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Source– This post is based on the article “Generic drugs for 4 Rare diseases made available in India” published in “The Hindu” on 24 November 2023.
Why in the News?
The Union Health ministry has made available generic drugs for rare diseases for the first time. Presently, they are made available for four rare diseases Tyrosinemia-Type 1, Gauchers Disease, Wilson’s Disease, and the Dravet-Lennox Gastaut Syndrome.
In the next few months, the Ministry also plans to include Phenylketonuria and Hyperammonemia to the list.
What is the significance of this move?
It will reduce the cost of these generic medicines and make it more accessible.
Diseases for which generic drugs will be made available
| Rare Disease | Details |
| Tyrosinemia-Type 1 | Tyrosinemia type I is an inherited metabolic disorder in which the body lacks an enzyme called fumarylacetoacetate hydrolase (FAH) which is needed to break down the amino acid tyrosine. |
| Gauchers Disease | Gaucher disease is the result of a buildup of certain fatty substances in certain organs, particularly in spleen and liver. |
| Wilson’s disease | Wilson’s disease is a rare inherited disorder that caused by abnormal copper accumulation in your liver, brain and other vital organs. |
| Dravet-Lennox gastaut syndrome | Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS) are rare drug-resistant epileptic conditions, characterised by seizures. |
What are rare diseases?
1. There is no universally accepted definition of rare diseases; However, the World Health Organisation (WHO) defines rare disease as often debilitating lifelong disease or disorder condition with a prevalence of one or less per 1,000 population.
2. Indian Council of Medical Research (ICMR) defines rare diseases as a disease with one occurrence in 2,500 people.
3. Nearly 80% of these diseases are genetic in nature.
4. The Central Government has prioritised the manufacturing of drugs to treat 13 extremely rare diseases, in order to bring down the exorbitant cost of these medicines.
| For more information on rare diseases Click Here to read |
What are Generic drugs & its significance?
1. A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use.
2. The Indian government began encouraging more drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.
3. They are usually cheaper than the name brands and can make healthcare more accessible.
| For more information on Generic Drugs Click Here to read |
What are the recent initiatives taken by Government of India for treatment of Rare Diseases?
The Government has launched National Policy for Rare Diseases (NPRD), 2021 for the treatment of rare disease patients.
| For more information on Initiatives taken Click Here to read |
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