Is Stem Cell Therapy Approved / Legal In India?

In India, as well as across the globe, stem cell treatment has shown encouraging outcomes. The remarkable and distinct characteristics of stem cells aid in the treatment of a wide range of illnesses, including life-threatening degenerative diseases.

In India, there has been a surge in demand for stem cell treatment to replace the costly, painful, time-consuming, and ineffective traditional therapies used to treat a variety of severe chronic illnesses.

Despite the fact that India’s New Drugs and Clinical Rules 2019 are in effect, certain clinics continue to provide untested and unregulated stem cell treatments without putting stem cell-related items through clinical trials. The continuation of embryonic stem cell treatment for certain of their patients was recently upheld by the Delhi High Court.

New regulations suggested by India’s health ministry aim to put a stop to unscrupulous medical practitioners who promise desperate patients stem cell-based miraculous cures yet operate outside the law.

The proposed Pharmaceuticals and Cosmetics (Amendment) Rules of 2018, which were released in April for stakeholder feedback, aim to regulate stem cells and stem cell-based products as drugs, putting them under the Drugs and Cosmetics Act of 1940.

This implies that all therapeutic uses of stem cells (for therapy) and their products will need clinical studies to establish their safety and effectiveness, as well as licences to produce and sell them. No clinics or hospitals will be allowed to deliver these treatments unless they have fulfilled the stringent requirements for clinical studies to demonstrate that their stem cell-based therapies function.

Plants and animals have stem cells, which are undifferentiated cells that may either stay as stem cells or become differentiated (or specialised) to create various tissues and organs. For their potential to replace faulty or damaged cells and therefore cure a range of degenerative illnesses such as Parkinson’s, injuries to the spine, and even cancer, stem cells’ ability to differentiate has been the focus of considerable medical research—and some limited therapeutic uses.

The new regulations from India’s health ministry are intended at controlling the 300 or so self-styled clinics and hospitals that have been providing a variety of untested and unproven stem cell “therapies” while charging patients large amounts of money. The Indian Council of Medical Research has previously said that it opposes a regulatory exemption for minimally modified stem cells, claiming that many of the applications for these cells are untested.

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