Stuti Malhotra v. Union of India and Anr.

Delhi High Court · 31 Oct 2019 · 2019:DHC:7474-DB
G. S. Sistani; Anup Jairam Bhambhani
W.P.(C)7550/2019
2019:DHC:7474-DB
administrative appeal_dismissed Significant

AI Summary

Delhi High Court permitted continuation of stem cell therapy pending final regulatory clarity under the New Drugs and Clinical Trial Rules, 2019, while keeping all substantive issues open for future adjudication.

Full Text
Translation output
$-6 to 10 HIGH COURT OF DELHI
W.P.(C)7550/2019& CM APPL.No.31368/2019
STUTI MALHOTRA THROUGH: HER LEGAL GUARDIAN/NEXT
FRIEND MR.SUMAN KUMAR MALHOTRA Petitioner
VERSUS
UNION OFINDIA AND ANR. Respondents
W.P.(C)7551/2019& CM APPL.No.31371/2019
PALLAVIKA ADESHRA Petitioner
VERSUS
UNION OFINDIA& ANR Respondents
W.P.(C)7552/2019& CM APPL.No.31374/2019
JAGDISH MAKFIIJA Petitioner
VERSUS
W.P.(C)7593/2019& CM APPL.No.31589/2019
ASHUTOSH KALIA THROUGH: HIS LEGAL GUARDIAN/ NEXT
FRIEND MRS.RITU KALIA Petitioner
VERSUS
W.P.(C)7594/2019& CM APPL.No.31592/2019
MOHAMMAD MUSTHAFA Petitioner 2019:DHC:7474-DB
I I in all the matters.
Mr.Rajesh Gogna,CGSC for UOI with Mr.Upendra Sai,Advocate for respondent no.1 in the all matters.
Mr.Anuj Aggarwal,Adv.for GNCTD with Mr.Ankit Monga,Adv. for respondent no.2 in items no.8,9& 10.
Mr. Shadan Farasat, ASC for GNCTD with Ms.Hafsa Khan,Adv. for respondent no.2 in items no.6 &7.
Mr.Deepak Khadaria, Mr.Tushar Jarwal, Ms.Suman Yadav, Mr.Haarish Fazil, Mr.Kunal dutt and Amr.Shatadal Ghosh, Advocates for respondent no.3/Nuteck Medi World Clinic.
Mr.Anuj Aggarwal,GNCTD with Mr.Ankit Monga,for respondent no.2 in items no.8,9and 10.
CORAM:
HON'BLE MR.JUSTICE G.S.SISTANI
HON'BLE MR.JUSTICE ANUP JAIRAM BHAMBHANI
31.10.2019 Learned counsels for the respondents submit that identical matters have been disposed of by Division Bench-I of this Court by an order dated
04.09.2019;and accordingly,the present matters may also be disposed ofin the same terms.
By way of the petitions, five petitioners have approached this Court seeking relief to the effect that their treatment through stem cell therapy be permitted to be confirmed. Diseases of the petitioners as mentioned in the petitions are detailed below:
SI.No. W.P.tCI No. Name ofthe Petitioner Disease
ORDER

1. 7550/2019 Stuti Malhotra Cerebral Palsy Movement disorder caused by abnormal 10cord injury

5. 7594/2019 Mohammad Mushtafa Duchenne's Muscular Dystrophy(DMD) Counsel for the petitioners submits that their sole purpose in filing ofthe present petitions is that the petitioners may be permitted to receive Human Embryonic Stem Cell Therapy in terms ofthe various earlier orders passed from time-to-time, with a direction to respondent No.3/Nuteck Medi World Clinic to continue to provide such treatment, till there is some finality as to the application ofthe Rule2(w)and(v)ofthe New Drugs and Clinical Trial Rules,

2019. While it is the stand ofrespondent No.lAJnion ofIndia and respondent No.2/Govemment of NCT of Delhi that the effect of notification ofthe neew clinical trial rules would be that the medicine/treatment being administered to the petitioners would fall within the definition of'new drug'and would require approval from the concerned authority, the stand of respondent no.3/Nuteck Medi World Clinic is that the treatment does not fall within the definition of 'new drug'. However,counsel states that respondent No.3 is yet to decide the future course of action after passing of order dated 24.09.2019 by the Drug Controller General(India). We are ofthe considered view that the present petitions are essentially covered by the decision rendered by Division Bench-I ofthis Court and also the decisions rendered by this Court in W.P.(C) Nos.5148/2019, 6753/2019, 6759/2019&6760/2019. However,we deem it appropriate to modify our order dated 16.07.2019 to the extent that since the Drugs Controller General(India) ^3 All questions,legal and factual, with respectto the rights and contentions ofrespondentNo.3 are keptopen;and this order is entirely without prejudiceto all rights ofthe parties. G.S.SISTANirr^ OCTOBER 31,2019/rb 7550/2019 etc.

ANUP JAIRAM BHAMBHANI,J page3of[3]