Anti-Rabies
Vaccines
†927.
SHRI RAJU SHETTI:
Will
the Minister of HEALTH AND
FAMILY
WELFARE
LokLF;
vkSj ifjokj dY;k.k ea=h
be
pleased to state:
(a)
the number of persons died due to
rabies
in the country during each of the last
three
years and the current year, State/UTwise;
(b)
whether the Government provides
funds
to the States for procurement of antirabies
vaccine
under National Rural Health
Mission
(NRHM);
(c)
if so, the details thereof during the
above
said period, State/UT-wise; and
(d)
the preventive steps taken/being
taken
by the Government to check deaths
due
to dog bites in the country?Anti-Rabies Vaccines
†927.
SHRI RAJU SHETTI:
Will
the Minister of HEALTH AND
FAMILY
WELFARE
LokLF;
vkSj ifjokj dY;k.k ea=h
be
pleased to state:
(a)
the number of persons died due to
rabies
in the country during each of the last
three
years and the current year, State/UTwise;
(b)
whether the Government provides
funds
to the States for procurement of antirabies
vaccine
under National Rural Health
Mission
(NRHM);
(c)
if so, the details thereof during the
above
said period, State/UT-wise; and
(d)
the preventive steps taken/being
taken
by the Government to check deaths
due
to dog bites in the country?
The National
Guidelines for Stem Cell Research prohibit stem cell therapy and consider its
use for any other purpose outside the domain of clinical trial unethical in the
country. As per the National Guidelines for Stem Cell Research (2013), at
present, there are no approved indications for stem cell therapy other than the
hematopoietic stem cell transplantation (HSCT) for hematological disorders.
Accordingly, all stem cell therapy other than the above shall be treated as
investigational and conducted only in the form of a clinical trial after
obtaining necessary regulatory approvals. Use of stem cells for any other
purpose outside the domain of clinical trials will be considered unethical and
hence is not permissible.
The Indian
Council of Medical Research (ICMR) has informed that the research on embryonic
stem cell involves creating embryonic stem cell lines, which may lead to
commoditization of human tissue and cells with inherent risk of exploitation of
individuals, particularly those belonging to underprivileged groups. Another
concern is the misuse of the material for germline engineering and reproductive
cloning. Hence, the research involving embryonic stem cells requires very close
monitoring by the local committees. The details on Ethical considerations in
use of embryonic stem cells are appended as given below:
Ethical
Consideration Determining Specific Principles Related to Stem Cell Research.
Stem Cells are unique in many ways. The
two basic characteristics of pluripotent stem cells are their capacity for
self-renewal and multi lineage differentiation. They may survive indefinitely
and differentiate unpredictably when introduced into the human host. They may
also give rise to tumors such as teratomas. Some of the major concerns that are
specific to their collection, processing, storage and use, particularly of the
human ES cells for translational research are listed below:
1.1
Health
and Safety of Donors: Prior to procurement of stem cells for
research, it is mandatory to obtain informed consent from the donor. The donor
must be informed about the need for screening of transmittable diseases (about
which the donor may or may not be aware of) and possible risks involved in
donation particularly during major invasive procedures such as ovum or bone
marrow donation, under local or general anaesthesia. The donor shall also be
informed that cell lines may be generated from the donated material and that
these may be banked and shared with other scientific groups. The cell lines may
also undergo genetic manipulation, and have the potential for
commercialization. In the latter event however, the intellectual Property
Rights (IPR) will not vest with the donor. Also, while confidentiality and
privacy are sacrosanct, provision must be made for traceability in a contingency
situation. The donor should be made aware that he/she may be contacted in
future for specific requirement.
Special care needs to be taken if cells
are obtained from embryos and foetuses. Also, donation of gametes and embryos
raise special ethical and moral concerns. It is necessary to ensure that the
donors are not exploited and commoditized.
1.2
Manufacture
and Quality Assurance of Stem Cell Products: It is
recognised that human adult tissues also have an inherent population of stem
cells. In order to obtain these cells in sufficient numbers, some degree of
processing, enrichment and/or in vitro expansion may be required. Further,
manipulations may be needed to enhance their utility. One of the challenges in
testing the potency of stem cells is the lack of suitable animal models.
Innovative surrogate assays are needed for the purpose.
1.2.1
I
case of human ES or IPS cells, targeted differentiation may be required to generate
appropriate cells of interest and to separate them from undifferentiated cells.
For individualized preparation of IPS cells, abbreviated tests of safety and
efficacy are needed to provide timely release of the therapeutic product.
1.2.2 Cell
culture techniques require stringent controls to avoid contamination and batch
to batch variation. In case autologous or histocompatible iPS cells are used,
the cell product should be processed individually for each patient.
1.2.3Therapeutic
cell products should be prepared as incompliance with the GLP/GMP/GTP
guidelines and other laboratory conditions depending on the purpose of each
use.
1.2.4All
reagents and media used in the process should be of ‘clinical grade’, intended
to be administered to humans.
National
Guidelines for Stem Cell Research (2013) apply to all stakeholders including
individual researchers, organizations, sponsors, oversight/regulatory
committees and any others associated with both basic and clinical research on
all types of human stem cells and their derivatives.
As
per the National Guidelines for Stem Cell Research (2013), an additional layer
of oversight, besides the institutional Ethics Committee (IEC), in the form of
Institutional Committee for stem cell research (IC-SCR) and National Apex
Committee for Stem Cell Research and Therapy (NAC-SCRT) has been introduced to
review and monitor stem cell research at the institutional as well as National
level. A National apex committee for stem cell research and therapy (NAC-SCRT)
will monitor and oversee activities at national level and institutional
Committee for stem cell research (IC-SCR) at institutional level. These
oversight committees shall ensure that review, approval and monitoring of all
research projects in the field of stem cell research are done rigorously and
effectively as per the National Guidelines. This mechanism of additional review
has been accepted by the scientific community in the country and the NAC-SCRT
has become operational after its notification by Department of Health Research
(DHR) on 29th October 2012. Till date, 82 organizations/Institutes
across the country have applied for registration of their IC-SCRs with
NAC-SCRT, out of which only 5 institutes have fulfilled the criteria and have
been granted registration.
ICMR is promoting activities under the
area of Stem Cell Research. Besides promotion of basic/clinical research, ICMR
is also involved in framing guidelines for stem cell research for scientists
and clinicians working in the field. However, the details of funds allocated
and utilized during past three years and current year in respect of ICMR,
Department of biotechnology, Department of Science and Technology and AIIMS are
given in the statement is given below:
The
details of funds allocated and utilized during past three years and current
year with respect
to
ICMR are given below:-
|
Financial
Year
|
2011-2012
|
2012-13
|
2013-14
|
2014-till
date
|
|
Allocations
for new projects
|
Rs.
1,87,92,320
|
Rs.
2,67,20,833
|
-
|
-
|
|
Utilized
funds for ongoing projects
|
Rs.
1,12,02,940
|
Rs.
1,32,94,058
|
Rs.
1,50,13,000
|
Rs.
3,15,18,183
|
Besides ICMR, Department of
Biotechnology (DBT) and Department of Science and Technology (DST) are also
promoting research activities in the field of stem cell research, Details
provided by DBT are given below:-
|
Financial
Year
|
2011-2012
|
2012-13
|
2013-14
|
2014-till
date
|
|
Allocations
for new projects
|
Rs.
9.50 Crore
|
Part of Rs.
203.00 crore of Medical biotechnology
|
Part
of Rs. 228.00 crore of Medical biotechnology
|
Separate
Budget has not been allocated
|
|
Utilized
funds for ongoing projects
|
Rs.
9.38 crore
|
Rs.
7.10 crore
|
Rs.
7.45 crore
|
Rs.
4.50 crore
|
As
far as AIIMS, New Delhi is concerned, the details of the projects (basic
research using Stem Cell) funded by the Institute alongwith the amount
allocated and utilized for these projects during the last three years and
current year are given below:-
|
S.
No.
|
Year
|
Projects
(basic research using Stem Cell)
|
Amount
Sanctioned
|
Amount
Utilized
|
|
1.
|
2011-12
|
Comparative
analysis of expansion and differentiation potential of MSC derived from
Dental pulp and Bone marrow
|
1.0
lakh
|
1.0
lakh
|
|
2.
|
2012-13
|
To
compare the differentiation potential of mesenchymal stem cells derived from
different sources (bone marrow, adipose tissue & dental pulp) into cardiomyocytes
using 5- azacytidine and TGFB1 as inducers.
|
4.0
lakh
|
4.0
lakh
|
|
3.
|
2013-14
|
NIL
|
NIL
|
|
4.
|
2014-15
|
4.0
lakh
|
3.5
lakh
|
The Health Minister, Shri J P Nadda stated this in a written reply
in the Lok Sabha here today.
*****
MV/BK/LK