WHAT IS STEM CELL?

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 the laboratory ,  stem cells divide to form more cells called daughter cells.  These daughter cells either become new stem cell ( 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.

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 cell can then implanted into a person . 
• 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 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.
• It's 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.