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In view of the absence of any licenses under the New Drugs and Clinical Rules, 2019 for providing stem cell treatments, the Delhi High Court has allowed a clinic in New Delhi to continue providing a treatment called ‘Embryonic Stem Cell therapy’ to certain patients until such time a licence is processed under the Rules.
The order was passed by a Division Bench of Justices GS Sistani and Jyoti Singh in petition preferred by two minor children who are patients of Cerebral Palsy.
The Court was informed that the Petitioners visited a clinic ‘Nutech Mediworld’ at Green Park, New Delhi to receive stem cell treatments called Embryonic Stem Cell therapy. The Court was further informed that the Petitioners had shown “visible improvements” from the treatment.
The Petitioner’s grievance was aimed towards the notification of New Drugs and Clinical Rules, 2019 by the Central Government. As per the Rules, ‘stem cell-derived products’ were included under the definition of ‘new drugs’ which required approval from the concerned authority under the Rules before it could be provided to patients.
Embryonic Stem Cell therapy fell under the definition of “new drugs” and could thus not be provided anymore without the requisite approval under the Rule.
The Petitioners approached the High Court for relief after the clinic stopped providing medical treatment to the Petitioners in view of the Rules.
The Petitioners contended that the treatment was required for the day-to-day sustenance of their lives and basic activities. It was thus submitted that till the Rules fall in place and a marketing license is provided during the intervening period, serious prejudice would be caused to the health of the petitioners.
By the time an application is made to the concerned authority i.e. The Drug Controller under the Central Government and a decision is taken, at least a few months would lapse, the Petitioners contended.
In the absence of the treatment, life of the petitioners would be in jeopardy as they would rapidly lose their muscle strength and grow fatigued on account of their condition, the Court was informed.
The Petitioner, therefore, sought a direction to the Central Government to allow Nutech Mediworld clinic to continue to provide the treatment to the petitioners till such time the formalities are completed or till Nutech Mediworld clinic or at least some other clinic obtains a licence.
After hearing the parties, the Court concluded that in these circumstances, it was apposite to direct, as in interim measure, that the treatment being provided to the petitioner would not be impeded.
“.. as an interim measure and till such time Nutech Mediworld clinic or at least some other clinic applies for a licence and the licence is processed, the Nutech Mediworld clinic would continue to provide treatment to the petitioners.”
The Court nonetheless directed the clinic to submit all the information with respect to the treatment being afforded to the Petitioners to the Central Drugs Standard Control Organisation (CDSO), within a period of one week.
The Authority shall then examine whether the said treatment or the products being administered to the petitioners, prima facie, fell within the scope of ‘New Drugs’ and communicate its view to the petitioners and the clinic.
This arrangement is without prejudice to the rights and contentions of both the parties.
The Petitioners were represented by Advocates Ajay Kohli and Pooja Vohra,
Centre was represented by Standing Counsel Kirtiman Singh with Advocate Waize Ali Noor.
Read the order: