- 26 Apr 2019
- 3 min read
Recently, Doctors in Mumbai used stem cell therapy to save life of a premature baby boy, who was suffering from a chronic lung disease.
- Stem cells are the body's raw materials — cells from which all other cells with specialized functions are generated.
- Under certain conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells.
- These daughter cells either become new stem cells (self-renewal) or become specialized cells (differentiation) with a more specific function, such as blood cells, brain cells, heart muscle cells or bone cells.
- No other cell in the body has the natural ability to generate new cell types.
- What is stem cell therapy?
- Stem cell therapy, also known as regenerative medicine, promotes the repair response of diseased, dysfunctional or injured tissue using stem cells or their derivatives.
- Stem cells can then be implanted into a person. For example Mumbai baby boy was injected with 40 million stem cells and gradually the lungs began to repair. In this case, doctors used mesenchymal stem-cell therapy (these are adult stem cells and are different from Embryonic stem cells) on an experimental basis
- Why it is an issue?
- In March 2019, the Union Health Ministry had notified the ‘New Drugs and Clinical Trial Rules, 2019’ which state that stem-cell derived products are to be used as “new drugs”. “This means that any doctor who uses stem-cell therapy needs to take permission from the government.
Clinical Trial Regulations In India
- Central Drugs Standard Control Organization (CDSCO) which comes under the Ministry of Health and Family Welfare is the main body which works on development of regulatory procedures and standards for drugs, cosmetics, diagnostics and devices.
- It lays down regulatory guidance by amending acts and rules; and regulates new drug approval process.
- Its main objective is to standardize clinical research and bring safer drugs to the Indian market.
- The Drug Controller General of India (DCGI) is responsible for giving regulatory permissions for the conduct of clinical trials and is responsible for approval of marketing licenses for drugs in India.