Indian scientists object to export of human biological material for research
BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7371.990/b (Published 02 November 2002) Cite this as: BMJ 2002;325:990All rapid responses
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Dear sir
For the intimation of one and all, the website of the Indian Council of
Medical Research , as of now , has all the information required about the
regulations that are to be followed for taking out biological materials
for the purpose of research outside India. I am not aware , however,
whether the information existed or did not exist in the said website when Dr.Peter Forster claimed its non existence.
Anybody interested in any future research that might involve such export
of biological materials can now easily access the regulations at the url
icmr.nic.in
I hope this helps sort a few things out for the future.
Competing interests:
Holder of ICMR studentship
Competing interests: No competing interests
Dear sir ,
There being no other Indian reaction except mine as of today , I
assume that Basudeb Chaudhuri refers to my response to G.Mudur's News
Extra article(BMJ 2002; 325:990 (2 November) when he says that he is
"forced to react to the Indian reactions". I would like to raise a few
points here.
He admits that "genetic resources and their ownership is an important
question" but does not address his point of admittance. In fact , in my
response I tried to raise this very point . The suggestion he makes to
Indian researchers to get on with their work is fine. But raising the
issue of what he rightly points out as the "important question" of
"genetic resources and their ownership" is hardly an act of restriction of
research.It is the sovereign right of every nation to regulate the nature
of material being taken out of the land. All countries have similar
guidelines and legislations and they are framed to be followed. Nobody has
problems with foreign teams doing research after due permission has been
taken from the concerned national authority about the materials which they
intend to ship out of the country.Scientific research and law of the land
are not mutually antagonistic as he makes them out to be , with the latter
trying to put restrictions on the former. I don't understand why he finds
the fact that foreign teams need to follow certain guidelines to ship
materials out of a country , so very irksome.It is a universal rule.
This is the very rule that might have been breached in the case of
Dr.Forsters' study due to some reason. But the fact remains that there has
been a breach of guideline.
It is an objective reality that there are Indians all the world doing
research. But they aren't doing it by breaching guidelines of the country
where they are working , are they? If not , I fail to see the parallelism
Basudeb Chaudhuri wanted us to see. Yes , it is perfectly normal for
foreign teams to come to India and do the same, that is ,following
guidelines of the country of work with regards to taking biological
materials out of that country. Now , this is a perfect reciprocation and
nobody has qualms with that and research can and will flourish.
In the concluding part of his response , Basudeb Chaudhuri points out
that Indian regulations with regards to science are "idiotic " and asks
Indian science policy makers not to create problems unless "somebody is
not stealing our resources".Could Basudeb Chaudhuri point out , which part
of the Indian regulation with regards to the export of human biological
material for research does he find "idiotic". Which clause in it does he
think will create problems for some researcher who is not out to steal our
resources for any benefits ? I am sure many of us back in India would like
know that.
If there is not (and I know there is not) such a regulation in India
which debarrs seekers of truth , it is even my call that the rule of law
be enforced so that it does not lose its biological resources to
profiteers masquerading as scientists.
I would again like to congratulate Dr.Forster on being so candid
about the fact that he was oblivious of the existing regulations. If he
had known , his kind of work would have had no problems in getting
permission for the export of human biological material for research .
Yours sincerely
Garga Chatterjee
Medical College, Calcutta
University of Calcutta
Competing interests:
None declared
Competing interests: No competing interests
In his letter, Dr Peter Forster makes two new points:
- that I did not mention that Dr Lucy Forster, the first author of
the paper, is an Indian national,
- that the guidelines are not available on the website of the Indian
Council of Medical Research.
His third point, that this research has no commercial application, is
already covered in the news story.
While I was working on the story, I did bring up each of these points
several times during my interviews with health officials and biologists in
India who are accusing them of breaching guidelines.
According to them, neither of these two points could be used to
justify the violation of the guidelines. They said researchers, whether
Indian or international, taking out biological samples are expected to be
aware of the guidelines. In fact, one person whom I had interviewed, a
senior member of the bioethics committee of the Indian Council of Medical
Research, in his response to this point, had said: "Ignorance of law -- in
this case guidelines -- is never a valid excuse."
The absence of the guidelines on the Council's website is
unfortunate. I have already quoted Indian researchers in the story, saying
that the Indian government has failed to implement these guidelines.
The other point, that Dr Lucy Forster is an Indian national and that
this work was part of her PhD dissertation, also does not change the story
in any way. The fact remains, as Dr Forster acknowledged during my
telephone interview with him, that no hospital or research centre in India
was ever involved in this study. The PNAS paper also does not list any
collaborating Indian institution.
The PNAS paper identifies Dr Lucy Forster as affiliated to the
University of Cambridge and to the University of Munster, and not to any
institution in India. Given that background, health officials and
researchers here say that this is a case where foreign researchers have
used local knowledge and expertise of an Indian national to access
biological material from India.
Sincerely,
Ganapati Mudur
Competing interests:
None declared
Competing interests: No competing interests
Having read the Indian press report and one reaction in the BMJ, and
being an economist by profession, I am forced to react to the Indian
reactions. Of course genetic resources and their ownership is an important
question, but why don't the Indian professionals who have reacted
negatively just get on with the job of doing research instead of trying to
restrict the research of others? This is a completely blinkered attitude -
there are thousands and thousands of Indians all over the world, including
India, doing research in a variety of domains and being encouraged to do
so, and isn't it perfectly normal that foreign teams should also come and
do the same in India? Indian regulations have generally been a disaster
for our economy and for the advancement of science and knowledge - so long
as somebody is not stealing our resources, let us remain an open society
and try to persuade the government to reduce idiotic regulations and to
get on with the real job of human capital and infrastrucutral development
and enforcing the rule of law.
Basudeb Chaudhuri.
Competing interests:
None declared
Competing interests: No competing interests
Dear Sir,
After going through the article from your correspondent Ganapati Mudur
(BMJ 2002; 325:990 (2 November) and Dr. Forster's response to the same ,
there are a few points which I would like to make. Firstly a general
statement like "Indian scientists are accusing the foreign researchers of
violating national guidelines" as done my G.Mudur is unfortunate.The
article , though raising a valid point fails to address why ICMR and other
such agencies have failed to monitor the export of biological material
from India, that is inquiring why "there’s still no machinery to
implement it".
But it is also not apparent why Dr.Forster goes into a quasi-defence mode
when he responds back.Dr. Lucy Forster may be an Indian by birth but that
does not automatically give her the right to use biological material from
India for research conducted under the auspices of foreign universities.
She might have her Ph.D. dissertation out of this , but that does not qualify her
to use the material. So the statement about Dr. Lucy Forster's Indian
origins is but irrelevant. Dr. Forster is candid about his team's
ignorance of the guidelines but in a way defends himself by the fact that
the ICMR website did not contain it. In developing countries like India ,
showcasing through the internet is but a new concept. So anything and
everything about the ICMR is not available on its site. This is an Indian
reality to which researchers on the ground ought to be familiar with as
they probably were about currency conversion rates. Though their work did
not have commercial implications , that was known only after the
publication came in. And biological samples can be used for research
purposes in more than one way.So , if the callous attitude of the Indian
establishment to frame guidelines but not to implement them , remains ,
then in future biological materials may be taken out of India for projects
not as non-commercial as Dr.Forster's endeavour.
Yours sincerely
Garga Chatterjee
Medical College , Calcutta
University of Calcutta
Competing interests: None declared
Competing interests: No competing interests
Dear Sir,
Your correspondent Ganapati Mudur (BMJ 2002; 325:990 (2 November)
suggests with reference to our recent paper in the Proceedings of the National
Academy of Sciences (2002;99: 1390-4) on the mutation rate of mtDNA that "Indian
scientists are accusing the foreign researchers of violating the national guidelines". He
omitted, however, to make any
mention of the first author of our paper, Dr. Lucy Forster, who is
herself Indian and indeed from Kerala, where the thorium-rich sand is
located. The research
formed the basis for her Ph.D dissertation.
It is the case that none of the co-authors was aware of the
guidelines to which your
correspondent refers nor have we now been able to find any mention of
them on the website of
the Indian Council of Medical Research. It is in any case not likely
that the research in question
as such would lead to a patent or other commercial applications. It
does however lead to the
interesting conclusion, relevant to human population history, that
some high estimates for the
mtDNA mutation rate are not well founded.
Yours sincerely
Peter Forster
Competing interests:
None declared
Competing interests: No competing interests
Re: Indian scientists object to export of human biological material for research
I have only now come across this discussion by chance & would like to give my opinion regarding the matter.
The guideline for exchange of Biological materials was very much there on ICMR website since ICMR is the secretariat for Health Ministry's Screening Committee for reviewing international collaborative research especially when Indian biological materials are exchanged for research. The order of Ministry of Health (O.M. No.19015/53/1997 - IH Pt.) was very much there in existence when the research using Indian samples was done. It is also a sad fact that many researchers even today are not that aware of the requirement to follow the guideline and bypass the procedure. Unless ICMR is intimated about such an event there is no way in which it can act. There are a number of workshops being held on the ethical guidelines where this fact is being highlighted but India is a huge country to cover for generating awareness. US has been compiling guidelines and regulations of many countries including India to guide their researchers about the requirements to be abided by when choosing non-US sites. There the above mentioned guideline is separately noted & given prominence. The UK ethics committees which are supposed to be more educated than the Indian ones should have overseen this requirement before approving the study.
Competing interests: No competing interests