# The Indian regulatory framework and the surge of unproven stem cell therapies—a call for diagnosis

## TL;DR

This paper examines India's regulatory issues regarding unproven stem cell therapies and suggests reforms to protect patients and promote scientific progress.

## Contribution

The paper provides a critical analysis of India's stem cell regulatory framework and proposes actionable reforms to address the rise of unproven therapies.

## Key findings

- India's stem cell regulatory framework suffers from ambiguous laws and poor implementation.
- The lack of regulation has led to India becoming a hub for unproven stem cell tourism.
- Proposed reforms include better funding, consolidated clinical regulation, and public engagement.

## Abstract

Stem cell science lies at the heart of regenerative medicine; it is believed to have the potential to address several otherwise incurable diseases. However, even though stem cell interventions are at the experimental stage, they are advertised as a panacea for various human maladies. India, like other jurisdictions across the globe, has witnessed the mushrooming of ‘experts’ and ‘clinics’ selling (unproven) stem cell therapies to vulnerable and desperate patients. The unscrupulous activities in the stem cell industry endanger patients and hinder legitimate scientific progress. In light of the crisis of unproven stem cell therapies, I seek to comprehensively study the Indian regulatory framework on stem cells. The article identifies multiple issues in the framework—the inherent ambiguity in the governing laws, the unscientific functioning of the regulatory institutions, the poor implementation of the existing laws, and the seemingly consequent rise of India as an unregulated stem cell tourism hub. The suggested reforms broadly include streamlined funding, consolidated clinical regulation, and public engagement. The policymakers shall consider redefining their playbook to facilitate a conducive atmosphere for the growth of stem cell science.