Yash Charitable Trust vs. Union Of India

2026 INSC 96
REPORTABLE

IN THE SUPREME COURT OF INDIA
ORIGINAL CIVIL JURISDICTION

WRIT PETITION (C) NO. 369 OF 2022

YASH CHARITABLE TRUST & ORS. …PETITIONER(S)

VERSUS

UNION OF INDIA & ORS. …RESPONDENT(S)




J U D G M E N T



Signature Not Verified
Digitally signed by
VISHAL ANAND
Date: 2026.01.30
15:25:33 IST
Reason:



J.B. PARDIWALA & R. MAHADEVAN, JJ.:
For the convenience of exposition, this judgment is divided into the following parts:-
INDEX

A. FACTUAL MATRIX ...................................................................................... 3
B. SUBMISSIONS OF THE PARTIES .............................................................. 8
a. Submissions on behalf of the Petitioners ................................................. 8
b. Submissions on behalf of the Respondent no.1/Union of India ...........12
c. Submissions on behalf of the Respondent no.2/National Medical
Commission ..............................................................................................14
d. Submissions on behalf of the Respondent no.9/Neurogen Brain and
Spine Institute Private Limited ..............................................................16
e. Submissions on behalf of the Respondent no.10/ Reelabs Pvt. Ltd. ...20
f. Submissions on behalf of Respondent no.11/Saffron Naturele
Products Ltd. ............................................................................................21
g. Submissions on behalf of the Respondent no.13/ Parents’ Forum for
Stem Cells in Autism and Cerebral Palsy .............................................22
C. ISSUES FOR DETERMINATION .............................................................. 23
D. ANALYSIS ..................................................................................................... 24
a. Maintainability of the present PIL: .......................................................24
b. What are stem cell ‘therapies’ in ASD? .................................................24
c. Is it permissible for medical practitioners to offer stem cell ‘therapy’
in ASD as a service? .................................................................................27
(i) Significance of the Ethics & Medical Registration Board, National Medical
Commission Recommendations dated 06.12.2022: .................................... 37
W.P. (C) No. 369 of 2022 Page 1 of 98

(ii) Significance of the National Guidelines for Stem Cell Research, 2017 and
the Evidence Based Status of Stem Cell Therapy for Human Diseases,
2021 ............................................................................................................. 41
th
(iii) Significance of the DTAB’s 84 Meeting Recommendations dated
27.08.2019: .................................................................................................. 46
iv) Significance of the “List of practices and procedures involving cell or stem-
cell based preparations for therapeutic purposes as identified by experts
(other than Standard of Care provided by ICMR),” [purportedly shared by
the Minister, MoFHW, Government of India vide email dated
19.01.2023]: ................................................................................................. 50
d. Right to choose a ‘treatment’ in light of ‘consent’ and ‘patient
autonomy’ .................................................................................................53
e. Permissibility of administering stem cells for therapeutic use in ASD
for the purpose of research/clinical trial: ..............................................58
(i) Do ‘stem cells’ administered for therapeutic use in ASD fall within the
definition of “drug” under the Drugs Act, 1940? ........................................ 59
(ii) Regulatory pathway to be followed for administering stem cells for
therapeutic use in ASD in Clinical Trial/Research setting .......................... 67
(iii) Consequences of non-compliance: .............................................................. 83
E. SOME MEANINGFUL SUGGESTIONS ...................................................87
F. CONCLUSION: .............................................................................................89


W.P. (C) No. 369 of 2022 Page 2 of 98

A. FACTUAL MATRIX
1. By this writ petition in public interest, the petitioners have raised certain
concerns relating to the rampant promotion, prescription and administration
of stem cell “therapy” for the treatment of Autism Spectrum Disorder
(hereinafter, “ ASD ”) by several clinics across the country. At the core of the
present petition is the issue of legal permissibility of the administration of
stem cells for palliative and/or curative treatment of ASD by clinics.

2. The present petition alleges that although the stem cell “therapy” could be said
to be still at an experimental stage, yet the same is being touted as a ‘treatment’
and/or ‘cure’ for ASD by various clinics/hospitals/institutions in flagrant
violation of the existing legal framework and guidelines. The petition claims
that the individuals diagnosed with ASD and their
parents/guardians/caregivers who are unaware of the scientific and legal
intricacies, unsuspectingly place their implicit faith in such
clinics/hospitals/institutions in the hope of there being a miraculous cure and
consequently, fall victim to cost-intensive procedures such as the present one.
It is alleged that stem cell therapy for ASD is illegal and does not provide for
safety-nets that are available to the subjects of clinical trials under the present
regulatory framework. The petition alleges that despite a framework for the
regulation of such therapies being present, the enforcement of the same is not
being undertaken by the respondent nos. 1-8 respectively. Therefore, in the
absence of any other recourse, the present writ petition has been filed as a
Public Interest Litigation (hereinafter, “ PIL ”) before this Court, seeking
directions for the effective implementation of the present regulatory
framework.

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3. In order to demonstrate the premise of its concerns, the present petition
provides an illustrative list of clinics in India which are allegedly advertising
and offering services of stem cell ‘therapy’ as a cure for ASD. To further
buttress the claim that recent years have seen a mushrooming of such stem
cell ‘therapies’ being offered by clinics/hospitals/institutions, it was
th
highlighted that, on 04.08.2017, this issue was brought to the notice of the 16
Lok Sabha in the form of the Unstarred question no. 3448. The Minister of
State, Ministry of Health and Family Welfare (“ MoHFW ”), Government of
India, responded by providing a list of 59 entities that are engaged in this
practice of offering stem cell therapy, but informed that the number of
reported cases is not maintained centrally. The response further went on to
state that, “ The Guidelines for Stem Cell Research and Therapy were released
by the Indian Council for Medical Research (ICMR) in collaboration with the
Department of Biotechnology. Later, the National Guidelines for Stem Cell
Research (NGSCR) were issued which guide clinicians and scientists to
conduct research scientifically. ”

4. It is not in dispute that, as of today, no proven cure having guaranteed efficacy
has been discovered for the treatment of ASD. However, there is a significant
volume of ongoing research in the field which claims that the use of stem cells
can alleviate the symptoms of the condition. While the efficacy of the use of
stem cells as a cure and/or for the purpose of alleviating the symptoms of ASD
is still debatable, yet the question before us is whether it is legally permissible
to administer stem cells on individuals diagnosed with ASD as a routine
healthcare procedure.

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5. The chronology of events subsequent to the filing of the present petition also
hold some significance. It is pertinent to note that the present matter was first
listed before this Court on 20.05.2022. However, there have been some
developments in the regulatory framework regarding stem cell research and
its application in India during the course of the present proceedings. The
present petition was filed on 06.05.2022, hinged on the allegation that there is
a serious lapse on the part of the respondent nos. 1-8 respectively, in
preventing the rampant administration, promotion and prescription of stem-
cell “therapy” for the treatment of ASD. The same was said to be in violation
of the New Drugs and Clinical Trial Rules, 2019 (the “ NDCT Rules, 2019 ”)
promulgated under the Drugs and Cosmetics Act, 1940 (the “ Drugs Act,
1940 ”) and also in violation of the National Guidelines for Stem Cell
Research, 2017 (hereinafter, the “ NGSCR 2017 ”) published by the
respondent no. 3/Indian Council of Medical Research (“ ICMR ”).
Subsequently, a number of documents were released in the public domain and
since they are directly concerned with the present matter, we have looked into
the same. The documents are as follows:

i. The recommendations of the Committee on Stem Cell Use in ASD,
dated 06.12.2022, issued by the Ethics and Medical Registration Board
(“ EMRB ”) of the respondent no. 2/National Medical Commission
(“ NMC ”)

ii. The draft dated 31.05.2023 published by the respondent no. 3/ICMR
seeking inputs on the proposed dissolution of the National Apex
Committee for Stem Cell Research & Therapy (the “ NAC-SCRT ”).

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iii.The Order dated 03.03.2024, issued by the Department of Health Research,
Ministry of Health (“ DHR ”), Ministry of Health and Family Welfare
(“ MoHFW ”), Government of India, dissolving the NAC-SCRT.

6. The recommendations of the Committee on Stem Cell Use in ASD dated
06.12.2022, issued by the EMRB of NMC, came to be challenged by a
member of the respondent no. 13/Parents’ Forum for Stem Cells in Autism
and Cerebral Palsy (the “ Parents Forums ”), before the Delhi High Court in
a writ petition titled Dalip Kaur and Anr. v. Union of India and Anr., WP(C)
No. 6850/2023 . More particularly, the writ petition sought to assail the
recommendation no. (ii) thereof and stated that it posed an issue for the
patients who were undergoing stem cell therapy since it provided that, “In
view of the above recommendation, use of Stem Cell in ASD, its promotion
and advertisement will be considered as professional misconduct.”. The issue
raised before the Delhi High Court was that, as a consequence of the said
recommendations dated 06.12.2022, the ongoing treatments were being
abruptly discontinued because the doctors were unwilling to continue due to
the fear of being subjected to proceedings for professional misconduct.
Although the matter is still pending final adjudication before the Delhi High
Court, yet vide the interim order dated 31.08.2023, it was observed that
medical advancements often encompass, both known and unforeseen risks,
and individual autonomy in making informed decisions about treatment
options is the cornerstone of patient rights. In the spirit of patient autonomy,
and also considering that the patients were fully aware of and were willing to
assume potential risks, the High Court permitted the continuation of the stem
cell treatment since any abrupt cessation of the treatment might not be in the
W.P. (C) No. 369 of 2022 Page 6 of 98

best interests of the patients involved. It is to be noted that the said interim
order never came to be challenged by the respondents till date.

7. The relevant observations made by the Delhi High Court in Dalip Kaur
(supra) are reproduced hereinbelow:
“12. Upon reviewing the evidence and testimony presented,
several factors weigh heavily on this Court’s decision. First and
foremost, the anecdotal evidence, notably from Dr. Sandhya
Gokavarapu, underscores potential benefits of the stem cell
treatment, especially when early discontinuation might result in
detrimental setbacks. The cautionary account from Dr. Gulati,
though valid, pertains to a non-ASD case and lacks thorough
documentation in the report, making it less directly applicable
to the matter at hand. We must also acknowledge that medical
advancements often encompass both known and unforeseen
risks, and individual autonomy in making informed decisions
about treatment options is the cornerstone of patient rights. In
the spirit of patient autonomy, it is noteworthy that the
Petitioners are not seeking financial assistance from the State
and are fully aware of and willing to assume potential risks.
Their choice underscores their conviction in the treatment’s
benefits for their loved ones. Given these considerations, it
becomes clear that an abrupt cessation of the treatment might
not be in the best interests of the patients involved. Thus, while
the Petitioners are granted permission to continue the stem cell
treatment, they must do so with full knowledge and at their own
risk. Simultaneously, the urgency of this situation calls upon the
NMC to expedite its review process and come to a conclusive
decision, bearing in mind the Committee’s recommendations.”

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8. It is in light of the aforesaid factual backdrop, that we must look into the
regulatory framework governing the administration of stem cells as a routine
healthcare procedure for the treatment of ASD.

B. SUBMISSIONS OF THE PARTIES
a. Submissions on behalf of the Petitioners
9. Mr. Siddharth Nath, the learned counsel appearing for the petitioners
submitted that the present writ petition has been filed seeking to curb the
unrestricted marketing and commercialisation of stem cell therapy for patients
diagnosed with ASD. He submitted that medical experts across the world hold
the view that stem cell therapy has not been proven to be safe, or effective for
ASD and more research is required in controlled environements, before such
treatment can be offered to patients.
10. On the issue of maintainability, it was submitted that the present writ petition
has been filed as a Public Interest Litigation with the sole intent to secure the
rights of those with ASD, and that the petitioners otherwise have no personal
interest in the matter. The learned counsel further submitted that no relief qua
any individual clinic has been sought by the petitioners. Yash Charitable Trust
(hereinafter, the “ petitioner no. 1 ”) is a non-government organisation,
registered as a trust in the State of Maharashtra, with its focus on providing
skill development, training, livelihood opportunities and mental health
support through counselling, consultations and other therapeutic interventions
to persons with intellectual and developmental disabilities including ASD. Dr.
Vibha Krishnamurthy (hereinafter, the “ petitioner no. 2 ”) is a developmental
paediatrician with 22 years of combined experience both in India as well as
W.P. (C) No. 369 of 2022 Page 8 of 98

the United States of America. She is said to have been actively involved in
several non-profit activities centering around the research, advocacy and
training in the field of child rights and disabilities. The Forum for Medical
Ethics Society (hereinafter, the “ petitioner no. 3 ”) is an organisation which
focuses on spearheading public engagement around the interplay of ethics
with contemporary issues in health and allied themes. Mr. K.S. Ganpathy
(hereinafter the “ Petitioner no. 4 ”), is the parent of a child who had received
stem cell therapy for the treatment of ASD in year 2011, and the treatment is
said to have been administered by one Dr. Alok Sharma in Surana Hospital,
Chembur, Maharashtra. While the said hospital has not been made a party to
the present proceedings, the institute of which Dr. Alok Sharma is a director,
has been impleaded as Respondent no. 9 in this matter, in lieu of the Order
dated 20.05.2022 of this Court.

11. The learned counsel for the petitioners submitted that the administration of
stem cell ‘therapies’ by clinics/hospitals commercially for a fee, is in
contravention of the NDCT Rules, 2019. He argued that such stem cell
therapies are permitted to be undertaken only in the limited form of clinical
trials. Rule 2(1)(w)(v) of the NDCT Rules, 2019 includes “stem cell derived
products” and this would unambiguously imply that stem cell therapies would
come to be governed by the clinical trial rules provided thereunder.
12. He also submitted that the NDCT Rules, 2019 is being violated by the
clinics/hospitals administering stem cell therapies for the treatment of ASD
since they are operating without any permission from the Central Licensing
Authority, and without any protocol being approved by the Ethics Committee
for clinical trials.
W.P. (C) No. 369 of 2022 Page 9 of 98

13. He further submitted that the actions of the clinics/hospitals violate Rule 74
of the NDCT Rules, 2019 which prohibits the manufacture for sale or for
distribution, any new drug except in accordance with the Drugs Act, 1940 and
the NDCT Rules, 2019. He pointed out that neither has there been any clinical
trial for stem cell therapy in ASD, nor has any permission been granted in lieu
of an application made under Rule 91 of the NDCT Rules, 2019 through which
the manufacture of an unapproved new drug under clinical trial for the
treatment of patients with life threatening diseases, can be undertaken.
14. The learned counsel highlighted that since the stem cell therapies are being
undertaken by the clinics/hospitals as a commercial venture and not as a
clinical trial under the NDCT Rules, 2019, the subjects of such therapies are
not protected by the safeguards that are otherwise available to clinical trial-
subjects under Chapter VI of the NDCT Rules, 2019. Such safeguards include
compensation in case of injury, disability or death during the clinical trial of
a new drug or investigational new drug.
15. The learned Counsel further submitted that the respondent no.3 has
consistently maintained that the stem cell therapy for ASD is unapproved,
unproven and not recommended. He sought to distinguish the ICMR-
approved stem cell and cell-based product called ‘stempeucel’ from the stem
cell therapies administered for the treatment of ASD by stating that
‘stempeucel’ is the only stem cell and cell-based product from India which
has been granted a manufacturing and marketing license by the Central Drugs
Standard Control Organisation (CDSCO). Further, the learned counsel drew
our attention to the NGSCR 2017 and a report on the Evidence based Status
of Stem Cell Therapy for Human Diseases, 2021 respectively, to submit that
W.P. (C) No. 369 of 2022 Page 10 of 98

these documents issued by the respondent no. 3 conclude that stem cell
therapies should not be offered as a standard or routine procedure to the
patients diagnosed with ASD.
16. The learned counsel also laid much emphasis on the recommendations dated
06.12.2022 issued by the EMRB of the respondent no. 2, to argue that these
recommendations unequivocally state that the use, promotion and
advertisement of stem cell therapy for ASD would constitute ‘professional
misconduct’.
17. In arguendo , the learned counsel for the petitioner submitted that the
clarification dated 09.02.2021 issued by the respondent no. 1 states that the
expression “stem cell derived product” as occurring in the NDCT Rules, 2019
does not include stem cell therapy for the treatment of ASD. If the said
clarification is taken into account, then the respondent no. 1 would have to
explain as to how the administration of such a therapy could be considered as
‘professional misconduct’ as stated by the EMRB of the respondent no. 2.
18. In the last, the learned counsel submitted that even if the stance of the
respondent no.1, more particularly the stance that there are no provisions
prescribed under the Drugs Act, 1940 to regulate therapies and/or treatments,
is taken into account, the respondent no. 1 is under an obligation to indicate
as to how such practices are to be regulated. The failure to do so would result
in a regulatory grey area which may come to be exploited for commercial
gain.

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b. Submissions on behalf of the Respondent no.1/Union of India
19. Mr. Vikramjit Banerjee and Ms. Aishwarya Bhati, the learned Additional
Solicitor Generals of India submitted that although a medicinal “product”
derived from cells or stem cells is regulated under the Drugs Act, 1940 yet,
there are no provisions prescribed under the said Act to regulate therapies or
treatments.
20. It was submitted that as per Rule 100 of the NDCT Rules, 2019, the Central
Licensing Authority has constituted an Expert Committee to evaluate the
scientific and technical matters relating to the approval of stem cell and cell
based drug ‘products’.
21. It was further submitted that, vide letter dated 09.02.2021, a direction under
Section 33P of the Drugs Act, 1940 was issued by the MoHFW to the
Principal Health Secretaries of all the States and UTs respectively, clarifying
the scope of the term “stem cell derived product” defined under the NDCT
Rules, 2019. According to the said clarification, a “stem cell derived product”
would mean “ a drug which has been derived from processed stem cells and
which has been processed by means of substantial or more than minimum
manipulation with the objective of propagation and/or differentiation of a cell
or a tissue, cell activation and production of a cell line which includes
pharmaceutical or chemical or enzymatic treatment altering biological
characteristic combining with a non-cellular component, manipulation by
genetic engineering including gene-editing and gene modification ”.

22. It was submitted that a drug would fall within the definition of a “stem cell
derived product” if there is substantial or more than minimal manipulation of
the cell. It is only the cell based products and tissue based products which
W.P. (C) No. 369 of 2022 Page 12 of 98

have been processed by means of substantial or more than minimal
manipulation, as per the criteria mentioned above, that are covered under the
NDCT Rules, 2019. “Substantial or more than minimal manipulation of the
cell” could be said to exist in the following situations:
i) Ex-vivo alteration in the cell population (T-cell depletion, cancer
cell depletion); or
ii) Expansion which is expected to result in the alteration of a
function.

23. The learned ASG also highlighted those instances which do not fall within the
meaning of the phrase “substantial or more than minimal manipulation” and
in fact, only constitute a minimal manipulation of cells, thereby falling outside
the regime prescribed under NDCT Rules, 2019. Those are as follows:
i) Isolation of tissue,
ii) Washing, centrifugation, suspension in acceptable medium,
iii) cutting, grinding, shaping, disintegration of tissue,
iv) Separation of cells,
v) Isolation of a specific cell,
vi) Treatment with antibiotics,
vii) Sterilization by washing,
viii) Freezing, thawing,
ix) Stem cells removed from an individual for implantation of such
cells into the same individual for use under the same surgical
procedure should not undergo processing steps beyond rinsing,
cleaning or sizing and these steps are not considered as
processing.

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24. The learned ASG also referred to the recommendations of the Committee on
Stem Cell Use in ASD dated 06.12.2022 issued by the EMRB of the
respondent no. 2 and the report on the Evidence Based Status of Stem Cell
Therapy for Human Diseases, 2021 issued by the respondent no. 3
respectively, to submit that there exists no treatment that can cure ASD. It
was submitted that these documents clearly reflect that stem cell therapy is
not recommended and should not be offered as a standard or routine therapy
to patients diagnosed with ASD, in clinical practice.

c. Submissions on behalf of the Respondent no.2/ National Medical
Commission
25. Mr. Prateek Bhatia, the learned counsel appearing on behalf of the respondent
no. 2/National Medical Commission submitted that the respondent no.
3/ICMR has independently evaluated the evidence-based efficacy of the
therapeutic use of stem cells in the treatment of ASD by taking inputs from
medical specialists and by reviewing the existing medical and scientific
literature. The learned counsel pointed out that the respondent no. 3/ICMR in
its report titled ‘Evidence Based Status of Stem Cell Therapy for Human
Diseases, 2021’ has concluded that a ‘critical review of the studies reported
so far does not support the use of stem cell therapy over and above the
behavioural and supportive therapies of ASD”, and that based on this
conclusion, the respondent no. 3/ICMR has recommended that stem cell
therapy should not be offered as a standard or routine therapy to patients
diagnosed with ASD, until there is any revision in the recommendation upon
a periodic review.
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26. Insofar as the Recommendations of the Committee on Stem Cell Use in ASD
dated 06.12.2022 issued by the EMRB of the respondent no. 2 is concerned,
the learned counsel submitted that it is pursuant to this Court’s order dated
18.07.2022 that a committee of experts had been constituted by the EMRB of
the respondent no. 2 to examine the issues related to the use of stem cell
therapy for ASD. This is how the recommendations came to be given. The
committee of experts, based on the available evidence, and after due
deliberation and discussion, submitted the aforesaid report dated 06.12.2022.
The experts concluded that, for the present, there was no evidence available
to reach the conclusion that stem cell therapy is effective in treating ASD and
accordingly, the committee had disapproved the administration of stem cell
therapy for the treatment of ASD. The report further concluded that the
prevailing practice of treating ASD using stem cells is unethical and therefore,
recommended that the use of stem cell therapy for ASD along with its
promotion and advertisement would be considered as ‘professional
misconduct’. The report however added that the aforesaid recommendation
would be reviewed periodically as and when new evidence based research
comes to light.
27. The learned counsel also submitted that the MoHFW, Government of India,
took note of the recommendations dated 06.12.2022 issued by the EMRB of
the respondent no. 2 as well as the report on the ‘Evidence Based Status of
Stem Cell Therapy for Human Diseases, 2021’ issued by the respondent no. 3
respectively and thereby, declined to approve the use of stem cell therapy for
the treatment of ASD.
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28. In the last, the learned counsel submitted that the MoHFW, the respondent no.
2 and respondent no. 3 respectively have not approved the use of stem cell
therapy for the treatment of ASD, and that any registered medical practitioner
found indulging in the act of prescribing, recommending, administering, and
advertising stem cell therapy would be liable to face disciplinary action for
professional misconduct under the Indian Medical Council (Professional
Conduct, Etiquette and Ethics) Regulations, 2002 / National Medical
Commission Registered Medical Practitioner (Professional Conduct)
Regulations, 2023. He submitted that such complaints would be dealt with by
the respective State Medical Councils in accordance with the procedure
prescribed under the aforesaid regulation.

d. Submissions on behalf of the Respondent no.9/Neurogen Brain and
Spine Institute Private Limited
29. Mr. Utkarsh Sharma, the learned counsel appearing for the respondent no. 9/
Neurogen Brain and Spine Institute Private Limited questioned the
maintainability of the present petition. He alleged that the present petition is
a result of motivated interests since the petitioner no. 2 who provides
rehabilitation therapies for ASD is apprehensive about its commercial
interests being adversely affected by the stem cell therapies which are the
subject matter of the present petition.
30. The learned counsel emphasised on distinguishing stem cell therapy being
delivered as a ‘product’ as opposed to it being delivered as a ‘procedure’. He
argued that the stem cell therapy is only delivered as a ‘product’ when the
‘stem cell derived product(s)’ are manufactured by companies and sold to
various hospitals/doctors, whereas, the stem cell therapy is delivered as a
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‘procedure’ when a doctor, in a hospital, takes cells from a patient and
administers them back into the same patient.
31. He submitted that it is only the ‘drugs’, and not the ‘procedures’ which are
covered by the Drugs Act, 1940 and the rules thereunder, including the NDCT
Rules, 2019. The direction dated 09.02.2021 issued by the MoHFW to the
Principal Health Secretaries of all the States under Section 33P of the Drugs
Act, 1940 clarified that stem cells removed from an individual for the purpose
of its implantation back into the same individual, for use in the same surgical
procedure, need not undergo steps beyond rinsing, cleaning or sizing and that
these steps would not be considered as processing. As a result, an autologous
cell/stem cell therapy which does not undertake any steps beyond rinsing,
cleaning or sizing, cannot amount to a ‘stem cell derived product’ under the
definition of ‘new drug’ given in Rule 2(1)(w) of the NDCT Rules, 2019.
Thus, it was submitted that neither can such therapy be termed as a ‘drug’ nor
can the yardsticks and parameters applicable to a drug be applied to such
therapy. In this context, he submitted that the respondent no. 9 who
administers an autologous bone-marrow derived cell/stem cell
therapy/procedure uses the patient’s own body part and is therefore, not a
‘drug’.
32. He submitted that the stem cell therapy procedure that is carried out by the
respondent no. 9, is being done after obtaining due approval from the
Institutional Ethics Committee registered with the Central Drugs Standard
Control Organisation ( hereinafter, the “ CDSCO ”) and in accordance with the
permission granted by the Health Ministry of the State of Maharashtra vide
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order dated 29.02.2024 whereby the cancellation of registration of the
respondent no. 9 was set aside.
33. The counsel relied on a certain “List of Practices and Procedures involving
cell or stem cell-based preparations for therapeutic purposes as identified by
experts”, which has been prepared by the MoHFW in year 2022, and this list
is said to have purportedly categorised the use of ‘bone marrow derived stem
cells’ as a ‘clinical option’ for autism.
34. The learned counsel invited our attention to the recommendation made by the
Drugs Technical Advisory Body (“ DTAB ”) in its 84th meeting dated
27.08.2019, wherein it was stated that the routine
practices/transplantations/surgeries/therapies involving stem cells,
undertaken by doctors for the treatment of their own patients, without any
intention to commercialise the same outside of their own hospitals/clinics,
would fall outside the purview of the 1940 Act and the 2019 Rules
respectively.
35. The learned counsel further contended that the petitioners’ reliance on the
NGSCR 2017 guidelines issued by the respondent no. 3 is misplaced since
they do not have any statutory force and are not binding in nature. In this
regard, he also submitted that a clarification had been sought from the
respondent no. 3 by one Nitin Khanapure, through an RTI application made
under the Right to Information Act, 2005, regarding the nature of the NGSCR
2017 i.e., whether such guidelines are a ‘guidance document or a regulatory
document’. In response to the said RTI application, the respondent no. 2 in its
reply dated 16.08.2020 stated that the NGSCR 2017 only constitute a
guidance document. By placing significant reliance on the aforesaid response,
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the learned counsel fortified his contention that the respondent no. 3 is a non-
statutory body and hence the NGSCR 2017 do not have any binding force.
36. Moreover, the learned counsel submitted that the respondent no. 3 had
withdrawn itself from all regulatory matters pertaining to stem cell research,
vide its public notices dated 31.05.2023 and 03.03.2024 respectively.
Therefore, any reliance placed on the 2017 guidelines which predate these
withdrawal notices would be incorrect.
37. The counsel brought to our notice the orders of the Delhi High Court in
Abhishek Agarwal & Anr. v. Union of India & Anr., W.P.(C) 5147/2019
and Dalip Kaur (supra) respectively, which in his opinion, had the occasion
to deal with the issue of stem cell therapies extensively and had arrived at the
conclusion to permit its continuation.
i. In the order dated 04.09.2019 passed in Abhishek Agarwal (supra) , the
Delhi High Court had observed that,
“4. The position, as it emerges from the Status Note dated 14th
June, 2019 filed by the Central Drugs Standard Control
Organization (CDSCO), is that, while treatment using “stem
cells” is permissible, treatment using “stem cells derived
products” requires a licence under the Rules, 2019….
xxx
6. We, therefore, allow the petitioners to continue such
treatment, from the clinic, till a final decision is taken, by the
CDSCO, regarding the aspect of coverage, or otherwise, of the
clinic, under the Rules, 2019. ”

38. It was submitted by the learned counsel that Dalip Kaur (supra) which deals
with the validity of the EMRB recommendations dated 06.12.2022 issued by
the respondent no. 2 is pending adjudication. However, he submitted that the
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said report does not have the force of law since the EMRB is merely an
autonomous board constituted under Section 16 read with Section 27 of the
NMC Act. The EMRB does not have any statutory power and any
recommendation of the EMRB cannot be declaratory or binding in nature,
especially in the absence of an explicit acceptance by the respondent no. 2. He
also submitted that in light of the proviso to Section 27 of the NMC Act, the
EMRB can act only through the State Medical Councils and not otherwise.

e. Submissions on behalf of the Respondent no.10/ Reelabs Pvt. Ltd.
39. Mr. Nikilesh Ramachandran, the learned counsel appearing for the respondent
no. 10/ Reelabs Pvt. Ltd. submitted that the respondent no. 10 is a biotech
company primarily involved in Cord Blood Banking and holds the requisite
licence to collect, process, test, store, bank and release umbilical cord blood
stem cells. He further submitted that the respondent no. 10 is primarily
engaged in the treatment of 80 disorders (excluding ASD) using stem cell
therapy, as approved under Annexure III of the NGSCR 2017.
40. The learned counsel submitted that the respondent no. 10 acts in strict
compliance with the NGSCR 2017 as well as the NDCT Rules, 2019. He
categorically denied the petitioners’ allegations that the website of the
respondent no. 10 has advertised stem cell therapy as a cure for ASD. He
submitted that the said website merely provides a list of the ICMR-approved
treatable diseases which does not include ASD. Therefore, he would submit
that respondent no. 10 does not engage in any form of false advertising
including claims to cure ASD.

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f. Submissions on behalf of Respondent no.11/Saffron Naturele Products
Ltd.
41. Ms. Swarupama Chaturvedi, the learned senior counsel (as Her Ladyship then
was) appearing for the respondent no. 11/Saffron Naturele Products Ltd.,
submitted that respondent no. 10 is a private limited company engaged in
research-oriented development and production of different types of stem cells
and primary cells. She submitted that the respondent no.10 is engaged in the
processing of stem cells but is not involved in providing any therapy to the
patients.
42. She argued that since the respondent no. 10 is merely engaged as a vendor in
supplying the processed stem cell to the patients or the hospitals as per their
requirement, the onus of compliance with any rules lies with such patients or
hospitals only and does not place any obligation on the respondent no. 10.
43. She further submitted that the respondent no. 10 does not have any
infrastructure. It has no medical practitioners/medical manpower on roll or
any facility to carry out any medical treatment of any kind, much less of the
kind as is alleged by the petitioners.
44. She submitted that since the respondent no. 10 is not engaged in the end-use
of the stem cells it supplies, it is not answerable as regards to the legal
permissibility of such alleged medical treatment of ASD using stem cell
therapy. However, she further went on to submit that there is no law which
governs stem cell therapy and the guidelines are non-judicious in nature.

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g. Submissions on behalf of the Respondent no.13/ Parents’ Forum for
Stem Cells in Autism and Cerebral Palsy
45. Mr. Nitesh Ranjan, the learned counsel appearing for the respondent no. 13
submitted that the respondent no. 13 is a registered society comprising of
parents and family members of children diagnosed with autism and cerebral
palsy, who are undergoing autologous cell/stem cell therapy. He submitted
that the respondent no. 13 had preferred to be impleaded in the present matter
in order to oppose the present petition since in their opinion, allowing the
present petition would lead to the denial of stem cell therapies to their children
who have seen a marked improvement owing to autologous mononuclear
cell/stem cell therapy. We were also informed that it is one of the members of
the respondent no. 13 who had preferred the writ petition in Dalip Kaur
(supra) before the Delhi High Court.
46. The learned counsel submitted that the autologous cell therapy is performed
using the patient’s own cells, without the injection of any external or foreign
object. He submitted that process involves obtaining the bone marrow from
the hip bone; isolation of the mononuclear cells from the bone marrow using
the density gradient centrifugation method and the immediate injection of
these cells intrathecally via lumbar puncture into the same patient. He would
submit that the use of one’s own body part cannot and does not fall within the
definition of a ‘drug’ under the Drugs Act, 1940 or under any other law.
47. Furthermore, the learned counsel mirrored the submissions that were made by
respondent no. 9 with respect to (a) the difference between ‘stem cell derived
product’ and ‘stem cell therapy’ respectively under the scheme of the NDCT
Rules, 2019; (b) the statutory clarification regarding the meaning of “stem cell
derived product” issued under Section 33P of the 1940 Act; (c) the
W.P. (C) No. 369 of 2022 Page 22 of 98

th
recommendations made by the DTAB in its 84 meeting; (d) the list issued
by the MoHFW whereby ‘bone marrow derived stem cells’ was mentioned as
a ‘clinical option’ for autism; and (e) the challenge to the recommendations
made by the EMRB report dated 06.12.2022 before the Delhi High Court in
Dalip Kaur (supra) .
48. He further submitted that the right to life under Article 21 of the Constitution
contains within its fold, the undeniable fundamental right of the patient and
their care-givers to choose the best or any available treatment which could
potentially lead to an improvement in the health or condition of the patient.
He submitted that if the prayers in the present petition are granted, it could
lead to a deprivation of the fundamental right of the patient to seek and avail
medical treatment with full and free consent. He argued that the potential of
risk or the lack of guaranteed efficacy cannot be made a valid ground to deny
the patient a therapy or treatment, to which the patient or their guardian has
given their explicit consent. To demonstrate that patients receiving stem cell
therapy have witnessed improvements in their condition, the learned counsel
placed before us medical records, including the copies of brain scans of those
patients whose parents/guardians are members of the respondent no. 13.
C. ISSUES FOR DETERMINATION
49. Having heard the learned counsel appearing for the parties and having gone
through the materials on record, the following questions fall for our
consideration:
i. Whether doctors/clinics/hospitals/institutions are legally permitted to
offer stem cell ‘therapy’ as a routine healthcare service?
W.P. (C) No. 369 of 2022 Page 23 of 98

ii. Whether the Drugs Act, 1940 and the NDCT Rules, 2019 provide a
framework for the regulation of research in stem cell therapies which
are used for the treatment of ASD?
D. ANALYSIS
a. Maintainability of the present PIL:
50. Upon a perusal of the facts on record, it is clear that the present petition raises
an issue of public importance.

51. The respondents’ contention that the present petition which arises out of the
petitioner no.1’s apprehension regarding stem cell therapies posing a potential
threat to its commercial interests is untenable. Even if there is an underlying
commercial competition amongst the service providers of various modes of
treatment, it does not discredit the petition’s main concern that there is
considerable confusion among the stakeholders, those administering as well
as receiving such ‘therapies’ regarding the regulatory framework. The facts
on record indicate that the petitioners are bona fide and no personal grievance
is sought to be addressed through the present petition.

52. The present petition, therefore, is held to be maintainable.

b. What are stem cell ‘therapies’ in ASD?
53. At the outset, it is necessary to clarify the scope of the term stem cell
“therapies”. It is relevant to note that there is no statutory definition of the
term “therapy” under the Drugs Act, 1940 or the rules promulgated
thereunder. Hence, we turn to the guidelines and related documents issued by
the ICMR and DHR to understand the term in the context of the therapeutic
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use of stem cells in ASD. The primarily relevant ICMR-DHR guidelines and
documents in this regard are the NGSCR 2017, the Evidence Based Status of
Stem Cell Therapy for Human Diseases 2021 (“ EBSSCT, 2021 ” ) , and the
National Ethical Guidelines for Biomedical and Health Research Involving
Human Participants, 2017 (" National Ethical Guidelines ”).

54. While the guidelines issued by the ICMR and DHR do not define the term
‘stem cell therapy’, yet we find a representative overview thereof in Chapter
5 of the EBSSCT, 2021 which deals with the evidence-based status of
therapeutic use of stem cells in ASD.

55. The representative studies outlined by the ICMR in the EBSSCT, 2021
indicate that research on the therapeutic use of stem cells in ASD involves
administering various types of stem cells such as human embryonic stem
cells, human cord blood mononuclear cells, umbilical cord derived
mesenchymal stem cells, autologous umbilical cord blood stem cells, fetal
stem cells, autologous bone marrow mononuclear cells and bone marrow
aspirate concentrate stem cells. The routes of administration of these stem
cells for therapeutic use in ASD also vary considerably, ranging from
intravenous (IV), intramuscular (IM), epidural, popliteal block, brachial
plexus block, intrathecal(IT), epidural catheter caudal, deep spinal muscle,
combined IV and IT transplantation, peripheral IV infusion, subcutaneous,
etc. This clearly underscores that therapeutic use of stem cells in ASD is
undertaken in the form of administering stem cells and that there is significant
variation in the type of stem cells used as well as their route of administration.

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56. At this stage, we may take note of the respondents’ submissions as regards the
distinction between ‘drugs’ and ‘therapies’. As noted above, the therapeutic
use of stem cells in ASD involves the administration of various types of stem
cells through different routes. Hence, it is necessary to determine whether the
stem cells that are administered for therapeutic use in ASD fall within the
definition of “drug” under the Drugs Act, 1940.

57. However, we find it apposite to clarify at the threshold that irrespective of
categorization of the stem cells administered for therapeutic use as “drugs”
under the Act, 1940, the issue of the permissibility of their administration as
a clinical service, cannot be determined ipso facto . In other words, it cannot
be said that merely because certain stem cells which are administered for
therapeutic use in ASD may not fall within the definition of “drugs” under the
Drugs Act, 1940, they would, by default, be permitted to be offered to patients
as a clinical service. It is no gainsaying that to ascertain the permissibility of
administering such stem cell therapies for ASD, the focus of inquiry has to
primarily be from the angle of standard of care owed by medical professionals
to their patients.

58. Therefore, for the purpose of determining the issues before us, we would first
determine whether stem cells are permitted to be administered for therapeutic
use in ASD as a commercial service or not. If it is found that therapeutic use
of stem cells in ASD cannot be offered as a commercial service, we would
then consider whether such stem cells may nevertheless be administered in a
research or clinical trial setting. In order to identify the appropriate regulatory
route for undertaking such clinical trial or research, we would delve into the
W.P. (C) No. 369 of 2022 Page 26 of 98

question of whether stem cells administered for therapeutic use in ASD fall
within the definition of “drugs” under the Drugs Act, 1940.

c. Is it permissible for medical practitioners to offer stem cell ‘therapy’ in
ASD as a service?


59. We may refer to a few landmark judgments of this Court which have laid
down the law on the duty of care owed by a medical practitioner towards its
patient in order to determine whether stem cell ‘therapy’ in ASD can be
offered as a clinical treatment or not. A Three-Judge Bench of this Court in
Indian Medical Association v. V.P. Shantha and others reported in (1996)
86 COMP 806 , paved the way for adopting and applying the “ Bolam Test” in
the Indian landscape of medical negligence jurisprudence to determine the
standard of care which is required from medical practitioners as laid down in
the landmark English case of Bolam v. Friern Hospital Management
Committee reported in (1957) 1 WLR 582 . The observations of McNair J. in
Bolam (supra) are reproduced below:
“Before I turn to that, I must tell you what in law we mean by
"negligence." In the ordinary case which does not involve any
special skill, negligence in law means a failure to do some act
which a reasonable man in the circumstances would do, or the
doing of some act which a reasonable man in the circumstances
would not do; and if that failure or the doing of that act results
in injury, then there is cause of action. How do you test whether
this act or failure is negligent? In an ordinary case it is
generally said you judge it by the action of the man in the street.
He is the ordinary man. In one case it has been said you judge
it by the conduct of the man on the top of a Clapham omnibus.
He is the ordinary man. But where you get a situation which
involves the use of some special skill or competence, then the
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test as to whether there has been negligence or not is not the
test of the man on the top of a Clapham omnibus, because he
has not got this special skill. The test is the standard of the
ordinary skilled man exercising and professing to have that
special skill. A man need not possess the highest expert skill; it
is well established law that it is sufficient if he exercises the
ordinary skill of an ordinary competent man exercising that
particular art. I do not think that I quarrel much with any of the
submissions in law which have been put before you by counsel.
Mr. Fox-Andrews put it in this way, that in the case of a medical
man, negligence means failure to act in accordance with the
standards of reasonably competent medical men at the time.
That is a perfectly accurate statement, as long as it is
remembered that there may be one or more perfectly proper
standards; and if he conforms with one of those proper
standards, then he is not negligent. Mr. Fox-Andrews also was
quite right, in my judgment, in saying that a mere personal
belief that a particular technique is best is no defence unless
that belief is based on reasonable grounds. That again is
unexceptionable. But the emphasis which is laid by the defence
is on this aspect of negligence, that the real question you have
to make up your minds about on each of the three major topics
is whether the defendants, in acting in the way they did, were
acting in accordance with a practice of competent respected
professional opinion. Mr. Stirling submitted that if you are
satisfied that they were acting in accordance with a practice of
a competent body of professional opinion, then it would be
wrong for you to hold that negligence was established.”
(Emphasis supplied)
60. This Court in V.P. Shantha ( supra ) also referred an earlier decision of this
Court in Laxman Balkrishna Joshi v. Trimbak Bapu Godbole , reported in
1968 SCC OnLine SC 260 as follows:
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“ 31. In an action for negligence in tort against a surgeon this
Court, in Laxman Balkrishna Joshi v. Trimbak Bapu Godbole
has held: (SCR p. 213)
" The duties which a doctor owes to his patient are clear.
A person who holds himself out ready to give medical
advice and treatment impliedly undertakes that he is
possessed of skill and knowledge for the purpose. Such a
person when consulted by a patient owes him certain
duties, viz., a duty of care in deciding whether to
undertake the case, a duty of care in deciding what
treatment to give or a duty of care in the administration
of that treatment. A breach of any of those duties gives a
right of action for negligence to the patient. The
practitioner must bring to his task a reasonable degree
of skill and knowledge and must exercise a reasonable
degree of care. Neither the very highest nor a very low
degree of care and competence judged in the light of the
particular circumstances of each case is what the law
require. ”
(Emphasis supplied)

61. An examination of the jurisprudence developed by this Court while dealing
with cases of medical negligence has consistently recognised the standard of
fiduciary duty that medical professionals owe to their patients, i.e. a duty to
exercise a reasonable degree of care, skill, and knowledge expected of a
prudent medical practitioner in the same field. This ‘standard of care’ was also
recognised by this Court in Jacob Mathew v. State of Punjab , reported in
(2005) 6 SCC 1 , and Kusum Sharma v. Batra Hospital , reported in (2010) 3
SCC 480 . This Court recently reaffirmed the same in M.A. Biviji v. Sunita
and Others , reported in (2024) 2 SCC 242 . The following excerpt from the
judgment of this Court in M.A. Biviji (supra) , succinctly summarises the
W.P. (C) No. 369 of 2022 Page 29 of 98

concept of ‘duty of care’ that is owed by medical practitioners towards their
patients. The relevant portions of the judgment in M.A. Biviji (supra) are
reproduced below:
“ 35. Before proceeding further, let us understand what this
Court has found to constitute medical negligence. In Jacob
Mathew v. State of Punjab, the Court held: (SCC pp. 32-33,
para 48)
"48. ... (1) Negligence is the breach of a duty caused by
omission to do something which a reasonable man
guided by those considerations which ordinarily regulate
the conduct of human affairs would do, or doing
something which a prudent and reasonable man would
not do. The definition of negligence as given in Law of
Torts, Ratanlal & Dhirajlal (edited by Justice G.P.
Singh), referred to hereinabove, holds good. Negligence
becomes actionable on account of injury resulting from
the act or omission amounting to negligence attributable
to the person sued. The essential components of
negligence are three:"duty", "breach", and "resulting
damage".

(2) Negligence in the context of medical profession
necessarily calls for a treatment with a difference. To
infer rashness or negligence on the part of a professional,
in particular a doctor, additional considerations apply.
A case of occupational negligence is different from one
of professional negligence. A simple lack of care, an
error of judgment or an accident, is not proof of
negligence on the part of a medical professional. So long
as a doctor follows a practice acceptable to the medical
profession of that day , he cannot be held liable for
negligence merely because a better alternative course or
method of treatment was also available or simply
W.P. (C) No. 369 of 2022 Page 30 of 98

because a more skilled doctor would not have chosen to
follow or resort to that practice or procedure which the
accused followed. When it comes to the failure of taking
precautions, what has to be seen is whether those
precautions were taken which the ordinary experience of
men has found to be sufficient; a failure to use special or
extraordinary precautions which might have prevented
the particular happening cannot be the standard for
judging the alleged negligence. So also, the standard of
care, while assessing the practice as adopted, is judged
in the light of the knowledge available at the time of the
incident, and not at the date of trial. Similarly, when the
charge of negligence arises out of failure to use some
particular equipment, the charge would fail if the
equipment was not generally available at that particular
time (that is, the time of the incident) at which it is
suggested it should have been used.

(3) A professional may be held liable for negligence on
one of the two findings: either he was not possessed of
the requisite skill which he professed to have possessed,
or, he did not exercise, with reasonable competence in
the given case, the skill which he did possess. The
standard to be applied for judging, whether the person
charged has been negligent or not, would be that of an
ordinary competent person exercising ordinary skill in
that profession. It is not possible for every professional
to possess the highest level of expertise or skills in that
branch which he practices. A highly skilled professional
may be possessed of better qualities, but that cannot be
made the basis or the yardstick for judging the
performance of the professional proceeded against on
indictment of negligence."

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36. Following Jacob Mathew, the Court in Kusum Sharma v.
Batra Hospital laid down the following principles that are to be
considered while determining the charge of medical negligence
(Kusum Sharma case, SCC pp. 506-507, para 89)

"89. (I) Negligence is the breach of a duty exercised by
omission to do something which a reasonable man,
guided by those considerations which ordinarily regulate
the conduct of human affairs, would do, or doing
something which a prudent and reasonable man would
not do.

*

(III) The Medical Professional is expected to bring a
reasonable degree of skill and knowledge and must
exercise a reasonable degree of care. Neither the very
highest nor a very low degree of care and competence
judged in the light of the particular circumstances of
each case is what the law requires.

(IV) A medical practitioner would be liable only where
his conduct fell below that of the standards of a
reasonably competent practitioner in his field.

(V) In the realm of diagnosis and treatment there is scope
for genuine difference of opinion and one professional
doctor is clearly not negligent merely because his
conclusion differs from that of another professional
doctor.

(VI) The medical professional is often called upon to
adopt a procedure which involves higher element of risk,
but which he honestly believes as providing greater
W.P. (C) No. 369 of 2022 Page 32 of 98

chances of success for the patient rather than a
procedure involving lesser risk but higher chances of
failure. Just because a professional looking to the gravity
of illness has taken higher element of risk to redeem the
patient out of his/her suffering which did not yield the
desired result may not amount to negligence.

(VII) Negligence cannot be attributed to a doctor so long
as he performs his duties with reasonable skill and
competence. Merely because the doctor chooses one
course of action in preference to the other one available,
he would not be liable if the course of action chosen by
him was acceptable to the medical profession.
*

(IX) It is our bounden duty and obligation of the civil
society to ensure that the medical professionals are not
unnecessarily harassed or humiliated so that they can
perform their professional duties without fear and
apprehension."

37. As can be culled out from above, the three essential
ingredients in determining an act of medical negligence are:
(1) a duty of care extended to the complainant,
(2) breach of that duty of care, and
(3) resulting damage, injury or harm caused to the complainant
attributable to the said breach of duty.

However, a medical practitioner will be held liable for
negligence only in circumstances when their conduct falls
below the standards of a reasonably competent practitioner.

38. Due to the unique circumstances and complications that
arise in different individual cases, coupled with the constant
advancement in the medical field and its practices, it is natural
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that there shall always be different opinions, including
contesting views regarding the chosen line of treatment, or the
course of action to be undertaken. In such circumstances, just
because a doctor opts for a particular line of treatment but does
not achieve the desired result, they cannot be held liable for
negligence, provided that the said course of action undertaken
was recognised as sound and relevant medical practice . This
may include a procedure entailing a higher risk element as well,
which was opted for after due consideration and deliberation
by the doctor. Therefore, a line of treatment undertaken should
not be of a discarded or obsolete category in any circumstance.

39. To hold a medical practitioner liable for negligence, a
higher threshold limit must be met. This is to ensure that these
doctors are focused on deciding the best course of treatment as
per their assessment rather than being concerned about
possible persecution or harassment that they may be subjected
to in high-risk medical situations. Therefore, to safeguard these
medical practitioners and to ensure that they are able to freely
discharge their medical duty, a higher proof of burden must be
fulfilled by the complainant. The complainant should be able to
prove a breach of duty and the subsequent injury being
attributable to the aforesaid breach as well, in order to hold a
doctor liable for medical negligence. On the other hand,
doctors need to establish that they had followed reasonable
standards of medical practice.”
(Emphasis Supplied)

62. What is discernible from the aforesaid exposition is that every medical
practitioner owes to his patient a duty to exercise a reasonable degree of care,
skill, and knowledge expected of a prudent medical practitioner in the same
field. The dictum of this Court in the aforesaid decisions also clarifies that this
‘standard of care’ requires a medical practitioner’s conduct to be judged not
W.P. (C) No. 369 of 2022 Page 34 of 98

by the highest expert standard, but by that of an ordinary competent
practitioner, acting with due care in the circumstances prevailing at the time
of treatment. The test, therefore, is one of reasonableness, not perfection.

63. The natural corollary of the above principles is that a medical practitioner
cannot be said to meet the standard of reasonable care if they administer an
intervention that lacks credible scientific evidence of safety and efficacy, or
where authoritative medical bodies unequivocally state that such form of
treatment is not recommended. This flows directly from the requisite standard
of care emphasised in V.P. Shantha (supra) , Jacob Mathew (supra) , as also
reaffirmed in M.A. Biviji (supra) , that is, a doctor’s conduct must conform to
a “ practice acceptable to the medical profession of that day” when “judged
in the light of the knowledge available at the time of the incident”. The
jurisprudence makes it clear that liability does not arise merely because an
alternative approach existed, but rather, liability arises when the course
adopted is one which the ordinary, reasonably competent medical practitioner
would not regard as a sound and acceptable medical practice in light of the
prevailing body of medical knowledge. In M.A. Biviji (supra), this Court
reiterated that a medical practitioner is insulated from negligence liability
provided that “ the said course of action undertaken was recognised as sound
and relevant medical practice” and is supported by the knowledge available
at the time of the incident. Therefore, it can be deduced that if a treatment is
characterised by the relevant scientific community or regulatory authorities as
unproven, experimental, obsolete, or lacking justification, such a treatment
cannot be defended as an exercise of due care and reasonable judgment by a
medical practitioner.

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64. The note of caution sounded by this Court in M.A. Biviji ( supra ) that a
particular line of treatment undertaken should be regarded as a “sound and
relevant medical practice” and that “ it should not be a discarded or obsolete
category in any circumstance” is of crucial importance. Keeping this in mind
ensures that patients are treated in accordance with established, evidence-
based medical norms, and prevents medical practitioners from resorting to
speculative, unproven, or experimental interventions when there is absence of
any credible scientific evidence or professional opinion. In other words, a
practitioner who disregards this caveat and administers speculative, unproven,
or experimental treatments even when credible professional bodies expressly
advise against the use of such a treatment, the administration of such a
treatment would fail to satisfy the standard of reasonable care necessitated
under the established medical negligence jurisprudence in India. The only
circumstance in which an experimental treatment may be provided is when it
is administered within an approved research or clinical trial setting.

65. It is in the backdrop of these principles that we would now proceed to
evaluate whether therapeutic use of stem cells in ASD meets the threshold of
reasonable standard of care that medical practitioners owe towards their
patients. In order to do so, we would look into the following documents which
encapsulate the current state of knowledge and professional opinion on the
subject matter:

i. The EMRB-NMC Recommendations dated 06.12.2022;
ii. The NGSCR 2017 and the Evidence Based Status of Stem Cell Therapy
for Human Diseases, 2021 jointly published by the ICMR and the DHR;
th
iii. The DTAB’s 84 Meeting Recommendations dated 27.08.2019; and
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iv. The list of practices and procedures involving cell or stem-cell based
preparations for therapeutic purposes as identified by experts (other
than Standard of Care provided by ICMR), [purportedly shared by the
Minister, MoFHW, Government of India vide email dated 19.01.2023]

(i) Significance of the Ethics & Medical Registration Board, National
Medical Commission Recommendations dated 06.12.2022:

66. The Ethics & Medical Registration Board (“ EMRB ”) of the NMC constituted
a committee of experts to examine the issues related to the prescription,
recommendation or administration of stem cell treatment for ASD, and the
report containing the expert committee’s recommendations was published by
the EMRB on 06.12.2022. The expert committee reviewed the available
scientific literature in the field of stem cell research for ASD and examined
the veracity of the unproven hypothesis that this treatment helps in offering
neural cell protection by enhancing neural tissue repair and preventing
ongoing neuronal damage, thereby reducing the severity of autistic symptoms.
It noted that the quality of research in this area is poor and indicated that based
on the existing research pool, it was not possible to draw any firm conclusions
on the efficacy of stem cell therapy in ASD. It also emphatically highlighted
that none of the current international guidelines recommend stem cell therapy
as a treatment for ASD. Its observation reads as follows:
“Guidelines and expert opinions: National and international
guidelines, including ICMR guidelines are uniform in their
conclusion that there is insufficient evidence for SCT in ASD
and do not recommend it as a treatment for ASD, and call for
more high-quality research. Many experts in the field have
W.P. (C) No. 369 of 2022 Page 37 of 98

noted prevailing unethical practice of offering SCT as a
treatment for ASD. Further, they have expressed concern and
warned about indiscriminate promotion and predatory
marketing of stem cell therapies in ASD leading to creation of
false hopes, unrealistic expectations, and exploitation of the
affected population and their families. Jessica Sun and Joanne
Kurtzberg, eminent researchers in this area, have expressed
concerns about predatory marketing practices, and
unwarranted raising of hopes despite the absence of good
quality scientific evidence and exploitation of patients and their
families Similarly, Antonio Narzisi in 2022 stated that "The take
home message that needs to be considered is that, to date, the
scientific evidence on the use of stem cells for the treatment of
ASD is insufficient,..." and that offering SCT for ASD in the
current state of scientific research is clearly unethical.
In conclusion, there is as yet insufficient and inadequate
scientific evidence on efficacy of the SCT in ASD. Therefore,
SCT cannot be recommended as it treatment for ASD.”

67. Based on its review, the expert committee made certain recommendations that
are critical to the present adjudication. The expert committee’s
recommendations published in the EMRB report dated 06.12.2022 are as
follows:
“RECOMMENDATIONS:
i. Current Status: Stem cell therapy is not recommended as a
treatment for Autism Spectrum Disorder (ASD) in clinical
practice.
ii. In view of the above recommendation, use of Stem cell in
ASD, its promotion and advertisement will be considered as
professional misconduct.
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iii. Further research needs to be conducted and encouraged in
terms of well-designed Double-blind RCT’s to explore the
safety and efficacy of Stem Cell Therapy in ASD.
iv. These recommendations will be updated periodically.”
(Emphasis supplied)

68. These recommendations of the EMRB expert committee 06.12.2022 were
approved by the NMC in its meeting dated 28.03.2024 and thereafter
published on the NMC website.

69. The EMRB is constituted by the Central Government as an Autonomous Body
under Section 16(d) of the NMC Act, 2019. As per Section 27(1)(b), the
EMRB has the power to regulate professional conduct and promote medical
ethics in accordance with the regulations framed under the NMC Act, 2019.
Moreover, as per Section 27(2) of the NMC Act, 2019, the EMRB may, in the
discharge of its functions, make such recommendations to, and seek such
directions from, the NMC, as it deems necessary. Sections 27(1)(b) and 27(2),
respectively, read thus:

“27. Powers and functions of Ethics and Medical Registration
Board.- (1) The Ethics and Medical Registration Board shall
perform the following functions, namely:-
*
(b) regulate professional conduct and promote medical ethics
in accordance with the regulations made under this Act:
Provided that the Ethics and Medical Registration Board
shall ensure compliance of the code of professional and ethical
conduct through the State Medical Council in a case where such
State Medical Council has been conferred power to take
disciplinary actions in respect of professional or ethical
W.P. (C) No. 369 of 2022 Page 39 of 98

misconduct by medical practitioners under respective State
Acts;
*
(2) The Ethics and Medical Registration Board may, in the
discharge of its duties, make such recommendations to, and
seek such directions from, the Commission, as it deems
necessary.”
(Emphasis supplied)

70. The EMRB is a statutory body under the NMC Act, 2019, responsible for
regulating professional conduct and promoting medical ethics, therefore, its
recommendations, once approved by the NMC, serve as authoritative
guidance on what constitutes ethical and professionally acceptable conduct
for medical practitioners in India. The EMRB’s recommendations expressly
state that stem cell therapy for ASD is not recommended, for lack of adequate
evidence, and that its use or promotion amounts to professional misconduct.
In such view of the matter, could it be said that the administration of stem cell
for therapeutic use in ASD constitutes a “sound and relevant medical
practice” or a “ practice acceptable to the medical profession of that day”
when “judged in the light of the knowledge available at the time of the
incident” ? In light of this Court’s dictum in M.A. Biviji (supra) and V.P.
Shantha (supra) , our answer to this question must be an emphatic ‘No’. There
is no manner of doubt left in our minds that if any medical practitioner offers
such stem cell therapy in ASD as a clinical service, he/she would fail to meet
the reasonable standard of care which the law requires a medical practitioner
to discharge.

W.P. (C) No. 369 of 2022 Page 40 of 98

(ii) Significance of the National Guidelines for Stem Cell Research, 2017
and the Evidence Based Status of Stem Cell Therapy for Human
Diseases, 2021

71. The NGSCR 2017 as well as the EBSSCT 2021 are documents which have
been published by the ICMR on behalf of the Secretary DHR, MoHFW &
DG, ICMR. According to the Government of India (Allocation of Business)
Rules, 1961 (“ Business Allocation Rules, 1961 ”), the DHR is responsible for
the promotion and coordination of basic, applied and clinical research
including clinical trials and operational research in areas related to medical,
health, biomedical and medical profession and education through
development of infrastructure, manpower and skills in cutting edge areas and
management of related information thereto. The DHR is also responsible for
promoting and providing guidance on research governance issues, including
ethical issues in medical and health research. Moreover, even though the
ICMR is an autonomous body registered under the Societies Registration Act,
1860, yet as per the Business Allocation Rules, 1961, the Indian Council of
Medical Research is also listed as a business allocated to the DHR.

72. Given this framework, it is limpid that the documents published by the ICMR
as authorized by the DHR represent the well-researched scientific and ethical
position of the apex bodies entrusted with the responsibility of overseeing
biomedical research in the country. Thus, we find that the said documents,
though not binding by themselves, yet can certainly be relied upon as credible
source to assess whether a certain practice is acceptable to the medical
profession of that day” when “judged in the light of the knowledge available
at the time of the incident” and whether a line of treatment undertaken should
W.P. (C) No. 369 of 2022 Page 41 of 98

be regarded as a “sound and relevant medical practice” and not as a
“ discarded or obsolete category in any circumstance” . The relevance of these
ICMR publications lie not in their binding force in a standalone manner, but
in the role they play in evidencing the contemporary scientific and ethical
baseline of the medical profession.

73. Chapter 5 of the EBSSCT 2021 which deals with therapeutic use of stem cells
in ASD has already been referred to by us hereinabove. This document clearly
and emphatically states that critical review of the studies reported so far do
not support the use of stem cell therapy over and above the behavioural and
supportive therapies for ASD. The ICMR in this document further states that
based on the review of available scientific evidence, stem cell therapy should
not be offered as a standard or routine therapy to patients with ASD. The
relevant paragraphs from the said Chapter 5 of the EBSSCT 2021 are
reproduced below:
“Have stem cells been used in ASD?
Along with supportive therapies and drug treatment, few studies
have tested the use of various forms of stem cells to improve the
outcome in children with Autism. We are aware that many
Indian patients with ASD have been offered different types of
stem cell therapies as a standard treatment option and not as
part of any approved clinical trial / research. ICMR with inputs
from medical specialists in this field has reviewed the existing
scientific and medical literature and submissions from
practicing doctors and their professional societies regarding
any evidence-based safety and efficacy of stem cells in ASD.
Critical review of the studies reported so far do not support the
use of stem cell therapy over and above the behavioural and
supportive therapies for ASD.
W.P. (C) No. 369 of 2022 Page 42 of 98


Recommendations (2021): Based on the review of available
scientific evidence, stem cell therapy should NOT be offered as
a standard or routine therapy to patients with Autism. These
guidelines will be periodically reviewed for any new evidence
showing benefit or harm with the use of stem cells for Autism
Spectrum Disorder. Therapeutic use of any type of stem cell in
Autism should be restricted to clinical trials only after
obtaining necessary regulatory approval as defined in National
Guidelines for Stem Cell Research-2017. The patients
participating in these clinical trials should be closely monitored
for the possibility of any harm with use of stem cells. As per the
National Ethical Guidelines for Biomedical and Health
Research Involving Human Participants - 2017, trial
participants should have read and signed the informed consent
form which explains them the alternative therapies, possible
benefits as well as harm due to experimental treatments like
stem cell therapy. Participants should not be made to pay for
any expenses incurred beyond routine clinical care and which
are research related including tests, investigations and any
interventions (such as stem cells). This is applicable to all
participants,
including those in comparator/control groups. Participants in
a clinical trial should be provided compensation in the event of
any harm or permanent injury or death due to the use of
experimental stem cell therapy.

*
Summary of Evidence and Recommendations for Medical /
Scientific Professionals (2021)

Based on the review of available scientific evidence, stem cell
therapy should NOT be offered as a standard or routine therapy
to patients with Autism Spectrum Disorder.
W.P. (C) No. 369 of 2022 Page 43 of 98


CAUTIONARY NOTE
The experts observed that severe autism can have a major
impact on the quality of life of the affected child and the family.
There is therefore a need to undertake research into the causes
and more effective management of ASD. Since conventional
management fails to control
symptoms in many cases, such families see hope in some
miraculous recovery with the use of stem cells without
understanding the risks versus benefit ratio. It is therefore
imperative that use of any type of stem cells in ASD should be
restricted to clinical trials with necessary approval from
regulatory authorities in India and as per the National
Guidelines on Stem Cell Research – 2017.

*
These guidelines will be periodically reviewed for any new
evidence showing benefit or harm with the use of stem cells for
Autism Spectrum Disorder.”
(Emphasis supplied)

74. The NGSCR 2017 goes as far as to state that the use of stem cells in patients
(other than for hematopoietic stem cell reconstitution for approved
indications) outside an approved clinical trial is unethical and shall be
considered as malpractice. The observations from the NGSCR 2017 reads
thus:
“We are committed towards stem cell treatments that are safe
and have proven efficacy. The Guidelines for Stem Cell
Research and Therapy in 2007 was a step towards this
commitment, which were revised after public consultations and
released as National Guidelines for Stem Cell Research
(NGSCR-2013). The National Guidelines for Stem Cell
W.P. (C) No. 369 of 2022 Page 44 of 98

Research, 2017 is an outcome of concerted efforts of different
stakeholders. It has been formulated taking into account several
new scientific and technical advancements as well as the
perceived challenges in the field. Efforts were made to bring
together all concerned ministries/agencies to chalk out
strategies to curb rampant unethical practices of banking and
therapeutic application. The recommendations of the Inter-
Ministerial/Inter-Agency meetings have helped to shape these
guidelines. Detailed and extensive consultation with
stakeholders were held and their suggestions taken into account
before finalization. Most importantly, the guidelines have been
harmonized with existing rules and regulations resulting in a
comprehensive document.

The 2017 guidelines, reiterate that any stem cell use in patients,
other than that for hematopoietic stem cell reconstitution for
approved indications, is investigational at present.
Accordingly, any stem cell use in patients must only be done
within the purview of an approved and monitored clinical trial
with the intent to advance science and medicine, and not
offering it as therapy. In accordance with this stringent
definition, every use of stem cells in patients outside an
approved clinical trial is unethical and shall be considered as
malpractice.”
(Emphasis supplied)

75. The ICMR publications clearly set out the contemporary scientific position
on therapeutic use of stem cells in ASD, and that regardless of the binding
nature of the guidelines, these documents published by the ICMR would
function as authoritative indicators of what constitutes sound medical practice
and what falls outside the realm of defensible clinical judgment. These
documents published by the ICMR and endorsed by the DHR, unequivocally
W.P. (C) No. 369 of 2022 Page 45 of 98

state that the therapeutic use of stem cells in ASD, outside an approved clinical
trial is unethical and shall be considered as malpractice, since there is lack of
reliable conclusive research on the efficacy and safety of such procedures.
Therefore, if a medical practitioner, in blatant disregard of such authoritative
guidelines choose to offer stem cell therapies for ASD, as a clinical service,
outside of an approved clinical trial, then such medical practitioner would be
considered as having failed to act in accordance with reasonable standard of
care.
th
(iii) Significance of the DTAB’s 84 Meeting Recommendations dated
27.08.2019:
th
76. We now turn to the 84 DTAB Meeting Recommendations dated 27.08.2019,
which have been relied upon by the respondent nos. 9 and 13. The Drugs
Technical Advisory Body (“ DTAB ”) is a statutory body constituted by the
Central Government under Section 5(1) of the Drugs and Cosmetics Act, 1940
which reads thus,
“ 5. The Drugs Technical Advisory Board.- (1) The Central Government
shall, as soon as may be, constitute a Board (to be called the Drugs
Technical Advisory Board) to advise the Central Government and the
State Governments on technical matters arising out of the
administration of this Act and to carry out the other functions assigned
to it by this Act.”

77. It was recommended therein that it was stated that the routine
practices/transplantations/surgeries/therapies involving stem cells,
undertaken by doctors for the treatment of their own patients, without any
intention to commercialise the same outside of their own hospitals/clinics,
would fall outside the purview of the Drugs Act, 1940 and the NDCT Rules,
2019 respectively.

W.P. (C) No. 369 of 2022 Page 46 of 98

78. Further, one of the agendas for deliberation was consideration of the proposal
to incorporate a definition for the term “ stem cell derived product” under the
NDCT Rules, 2019. The DTAB accepted the proposal and recommended a
clarification of the term “stem cell derived product ”, which was subsequently
reproduced verbatim in the abovementioned direction dated 09.02.2021
issued by the Drugs Regulation Section, Department of Health & Family
Welfare, MoHFW, Government of India under Section 33P of the Drugs Act,
1940.

th
79. However, there is another crucial aspect of the 84 DTAB meeting that
th
warrants attention. At the 84 meeting itself, the DTAB further deliberated on
the agenda and went on to recommend that the routine
practices/transplantations/surgeries/therapies undertaken by doctors
involving stem cell for treatment of their own patients, and not for
commercialisation of the same outside their own hospitals/clinics, would fall
outside the purview of Drugs Act, 1940 and the NDCT Rules, 2019 and should
therefore be dealt outside the said regulation. The said additional
th
recommendations made by the DTAB at its 84 meeting dated 27.08.2019 are
as follows:
“ DTAB deliberated the matter in length and in principle, agreed
to the proposal and further recommended that it is given to
understand that ICMR/ DHR is making guidelines for this and
therefore, while considering the issuance of such clarification
on stem cell derived products, those guidelines to be published
by the ICMR may be considered.

DTAB also recommended that, the routine practices/
transplantations/ surgeries/therapies undertaken by doctors
involving stem cell for treatment of their own patients and not
for commercialization of the same outside their own
W.P. (C) No. 369 of 2022 Page 47 of 98

hospitals/clinics fall outside the purview of Drugs and
Cosmetics Act, 1940 and the New Drugs and Clinical Trials
Rules, 2019. Therefore, shall be dealt outside the said
regulation.

Further, DTAB recommended that, till such time the
clarification about stem cell derived product is brought out by
ICMR etc., communication should be issued to the State
Licensing Authorities and other stake holders that the overall
issue is under process and it is inappropriate to intervene from
regulatory angle on routine
practices/therapies/surgeries/transplantations undertaken by
Registered Medical Practitioners/ physicians / doctors in their
clinics/hospitals involving such stem cells for the treatment of
their patients based on their medical expertise.”
(Emphasis supplied)

80. However, what is significant to note is that unlike the clarification on the
definition of the term “ stem cell derived products ”, the above-quoted further
th
recommendations made by the DTAB at its 84 meeting on this agenda itself,
were not incorporated in the clarification dated 09.02.2021 issued under
Section 33P of the Drugs Act, 1940. Moreover, no communication was issued
to the State Licensing Authorities or other stakeholders to restrain them from
intervening in routine practice/therapies/surgeries/transplantations
undertaken by Registered Medical Practitioners/ physicians / doctors in their
clinics/hospitals involving such stem cells for the treatment of their patients
based on their medical expertise.

81. Given that the DTAB is merely an advisory body, its recommendations are
not binding unless formally accepted and published by the Central
Government. Hence, the respondents’ reliance on the unadopted
th
recommendations of the DTAB’s 84 meeting, which were reproduced
W.P. (C) No. 369 of 2022 Page 48 of 98

neither in the Central Government’s direction dated 09.02.2021 nor in any
other subsequent direction, is misplaced. In the absence of any governmental
acceptance or adoption of the DTAB’s recommendations, these
recommendations remain merely minutes of internal deliberation and do not
constitute authoritative guidance conferring legitimacy upon
commercialisation of routine therapeutic use of stem cells in ASD outside
clinical trials.

82. Moreover, what further weakens the weight of the DTAB’s recommendations
is the inconsistency inherent in its recommendation that, “the routine
practices/ transplantations/ surgeries/therapies undertaken by doctors
involving stem cell for treatment of their own patients and not for
commercialization of the same outside their own hospitals/clinic fall outside
the purview of Drugs and Cosmetics Act, 1940 and the New Drugs and
Clinical Trials Rules, 2019. Therefore, shall be dealt outside the said
regulation.” The DTAB does not explain how it arrives at the distinction
between commercialisation within and outside one’s own hospital/clinic. The
DTAB does not even clarify what would amount to commercialization outside
one’s own hospital/clinic. In our opinion, the basis for arriving at such a
touchstone of determination is arbitrary and lacks any rational basis. Such
distinction dilutes the position taken by the ICMR against the therapeutic use
of stem cells in ASD other than in clinical trials as there is, till date, no body
of scientific literature that supports the efficacy of such therapy.
W.P. (C) No. 369 of 2022 Page 49 of 98

iv) Significance of the “List of practices and procedures involving cell or stem-cell
based preparations for therapeutic purposes as identified by experts (other than
Standard of Care provided by ICMR),” [purportedly shared by the Minister,
MoFHW, Government of India vide email dated 19.01.2023]:

83. Respondent no. 9 and 13 have submitted that in 2022, in a short document
titled “ List of practices and procedures involving cell or stem-cell based
preparations for therapeutic purposes as identified by experts (other than
Standard of Care provided by ICMR)” prepared by the the MoHFW,
Government of India, “ bone-marrow derived stem cells ” has been listed as a
“ clinical option ”. However, in order to ascertain the significance of the
document, we have to first determine whether the list has been formally
adopted by the MoHFW or not.

84. Respondent no. 9 has submitted that the said list was sent as an attachment by
the erstwhile Minister of Health and Family Welfare, Government of India,
vide email dated 19.01.2023, to respondent no. 9’s director Dr. Alok Sharma.
The body of the said email dated 19.01.2023 which has been brought to our
attention by respondent no. 9 reads thus:
“ Sir,
This is in reference to your mails and receipts dated 10.01.2023
regarding suggestions and recommendations for stem cell SOP/
Guidelines finalization. This is to acknowledge that the list of
documents, research papers, thesis, global publications on cell
and stem cells procedures as well as the list of practices and
procedures involving cell and stem cell based preparations for
therapeutic purposes as identified are attached for
information. ”

W.P. (C) No. 369 of 2022 Page 50 of 98

85. There are multiple issues with relying on this private communication to assess
the reasonable standard of care to be undertaken by a medical practitioner.
First, neither the body of the email, nor the list itself clearly states whether
such a list has been formally adopted and published by the MoHFW or not.
Apart from the title of the list merely mentioning “ as identified by experts
(other than Standard of Care provided by ICMR) ”, the document does not
even go on to mention who these ‘experts’ are, and is silent on how the list is
to be construed vis-à-vis the ICMR’s guidelines.

86. Respondent no. 13 argued that the MoHFW has recognised administration of
“ Bone marrow derived Stem Cells” as a “ Clinical option ” for ASD on the
basis of the said list. However, in the same breath, it has also relied inter alia ,
on an open platform petition on the website “change.org”. The said online
petition dated 01.03.2023 titled “ Support & Facilitate Stem Cell Therapy as
a treatment for Autism and other disabilities ” states that the said list has been
prepared and ‘finalized’ but not approved or released to the public. Therefore,
there is gross inconsistency between the submission and the supporting
documentation sought to be relied upon by the respondent no.13 on this
aspect.
87. Moreover, the said list has not been addressed by the respondent no. 1 or
respondent no. 2 in their submissions.
88. Since the veracity of the status of the list could not be established by the
respondents, the said list cannot be said to have any bearing on a medical
practitioner’s decision on the suitability of offering therapeutic use of stem
cells in ASD as a clinical service. Be that as it may, there is no gainsaying that
W.P. (C) No. 369 of 2022 Page 51 of 98

any novel therapy utilizing stem cells ought to undergo clinical trial before
being offered as a clinical service.
89. Therefore, based on a careful perusal of the above-mentioned documents, we
arrive at the conclusion that the ICMR publications elaborately set out the
contemporary scientific position on the therapeutic use of stem cells in ASD
and therefore, function as authoritative indicators of whether such use of stem
cells is recognised as sound and relevant medical practice. The DTAB
recommendations and the purported MoHFW list, both of which have not
been formally published or adopted by the government, are not authoritative
documents which could alter this position to confer any legitimacy upon
therapeutic use of stem cells in ASD outside of clinical trial settings. When
determining whether a practitioner has acted in accordance with the
reasonable standard of care, the authoritative weight lies with the evidence-
based guidance of the ICMR , endorsed by the DHR which is entrusted with
the scientific and ethical governance of biomedical research.
90. Therefore, we arrive at the conclusion that, since therapeutic use of stem cells
in ASD is not recognised as ‘a sound and relevant medical practice’ as per the
knowledge available at present, the medical practitioners who offer the same
as a clinical service, outside of an approved and monitored research/clinical
trial, fail to meet the reasonable standard of care owed by them towards their
patients. Hence, until there is further research which establishes this as a sound
and relevant medical practice, stem cell ‘therapies’ for ASD cannot be offered
by medical practitioners as a clinical service, outside an approved and
monitored clinical trial/research setting.
W.P. (C) No. 369 of 2022 Page 52 of 98

d. Right to choose a ‘treatment’ in light of ‘consent’ and ‘patient
autonomy’
91. We are, however, cognizant of the profound difficulties faced by the
individuals diagnosed with ASD and their caregivers which often drive them
to explore experimental or unproven interventions in the hope that even partial
symptomatic relief may be achieved. Respondent no. 13 submits that many of
its members, who are themselves medical practitioners, have opted for stem
cell interventions for ASD offered by various clinics as a paid medical service.
These parents/guardians claim to have taken these decisions after giving due
consideration to the purported benefits and associated risks, and they believe
they are providing ‘informed consent’ on behalf of their children. We respect
the choice of the parents/guardians, however, it remains to be seen whether
the individuals or their parents/guardians/caregivers can demand a right to
choose a medical intervention merely because they claim to have consented
to undergo such therapies on the basis of an informed understanding of its
risk-benefit analysis. Therefore, we find it apposite to address ourselves on
what is a valid consent for the purpose of undergoing a medical treatment.

92. A Three-judge Bench of this Court in Samira Kohli v. Dr. Prabha
Manchandra and Another reported in (2008) 2 SCC 1 had dealt with the
information that is required to be furnished by a doctor to secure consent. In
order to delineate what would be the threshold of “adequate information” to
be furnished by the doctor to obtain consent, this Court in Samira Kohli
(supra) summarised the principles as follows:
“ 49. We may now summarise principles relating to consent as
follows:
W.P. (C) No. 369 of 2022 Page 53 of 98

(i) A doctor has to seek and secure the consent of the patient
before commencing a "treatment" (the term "treatment"
includes surgery also). The consent so obtained should
be real and valid, which means that: the patient should
have the capacity and competence to consent; his consent
should be voluntary; and his consent should be on the
basis of adequate information concerning the nature of
the treatment procedure, so that he knows what he is
consenting to.

(ii) The "adequate information" to be furnished by the doctor
(or a member of his team) who treats the patient, should
enable the patient to make a balanced judgment as to
whether he should submit himself to the particular
treatment or not. This means that the doctor should
disclose (a) nature and procedure of the treatment and
its purpose, benefits and effect; (b) alternatives if any
available; (c) an outline of the substantial risks; and (d)
adverse consequences of refusing treatment. But there is
no need to explain remote or theoretical risks involved,
which may frighten or confuse a patient and result in
refusal of consent for the necessary treatment. Similarly,
there is no need to explain the remote or theoretical risks
of refusal to take treatment which may persuade a patient
to undergo a fanciful or unnecessary treatment. A
balance should be achieved between the need for
disclosing necessary and adequate information and at
the same time avoid the possibility of the patient being
deterred from agreeing to a necessary treatment or
offering to undergo an unnecessary treatment.

(iii) Consent given only for a diagnostic procedure, cannot be
considered as consent for therapeutic treatment. Consent
given for a specific treatment procedure will not be valid
for conducting some other treatment procedure. The fact
W.P. (C) No. 369 of 2022 Page 54 of 98

that the unauthorised additional surgery is beneficial to
the patient, or that it would save considerable time and
expense to the patient, or would relieve the patient from
pain and suffering in future, are not grounds of defence
in an action for negligence or assault and battery. The
only exception to this rule is where the additional
procedure though unauthorised, is necessary in order to
save the life or preserve the health of the patient and it
would be unreasonable to delay such unauthorised
procedure until patient regains consciousness and takes
a decision.

(iv) There can be a common consent for diagnostic and
operative procedures where they are contemplated.
There can also be a common consent for a particular
surgical procedure and an additional or further
procedure that may become necessary during the course
of surgery.

(v) The nature and extent of information to be furnished by
the doctor to the patient to secure the consent need not
be of the stringent and high degree mentioned in
Canterbury but should be of the extent which is accepted
as normal and proper by a body of medical men skilled
and experienced in the particular field. It will depend
upon the physical and mental condition of the patient, the
nature of treatment, and the risk and consequences
attached to the treatment.”
(Emphasis supplied)

93. The aforesaid exposition clearly states that a pre-condition for a valid consent
to be obtained is the disclosure of adequate information concerning the nature
of the medical treatment, so that the patient knows what he is consenting to.
W.P. (C) No. 369 of 2022 Page 55 of 98

It was further clarified that the “adequate information” must enable the patient
to make a balanced judgment and should be of the extent which is accepted as
normal and proper by a body of medical men skilled and experienced in the
particular field. This would mean that such adequate information has to be
present in the first place. If the available information itself is not adequate,
there cannot logically be a disclosure of such a nature that could enable a
patient to give their consent.

94. The therapeutic use of stem cells in ASD falls in such a category of treatments
as there is a dearth of established scientific evidence on its efficacy and safety.
As a result, the doctors do not have “adequate information” to provide to their
patients in the first place. Where scientific evidence is absent or inconclusive,
and where neither efficacy nor risk profile is established in a manner that
would be accepted as normal and proper by a body of medical practitioners
skilled and experienced in the particular field, the pre-requisite of disclosure
of adequate information to obtain a valid consent cannot be satisfied. In the
absence of such necessary data, the very foundation of the “adequate
information” standard laid down by the Three-judge Bench of this Court in
Samira Kohli (supra) collapses.

95. While dealing with the scope of consent, we may refer to a crucial observation
made by Chandrachud J., in his concurring opinion in Common Cause (A
Registered Society) v. Union of India and Another , reported in (2018) 5 SCC
1 . It was clarified and underscored therein that consent is recognised to the
extent that it gives an individual the ability to opt in or opt out of a treatment
that is offered, but such autonomy cannot be taken to mean that the right to
W.P. (C) No. 369 of 2022 Page 56 of 98

demand a particular form of treatment has been conferred on the patient. The
relevant observation reads thus:
“ 398. […] Consent gives an individual the ability to choose
whether or not to accept the treatment that is offered. But consent
does not confer on a patient the right to demand that a particular
form of treatment be administered, even in the quest for death
with dignity. […] "
(Emphasis supplied )

96. Consent is a mode of exercising patient autonomy. Since consent does not
confer on a patient the right to demand a particular form of treatment, patient
autonomy cannot be stretched to seek an entitlement to subject oneself to a
clinical procedure that is scientifically unvalidated, ethically impermissible,
and outside the bounds of reasonable medical practice. Seen in such light,
consent for undergoing a medical procedure cannot be equated with a mere
exercise of choice. ‘Consent’ is an informed authorisation, grounded in
adequate disclosure of the nature, procedure, purpose, benefits, effects,
alternatives, substantial risks; and adverse consequences of refusing
treatment. ‘Choice’ reflects what an individual or its
parents/guardians/caregivers may desire to opt for, but ‘consent’ in the context
of a medical procedure requires that such choice be shaped and supported by
adequate information. Where the requisite information in unavailable, a
choice cannot mature into a valid consent. We have already arrived at the
finding hereinabove that therapeutic use of stem cells in ASD cannot be
offered as a service by medical practitioners until there is further research
which establishes this as a sound and relevant medical practice. In such
W.P. (C) No. 369 of 2022 Page 57 of 98

circumstances, the individuals diagnosed with ASD, or their
parents/guardians/caregivers cannot demand that such a form of procedure be
administered as a clinical service.

97. However, although one cannot demand that a form of medical intervention be
permitted to be administered, one would still have the liberty to participate in
an approved and regulated research/clinical trial involving such medical
interventions. Having said that, we would like to add a word of caution to it
as well. The ICMR in its National Ethical Guidelines for Biomedical and
Health Research Involving Human Participants, 2017 warns about the risk of
“therapeutic misconception”, i.e. a misconception by participants believing
that the purpose of clinical trials/research is to administer treatment rather than
to conduct research, and therefore potential participants should be mindful of
the same.

e. Permissibility of administering stem cells for therapeutic use in ASD for
the purpose of research/clinical trial:

98. In order to determine the regulatory pathway applicable to any research or
clinical trial involving the administration of stem cells for therapeutic use in
ASD, it is necessary to ascertain whether the stem cells proposed to be
administered for such use, fall within the definition of “drug” under the Drugs
Act, 1940. This inquiry is determinative because the answer to that in turn
would govern the procedural requirement for undertaking a research or
clinical trial in this regard.
W.P. (C) No. 369 of 2022 Page 58 of 98

(i) Do ‘stem cells’ administered for therapeutic use in ASD fall within the
definition of “drug” under the Drugs Act, 1940?

99. The term “drugs” has been defined in Section 3(b) of the Drugs Act, 1940 as
follows:
“ Definitions. —In this Act, unless there is anything repugnant
in the subject or context, —
xxx
(b) "drug" includes-
(i) all medicines for internal or external use of human beings or
animals and all substances intended to be used for or in the
diagnosis, treatment, mitigation or prevention of any disease or
disorder in human beings or animals, including preparations
applied on human body for the purpose of repelling insects like
mosquitoes;
(ii) such substances (other than food) intended to affect the
structure or any function of the human body or intended to be
used for the destruction of [vermin] or insects which cause
disease in human beings. animals, as may be specified from
time to time by the Central Government by notification in the
Official Gazette;
(iii) all substances intended for use as components of a drug
including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the
diagnosis, treatment, mitigation or prevention of disease or
disorder in human beings or animals, as may be specified from
time to time by the Central Government by notification in the
Official Gazette, after consultation with the Board;”
(Emphasis supplied)

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100. Clause (i) of Section 3(b) of the Drugs Act, 1940 is of particular relevance for
determining whether stem cells, proposed to be administered for therapeutic
use in ASD, fall within the definition of a ‘drug’. A bare textual reading of the
provision indicates that the term ‘drug’ includes not only ‘medicines’ but also
‘ all substances intended to be used for or in the diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or
animals ’. We may refer to a few landmark judgments of this Court, in order
to understand the scope of the broad term “substances” appearing in Section
3(b)(i).
101. This Court in Chimanlal Jagjivan Das Sheth v. State of Maharashtra
reported in 1962 SCC OnLine SC 16 , had observed that the definition of
“drugs” under Section 3(b) of the Drugs Act, 1940 is comprehensive enough
to include within its ambit not only medicines but also substances intended to
be used for or in the treatment of diseases of human being or animals. It was
observed that the wide scope of the term “drug” extended beyond medicines,
and that by use of the term ‘substances’, the definition introduces a distinction
between medicines and those other things which are not medicines strictly so
but are used for the purpose of treatment. The relevant observation of this
Court in C himanlal ( supra ) reads as follows:
“3. ... The said definition of "drugs" is comprehensive enough
to take in not only medicines but also substances intended to be
used for or in the treatment of diseases of human beings or
animals. This artificial definition introduces a distinction
between medicines and substances which are not medicines
strictly so-called. The expression "substances", therefore, must
be something other than medicines but which are used for
treatment. The part of the definition which is material for the
present case is "substances intended to be used for or in the
W.P. (C) No. 369 of 2022 Page 60 of 98

treatment". The appropriate meaning of the expression
"substances" in the section is "things". It cannot be disputed,
and indeed it is not disputed, that absorbent cotton wool, roller
bandages and gauze are "substances" within the meaning of the
said expression. If so, the next question is whether they are used
for or in "treatment". It is not necessary for the purpose of this
appeal to define exhaustively "the substances" falling within the
definition of "drugs"; and we consider that whether or not
surgical instruments are "drugs", the articles concerned in this
case are.”
(Emphasis supplied)
102. This aforesaid observation was further clarified by a three-Judge Bench of this
Court in Ishwar Singh Bindra and Others v. State of U.P. reported in 1968
SCC OnLine SC 98 , wherein it was observed that the dictum in C himanlal
( supra ) construes the term “substances” as corporeal matter that is used for
treatment but constitutes a class of items different from “medicine”. However,
for the term to be read so, it becomes imperative to understand the word “and”
in the expression “ all medicines for internal or external use of human beings
or animals and all substances intended to be used for or in the diagnosis,
treatment, mitigation or prevention of any disease or disorder in human
beings or animals ” used in Section 3(b)(i) and the same has to be read in a
disjunctive manner. The relevant observation of this Court in Ishwar Singh
Bindra ( supra ) read thus:
“10. […] The dictionary meaning of the words "medicines and
substances" may be noticed. In Shorter Oxford English
Dictionary the appropriate meaning of "medicine" is
"medicament especially one taken internally- medicament
generally". The meaning of "substance" relevant for our
purposes is "any particular kind of corporeal matter-a species
of matter of a definite chemical position-a piece or a mass of
W.P. (C) No. 369 of 2022 Page 61 of 98

particular kind of matter-a body of a specified composition or
texture".
11. Now if the expression "substances" is to be taken to mean
something other than "medicine" as has been held in our
previous decision it becomes difficult to understand how the
word "and" as used in the definition of drug in Section 3(b)(i)
between "medicines" and "substances" could have been
intended to have been used conjunctively. It would be much
more appropriate in the context to read it disjunctively [sic]. In
Stroud's Judicial Dictionary, 3rd Edn. it is stated at p. 135 that
"and" has generally a cumulative sense, requiring the fulfilment
of all the conditions that it joins together, and herein it is the
antithesis of or. Sometimes, however, even in such a connection,
it is, by force of a contexts, read as "or". Similarly in Maxwell
on Interpretation of Statutes, 11th Edn., it has been accepted
that "to carry out the intention of the legislature it is
occasionally found necessary to read the conjunctions 'or' and
'and' one for the other".
(Emphasis supplied)
103. What is discernible from the aforesaid is that though stem cells may not,
strictly speaking, qualify as ‘medicines’ yet, they would fall within the
purview of “drugs” as ‘substances’ under Section 3(b)(i). We say so because
stem cells can be said to be corporeal matter, a species of matter of a definite
chemical position, a piece or a mass of particular kind of matter, a body of a
specified composition or texture, and is intended to be used for or in the
treatment of diseases of human beings or animals. Accordingly, stem cells
satisfy the statutory description of “ substances intended to be used for or in
the treatment of diseases ”.
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104. The Drugs Act, 1940 along with the Rules thereto make a further sub-
categorization of “new drugs”. It is worth noting that there is a sub-set within
the category of stem cells, that falls within the category of “new drugs”. Rule
2(1)(w) of the NDCT Rules, 2019, defines the term “new drug” and sub-clause
(v) of the said provision categorizes “stem-cell derived product…intended to
be used as drug ” within the said definition. The Explanation to Rule 2(1)(w)
goes on to state that drugs referred to in sub-clauses (iv) and (v) shall always
be deemed to be new drugs. Rule 2(1)(w)(v) along with the corresponding
Explanation reads as follows:
“2. Definitions
(1) In these rules, unless the context otherwise requires,—
*
(w) "new drug" means,—
*
(v) a vaccine, recombinant Deoxyribonucleic Acid (r-
DNA) derived product, living modified organism,
monoclonal anti-body, cell or stem cell derived product,
gene therapeutic product or xenografts, intended to be
used as drug;
Explanation: The drugs, other than drugs referred to in
sub-clauses (iv) and (v), shall continue to be new drugs
for a period of four years from the date of their
permission granted by the Central Licencing Authority
and the drugs referred to in sub-clauses (iv) and (v) shall
always be deemed to be new drugs;
(Emphasis supplied)

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105. It is important to note that the Explanation to Rule 2(1)(w) of the NDCT
Rules, 2019, places a deeming provision due to which drugs referred to in sub-
clauses (iv) and (v) shall always be deemed to be new drugs. Due to this
deeming provision, stem-cell derived products shall always be deemed to be
‘new drugs’. The perpetual nature of this categorization is particularly
important from a regulatory point of view. The legislature, through the
deeming provision in the Explanation, has expressed its intention to keep
stem-cell derived products under the licensing purview of the Central
Licensing Authority only when such products are being used for commercial
purposes. A perusal of the statutory scheme of the NDCT Rule, 2019 indicates
that such higher threshold of scrutiny is present only for stem-cell derived
products and not for stem cells in general.

106. With a view to obviate any confusion amongst the stakeholders dealing with
stem cells, we may clarify the meaning of the term “stem cell derived
product”. We may refer to the directions issued by the Drugs Regulation
Section, Department of Health & Family Welfare, MoHFW, Government of
India Section 33P of the Drugs Act, 1940 along with the clarification dated
09.02.2021 (“ MoHFW Clarification” ) , which reads thus:
“It is clarified that "stem cell derived product" means a drug
which has been derived from processed stem cells and which
has been processed by means of substantial or more than
minimal manipulation with the objective of propagation and /
or differentiation of a cell or tissue, cell activation, and
production of a cell-line, which includes pharmaceutical or
chemical or enzymatic treatment, altering a biological
characteristic, combining with a non- cellular component,
manipulation by genetic engineering including gene editing &
gene modification.
W.P. (C) No. 369 of 2022 Page 64 of 98


For the above purpose:
i. Substantial or more than minimal manipulation means
ex-vivo alteration in the cell population (T-Cell
depletion, cancer cell depletion), expansion, which is
expected to result in alteration of function.

ii. The isolation of tissue, washing, centrifugation,
suspension in acceptable medium, cutting, grinding,
shaping, disintegration of tissue, separation of cells,
isolation of a specific cell, treatment with antibiotics,
sterilization by washing or gamma irradiation, freezing,
thawing and such similar procedures are regarded as
minimal manipulation and are not considered as
processing by means of substantial or more than minimal
manipulation.

iii. Stem cells removed from an individual for
implantation of such cells only into the same individual
for use during the same surgical procedure should not
undergo processing steps beyond rinsing, cleaning or
sizing and these steps shall not be considered as
processing.

Further, the cell based products and tissue based products
which have been processed by means of substantial or more
than minimal manipulation as per criteria mentioned above are
also covered under the New Drugs and Clinical Trials Rules,
2019.”
(Emphasis supplied)

107. The aforesaid clarification dated 09.02.2021 indicates that not all types of
stem cells would amount to “stem-cell derived product” under Rule
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2(1)(w)(v) of the NDCT Rules, 2019. Whether a particular type of stem cell
qualifies as a “stem-cell derived product” would depend on (i) the stem cell
being “processed”, and (ii) the degree of manipulation that such stem cell is
subjected to. If a stem cell has been processed by means of substantial or more
than minimal manipulation, only then will such stem cell become a stem-cell-
derived product and fall within the definition of “new drugs” under Rule
2(1)(w) of the NDCT Rules, 2019. The MoHFW Clarification also provides
what amounts to processing and substantial or more than minimal
manipulation.
108. We find it apposite to note that clause (iii) of the MoHFW Clarification places
a restriction on the processing that a stem cell could be subjected to, when it
is removed from an individual for implantation of such cells in the same
individual, for use during the same surgical procedure (autologous stem cells).
Such processing is limited to the extent of rinsing, cleaning or sizing which
are not considered to be “processing” itself for the purposes of the NDCT
Rules, 2019. What can be discerned from the MoHFW Clarification and the
definition of stem-cell derived products therein, is that autologous stem cells
for the purpose of implantation during the same surgical procedure would not
qualify as stem-cell derived products in terms of the Drugs Act, 1940 and
NDCT Rules, 2019. Naturally, such stem cells would not be considered a
“new drug” under the NDCT Rules, 2019.
109. However, we may clarify with a view to obviate any confusion, that though
autologous stem cells such as those used for the therapy provided to persons
with ASD, do not meet the criteria of being a new drug under the NDCT
Rules, 2019, yet they fall under the broader definition of “drugs” in the Drugs
W.P. (C) No. 369 of 2022 Page 66 of 98

Act, 1940. Therefore, the protections available under the scheme of the said
Act is available even in respect of such medicines or substances that do not
qualify as new drugs governed by the NDCT Rules, 2019.
110. In such view of the matter, it cannot be said that the standard of adequate
scientific evidence as regards the efficacy of a drug or treatment is
inapplicable to the stem cell therapies merely because such therapies are not
governed as “new drugs” by the NDCT Rules, 2019. Though such therapies
may not be “new drugs”, yet their novel and evolving nature remains
undisputed. For this reason, we may say without any manner of doubt that the
therapeutic use of stem cells for treatment of ASD cannot be recognized as ‘a
sound and relevant medical practice’ unless there is scientific material on
record to indicate its efficacy and safety standards.
111. In our considered view, the only situation in which administration of stem
cells for therapeutic use in ASD may be permissible is within the
research/clinical trial setting. To do so, it is imperative for us to delineate a
regulatory pathway for the same.
(ii) Regulatory pathway to be followed for administering stem cells for
therapeutic use in ASD in Clinical Trial/Research setting

112. We have already concluded that since therapeutic use of stem cells in ASD
is not recognised as ‘a sound and relevant medical practice’ on the basis of
present scientific knowledge, medical practitioners who offer the same as a
clinical service, outside an approved and monitored research/clinical service,
fail to meet the reasonable standard of care owed by them towards their
patients. However, this does not prevent research in the field of stem cell for
W.P. (C) No. 369 of 2022 Page 67 of 98

potential therapeutic use in ASD, provided that the same is undertaken
strictly within the confines of an approved and monitored clinical
trial/research setting. The regulatory framework for conducting such research
or clinical trial would vary, depending on whether the stem cell proposed to
be administered amount to being “stem-cell derived product” or not.

113. In case of administration of “stem-cell derived products”, the regulatory
framework applicable to clinical trials of “new drugs” under the NDCT, 2019
read with the Drugs Act, 1940 and the Drugs Rules, 1945 is attracted. The
NDCT Rules, 2019 mandate the creation of an Ethics Committee (the “ EC ”)
at an institutional level under Rule 7 thereof and such Committee is required
to apply for registration in terms of Rule 8. The Central Licensing Authority,
upon a scrutiny of the information and documents furnished along with the
application, may either register the EC or reject the application. Such
registration, when granted, remains valid for a period of five years from the
date of issuance, unless suspended or cancelled by the Central Licensing
Authority. Once the EC is registered, it becomes competent to grant approval
to any clinical trial being conducted by the institution which falls under the
Committee’s purview. This stipulation is limpid from the perusal of Rule 6 of
the NDCT Rules, 2019. In other words, whoever intends to conduct clinical
trial of a stem-cell derived product, would necessarily be required to have
approval of an EC to do so.

114. In the process of granting such approval, the EC, by virtue of Rule 11 of the
NDCT Rules, 2019, is tasked with the function to review and accord approval
to a clinical trial study protocol and other related documents, and to oversee
the conduct of clinical trials to safeguard the rights, safety and wellbeing of
W.P. (C) No. 369 of 2022 Page 68 of 98

trial subjects in accordance with the NDCT Rules, 2019, the CDSCO Good
Clinical Practices guidelines and other applicable regulations. The host of
functions which the EC has been tasked with under Rule 11, indicates that the
it plays a pivotal role in monitoring and ensuring regulatory compliance and
stakeholder safety. Such role is further underscored by Rule 20 of the NDCT
Rules, 2019 which states that the work of every clinical trial site shall be
overseen by the EC before the initiation and throughout the duration of such
clinical trial.

115. The EC in turn is under the supervision of the Central Licensing Authority,
which has been empowered under Rule 14 of the NDCT Rules, 2019 to take
action against an EC that fails to comply with any provision of the Drugs Act,
2019 or the NDCT Rules, 2019. Once the clinical trial protocol is approved
by the EC, the person/institution/organisation which intends to conduct the
clinical trial would have to make an application to the Central Licensing
Authority seeking prior permission to conduct clinical trial of the new drug,
as per Rule 21 of the NDCT Rules, 2019. If such permission is granted under
Rule 22 of the NDCT Rules, 2019, then the entire regulatory framework
applicable to clinical trials, including the safeguards put in place for the trial
subjects would be applicable to the clinical trial involving administration of
stem cell derived products. Rule 25(xvi) of the NDCT Rules, 2019 also
empowers the Central Licensing Authority to exercise its discretion in order
to impose any other condition in writing with justification, in respect of
specific clinical trials, regarding the objective, design, subject population,
subject eligibility, assessment, conduct and treatment of such specific clinical
trial.

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116. Therefore, a bare perusal of the scheme of the NDCT Rules, 2019 indicates
that there is a robust mechanism in place to govern the clinical trials of “new
drugs” including “stem-cell derived products”. However, as we have pointed
out in the aforesaid, the stem cells employed for therapeutic use in the
treatment of ASD do not fall under the category of stem-cell derived products.
Such cells being autologous cells that are to be implanted during the same
surgical procedure, do not undergo processing that meets the threshold of
substantial manipulation [See: MoHFW Clarification dated 09.02.2021].

117. On a plain reading of the NDCT Rules, 2019, it is clear that the stem cells
which have not undergone processing by means of substantial or more than
minimal manipulation, would not be considered as a “new drug”. In such
view of the matter, any research involving such stem cells is to be governed
by the regulatory framework in place for “biomedical and health research”
under Chapter IV of the NDCT Rules, 2019. Rule 2(1)(g) of the NDCT Rules,
2019 defines “biomedical and health research” in the following terms:
“ 2. Definitions

(1) In these rules, unless the context otherwise requires,—
*
(g) biomedical and health research" means research including
studies on basic, applied and operational research or clinical
research, designed primarily to increase scientific knowledge
about diseases and conditions (physical or socio-behavioural);
their detection and cause; and evolving strategies for health
promotion, prevention, or amelioration of disease and
rehabilitation but does not include clinical trial as defined in
clause (j)”

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118. What is discernible from the aforesaid definition is that clinical trials
prescribed for the investigation of a “new drug”, are excluded from the ambit
of “biomedical and health research”. Though such a position is apparent from
the bare textual reading of Rule 2(1)(g), yet it cannot be said that clinical trials
have been given a go by entirely. We say so upon a reading of Rules 15 and
16(4) of the NDCT Rules, 2019. These provisions make the National Ethical
Guidelines for Biomedical and Health Research Involving Human
Participants (referred to as the “ National Ethical Guidelines ”) binding on the
conduct of any research that falls under the scope of Chapter IV of the NDCT
Rules, 2019. Clauses 4.2.4 and 7.9 of the National Ethical Guidelines, issued
by the ICMR, are of significance to the regulatory framework for biomedical
and health research because of the legal enforceability accorded to these
provisions by the NDCT Rules, 2019. Clauses 4.2.4 and 7.9 of the National
Ethical Guidelines read thus:
“4.2.4. Stem cell proposals should be reviewed and approved
by the institutional committee for stem cell research (IC-SCR)
before being submitted to the EC for consideration, in
accordance with the National Guidelines for Stem Cell
Research (2017).
---xxx---
“ 7.9.1 Except haemopoietic stem cell transplantation for
haematological disorders, any other uses of stem cells are
categorized as research and must be conducted as clinical
trials, needing the approval of the EC, IC-SCR (permissible
research), National Apex Committee for Stem Cell Research
and Therapy (NAC-SCRT) (restricted research) and CDSCO
(IND products and drugs) as the case may be." Use of stem cells
outside the domain of a clinical trial for any purpose is
considered unethical and hence not permissible. ”
(Emphasis supplied)
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119. Clauses 4.2.4 and 7.9.1 lend clarity as regards the regulatory regime for any
research in stem cells that do not undergo processing by means of substantial
or more than minimal manipulation, while carving out an exception for
haemopoietic stem cell transplantation for haematological disorders. In other
words, Rules 15 and 16(4) of the NDCT Rules, 2019, by giving binding effect
to the National Ethical Guidelines, mandate that any research involving stem
cells would have to be undertaken as a clinical trial. The natural corollary of
this stipulation is that the therapeutic use of such stem cells cannot be offered
as a medical treatment for ASD.

120. Having conclusively established that stem cell therapy for ASD can be
administered only in clinical trial/research setting, we may look at the binding
nature of the ICMR guidelines from one another angle. Regulation 7.22 of the
Indian Medical Council (Professional Conduct, Etiquette and Ethics)
Regulations, 2002 (the “ IMC Regulations, 2002 ”) promulgated under the
Indian Medical Council Act, 1956 (“ IMC Act, 1956 ”) enjoin upon the
medical practitioners, the duty of following the ICMR guidelines while
undertaking research that involves patients or volunteers. Since the
administration of stem cells would necessarily have to be undertaken in the
form of research, Regulation 7.22 gains significance as it has the effect of
making inter alia , the NGSCR, 2017 as well as the National Ethical
Guidelines, binding on medical practitioners.

121. It may be argued by the respondents herein that the IMC Regulations, 2002
cease to place any legal obligations after the enactment of the National
Medical Council Act, 2019 (the “ NMC Act, 2019 ”) which repeals the IMC
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Act, 1956. However, Section 61(2) of the NMC Act, 2019, which is a
transitory provision, lends much clarity in this regard. Section 61(2) provides
that till new standards or requirements are specified under the NMC Act, 2019
or the rules and regulations are made thereunder, the provisions under the
Erstwhile IMC Act, 1956 or regulations thereunder, viz. IMC Regulations,
2002, shall continue to remain in force.

122. It can be clearly discerned from the aforesaid that Regulation 7 of the IMC
Regulations, 2002 shall continue to be in force. Regulation 7 provides a list
of acts, commission or omission that constitute professional misconduct and
render a medical practitioner liable for disciplinary action. We may refer to
Regulation 7.22 which relates to actions that constitute professional
misconduct during conduct of research. The said provision reads thus:
“ 7.22: Research: Clinical drug trials or other research
involving patients or volunteers as per the guidelines of ICMR
can be undertaken, provided ethical considerations are borne
in mind. Violation of existing ICMR guidelines in this regard
shall constitute misconduct. Consent taken from the patient for
trial of drug or therapy which is not as per the guidelines shall
also be construed as misconduct.
(Emphasis supplied)

123. The aforesaid rules and regulations promulgated under the Drugs Act, 1940
and the IMC Act, 1956 respectively, leave no manner of doubt in our minds
that the ICMR Guidelines, more particularly, the NGSCR 2017 and the
National Ethical Guidelines, are statutory mandates and not mere guiding
principles for the purpose of research in the field of therapeutic use of stem
cells for treatment of ASD. Therefore, there is no gainsaying that the guideline
requiring the administration of stem cells to be done in a clinical trial/research
W.P. (C) No. 369 of 2022 Page 73 of 98

setting are binding in nature and any failure to do so would constitute
professional misconduct.

124. Though the legal obligation as regards the regulation of stem cells that are not
stem-cell derived products is clearly traceable to the NDCT Rules, 2019 as
well as the IMC Regulations, 2002, yet it is imperative to note that the
provisions thereunder do not directly address the requirement of clinical trials.
The NDCT Rules, 2019 provide that for the categories of stem cells that
qualify as “new drugs” under the NDCT Rules, 2019, the requirement to
follow the clinical trial pathway flows as a matter of statutory mandate. On
the other hand, stem cells that do not meet the threshold of a “new drug” are
presently subjected to the clinical trial regulatory framework by virtue of
Clause 4.2.4 and Clause 7.9.1 of the Ethical Guidelines, 2017. In other words,
the normative source for the regulation of stem cells that do not undergo
substantial or more than minimal manipulation is found in the Guidelines of
ICMR rather than the NDCT Rules, 2019 or the IMC Regulations, 2002.
These ICMR Guidelines, such as the National Ethical Guidelines are
susceptible to change at an institutional level, unlike parliamentary
enactments or delegated legislations.

125. Section 38 of the Drugs Act, 1940 mandates that every rule made under the
Act shall be laid as soon as may be after it is made, before each House of
Parliament. Therefore, amendments made to the NDCT Rules, 2019 are
required to be presented before the Parliament for approval. However, there
is no corresponding requirement for an amendment brought about in the
Ethical Guidelines, thereby making it more readily amendable. What follows
from the aforesaid is that the regulatory framework for clinical trials in cases
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of administering of stem cells other than stem-cell derived products, is
dependent on and subject to any changes in the National Ethical Guidelines
and such amendments thereto are not afforded the same statutory safeguards
as the Rules themselves that make the Guidelines legally enforceable.

126. Further, the distinction in normative source is crucial because there is a sharp
difference in the safeguards that are available to subjects of a clinical trial as
opposed to those of a biomedical and health research. While the NDCT Rules,
2019 emphatically provide for safety measures such as medical management
and compensation in case of serious adverse events, there is no corresponding
mandatory liability in case of biomedical and health research, and it has been
left to the discretion of the respective ECs to decide the appropriate quantum,
if any, of the same.

127. The normative basis would also assume importance because it places a
practical obligation on the medical practitioner, institution, or organisation to
correctly determine whether the stem cells proposed to be administered have
undergone processing by means of substantial or more than minimal
manipulation that would render them as a new drug. This evaluative step is
fundamental to identifying the applicable regulatory pathway, i.e. whether to
be regulated as a clinical trial or as a biomedical and health research. While it
would not be a concern in the present state of things, if, at a subsequent point
in time, the National Ethical Guidelines were to be modified in a manner that
no longer renders all stem cell research as clinical trials, this distinction would
also need a provision to keep in check any attempt to circumvent the
applicable regulatory framework through non-disclosure or misrepresentation
of the degree of processing. While penalty can be imposed under Section
W.P. (C) No. 369 of 2022 Page 75 of 98

27(d) read with Section 18 of the Drugs Act, 1940 for manufacture of stems
cell amounting to drugs in contravention of the Drugs Act, 1940 or any rule
made thereunder, there is no corresponding deterrent beyond suspension or
cancellation of the EC registration for any violation of applicable provision
with respect to biomedical and health research.

128. It is as clear as a noon day that the lack of safeguards for biomedical and health
research in therapeutic use of stem cells is stark. However, even in light of
such glaring differences in how stem cells are regulated depending on their
manipulation, could it be said that those stem cells that do not undergo
substantial manipulation do not attract obligations arising from ethical
considerations in medicine? The answer to this question must be an emphatic
‘No’. As discussed in the aforesaid parts of this judgment, consent based on
adequate information is the bedrock of any medical decision made by both the
doctor and patient. This has been underscored in the National Ethical
Guidelines which warns about ethical problems like ‘therapeutic
misconception’. In our considered opinion, the manner in which the stem cell
therapies are being offered for treatment of ASD is illustrative of such
‘therapeutic misconception’.

129. We say so because the treatment is provided by clinics commercially and
suggested in alternative to other treatments available for ASD. As a
consequence, the parents and guardians who are presented with this treatment
option form the mistaken expectation that the goal of the treatment is their
direct personal benefit, much like routine medical care. However, for a novel
treatment method that has minimal scientific support, the standard of care that
ought to be provided in routine care and treatment can never be achieved. The
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only result that is possible to be achieved from performing novel treatments
is the production of generalizable knowledge. The benefits of conventional
medical treatment stand on the substructure of knowledge accumulated from
empirical analysis of the effects of such treatment. To lead patients and their
guardians to put faith in treatments wherein this substructure itself is absent
is, in our view, wholly unethical and against the tenets of medical
jurisprudence on ‘informed consent’.

130. We may refer to the broad principles laid down by this Court in Samira Kohli
(supra) while addressing the essentials of informed consent:
(i) First, consent obtained by a medical practitioner must be real and valid.
It is imperative that the following three conditions are met for a patient’s
consent to be valid:
• the patient should have the capacity and competence to consent;
• consent should be voluntary; and
• consent should be on the basis of adequate information,
concerning the nature of the treatment procedure, so that the
patient knows what the consent is for.
(ii) Secondly, “adequate information” about a procedure or treatment must
necessarily consist information about
• the nature and procedure of the treatment;
• its purpose and benefits;
• its likely effects and complications;
• any alternatives, if available;
• an outline of the substantial risks; and
• adverse consequences of refusing the treatment.
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131. Keeping the above principles in mind and the description and
recommendations of the ICMR as regards the therapeutic use of stem cells for
the treatment of ASD, we are of the view that the requirement of “adequate
information” about the said treatment method is not fulfilled simply because
sufficient information is not available regarding the same. Therefore, the
requirement of clinical trials and research in respect of a novel and
unconventional treatment method that is yet not supported by scientific
evidence, flows from core ethical considerations in medicine. The lack of a
clear regulatory framework is an issue of implementation of these core ethical
considerations. Any use of such lacunae to offer stem cell therapy as a routine
treatment in alternative to other options, is a contorted understanding of the
legal and ethical framework and hence, impermissible.

132. Be that as it may, in the instant case, the regulatory framework laid by the
NDCT Rules, 2019 and IMC Regulations, 2002, which make the NGSCR,
2017 and National Ethical Guidelines binding, provides adequate statutory
basis for us to hold that the use of stem cell therapy for treatment of ASD is
to be done only in a clinical trial/ research setting. What remains to be seen is
the workability of this regulatory framework.

133. Clause 7.9.1 of the National Ethical Guidelines mandates that use of stem cells
in a clinical trial/research setting requires the approval of the National Apex
Committee for Stem Cell Research and Therapy (NAC-SCRT). However, the
Order dated 03.03.2024 issued by the DHR dissolved the NAC-SCRT and
made it mandatory for the ethics committee for stem cell research involving
W.P. (C) No. 369 of 2022 Page 78 of 98

human participants to have a minimum of two stem cell experts in the ethics
committee. The dissolution of the sole national level body for the regulation
of research in stem cells is a major setback, especially when there is no
corresponding amendment to the National Ethical Guidelines that may offer
clarity in this regard. Even if we attempt to trace the regulatory powers to the
DHR, which is the parent institution under which the Erstwhile NAC-SCRT
was functioning, yet, Clause 2(vi) of the Order dated 03.03.2024 makes it
difficult for us to do so. The Order dated 03.03.2024 reads thus:

“ Sub: Dissolving the National Apex Committee for Stem Cell
Research and Therapy -reg
In supersession of this Department's order No. Q-
11011/15/2020- HR(ICMR)/eoffice -8076452 dated 25th
September 2020 on reconstitution of National Apex Committee
for Stem Cell Research and Therapy, it has been decided by the
competent authority to dissolve the National Apex Committee
for Stem Cell Research and Therapy (NAC- SCRT).

2. The undersigned is directed to convey that:
(i) The National Apex Committee for Stem Cell Research
and Therapy (NAC-SCRT has been dissolved and the
requirement of registration of IC- SCR with NAC-SCRT
is no longer required.

(ii) Stem cell research involving human participants,
their biological material and data will be reviewed by
Ethics committees (EC) with minimum two stem cell
experts in the Ethics committee.

(iii) The stem cell experts who attend the meeting may be
free from conflict of interest. They need not be permanent
members of IEC but may be co-opted whenever there are
W.P. (C) No. 369 of 2022 Page 79 of 98

stem cell related proposals. These stem cell experts
should be considered as part of quorum for the meeting
and at least one expert should be external.
(iv) EC will continue to be registered mandatorily with
DHR.
(v) EC must also be registered with CDSCO if its clinical
Trial.
(vi) No regulatory role is anticipated to be carried out by
DHR related to stem cell research.
(vii) Other stem cell related studies including basic/non
clinical /animal related studies may be reviewed at
institutional level.

3. This issues with the approval of Competent Authority.”
(Emphasis supplied)
134. A plain reading of the above-mentioned Order dated 03.03.2024 indicates that
there is a lacuna resulting in regulatory ambiguity for research involving stem
cells which are not stem-cell derived products. Though the National Ethical
Guidelines mandate that any research in the use of stem cells shall necessarily
be by way of a clinical trial, yet the larger regulatory framework within which
such Guidelines also function is provided by the Chapter IV of the NDCT
Rules, 2019 governing biomedical and health research. Rules 17 and 18
envisage a central role for the DHR in exercising an oversight on the ECs.
Rule 17 mandates an Ethics Committee constituted for such biomedical and
health research, to register with the authority designated by the DHR, and
empowers such designated authority to issue warning, suspend, debar or
cancel the registration of an ethics committee in case of any failure in
compliance. The offshoot of such oversight is the role of regulating
biomedical and health research through the Ethics Committees.
W.P. (C) No. 369 of 2022 Page 80 of 98

135. The National Ethical Guidelines provide that for biomedical and health
research in the field of stem cells that involves human participants, the NAC-
SCRT would be the body granting approval for restricted research in stem
cells. However, the Order dated 03.03.2024, for reasons unknown to us,
dissolved the NAC-SCRT and the regulatory oversight of stem cell research
was completely transferred to the institution specific ECs. In view of these
developments, the role of the DHR as envisaged by Rules 17 and 18 of the
NDCT Rules, 2019, gains prominence. We say so because, after the
dissolution of the NAC-SCRT, the results of stem cell research involving
human participants is to be reviewed by the ECs and in terms of the NDCT
Rules, 2019, the DHR exercises oversight on the ECs.

136. Having discussed the role of DHR as per the NDCT Rules, 2019, we may now
refer once again to the Order dated 03.03.2024, more particularly Clause 2(vi)
thereof which states that “ no regulatory role is anticipated to be carried out
by DHR related to stem cell research ”. Therefore, the said Order not only
dissolves the NAC-SCRT but also carves an exception as regards research in
stem cell in order to remove the DHR from performing any regulatory role in
the field. This presents an evident conflict between the NDCT Rules, 2019
and the Order dated 03.03.2024. Further, such conflict, if permitted to subsist,
would virtually amount to allowing an Executive Order to cut down the scope
of statutory rules and creating a regulatory vacuum in respect of stem cell
research.

137. We may refer to this Court’s dictum in State of M.P. v. G.S. Dall and Flour
Mills , reported in 1992 Supp (1) SCC 150 wherein it was held that Executive
W.P. (C) No. 369 of 2022 Page 81 of 98

instructions can only supplement a statute to address areas that are within the
statute’s purview but have not been covered thereby. However, in no situation
can such instructions run contrary to statutory provisions or whittle down their
effect. In Jaiveer Singh v. State of Uttarakhand , reported in (2024) 15 SCC
227 , this principle has been reiterated to establish the supremacy of statutory
rules. The relevant portion of the judgment in Jaiveer Singh (supra) is
reproduced below:
“45. It can thus be seen that it is a trite law that the Government
cannot amend or supersede statutory rules by administrative
instructions, but if the rules are silent on any particular point,
it can fill up the gaps and supplement the rules and issue
instructions not inconsistent with the rules already framed. It is
a settled proposition of law that an authority cannot issue
orders/office memorandum/executive instructions in
contravention of the statutory rules. However, instructions can
be issued only to supplement the statutory rules but not to
supplant it.”
(Emphasis supplied)

138. The aforesaid exposition lends much clarity as regards the applicability of
Clause 2(vi) of the Order dated 03.03.2024. We are of the considered view
that, in light of the Rules 17 and 18 of the NDCT Rules, 2019, excepting
research relating to stem cells from the regulatory purview of the DHR is not
possible. Therefore, the conduct of ECs in reviewing clinical trials for
biomedical and health research in stem cells has to be monitored closely and
regularly by the DHR or any authority appointed by it for this purpose.

139. Having gone through the NGSCR, 2017 and National Ethical Guidelines, we
find it apposite to note that stem cell research requires proper regulation
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backed by legislative mandate. Though the scheme of the NDCT Rules, 2019
and IMC Regulations, 2002 enable oversight, yet it would not be improper to
say that such scheme is far from ideal. In our considered view, there must be
a dedicated regulatory pathway for stem cell research including the
therapeutic use of the same for ASD along with a dedicated monitoring
authority. We insist on this for the sole reason that ambiguity in law should
not result in such lack of awareness amongst the public that it can be
capitalized on by persons interested in commercialization and profits.
Therefore, we call upon the MoHFW to reconsider this position and to clearly
specify the regulatory mechanism as well as the authority that shall exercise
regulatory oversight over biomedical and health research on stem cells
involving humans.
(iii) Consequences of non-compliance:
140. As per Section 27(1)(b) of the NMC Act, 2019, the EMRB has the power to
regulate professional conduct and promote medical ethics in accordance with
the regulations framed thereunder, provided that the EMRB ensures
compliance of the code of professional and ethical conduct through the State
Medical Council in a case where such State Medical Council has been
conferred power to take disciplinary actions in respect of professional or
ethical misconduct by medical practitioners under the respective State Acts.
Moreover, as per Section 27(2) of the NMC Act, 2019, the EMRB may, in the
discharge of its functions, make such recommendations to, and seek such
directions from, the NMC, as it deems necessary.

141. Sections 27(1)(b) and 27(2), respectively, read thus:

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“ 27. Powers and functions of Ethics and Medical Registration
Board.- (1) The Ethics and Medical Registration Board shall
perform the following functions, namely:-
…
(b) regulate professional conduct and promote medical ethics
in accordance with the regulations made under this Act:
Provided that the Ethics and Medical Registration Board
shall ensure compliance of the code of professional and ethical
conduct through the State Medical Council in a case where such
State Medical Council has been conferred power to take
disciplinary actions in respect of professional or ethical
misconduct by medical practitioners under respective State
Acts;
…
(2) The Ethics and Medical Registration Board may, in the
discharge of its duties, make such recommendations to, and
seek such directions from, the Commission, as it deems
necessary.”
(Emphasis supplied)

142. A perusal of Section 27(1)(b) & (2) of the NMC Act, 2019 would indicate
that though the EMRB has been conferred with the power to regulate
professional conduct and to promote medical ethics, yet such powers will have
to be exercised in accordance with the regulations framed under the NMC Act
itself, under Section 57 thereof. Section 57 of the NMC Act, 2019 reads as
follows:
“ 57. Power to make regulations.—(1) The Commission may,
after previous publication, by notification, make regulations
consistent with this Act and the rules made thereunder to carry
out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the
foregoing power, such regulations may provide for all or any of
the following matters, namely:—
…
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(zd) the manner of regulating professional conduct and
promoting medical ethics under clause (b) of sub-section
(1) of section 27;
…
(zi) the act of commission or omission which amounts to
professional or ethical misconduct under
clause (b) of the Explanation to section 30;”

143. It is worth noting that no regulations under Section 57 have been promulgated.
In such view of the matter, we may refer to Section 61(2) of the NMC Act,
2019 which provides for transitory provisions and ensures that the rules and
regulations promulgated under the Erstwhile IMC Act, 1956 continue to
occupy the field till the time regulations under the new NMC Act, 2019 are
introduced. Section 61(2) of the NMC Act reads as follows:
“ 61. Transitory provisions.-
…
(2) Notwithstanding the repeal of the Indian Medical Council
Act, 1956 (102 of 1956), the educational standards,
requirements and other provisions of the Indian Medical
Council Act, 1956 and the rules and regulations made
thereunder shall continue to be in force and operate till new
standards or requirements are specified under this Act or the
rules and regulations made thereunder:
Provided that anything done or any action taken as
regards the educational standards and requirements under the
enactment under repeal and the rules and regulations made
thereunder shall be deemed to have been done or taken under
the corresponding provisions of this Act and shall continue in
force accordingly unless and until superseded by anything done
or by any action taken under this Act.”
(Emphasis supplied)

144. Since Section 61(2) states that the regulations made under the Indian Medical
Council Act, 1956 would continue to be in force and operate till new standards
W.P. (C) No. 369 of 2022 Page 85 of 98

or requirements are specified under the NMC Act, 2019, the IMC Regulations,
2002 promulgated under the Erstwhile IMC Act, 1956, would continue to be
in force till the new regulations are in place.

145. Accordingly, Regulation 7 read with Regulation 8 of the IMC Regulations,
2002, which provide that commission of a professional misconduct would
render a medical practitioner liable for disciplinary action, govern conduct in
providing treatment or furthering research through clinical trial. Regulations
7 and 8 are squarely attracted if a medical practitioner administers, promotes
or advertises the therapeutic use of stem cells, outside of a clinical
trial/biomedical and health research setting, or if the ICMR guidelines are
violated in respect of the same.

146. As regards the errant clinics/organisations, we are of the firm view that action
must be taken against them by the appropriate authority, under Section 32 and
Section 40 respectively, of the Clinical Establishments (Registration and
Regulation) Act, 2010, which provide for the cancellation of registration and
penalty.

147. We also find it apposite to clarify that the regulatory framework under the
Drugs Act, 1940, read with the NDCT Rules, 2019, the National Ethical
Guidelines and the NGSCR, 2017, extends to the commercial banking and
processing of stem cells. According to Clause 14 of the NGSCR, 2017,
commercial banking of only Umbilical Cord Blood stem cells is permitted,
and licenses have to be issued for the same by the CDSCO. It must be noted
that commercial banking of all other biological materials is prohibited until
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there is further notification in this regard. Moreover, Rule 52 of the NDCT
Rules, 2019 prohibits manufacture of a new drug even for the purpose of
clinical trial or for examination, test and analysis without obtaining prior
permission from the Central Licensing Authority. Section 3(f) of the Drugs
Act, 1940 defines ‘manufacture’ broadly to include any process or even part
of a process for making, altering, ornamenting, finishing, packing, labelling,
breaking up or otherwise treating or adopting any drug with a view to its sale
or distribution. Consequently, any entity that intends to undertake even a part
of the processing of stem cells, would be required to obtain necessary prior
approvals which are to be undertaken for biomedical and health research, or
clinical trial, depending on the degree of processing involved. Therefore,
respondent no. 11’s contention that it is not bound by any regulation because
it does not administer the stem cells but merely processes them for
procurement by end-users such as hospitals/clinics/doctors or patients, is held
to be incorrect
E. SOME MEANINGFUL SUGGESTIONS

148. The discussion in the aforesaid is indicative of the shortfalls and faultlines in
the regulatory mechanism for stem cell research. Considering the nature of
such research and its potential, it is imperative to ensure that the law in this
regard is accessible and clear. As things currently stand, the legal framework
pertaining to stem cell research is fragmented and spread out across
legislations with little harmony. This makes both compliance and enforcement
an uphill task. The obscurity in the legal regime also enables manipulation of
patients’ vulnerabilities by errant medical practitioners. Such obscurity,
whether conscious or unintended, has arisen directly from legislative
shortsightedness.
W.P. (C) No. 369 of 2022 Page 87 of 98


149. In such view of the matter, we find it apposite to suggest the consolidation of
the rules, regulations and guidelines to govern stem cell based clinical trials
1
and research. The legislation ought to address the following points :
i. Clearly define stem cells and their derivates.
ii. Lay down a specific procedure for application for clinical trials,
including a flexible yet definite list of standards or guidelines that need
to be adhered to. Ideally, the NGSCR, 2017 and the National Ethical
Guidelines should be given a clearer statutory recognition through these
provisions.
iii. Set up a protective net for the safety and welfare of human subjects in
these trials through a rights-based approach through patient disclosure
and consent protocols. If the patient is opting for an unproven therapy
in a clinical trial setting, then higher standard of voluntary free
informed consent and associated protocols must be set. The patients
undergoing experimental therapies in clinical trial setting should not be
charged any amount for ‘treatment’, rather their participation is
voluntary. In case of injury or death, there should be a provision for
interim compensation on immediate basis.
iv. Provide a reasonable timeline for the completion of the licensing and
approval procedures.
v. Provide for periodic inspections of the clinical trial site.

1
Vaishnav M., “ The Indian regulatory framework and the surge of unproven stem cell therapies—a call for
diagnosis ”, 12 (2) Journal of Law and the Biosciences (2025), available at:
https://academic.oup.com/jlb/article/12/2/lsaf027/8329365
W.P. (C) No. 369 of 2022 Page 88 of 98

vi. Specify the procedure for approval and licensing of stem cell banks,
along with the list of standards and guidelines that need to be complied
with.
vii. Lay down the penalties for violation of the law, with imprisonment in
cases where the health of the patient/trial subject is endangered.

150. For the aforesaid points to be addressed in a meaningful manner, it is also
important that a dedicated authority that has clear and well-defined powers of
regulatory oversight is created. We suggest that the NAC-SCRT is constituted
once again to ensure proper and coherent monitoring and regulation of stem
cell research.

F. CONCLUSION:
151. We may summarize the conclusions that we have reached in the aforesaid:
i. Although, the stem cells administered for therapeutic use in ASD are
characterised as “drugs” under the Drugs Act, 1940, yet the same by
itself is not determinative of the fact that it is permissible to be
administered as a clinical service.

ii. Every medical practitioner owes to his patient a duty to exercise a
reasonable degree of care, skill, and knowledge expected of a prudent
practitioner in the same field. A medical practitioner cannot be said to
meet the standard of reasonable care if he administers an intervention
that lacks credible scientific evidence of safety and efficacy, or where
authoritative medical bodies unequivocally state that such form of
treatment is not recommended. This flows directly from the requisite
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standard of care emphasised by this Court in V.P. Shantha (supra) ,
Jacob Mathew (supra) respectively, as reaffirmed in M.A. Biviji
(supra) , that a doctor’s conduct must conform to a “ practice acceptable
to the medical profession of that day” when “judged in the light of the
knowledge available at the time of the incident”. The jurisprudence
makes it clear that if an intervention is characterised by the relevant
scientific community or regulatory authorities, as unproven,
experimental, obsolete, or lacking justification, such an intervention
cannot be defended as exercise of due care and reasonable judgment by
a medical practitioner.

iii. The note of caution sounded by this Court in M.A. Biviji ( supra ) that a
line of treatment undertaken should be regarded as a “sound and
relevant medical practice” and that “ it should not be a discarded or
obsolete category in any circumstance” ensures that patients are treated
in accordance with established, evidence-based medical norms, and
prevents medical practitioners from resorting to speculative, unproven,
or experimental interventions when there is absence of any credible
scientific evidence or professional opinion. In other words, a medical
practitioner who disregards this and administers speculative, unproven,
or experimental treatments even when credible professional bodies
have expressly advised against the use of such an intervention, may be
held liable on count of professional misconduct. We say so because the
administration of such a treatment would fail to satisfy the standard of
reasonable care necessitated under the established medical negligence
jurisprudence in India.

W.P. (C) No. 369 of 2022 Page 90 of 98

iv. The only circumstance in which an experimental treatment may be
provided is when it is administered within an approved research or
clinical trial setting.

v. Such documents published by the ICMR as authorized by the DHR
represent the well-researched scientific and ethical position of the apex
bodies entrusted with the responsibility of overseeing biomedical
research in the country. Such documents may not be binding by
themselves, yet can certainly be relied upon as credible source to assess
whether a particular “ practice is acceptable to the medical profession
of that day” when “judged in the light of the knowledge available at
the time of the incident” and whether a particular line of treatment
undertaken should be regarded as a “sound and relevant medical
practice” and not as a “ discarded or obsolete category in any
circumstance” . The relevance and importance of these ICMR
publications lie not in their binding force in a standalone manner, but
in the role they play in evidencing the contemporary scientific and
ethical baseline of the medical profession.

vi. A perusal of the EMRB-NMC Recommendations dated 06.12.2022,
read with the EBSSCT, 2021, the NGSCR, 2017 and the National
Ethical Guidelines respectively, formulated by the ICMR indicates that
the therapeutic use of stem cells for treatment of ASD is not
recommended as routine clinical treatment. These documents indicate
that the therapeutic use of stem cells for the treatment of ASD is not
recognized as a sound and relevant medical practice due to the lack of
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scientific support and empirical evidence regarding its efficacy. It is
categorically mentioned therein that any stem cell use in patients must
only be done within the purview of an approved and monitored clinical
trial with the intent to advance science and medicine, and not offering
it as therapy. Therefore, every use of stem cells in patients outside an
approved clinical trial is unethical and shall be considered as
malpractice. Therefore, medical practitioners who offer such stem cell
therapy as a routine clinical service and not in a research/clinical trial
setting, could be said to be failing to meet the reasonable “standard of
care” owed by them towards the patients as expounded by this Court in
M.A. Biviji (supra) and V.P. Shantha (supra) .

vii. As regards the question whether patient autonomy enables a person to
give consent to an unproven treatment, we are of the considered view
that a treatment cannot be demanded by a patient as a matter of right.
This Court’s dictum in Samira Kohli (supra) underscores that adequate
information as regards a particular treatment, is the bedrock and the
consent thereto should be on the basis of such adequate information. It
is undisputed that stem cell therapy for treatment of ASD does not fulfil
the essentials of ‘adequate information’. The validity of consent stems
from the nature and information available about the treatment. In the
absence of such knowledge, the patients may remain under therapeutic
misconception and anticipate such results from an unproven treatment
as may be expected from routine treatment and care. Following through
with the medical treatment even when patients are under such
misconception is, in our view, a gross violation of medical ethics.
Therefore, even though the patient may have voluntarily opted for such
W.P. (C) No. 369 of 2022 Page 92 of 98

procedure, yet, such choice does not amount to a valid consent to
undergo the treatment due to the lack of ‘adequate information’ to form
its basis. Having said so, we clarify that one would still have the liberty
to participate in an approved and regulated research/clinical trial
involving stem cell therapy for ASD.

viii. The reasons presented in the aforesaid discussion establish that stem
cell ‘therapies’ for ASD cannot be offered by medical practitioners as
a clinical service, outside an approved and monitored clinical
trial/research setting. In such a scenario, the regulation of such research
gains primacy.

ix. With a view to ascertain the regulatory pathway in respect of stem cell
therapies, we may clarify at the threshold that though autologous stem
cells such as those used for the therapy provided to persons with ASD,
may not meet the criteria of being a ‘new drug’ under the NDCT Rules,
2019, yet they fall under the broader definition of “drugs” in the Drugs
Act, 1940. We say so because all stem cells fall within the purview of
“drugs” as ‘substances’ under Section 3(b)(i) of the Drugs Act, 1940.
Therefore, there is no gainsaying that the scheme of the Drugs Act,
1940 envisages providing protections being available in respect of stem
cell therapy for ASD. We find that Chapter IV of the NDCT Rules,
2019, which relates to Biomedical and Health Research, provides such
safeguards and the necessary regulatory pathway in respect of stem cell
therapy for ASD.

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x. We may summarize the regulatory regimes for both “stem cell derived
products” as well as “stem cell therapies” respectively, as follows:

• In case of administration of “stem-cell derived products”, the
regulatory framework applicable to clinical trials of “new drugs”
under the NDCT, 2019 read with the Drugs Act, 1940 and the
Drugs Rules, 1945 is attracted.
• On the other hand, the stem cells which have not undergone
processing by means of substantial or more than minimal
manipulation, would not be considered as “new drug” under the
NDCT Rules, 2019. In such circumstances, any research involving
such stem cells is to be governed by the regulatory framework in
place for “biomedical and health research” under Chapter IV of
the NDCT Rules, 2019. Rules 15 and 16(4) respectively, thereof
provide binding effect to the National Ethical Guidelines, which
in turn provides in Clause 7.9.1 that any use of stem cells involving
human participants (except for haemopoietic stem cell
transplantation for haematological disorders) shall be undertaken
as a clinical trial. Furthermore, Clause 4.2.4 of the National Ethical
Guidelines mandates that review of proposals for research in stem
cells must be in accordance with the NGSCR, 2017. Since, Rules
15 and 16(4) respectively, of the NDCT Rules, 2019 make the
National Ethical Guidelines legally enforceable, we are of the
considered view that all stem cell research involving human
participants must necessarily be in a clinical trial setting.

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xi. Clauses 4.2.4 and 7.9.1 respectively, of the National Ethical Guidelines
mandate the constitution of Ethical Committees (ECs) to oversee stem
cell research. Further, approval from such ECs as well as the
Institutional Committee for Stem Cell Research (IC SCR) is also
required. Clause 7.9.1 provides that approval shall also be obtained
from the National Apex Committee for Stem Cell Research and
Therapy (NAC-SCRT). However, the Order dated 03.03.2024 issued
by the DHR dissolved the NAC-SCRT and made it mandatory for the
ECs overseeing stem cell research involving human participants to have
a minimum of two stem cell experts therein. Therefore, the entire
regulatory purview was given to the institution specific ECs.

xii. In the aforesaid view of the matter, the Rules 17 and 18 respectively, of
the NDCT Rules, 2019, which deal with the oversight of the ECs by the
Department of Health Research (DHR), are significant. We say so
because Rule 18 empowers the DHR or any body authorized by it to
suspend or cancel the registration of an EC in cases of the ECs’ failure
to comply with the Rules and National Ethical Guidelines. However,
Clause 2(vi) of the Order dated 03.03.2024 carves an exception for stem
cell research, to remove the DHR from exercising a regulatory role in
respect thereof. Clause 2(vi) of the said Order is in conflict with Rules
17 and 18 respectively, of the NDCT Rules, 2019. It is a settled position
of law that executive orders/ instructions/ office memorandum cannot
operate in contravention to statutory rules with the effect of supplanting
the statutory mandate. Therefore, in our considered view, the removal
of regulatory role of DHR in the field of stem cell research by way of
Clause 2(vi) of the Order dated 03.03.2024 is non est .
W.P. (C) No. 369 of 2022 Page 95 of 98


xiii. Therefore, we are of the firm view that non-compliance of the aforesaid
statutory mandate must attract consequences viz. professional
misconduct under Regulation 7.22 of the IMC Regulations, 2002 as
well as action under Sections 32 and Section 40 respectively, of the
Clinical Establishments (Registration and Regulation) Act, 2010,
which provide for the cancellation of registration and penalty.

152. It is unfortunate that the Union has let the matter worsen without any suitable
and timely intervention. Such inaction has led to several parents/guardians
seeking an unproven method of treatment for their children suffering from
ASD incurring huge financial cost and in alternative to other approved
treatments. It cannot be denied that various clinics, in flagrant violation of the
aforesaid statutory mandate, continued to recommend and perform stem cell
therapy as a routine clinical treatment for ASD because there was lack of
executive action against the same. Therefore, we urge the Union to
consolidate and clarify the position of law for enabling better implementation
of the same in this regard at the earliest and insist on the creation of a dedicated
authority for the regulatory oversight of stem cell research all across the
country. In this regard, we have suggested the enactment of a legislation that
may clarify several issues that plague the research in stem cells.

153. Before we close this judgment, we may address the issue as regards the
continuation of treatment which the patients might have already started
receiving prior to this judgment. Though we have held that stem cell therapy
is required to be undertaken in a clinical trial format, yet we are aware that
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starting such trials may take a significant amount of time and may not even be
conducted by the clinics that have been providing this therapy as a treatment.
We do not wish to leave the patients who are already undergoing the therapy
in any apprehension that discontinuing the same may prove to be detrimental
to their wellbeing. However, at the same time, we are also sure of our decision
that stem cell therapy for ASD cannot continue as a commercial endeavour in
the form of routine clinical treatment. Therefore, we direct the Secretary,
Ministry of Health and Family Welfare in consultation with the officials of
AIIMS and the National Medical Council, to provide the best possible
solution in this regard so as to ensure that such patients are able to continue
receiving the therapy till the time they can be re-routed to the institutions that
are conducting clinical trials. The Secretary, MoHFW shall file submissions
in compliance with this direction within a period of four (4) weeks from the
date of pronouncement of this judgment.

154. We treat this matter as part heard. The Registry shall notify this matter once
again after 4 weeks before this very Bench for the purpose of looking into the
submissions that the Secretary, MoHFW shall submit in compliance with the
aforesaid.


155. Once the Union’s stance is clear, we shall proceed to issue final directions.




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156. The Registry shall circulate one copy each of this judgment to all the High
Courts and to the Secretary, Ministry of Health and Family Welfare.


………………………………J.
(J. B. PARDIWALA)



………………………………J.
(R. MAHADEVAN)
New Delhi.
th
30 January, 2026.

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