Abhishek Agarwal and Anr. v. Union of India & Anr.

1. We have heard the counsel appearing forthe petitioner who has submitted that the petitioner is suffering from cerebral palsy (in W.P.(C)6703/2019). Other petitioners aresufferingfrom diseases,as mentioned in their writ petitions, and they are regularly getting treatment by way ofinjected stem cells at Nutech Mediworld,Green Park(referred to,hereinafter,as"the clinic ).

2. It is further submitted by counsel for the petitioners that as per new rules enacted bytherespondents,namely New Drugsand Clinical Trial Rules, 2019 (hereinafter referred to as "Rules, 2019"),"stem cells derived products" are now included in 'new drugs' under Rule 2(w)(v),and,resultantly,the clinic is notin apositionto continuethe therapy without obtaining a licence. It is also submitted by counsel for the petitioners that stopping of therapy will result in the deterioration ofhealth ofthese petitioners. It is further submitted by counsel for the petitioners that under the Rules, 2019, there is no the licence is to be obtained by the clinic to continue the treatntent which is already going on.

3. Counsel appearing for the respondents submitted that, if the clinic is injecting stem cells, the respondents have no objection because,forinjectingstem cells,theclinicis notrequiredtotakeany licence. Stem cells,perse. are notcovered bythe Rules,2019. As perthe Rules.2019,"Stem Cells Derived Products"are included m theRules,2019for which theconcerned clinic/hospitalhastotakea licence. It is clarified by counsel for the respondents that these petitionerscancontinuethetreatmentwhichtheyaretakingregularly fromtheclinic,includingthetreatmentgivenbytheclinicbyinjecting stem cells.

4 Theposition,asitemergesfromtheStatusNotedated14"June, 2019 filed by the Central Drugs Standard Control Organization (CDSCO),isthat,whiletreatmentusing"stem cells"is permissible, treatmentusing"stem cellsderivedproducts"requiresalicenceunder the Rules,2019. The clinic would contend that it providestherapy using"stem cells", and not"stem cells derived products". This, however,is an aspect between the clinic and the CDSCO. t is a thatitprovidestherapyusing"stemcells",andnot stemeel ' products". Thoughatentativeopinion,ofaCommiheeconstated o Laminethesaidrepresentation,whichisnotfavourabletotheelm ™sshowntothiscourt,nofinaldecisionhasbeencommunicate to a

5. The petitioners, in these eases, are, however, presently undergoing treatment using"stem eelltherapy" fromthe clinic. It.s an admitted position that discontinuance of the said treatment, even for a day, willhave severely deleterious effects ontheir health. Tdl such time a final decision is, therefore, taken, by the CDSCO, regarding the issue of whether the clinic is providing therapy using "stem cells", or "stem cells derivedproducts", we are of the opinion that the treatment presently being administered to these petitioners cannotbeallowedtobediscontinued,assuchdiscontinuanceislikely to have life-threatening consequences.

6 We therefore,allow thepetitioners to continuesuchtreatment, fromthedinic,tillafinaldecisionistaken,bytheCDSCO,regarding fl,e aspect of coverage, or otherwise, of the clinic,under theRules,

2019.

7 Wealsoclarify thatnodecision,adversetotheclinicregarding theaspectofitscoverageundertheRules,2019,wouldhetaken save and except in accordance withduelaw and dueprocedure and after givingtheclinicanadequateopportunityofbeingheard.

8. With these observations, these writ petitions are hereby disposed of. riMrin ---""-"-""din w-P-fnsuTCOli ChTrin in W.P.fnS148Q0i[2] rhiw- ->-)«iii/7ni9inWP(C)SldOTOl rhlTin in W.P. Cl*759 20 CM No.28-^63/2019i" W.P.(06763/2019 CM No.28^65/2019i" W.P.(C^616412019 CM No.283^7/2019in W I' (H6765/2019

1. In view of the orders passed in the writ petitions, these applicationsstand disposed of. SEPTEMBER04,2019/kr CHIEF JUSTICE C.HARI,J. SHA