Delhi High Court
Virender Singh Malik vs Union Of India And Anr. on 7 May, 2019
$~1
* IN THE HIGH COURT OF DELHI AT NEW DELHI
% Date of Order: 07th May, 2019
+ W.P.(C) 4717/2019
VIRENDER SINGH MALIK ..... Petitioner
Through Ms. Preeti Singh, Mr. Sunklan Panwar
and Mr. Shivam Jaiswal, Advocates
versus
UNION OF INDIA AND ANR. ..... Respondents
Through Mr. Yashish Chandra and Mr.
Yashaswi Chauksay, Advocates for
UOI with Mr. Sanjeev Kumar, Deputy
Drugs Controller(I).
Mr. Anuj Aggarwal, ASC with Mr.
Atul Goyal, Advocate for respondent
no.2/Durgs Control Department.
CORAM:
HON'BLE MR. JUSTICE G.S.SISTANI
HON'BLE MS. JUSTICE JYOTI SINGH
G.S. SISTANI, J. (ORAL)
CM.APPL 21830/2019 (Exemption)
1. Exemption allowed, subject to all just exceptions.
2. The application stands disposed of.
W.P.(C) 4717/2019
3. Counsel for the respondents submits that it is not necessary to file a
reply.
4. With the consent of the parties, the writ petition is set down for final
hearing and disposal.
5. Some necessary facts which are required to be noticed for the disposal
of the present writ petition are that the petitioner claims to be suffering
from a Neuro Muscular Disease which causes disorder, affects the
anterior horn of the spinal cord and affects the brain and leads to
weakening in the body muscles and is a rare and life threatening
disease. It is the case of the petitioner that he has been forced to
approach this Court on account of Notification "New Drugs and
Clinical Rule 2019" ("New Rule"), which has been issued by
respondent no.1, which includes "stem cell derived product" under the
definition of "new drug" Clause (V) of sub-clause (W) of Rule 2 of the
New Drugs and Clinical Trails Rules, 2019. It is contended that the
effect of this Notification would be that the medicine would fall under
the definition of "new drug" and would require approval from the
concerned authority in terms of the said Rule. It is pointed out that the
said Notification has resulted in stoppage of the petitioner's Human
Embryonic Stem Cell Therapy, which is a treatment required by the
petitioner for his day-to-day sustenance of life and basic actives and in
case this treatment is discontinued even for a few days, it would have a
serious impact on the petitioner as the clinic (NutechMediworld) which
is administering the medicine cannot function under the New Rules
until the licence is duly obtained. It is submitted that the New Rules
would require the clinics engaged in such "new drug" to take a
marketing licence and there is no provision for providing any interim
arrangements during the intervening period between an application
being made under the authority i.e. the Drug Controller, Government of
India and a decision. This process is likely to take a few months more
and in the interregnum since the treatment has been discontinued by the
clinic, the life of the petitioner would be in jeopardy and the petitioner
is rapidly losing his muscle strength and is facing growing fatigue on
account of his condition.
6. Learned counsel for the petitioner submits that the only relief which he
seeks is to seek a direction to the respondents to allow the
NutechMediworld clinic from where the petitioner is receiving
treatment to continue to provide the treatment to the petitioner till such
time the formalities are completed and the NutechMediworld clinic or
at least some other clinic obtains a licence.
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
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.
8. Accordingly, as an interim measure and till such time
NutechMediworld clinic or at least some other clinic applies for a
licence and the licence is processed, the NutechMediworld clinic would
continue to provide treatment to the petitioner.
9. In view of the agreed directions, the writ petition is disposed of, as
prayed by the counsel for the petitioner. This arrangement is without
prejudice to the rights and contentions of both the parties.
10. Dasti.
G.S. SISTANI, J
JYOTI SINGH, J
MAY 07, 2019
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