IMA endorses National Guidelines for Stem Cell Research
(NGSCR): The NGSCR-2013
covers only stem cell research, both basic and translational, and not
therapy as the same
is experimental as on date. Any stem cell use in patients, other than that for
hematopoietic stem cell reconstitution for approved indications, is
investigational and must only be done within the purview of an approved and
monitored clinical trial. Every use of stem cells in patients outside an
approved clinical trial is malpractice.
Points about stem cell therapy every IMA member must know
· There are no approved indications for stem cell therapy
other than the hematopoietic
stem cell transplantation (HSCT) for haematological disorders. Stem cell
therapies other than HSCT are investigational and can be conducted only
in the form of a
clinical trial following ICMR guidelines for clinical research after obtaining
necessary regulatory approvals. Use of stem cells for any other purpose
outside the domain
of clinical trial is unethical (Clause 10.3.1)
· Any violation of ICMR Clinical Research Guideline are
actionable professional misconduct under “Indian Medical Council (Professional
Conduct, Etiquette and Ethics) Regulations 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.”
· One dealing with pharmaceuticals and or allied industry
one also need to follow 6.8.1 e regulation of Indian Medical Council
(Professional Conduct, Etiquette and Ethics) Regulations:” Medical
Research: A medical practitioner may carry out, participate in, work in
research projects funded by pharmaceutical and allied healthcare industries. A
medical practitioner is obliged to know that the fulfilment of the following items (i) to
(vii) will be an imperative for undertaking any research assignment / project
funded by industry – for being proper and ethical. Thus, in accepting such a
position a medical practitioner shall:- (i) Ensure that the particular research
proposal(s) has the due
permission from the competent concerned
authorities. (ii) Ensure that such a research project(s) has the clearance of national/
state / institutional ethics committees / bodies. (iii) Ensure that it fulfils
all the legal
requirements prescribed for medical research. (iv) Ensure that the source and amount of
funding is publicly disclosed at the beginning itself. (v)
Ensure that proper care and facilities are provided to human volunteers, if
they are necessary for the research
project(s). (vi) Ensure that undue animal experimentations are not done and
when these are necessary they are done in a scientific and a humane way. (vii)
Ensure that while accepting such an assignment a medical practitioner shall
have the freedom to
publish the results
of the research
in the greater
interest of the society
by inserting such a clause in the MoU
or any other document / agreement for any such assignment”
The MCI ethics violation will attract “First
time censure, and thereafter removal of name from Indian Medical Register or
State Medical Register for a period depending upon the violation of the clause.”
· Stem cells clinical trials for conditions other HSCT will
require approval from Institutional
Ethics Committee (IEC) and Institutional Committee for Stem Cell Research
(IC-SCR) and CDSCO. The IEC
should be registered with Central Drug Standards Control Organization
DSSCO and IC-SCR with National Apex Committee for Stem Cell Research and
Therapy (NAC-SCRT). Only registered entities are permitted to conduct these
trails. Stem cells used for intervention should be processed/developed under
CDSCO certified GMP facility.
· Clinical trials using human stem cells should be in
compliance with Schedule Y of Drugs and Cosmetics Act and GCP
Guidelines of CDSCO (www.cdsco.nic.in)
as well as ICMR-Ethical Guidelines for Biomedical Research involving Human
Participants (http://www.icmr.nic.in/ethical_guidelines.pdf). All
clinical trials on stem cells shall be registered with Clinical Trial Registry
India (CTRI). (Clause 10.2)
o Any violation will be a professional misconduct as
per MCI ethics regulation 1.9 to be read with regulation 7.1
o 1.9: “Evasion of Legal Restrictions: The physician shall
observe the laws
of the country in
regulating the practice
of medicine and shall also not assist others to evade such laws. He should be
cooperative in observance and enforcement of sanitary laws and regulations
in the interest of
public health. A physician should observe the provisions of the State Acts like Drugs and
Cosmetics Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic
substances Act, 1985; Medical Termination of Pregnancy Act, 1971;
Transplantation of Human Organ Act, 1994; Mental Health Act, 1987;
Environmental Protection Act, 1986; Pre–natal Sex Determination Test Act, 1994;
Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with
Disabilities (Equal Opportunities and Full Participation) Act, 1995 and
Bio-Medical Waste (Management and Handling) Rules, 1998 and such other Acts,
Rules, Regulations made by the Central/State
Governments or local Administrative Bodies or any other relevant Act relating
to the protection
and promotion of public health”.
o MISCONDUCT: The following acts of
commission or omission on the part
of a physician shall constitute professional misconduct rendering him/her
liable for disciplinary action
o 7.1 Violation of the Regulations: If he/she
commits any violation of these Regulations.
· The physician/scientist engaged in stem cell research
shall avoid any activity that leads to unnecessary hype, or unrealistic
expectations in theminds
of study participants or public at large regarding stem cell therapy. The study participant and other
responsible family members must be given adequate and unbiased information
about the trial
protocol, its limitations and potential adverse effects. (Clause 7.5). The same is also
actionable under The Drugs
and Magic Remedies (Objectionable Advertisements) Act, 1954.
o Promotional advertisements by private banks offering
storage of cord blood for possible- future use are misleading. As there is no
scientific basis for preservation of cord blood for future self-use at present,
this practice is not recommended. The only exception is when
there is a child with a haematological disease curable by HPSC and the mother is pregnant. In such
situation storage and release of stem cells from cord blood of the new-born sibling,
subject to HLA match shall be recommended. On the other hand, parents should
be encouraged for voluntary donation to public cord blood banks for allogeneic
transplantation and research purposes. (Clause 12.2)
o "Disclaimers / Qualifiers" the advertisements should carry
so that there is a standard declaration which is unambiguous to a lay consumer?
· The IC-SCR and IEC shall ensure that the patients/participants
recruited under clinical trial shall not be charged including hospital stay and
laboratory based investigations. (Clause 10.2.5.5)
· Prior to enrolment of subjects in clinical trials or
procurement of stem cells for research, it is mandatory to obtain informed
consent from thedonor. (Clause 4.1)
· Independent informed consent in advance should be obtained
for termination pregnancy and for donation of the foetal material for
research. There should be no inducement for donation of
gametes/embryos/somatic cells by way of payment or in of lieu of medical
services, except for reimbursement of reasonable expenses for travel and loss
of wages incurred by the person
(amount to be decided by IC-SCR/ IEC). (Clause 13.1.2)
· Use of Umbilical cord blood stem cells (except when the HPSCs are used for
conditions approved for bone marrow HPSC transplantation) , HSC or MSC is
experimental at present and shall be permitted only under conditions of
controlled clinical trial by the IC-SCR/IEC
(Clause 12.2)
o In most of the haematological/genetic
disorders, child’s own stored cord blood stem cells cannot be used for the same child as those will
carry the same
defect.
· An institution or laboratory developing or processing stem
cells for human use should obtain NABL accreditation for all laboratory
procedures required for product development.
Presidential address on 28th December I
spoke “IMA also wants the government
to declare a special fund for rare diseases and orphan drugs.”
ICMR set up a registry of rare diseases. Apart from maintaining a
database, the registry,
set up on April 28 2017, will also help formulate policies on funding,
treatment and more. A disease is defined as rare when it affects less than one
in 2,500 individuals. Over 70mn Indians suffer from such disorders and live
with them throughout their lives. There are only 500 FDA-approved
drugs for over 7,000 rare diseases globally. There is often no cure, only
supportive care. Treatment is extremely costly too, ranging from lakhs to crores a
year. The health
ministry is currently discussing a draft policy for treatment of rare diseases.
In Gorakhpur issue IMA raised the absence of autopsies in
such cases
The under-five mortality rate in India stands at 50 per
1000 live births. The pilot
project that will begin in January, 2018, at New Delhi’s Safdarjung hospital,
is a part of the global
CHAMPS— Child Health and Mortality Prevention Surveillance, project, wherein
tissue biopsies of the brain,
liver, spleen and other tissues are taken in a minimally invasive way. This
will benefit in districts like Gorakhpur where child deaths are high. For six
months— January to June, all child deaths that take place at Safdarjung
hospital will be examined. Informed consent will be taken from the parents.
IMA Women Life Time Achievement Award to ICMR DG
Other issues: C. auris ICMR advisory, AMR,
NCD
May Measurement Month
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