Relevance: GS II (Social Justice – Health) & GS IV (Medical Ethics) | Source: The Hindu
1. The Human Context: Hope vs. Science
The Supreme Court has cracked down on clinics exploiting the desperation of parents.
The Ruling: The Court held that Stem Cell Therapy cannot be sold as a “treatment” or “clinical service” for Autism Spectrum Disorder (ASD).
The Exception: It can only be conducted within strictly monitored Clinical Trials or research settings.
The Reason: The Court noted a “dearth of scientific evidence.” Since the therapy is still experimental, marketing it as a “cure” is unethical and illegal.
2. The “Informed Consent” Paradox
The judgment introduced a critical legal principle regarding patient rights:
The Logic: “Informed Consent” means a doctor must explain all risks and outcomes to the patient.
The Paradox: Since the science of stem cells for Autism is uncertain, doctors themselves do not know the full risks. Therefore, they cannot possibly “inform” the parents adequately.
The Verdict: Consequently, even if a parent gives written consent, it is legally invalid because the prerequisite of “adequate disclosure” was never met.
3. Regulatory Lapse
The Court criticized the government for allowing “predatory” clinics to operate in a regulatory vacuum, violating the New Drugs and Clinical Trial Rules, 2019. It directed the Centre to set up a dedicated authority to oversee stem cell research.
UPSC Value Box
| Concept / Rule | Relevance for Prelims |
|---|---|
| Stem Cells | Special human cells that have the ability to develop into many different cell types (e.g., muscle cells, brain cells). They are classified as Totipotent (can make a whole human), Pluripotent (any tissue), or Multipotent (limited types). |
| Autism Spectrum Disorder (ASD) | A neurological and developmental disorder that affects how people interact with others, communicate, learn, and behave. It is a “spectrum” because symptoms vary widely in severity. |
| New Drugs and Clinical Trial Rules, 2019 | The primary regulations governing clinical trials in India. They mandate that any new therapy (like Stem Cells) must undergo phases of trials to prove safety before being sold as a treatment. |
Question
Q. With reference to the regulation of Stem Cell Therapy in India, consider the following statements:
- Stem cell therapy is currently approved as a standard clinical treatment for Autism Spectrum Disorder (ASD) by the Indian Council of Medical Research (ICMR).
- “Informed Consent” is legally valid even if the therapeutic risks are unknown, provided the patient signs a waiver.
- Stem cell derived products fall under the definition of “New Drugs” under the New Drugs and Clinical Trial Rules, 2019.
Which of the statements given above is/are correct?
- (a) 1 only
- (b) 3 only
- (c) 2 and 3 only
- (d) 1, 2 and 3
Correct Answer: (b)
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