Delhi HC Comes To Aid Of Man With Rare Life Threatening Disorder As Centre Covers "Stem Cell Products" Under New Drug Rules

Coming to the aid of a man suffering from a rare life-threatening neuromuscular disorder, the Delhi High Court has allowed the clinic from where he had been receiving stem cell therapy to provide him treatment even as the New Drugs and Clinical Rule, 2019 include "stem cell-derived products" as "new drugs" thereby requiring a clinic to obtain licence from central licensing authority for clinical trials, usage or treatment of stem cell.

Justice G S Sistani and Justice Jyoti Singh allowed the clinic to resume the treatment of the petitioner till such time it applied for a licence and the same was processed.

The court noted that the man was gradually losing muscle strength with the treatment coming to a halt following the new Drug Rules.

In the instant case, the petitioner suffered from a Neuro-Muscular Disease which causes disorder, affects the anterior horn of the spinal cord and the brain leading to weakening of muscles.

The petitioner approached the court as the "New Drugs and Clinical Trial Rules 2019" notified by the Centre in March 2019 for the first time included "stem cells and cell-based product" under the definition of "new drug" Clause (V) of sub-clause (W) of Rule 2.

As an effect of this notification, any kind of use of stem cell-derived products required approval from the Drug Controller and resulted in stoppage of the petitioner's Human Embryonic Stem Cell Therapy since the clinic where he was receiving the therapy could not function under the New Rules until a licence was duly obtained.

The petitioner rued lack of any interim arrangements during the intervening period between an application being made to the Drug Controller and a decision being made on it as resulted in stoppage of his treatment.

He told the court that discontinuation of the therapy for even few days hampered his day-to-day life as he was losing his muscle strength and experiencing growing fatigue.

The counsel for the petitioner urged that the clinic from where he has been taking therapy be allowed to administer the treatment till such time the formalities are completed.

"…this Court considers it apposite to direct, as an interim measure, that the treatment being provided to the petitioner will not be impeded. This is subject to the clinic in question submitting all the information as to the treatment being afforded to the petitioner to the Central Drugs Standard Control Organisation (CDSO), within a period of one week from today. 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."