Why in News?
The Central Government has amended the Drugs Rules, 1945 to bring Cell or Stem Cell-derived products, Gene Therapeutic Products, and Xenografts under the Centrally License Approving Authority (CLAA) framework, ensuring uniform regulation across India.
What is the Amendment?
- Expands the CLAA framework to include: Cell or Stem Cell-derived products, Gene therapeutic products and Xenografts.
- These products will now be subject to joint oversight by the Central and State Licensing Authorities.
What is the CLAA Framework?
- Established under the Drugs and Cosmetics Act, 1940.
- Provides joint regulatory supervision by Central Licensing Authority and State Licensing Authorities.
- Earlier covered critical biological products such as Vaccines, Large Volume Parenterals (IV solutions >100 ml), and Recombinant DNA (r-DNA)-based medicines.
- The amendment expands its scope to emerging advanced therapies.
Emerging Therapies Covered
1. Cell or Stem Cell-derived Products
- Therapies developed using stem cells or other living cells.
- Used in Regenerative medicine. CAR-T cell therapy for blood cancers such as leukemia and lymphoma.
2. Gene Therapeutic Products
- Modify or replace defective genes to treat diseases.
- Include Gene replacement therapy and Gene editing therapies.
- Used for Genetic disorders and Certain cancers.
3. Xenografts
- Animal tissue or organ-derived products transplanted into humans.
- Examples: Animal-derived heart valves.
- Applications: Cardiology and Orthopedics.
Why is the Amendment Important?
- Ensures uniform regulatory standards across all States.
- Enhances patient safety through stricter oversight.
- Strengthens regulation of rapidly evolving medical technologies.
- Aligns India’s regulatory framework with global best practices.
- Promotes innovation while ensuring safe adoption of advanced therapies.
UPSC Prelims Facts
- CAR-T (Chimeric Antigen Receptor T-cell) therapy is a form of immunotherapy in which a patient’s T-cells are genetically modified to attack cancer cells.
- Stem cells are undifferentiated cells capable of self-renewal and differentiation into specialized cell types.
- Gene therapy involves introducing, replacing, or editing genes to treat or prevent diseases.
- Xenotransplantation refers to transplantation of living cells, tissues, or organs from one species to another, usually from animals to humans.
[2026] Which of the following statements with regard to genetic medicine is/are correct ?
1. Genetic medicines correct/compensate for the faulty genes responsible for disease.
2. Engineered viruses and lipid nanoparticles are used as carriers of the genetic medicine.
3. Genetic medicines alter the entire DNA sequence.
Select the answer using the code given below :
[A] 1 only
[B] 2 and 3 only
[C] 1 and 2 only
[D] 1, 2 and 3