Delhi High Court
Shikha Through Her Legal Guardian ... vs Union Of India And Anr. on 28 May, 2019
$~23 & 24
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of Order : 28th May, 2019
+ W.P.(C) 6057/2019, CM Appl. 26118/2019 (stay)
SHIKHA THROUGH HER LEGAL GUARDIAN / NEXT FRIEND
MR. RAGHUBIR SINGH ..... Petitioner
versus
UNION OF INDIA AND ANR. ..... Respondents
+ W.P.(C) 6069/2019, CM Appl. 26192/2019 (stay)
MASTER UDAY DAS THORUTH HIS LEGAL GUARDIAN/
NEXT FRIEND MR. UTTAM DAS ..... Petitioner
versus
UNION OF INDIA AND ANR. ..... Respondents
Present : Mr. Ajay Kohli & Ms. Pooja Vohra, Advocates for petitioners
in both items.
Mr. Kirtiman Singh, CGSC for UOI with Mr. Waize Ali Noor,
Advocate in both items.
Mr. Anuj Aggarwal, ASC for R-2 with Mr. Atul Goyal,
Advocate in both items.
CORAM:
HON'BLE MR. JUSTICE G.S.SISTANI
HON'BLE MS. JUSTICE JYOTI SINGH
G.S. SISTANI, J. (ORAL)
CM APPL26119/2019 (Exemption) in W.P.(C) 6057/2019
CM APPL26193/2019 (Exemption) in W.P.(C) 6069/2019
1. Exemptions are allowed subject to all just exceptions.
2. Applications stand disposed of.
W.P.(C) 6057/2019 & W.P.(C) 6069/2019
3. Petitioners claim to be a patient of Cerebral Palsy, which is a movement
disorder caused by abnormal development or damage to the parts of the
brain that control movement, balance and posture. It is also the case of
the petitioners that they visited the clinic 'Nutech Mediworld at Green
Park, New Delhi' where stem cell treatments are provided. Since
February, 2019 till March, 2019, petitioner in W.P.(C) 6057/2019 and
from October, 2018 till March, 2019, petitioner in W.P.(C) 6069/2019
claim that they have shown visible improvement since the
transplantation of Embryonic Stem Cells, from October, 2018 onwards
as compared to their medical condition prior to the commencement of
their treatment.
4. Mr. Kohli, counsel for the petitioners submits that petitioners have been
forced to approach this court on account of a notification 'New Drugs
and Clinical Rules, 2019 ("New Rules"), which have been notified by
respondent no.1, which includes 'stem cell derived products' under the
definition of 'new drugs' Clause (v) of sub-clause (w) of Rule 2 of the
new Drugs and Clinical Trials Rules, 2019. It is contended that the
effect of this notification would be that the medicine prescribed would
fall under the definition of 'new drug' and would require approval from
the concerned authority in terms of the said rules. Learned counsel
submits that in view of the notification, the clinic has stopped providing
medical treatment i.e. Embryonic Stem Cell therapy, which is a
treatment required by the petitioners for their day to day sustenance of
life and basic activities, and in case, this treatment is discontinued
further, it would lead to a serious impact on their health. It is further
contended that the clinic in question i.e. Nutech Mediworld, which is
administering the medicine at present, cannot function under the New
Rules, unless the license is obtained. It is pointed out that till the rules
fall in place and the marketing license is provided during the
intervening period, serious prejudice would be caused to the health of
the petitioners i.e. between the application is made under the authority
i.e. Drug Controller, Govt. of India and a decision is taken, which
would not take place within a few months, in the interregnum, in the
absence of the treatment, life of the petitioners would be in jeopardy
and would rapidly lose their muscle strength and is facing growing
fatigue on account of their condition.
5. Learned counsel for the petitioners submits that the only relief which he
seeks is to seek a direction to the respondents to allow the Nutech
Mediworld clinic from where the petitioners are receiving treatment to
continue to provide the treatment to the petitioners till such time the
formalities are completed and the Nutech Mediworld clinic or at least
some other clinic obtains a licence.
6. Notice to show cause as to why these petitions be not admitted.
Counsels for the respondents accept notice.
7. In the aforesaid circumstances, 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
petitioners to the Central Drugs Standard Control Organisation
(CDSO), within a period of one week from today positively. The
concerned authority shall examine whether the said treatment or the
products being administered to the petitioners, 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 petitioners and the said clinic.
8. Accordingly, 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.
9. In view of the agreed directions, the writ petition is disposed of, as
prayed by the counsel for the petitioners. This arrangement is without
prejudice to the rights and contentions of both the parties.
CM Appl. 26118/2019 (stay) in W.P.(C) 6057/2019
CM Appl. 26192/2019 (stay) in W.P.(C) 6069/2019
10. In view of the order passed in the writ petitions, the applications stand
disposed of.
G.S.SISTANI, J
JYOTI SINGH, J
MAY 28, 2019
ck/
