ICMR published quot National Guidelines for Gene Therapy Product Development and Clin...........

Everyday Science (PCS) Health and Diseases

ICMR published "National Guidelines for Gene Therapy Product Development and Clinical Trials". Which of the following statements are

correct about Gene Therapy Product (GTP) ?

1. It is defined as any biological entity, having the required gene, that could introduce modifications in the genome for therapeutic benefit.

2. GTPs work by rpeairing replacing or deactivating dysfunctional disease-causing genes to restore normal function.

3. As per the New Drugs and Clinical Trial Rules (2019 , ) the GTPs falls under 'new drug' and shall always be deemed as 'new drug'.

4. Thalassemia , Gaucher's disease, Sickle cell anaemia and Haemophilia fall under the genetically inherited disease category.

Select the correct answer using the code given below :

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PCS Previous year General Studies paper 2020

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1, 2, 3 and 4

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Explanation:

- Statement 1: Correct. A Gene Therapy Product (GTP) is indeed defined as a biological entity that can introduce modifications in the genome for therapeutic purposes.

- Statement 2: Correct. GTPs can repair, replace, or deactivate dysfunctional genes to restore normal functions.

- Statement 3: Correct. In the New Drugs and Clinical Trial Rules (2019), GTPs are classified as 'new drugs' and are always considered 'new drug' for regulatory purposes.

- Statement 4: Correct. Thalassemia, Gaucher's disease, Sickle cell anemia, and Hemophilia are recognized as genetically inherited disorders.

- Correct Answer: Option 4 - 1, 2, 3 and 4.