India's CAR-T cell therapy gets market authorisation

Published
14th Oct, 2023

Context:

Recently, a Mumbai-based Immunoadoptive Cell Therapy Private Limited (ImmunoACT) announced the approval of India’s first chimeric antigen receptor (CAR) T-cell therapy by the Central Drugs Standard Control Organization (CDSCO) for treating leukaemias (cancers arising from the cells that produce white blood cells) and lymphomas (arising from the lymphatic system).

What is Chimeric Antigen Receptor (CAR) T-cell Therapy?

It is a type of cancer immunotherapy treatment.
Unlike chemotherapy or immunotherapy which involve taking drugs, CAR T-cell therapies use a patient's own cells.
They are modified in the laboratory to activate T-cells and target tumor cells.
Procedure:
T cells are taken from a patient’s blood and then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory.
The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion.

What are T Cells?

T cells, also known as T lymphocytes, are a type of white blood cell that plays a central role in the immune response.
T cells are involved in cell-mediated immunity, which means they help the body recognize and respond to foreign substances, such as viruses, bacteria, and abnormal cells, such as cancer cells.
There are two major types of T cells: the helper T cell and the cytotoxic T cell.
As the names suggest, helper T cells ‘help’ other cells of the immune system, whilst cytotoxic T cells kill virally infected cells and tumors.

Need for such T-cell Therapy:

Systemic therapy such as chemotherapy, which attacks cancer cells due to their fast growth.
Chemotherapy drugs have limited success and significant side effects because they affect many types of cells in the body.
Other treatments also known as immunotherapy, which work by binding to specific targets on the cancer or immune cells supporting its growth.
This approach is less toxic as it affects fewer non-tumor cells, but only works on tumours that have these targets.
Thus, using own living cell becomes an idea.

Role of Central Drugs Standard Control Organization (CDSCO)

Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
Central Drugs Standard Control Organization functions under the Directorate General of Health Services.