As per case facts, a Writ Petition was filed raising concerns about the widespread promotion and administration of stem cell therapy for Autism Spectrum Disorder (ASD) by various clinics as ... a routine service, despite its experimental status and alleged violation of existing legal frameworks. During the proceedings, new recommendations from the EMRB-NMC declared such therapy for ASD as "professional misconduct," which was challenged in a High Court, where an interim Order allowed ongoing treatments based on patient autonomy. The Petitioners argue these therapies are commercial ventures lacking proper safeguards, while Respondents contend they are 'procedures' not 'drugs', outside regulatory purview. The question arose whether medical practitioners can legally offer stem cell therapy for ASD as a routine healthcare service and if the Drugs Act provides a regulatory framework for such therapies. Finally, the Supreme Court concluded that stem cells for therapeutic use in ASD are "drugs" under the Drugs Act. It ruled that offering stem cell therapy for ASD as a routine clinical service is not a sound medical practice, lacks scientific evidence, and constitutes professional misconduct. Such therapies are permissible only in an approved clinical trial setting. The Court noted a regulatory vacuum after the dissolution of NAC-SCRT and conflicting Orders, urging the Union to clarify and establish a dedicated oversight authority, possibly through new legislation. For patients already undergoing therapy, a solution for continued treatment and re-routing to clinical trials must be provided.