5. 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 repairing, 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 :

1. Only 1 and 2

2. Only 2 and 3

3. Only 1, 2 and 3

4. 1, 2, 3 and 4

Correct Answer :

1, 2, 3 and 4