Order of the Delhi High Court in the matter of Aditya Bhatia Vs Union of India & Others dated 15/04/2019 regarding permission to avail “Human Embryonic Stem Cell Therapy” being provided to the petitoner (Aditya Bhatia) by Nutech Mediworld.

The petitioner states that he is suffering from Facioscapulohumeral Muscular Dystrophy (FSHD), and there is no other cure for the said condition. In these circumstances, the petitioner had approached the said clinic and is being administered the Human Embryonic Stem Cell Therapy. The petitioner is also conscious of the fact that the said therapy may not be a recognised therapy, and the products being administered to the petitioner may not have the approval of the concerned authority.

With a view to regulate such novel therapies, the Union of India had framed the New Drugs and Clinical Trials Rules, 2019. The petitioner seeks to challenge the constitutional vires of the New Drugs and Clinical Trials Rules, 2019. The High Court has been informed that there is no clarity as to whether the treatment being provided to the petitioner falls with the said Rules as no particulars of the same have been submitted by the said clinic.

ORDER: 

The Delhi High Court directs that as an interim measure, the treatment being provided to the petitioner be continued, subject to the clinic in question submitting all the information about the treatment being afforded to the petitioner to the Central Drugs Standard Control Organisation (CDSO). The concerned authority shall examine whether the said treatment or the products being administered to the petitioner, prima facie, fall within the scope of the expression ‘New Drugs’ as defined under Rule 2(1)(w) of New Drugs and Clinical Trials Rules, 2019, and communicate its view to the petitioner and the said clinic.