishment under this policy. In these centres, the timely treatment of rare diseases will be given to the patients who are affected by the rare diseases. 

5. Rare Diseases Fund: This fund will be created and regulated by the Ministry of Healthcare, India.  This organization will give financial support to the persons affected by rare diseases.

6. Awareness Creation: The education and awareness campaigns regarding rare diseases and their treatment should be conducted among the nation.

7. Research Development: Research related to rare diseases will be encouraged by this policy. This policy will be the backbone of research development. This research is mainly focused on the medicine used for the treatment of rare diseases.

8. Encouragement for Collaboration: This policy encourages the NGOs, private companies and public healthcare sectors to make a partnership with each other and work with the policy implementation.

Impacts on Society:

1. The lives of the poor Indians are being saved by providing financial assistance to the poor suffering from rare diseases.

2. The burden of a family suffering from a rare disease has been reduced by half.

3. Doctors treating rare diseases have been given extensive training.

4. The quality of methods and procedures for treating rare diseases has been improved.

5. Research on rare diseases and efforts to find drugs against them have made great progress.

6. The long-term medical expenses of those suffering from rare diseases have been reduced.

7. Pharmaceuticals imported from abroad for the treatment of rare diseases have been exempted from Basic and Integrated Goods and Services Tax.

8. Under this policy, 12 centres of excellence have been set up across the country to treat and prevent rare diseases.

9. Since rare diseases are classified into one, two, and three, priority is given to serious diseases and the lives of the people of India are being saved.

Critical Analysis of Policy:

          In this section, we are going to see the critical analysis of the National Policy for Rare Diseases 2021 with the advantages, and disadvantages of the policy and the suggestions that should be considered in future policy drafting.

Advantages:

1. Patients can get financial support.

2. Separate treatment centres (COEs) for rare diseases are the major plus point.

3. Prioritisation of diseases will result in timely treatment.

4. The definition of Rare Diseases will result in the clarity of treatment for that defined disease.

5. The research conducted for the treatment of rare diseases will make our nation as “Healthiest Country”.

6. A comprehensive focus on the treatment of rare diseases.

Disadvantages:

1. Sufficient funds are not allotted under this policy.

2. There is no time limit for the implementation of the policy.

3. The policy’s focus is on the treatment of rare diseases only.

4. The people are not aware of this policy.

5. Lacking focus on the preventive measures for rare diseases.

Suggestions:

1. Organize awareness programmes.

2. Extend the financial support without any limitations.

3. Regulate the policy implementation with the fixation of time.

4. The policy's focus should be on the both preventive and cure side.

5. Mobilize the medical facilities in the nation.

6. The supervising unit should be created for the implementation of policy.

7. The Indian Government should provide a part of this policy in the union budget.

         From the above analysis, we can come to an idea about the National Policy for Rare Diseases 2021. This policy needs many changes and effective implementation to achieve its goals and complete its purpose.

Key Stakeholders:

          Medical facilities are important for people in a country to live a healthy life without any disease. Moreover, it is very important to prevent the spread of rare diseases in the country. Therefore, the key players in the National Policy on Rare Diseases, an initiative taken by the Government of India to control rare diseases, are listed below.

1. Ministry of Health and Family Welfare: The Ministry's core objective is to foster the health, welfare and development of Indian citizens, thereby enhancing their quality of life. It is also responsible for ensuring that the health of the people of India is protected from any harm and that their effective functioning is ensured.

2. Department of Health Research: This department is responsible for reducing the incidence of rare diseases in India and ensuring that no disease or its impact increases in India. To achieve this objective, the National Consortium for Research and Development of Rare Diseases Treatments has been formed.

3. Centers of Excellence: One of the important things created under the National Policy for Rare Diseases is the 12 Centers of Excellence, which ensure timely treatment and quality medical care to those suffering from rare diseases in the country.

4. Central Technical Committee for Rare Diseases: The Central Technical Committee for Rare Diseases was formed to decide and clarify which diseases are included and which are not under the definitions compiled under the National Policy. Through this committee, the procedures mentioned under the National Policy will be easily implemented.

5. State Governments: No matter what scheme or policy is implemented by the Central Government, the objectives of that policy and scheme cannot be fully achieved without the cooperation of the State Governments. The State Governments monitor and regulate the functioning of this policy, so that treatment and financial assistance for rare diseases is functioning without any hindrance.

6. Patients and their families:  The main advantages of this policy will accrue to the patients and their families. Patients suffering from rare diseases and their families are the main factors in improving the treatment methods for rare diseases in the country. Without the patients suffering from rare diseases and their families, it is not possible to formulate and implement a national policy for rare diseases. There is no doubt that they are the source of this policy.

Conclusion:

         The year 2020 is considered a very important and amazing year in the history of world medicine. Because in 2020 and 21, the Coronavirus shook the world. India was no exception to the impact of that virus. Moreover, the incidence of many rare diseases started to increase gradually in India. The most important step taken by the Indian government to control the impact of these rare diseases is the National Policy for Rare Diseases 2021.          

          This policy is going to have a great impact on the lives of people suffering from rare diseases in India. Because under this policy, it has been ensured that financial assistance and necessary medical facilities are provided to patients suffering from rare diseases. Also, many activities have been taken to study and develop drugs that can control rare diseases.

          However, whether India, which provides medicine to the people of the world at affordable prices, has adequate medical facilities for its citizens has been a big question mark since independence. Regrettably, even today many poor Indian citizens are losing their lives without being able to get adequate medical facilities. How and when will the dream of every Indian citizen of free healthcare for all be remembered?

Let us protect the walking gods of doctors

Save the lives of those affected by diseases

Create a healthy country!

References:

1. https://pib.gov.in/PressReleasePage.aspx?PRID=2043516 (04/01/2025)

2. https://rarediseases.mohfw.gov.in/uploads/Content/1624967837_Final-NPRD-2021.pdf (07/01/2025)

3. https://www.drishtiias.com/daily-updates/daily-news-analysis/national-policy-of-rare-diseases#:~:text=Alternate%20Funding:,of%20patients%20of%20rare%20diseases. (08/01/2025)

4. https://haryanahealth.gov.in/rare-diseases/ (08/01/2025)

5. https://jgu.s3.ap-south-1.amazonaws.com/jsgp/A+Review+on+National+Policy+for+Rare+Diseases+-JJPP-Volume-6-Issue-I.pdf (08/01/2025)