YASH CHARITABLE TRUST Vs. UNION OF INDIA

JUDGEMENT

(1.) By this writ petition in public interest, the petitioners have raised certain concerns relating to the rampant promotion, prescription and administration of stem cell "therapy" for the treatment of Autism Spectrum Disorder (hereinafter, "ASD") by several clinics across the country. At the core of the present petition is the issue of legal permissibility of the administration of stem cells for palliative and/or curative treatment of ASD by clinics.

(2.) The present petition alleges that although the stem cell "therapy" could be said to be still at an experimental stage, yet the same is being touted as a 'treatment' and/or 'cure' for ASD by various clinics/hospitals/institutions in flagrant violation of the existing legal framework and guidelines. The petition claims that the individuals diagnosed with ASD and their parents/guardians/caregivers who are unaware of the scientific and legal intricacies, unsuspectingly place their implicit faith in such clinics/hospitals/institutions in the hope of there being a miraculous cure and consequently, fall victim to cost-intensive procedures such as the present one. It is alleged that stem cell therapy for ASD is illegal and does not provide for safety- nets that are available to the subjects of clinical trials under the present regulatory framework. The petition alleges that despite a framework for the regulation of such therapies being present, the enforcement of the same is not being undertaken by the respondent nos. 1-8 respectively. Therefore, in the absence of any other recourse, the present writ petition has been filed as a Public Interest Litigation (hereinafter, "PIL") before this Court, seeking directions for the effective implementation of the present regulatory framework.

(3.) In order to demonstrate the premise of its concerns, the present petition provides an illustrative list of clinics in India which are allegedly advertising and offering services of stem cell 'therapy' as a cure for ASD. To further buttress the claim that recent years have seen a mushrooming of such stem cell 'therapies' being offered by clinics/hospitals/institutions, it was highlighted that, on