ImmunoACT’s cell therapy to treat blood cancer gets CDSCO nod

• IIT Bombay-incubated Immune Adoptive Cell Therapy (ImmunoACT),has received Central Drugs Standard Control Organisation (CDSCO) marketing authorisation approval of the ‘first’ humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy
• It is the product for relapsed/refractory B-cell lymphomas and leukemia (blood cancer) in India.

Central Drugs Standard Control Organization (CDSCO)

• The Drug Controller General of India (DCGI) heads the Central Drugs Standard Control Organization (CDSCO).
• CDSCO is the central drug authority in India.
• CDSCO is a national level regulatory body under the Ministry of Health and Family Welfare.
• The body is responsible for approving licenses for certain categories of drugs.
• It is headquartered in New Delhi.
• There are six functioning central drug testing laboratories under CDSCO.
• The DCGI also establishes standards for the manufacturing, sales, import, and distribution of drugs in India.
• The DCGI also regulates medical and pharmaceutical devices.
• In case of any dispute with respect to the quality of the drug, the DCGI is the appellate authority.
• The DCGI prepares and maintains the national reference standard for drugs.

Prelims Takeaway

• Central Drugs Standard Control Organization