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UNCLAS SECTION 01 OF 08 NEW DELHI 000421 
 
SENSITIVE 
SIPDIS 
 
STATE FOR SEZANEH SEYMOUR IN OES/ENRC 
 
E.O. 12958: N/A 
TAGS: EAGR SENV TBIO
SUBJECT: INDIA: THE THEORY AND PRACTICE OF ACCESS TO 
BIOLOGICAL RESOURCES 
 
REF: SECSTATE 09667 
 
NEW DELHI 00000421  001.2 OF 008 
 
 
¶1. (U) SUMMARY:  The following answers reftel, paragraph 20 
request for information on Government of India (GOI) 
regulations governing benefit sharing and access to genetic 
resources.  India's National Biodiversity Authority (NBA) is 
the body responsible for managing and approving access to 
India's biological resources within a framework of Acts, 
Rules and Bills that attempt to define requirements for 
access.  In short, the process is inconsistent, 
implementation is spotty at best, the NBA admits it is a work 
in progress, and the responsible Ministry doesn't want to 
talk about it.  END SUMMARY 
 
¶2. (U) The National Biodiversity Authority publishes on its 
website (http://www.nbaindia.org) information on regulations 
and procedures for accessing and claiming intellectual 
property rights on Indian biological resources.  The Embassy 
also relied on the text of the 2002 National Biodiversity Act 
and 2008 Biodiversity action plan, and six publications 
reviewing India's 2002 National Biodiversity Act, its 
implementation, IPR issues related to biodiversity and 
traditional knowledge, and the National Biodiversity Strategy 
and Action Plan published by the NGO Kalpavriksh.  This 
response was informed by discussions with: 
 
-- Dr. P. L. Gautam, Chairperson of the NBA. 
-- Dr. K. Venkatraman, Secretary of the NBA. 
-- Dr. Arivudai Nambi, Principal Scientist for Biodiversity 
of the M.S. Swaminathan Research Foundation which provides 
consultation services for the NBA. 
-- Dr. Bandyopadhyay, Animal Husbandry Commissioner of the 
Department of Animal Husbandry and Dairying, Ministry of 
Agriculture. 
-- Dr. S. K. Sharma, NBA Committee Member and Director of the 
National Bureau of Plant Genetic Resources (NBPGR) - the 
national plant repository. 
-- Dr. Naresh Kumar, NBA Committee Member and Head of the R&D 
Planning Division at the Council of Scientific and Industrial 
Research (CSIR). 
-- Mr. R. K. Gupta, Head of Intellectual Property Management 
Division at CSIR. 
-- Dr. B. Ghosh, Deputy Director of the Institute of Genomics 
and Integrative Biology. 
-- Dr. Ravi Chellam, Country Director for the Wildlife 
Conservation Society. 
-- Ms. Krishna Sarma, Managing Partner of Corporate Law Group. 
 
------------------------ 
LEGISLATION AND REGULATION OF ACCESS TO BIOLOGICAL RESOURCES 
------------------------ 
 
¶3. (U) India ratified the Convention on Biological Diversity 
(CBD) in 1994.  In 2002, it passed the Biological Diversity 
Act (BDA) and in 2003 published implementation guidance 
through a set of Rules.  In order to manage access to India's 
biological resources, the Rules established a three tiered 
structure including the National Biodiversity Authority 
(NBA), the State Biodiversity Boards (SBB), and the 
Biodiversity Management Committees (BMC) at the local levels. 
 
 
¶4. (U) The NBA is designated the sole approving authority for 
foreign party (including non-resident Indian) access to 
biological resources in India.  It also regulates Indian 
requests for IPR on biological resources, advises the Central 
Government on conservation and biodiversity, and is 
responsible for determining and ensuring equitable sharing of 
benefits with local populations.  It is managed by the 
Ministry of Environment and Forests (MoEF) and comprised of 
rotating official members from several GOI ministries and 
Departments, as well as non-official members from NGOs and 
universities. 
 
 
NEW DELHI 00000421  002 OF 008 
 
 
¶5. (U) The SBBs are responsible for managing resident Indian 
access to biological resources, and have the power to 
restrict any activity in their state they determine to be 
detrimental to biodiversity.  However, procedures for 
obtaining permissions from the SBBs are not well defined, 
vary from state to state, and different Indian researchers 
utilize different procedures even within the same state.  For 
example, post has learned that certain Indian researchers 
merely inform the various SBBs of their activities without 
making formal access requests. 
 
¶6. (U) The BMCs represent the interests of the local 
population and document traditional knowledge and resources 
for IPR-related reference through the People's Biodiversity 
Registers (PBRs).  The NBA and SBBs are supposed to consult 
them before access or benefit sharing decisions are made 
regarding use of local resources or traditional knowledge, 
although this step is often not performed.  According to 
NBA's website, as of September 2008 there were 1453 BMCs 
nationwide although this number is wildly skewed by the state 
of Karnataka which reports 1354 BMCs.  This is most likely 
due to Karnataka's comparatively greater proactive interest 
in protecting its biodiversity. 
 
¶7. (U) The BDA defines biological resources as "plants, 
animals and micro-organisms or parts thereof, their genetic 
material and byproducts (excluding value added products) with 
actual or potential use or value, but does not include human 
genetic material".  According to Ms. Sarma, the definition 
does not encompass extracts of bacterial and fungal strains. 
There are four BDA-defined exemptions to the requirement of 
NBA approval for use: 
 
-- Local people and communities in the area have free access 
to use biological resources within India. 
 
-- Growers, cultivators, Vaids, and hakims. (NOTE: Vaids and 
hakims are practitioners of traditional medicine, and are not 
necessarily trained or certified by any authority. END NOTE) 
 
-- Normally traded commodities are exempted from the purview 
of the Act via formal notification procedures. 
 
-- Material used for collaborative research through 
government-sponsored or government-approved institutions 
subject to overall policy guidelines and approval of the 
Central Government. (NOTE: This is known as the MOU 
Exemption. END NOTE) 
 
¶8. (U) In addition, several additional acts and bills could 
have an impact on either access to or IPR claims for 
biological resources.  Given that Indian legislation is 
convoluted and constantly changing, the following may not be 
an all inclusive list: 
 
-- The Seeds Bill (introduced in 2004 but not yet enacted) 
would allow farmers, mostly seed producers who intend to 
engage in commercial sale, to register and license seed 
varieties. 
 
-- The 2005 Amendment to the Patents Act allows biological 
products - including living organisms - to be patented, but 
also permits a patent to be opposed on the grounds that it 
claims traditional knowledge.  A draft technology transfer 
law currently pending in Parliament may further impact the 
ability to claim biological resources related IPR. 
 
-- The 2001 Protection of Plant Varieties and Farmers' Rights 
Act created an Authority which provides a mechanism to 
register novel finished agricultural products - such as 
livestock breeds or plant varieties - and gives the 
registrant exclusive right to produce, sell, market, 
distribute, import or export the variety.  The Authority is 
not involved in approving access to biological resources in 
 
NEW DELHI 00000421  003.2 OF 008 
 
 
India, but may be consulted in determining eligibility for 
IPR. 
 
-- The Wild Life Protection Act (1972) protects wild animals, 
birds, and plants in national parks or notified sanctuaries, 
and creates a permit requirement for research on any 
biological resource designated under the Act. 
 
-- The Indian Forest Act (1927) and Forest Conservation Act 
(1980) deal with management of forests, conservation of 
forest land, and regulation of flora such as bacterial or 
fungal strains in reserved and protected forests, notified 
sanctuaries, and national parks. 
 
-- The National Biodiversity Resource Authority is in the 
process of being created under the Department of 
Biotechnology; it does not yet exist and a timeline for its 
establishment has not been fixed.  Post was unable to 
determine what roles or responsibilities it will have in 
regulating biological resources. 
 
¶9. (SBU) Actual implementation of the BDA has been 
troublesome and has created significant confusion among 
researchers, GOI officials, and even within the NBA itself. 
Input from our contacts and a Scioff review of available 
information shows that provisions of the NBA do not appear to 
be either widely publicized or known.  In addition, the 
procedures are complex and constantly changing, 
implementation is governed as much by exception as by rule, 
the decision process is not transparent, and Indian 
laboratories are looking for ways to avoid, rather than 
engage, the NBA process. 
 
¶10. (SBU) NBA's primary mode of information dissemination is 
their website.  However the site is outdated, incomplete, 
confusing to navigate, and does not provide information on 
any requirements, beyond NBA approval, necessary for access 
to biological resources.  Dr. Naresh Kumar said that NBA "is 
still evolving its jurisprudence at every meeting - for every 
step clarified there are a half step more issues."  This is 
borne out by a quick look at the NBA's 14 expert committees, 
of which only three have produced guidelines, four have draft 
guidelines, and seven have no guidelines.  Dr. Bandyopadhyay 
said that implementation is incomplete and slow.  Mr. Gupta 
said that the NBA is still very unclear about what materials 
come under its purview and is trying to determine what 
additional exemptions should exist. 
 
¶11. (SBU) Ravi Chellam noted that NBA had a lack of staff and 
capacity, which constrained its ability to handle 
applications in a thorough, timely, and transparent manner. 
The NBA expert committee and main body has both approved as 
many as 138 applications in a one day session, raising 
questions about the thoroughness of the review process and 
implying that NBA may not adequately confer with technical or 
traditional knowledge experts before making decisions.  While 
the vast majority of decisions thus far have been in favor of 
providing access and allowing IPR, without a more defined and 
transparent process any change in the NBA makeup or increase 
in influence of anti-sharing NGOs and activist groups could 
negatively shift future decisions. 
 
¶12. (SBU) Mr. Gupta commented that publishers of scientific 
journals generally require a researcher to deposit material 
into an international repository so that other scientists can 
verify their work.  The NBA mandates re-approval for any 
third-party transfer, which means that the international 
repository and every individual researcher who wants to 
access the material for verification would be required to 
submit an NBA application for access along with the 
accompanying fee.  It is easy to see how this would produce 
significant delays in research and collaboration and a 
reluctance to publish findings in legitimate peer-reviewed 
journals. 
 
NEW DELHI 00000421  004 OF 008 
 
 
 
¶13. (SBU) Whether through loose interpretation of the 
government's collaborative research exemption or through 
formal treaties or MOUs, our contacts described examples of 
mechanisms that Indian organizations have established to 
continue sample sharing and research without NBA involvement. 
 For example: 
 
-- Under the FAO-sponsored International Treaty on Plant 
Genetic Resources for Food and Agriculture, the germ plasm of 
crops specifically designated by India can be exchanged, 
including with non-signatories such as the U.S., without any 
requirement for NBA approval.  The GOI has designated entire 
repositories under this program. 
 
-- India's Ministries of Agriculture and Health have recently 
signed an MOU with the U.S. CDC to provide samples of Avian 
Influenza without requiring NBA approval. 
 
-- Several contacts acknowledged that samples which met the 
definition of a biological resource continued to be 
unofficially shared by government, academic and commercial 
laboratories.  One of our contacts works with 
chemically-produced compounds originally derived from Indian 
plants.  To avoid the NBA process, he has chosen to interpret 
the NBA's definition to exclude these compounds. 
 
¶14. (SBU) The few SBBs, BMCs, and local communities that are 
aware of the BDA's provisions appear to be unsure of their 
role and unaware of their right to negotiate Mutually Agreed 
Terms (MAT) for use of biological materials.  As such, they 
are often easily cut out of the process by the NBA.  A 
foreign researcher would, in the current process described by 
NBA, deal only with the NBA or Indian sponsor and not be in 
contact with any SBBs or BMCs, except in cases where 
endangered species access permits might be required. 
 
¶15. (SBU) In addition, few states have formed boards and most 
of those that have lack manpower or technical background to 
effectively engage on any of the BDA requirements or issues, 
according to our contacts and the Kalpavriksh publications. 
Ravi Chellam said that state boards refer Indian nationals to 
the NBA for approval to conduct research because they do not 
want to take a position on allowing or disallowing access. 
 
¶16. (SBU) The composition and roles of BMCs are also a topic 
of significant public concern and confusion, especially 
regarding inclusion of appropriate local and tribal group 
representation for benefit sharing discussions and MAT 
negotiations.  The NBA's website indicates the Indian sponsor 
is responsible for contacting BMCs to negotiate MAT and 
benefit sharing on behalf of the foreign party, after which 
the NBA would approve the arrangement.  However, we heard 
conflicting anecdotes about the actual application of the 
process which appears to vary considerably depending on state 
and locality.  For example, in Tamil Nadu, NBA officers Dr. 
¶P. L. Gautam and Dr. K. Venkatraman said that the process 
worked as it was supposed to, and Dr. Arivudai Nambi said his 
organization had liaised with "local authorities."  Our 
contacts in Delhi, however, suggested they dealt only with 
the NBA and were not aware of any direct discussions or 
negotiations with the local BMCs. 
 
------------------------ 
THE PROCESS FOR REQUESTING ACCESS 
------------------------ 
 
¶17. (U) According to the NBA website, foreign parties must 
file a separate application request for each activity 
involving biological resources - i.e. for research of 
material, transfer of material or knowledge, and permission 
to claim IPR - each of which requires payment of an 
application fee ranging from INR 500 - INR 10,000 (USD 10 - 
USD 200).  Applications are generally approved within three 
 
NEW DELHI 00000421  005 OF 008 
 
 
months, and the application process as described is: 
 
-- The foreign party identifies an Indian sponsor institution 
accredited by the Ministry of Science and Technology that 
will be responsible for the party's activities in India and 
also help the foreign party to obtain Prior Informed Consent 
(PIC) from and negotiate MAT with the relevant BMC or local 
organization. 
 
-- The foreign party or Indian sponsor then files the 
application (research, transfer of material or information, 
or IPR request) with the NBA. 
 
-- The relevant NBA expert committee reviews the application 
and gives a recommendation to the NBA, which meets at least 
quarterly to review applications.  The expert committee is 
supposed to consult with relevant technical experts, assess 
potential impact of the activity, and consult with BMCs to 
ensure benefit sharing has been adequately addressed. 
 
-- After NBA approves the application and before any activity 
can begin, the foreign party must sign an agreement with the 
NBA that specifies the terms and conditions of the activity. 
Sample agreements are posted on the NBA's website. 
 
-- The NBA dictates constraints for the research activity in 
the agreements.  Clauses might, for example, restrict the 
quantity or location of the material to be collected, limit 
time allowed to access the material, require that samples be 
deposited in an Indian national repository, restrict sharing 
of the research with any party not named in the agreement 
absent NBA re-approval, and demand that all research results 
be shared with Indian institutions. 
 
-- Commercial transfer and IPR agreements may also include 
these clauses, and will incorporate any discussion of benefit 
sharing or mutually agreed terms. 
 
¶18. (U) Indian researchers are not required to apply to the 
NBA to access biological resources within India, although 
they are supposed to go through the SBBs.  However, they do 
require NBA approval for transfer of materials or knowledge 
outside of India (if not covered by an exemption), for 
transfer for commercial purposes, and for IPR claims. 
 
------------------------ 
THE MOU EXEMPTION FAVORS GOVERNMENT INSTITUTIONS 
------------------------ 
 
¶19. (SBU) Overall, it appears that the government-affiliated 
laboratories, including those at universities, find the BDA 
and NBA to be less restrictive for their international 
research, largely because they can take advantage of the MOU 
exemption to share biological resources and knowledge without 
need for NBA approval.  Everyone we spoke with, except the 
NBA Chairperson and Secretary, openly encouraged us to tell 
U.S. researchers to use the Ministry-approved-MOU route and 
to avoid engagement with the NBA for any research-related 
requests. 
 
¶20. (SBU) Researchers working with private organizations such 
as NGOs, however, have no choice but to follow the NBA 
process.  Ravi Chellam and others claimed the paperwork 
requirements and cumbersome process impede their ability to 
work with international collaborators.  Because of the way 
research in India is organized, these requirements 
disproportionately impact those organizations working on 
wildlife and endangered species conservation and with 
biological resources found in national parks and other 
protected areas. 
 
------------------------ 
LIMITED REQUIREMENTS FOR PERMITS 
------------------------ 
 
NEW DELHI 00000421  006.2 OF 008 
 
 
 
¶21. (U) Permits are required for collection of any biological 
material designated under the Wildlife Protection Act, or 
acquired from the national parks, notified sanctuaries, or 
from reserved or protected forests as designated under the 
Forest Act.  In addition, Ms. Sarma indicated that permission 
for import and export of certain unspecified biological 
materials may require additional permission of the Director 
General of Foreign Trade. 
 
¶22. (U) Post did not find any suggestion that visa approvals 
were linked to NBA approvals.  There are no regulations for 
the shipment of biological resources between states within 
India.  India claims to follow international standards 
related to permits and handling for the import and export of 
biological resources, including quarantine procedures.  NBA 
also requires that samples of all imported and exported 
materials be sent to the designated national repositories 
(plant, animal, fish, insect, or microbial) for sequencing 
and future reference. 
 
¶23. (U) Dr. S. K. Sharma underscored that NBPGR, as the 
national repository for plant material, had primary 
responsibility for conducting quarantine checks and 
documenting all imported or exported plant material including 
seeds, propagates, and transgenic materials.  He said NBPGR 
also had authority to issue import/export permits and 
phytosanitary certificates.  Other national repositories 
presumably share similar responsibilities and authorities. 
 
------------------------ 
MAT AND PIC - THEORY VS PRACTICE 
------------------------ 
 
¶24. (SBU) According to the NBA, all agreements for IPR and 
for commercial transfer of material or knowledge, whether 
from foreign or Indian parties, must include a section on 
MAT.  The NBA website claims that Indian sponsors are to 
negotiate MAT with the local organizations before beginning 
research, but our review of research agreements on NBA's 
website show they do not generally include MAT.  As noted in 
paragraph 14, there is a disparity between the theory and 
practice of MAT negotiation and although BMCs are supposed to 
play a key role, this is not currently a widespread practice. 
 
¶25. (SBU) Our contacts indicated that government-approved 
MOUs generally include provisions for IPR and MAT, or are 
accompanied by Material Transfer Agreements that define those 
issues.  Dr. Arivudai Nambi indicated that in instances where 
a foreign party is collecting biological resources for a 
commercial purpose and thus seeking to profit, the NBA can 
renegotiate MAT after the specimen has been collected - a 
major disincentive for companies to get involved in specimen 
collection in India as the renegotiation could eliminate any 
gain from the research. 
 
¶26. (SBU) The NBA does not require upfront payments but 
instead imposes a royalty percentage usually running between 
2 and 5 percent which goes to the NBA-run biodiversity fund. 
The National Biodiversity Fund is supposed to disburse funds 
to state and local groups, presumably through the SBBs and 
BMCs, although there have been no indications of such 
transfers taking place.  The two NBA committee members we 
talked with said the royalty policy was still being 
formulated, the percentages were currently decided on a 
case-by-case basis, and that the NBA had not yet decided out 
how it would standardize decisions on royalties.  This lack 
of transparency has led to great consternation in the 
scientific community. 
 
¶27. (SBU) CSIR's IPR office has 205 approved applications, 
but has yet to sign an agreement because the NBA is demanding 
an exorbitant royalty percentage.  Our contact would not 
confirm the percentage demanded, though he did mention 10 
 
NEW DELHI 00000421  007 OF 008 
 
 
percent at one point in the conversation.  Our contact also 
noted that patents are often licensed to third parties, and 
that he had asked the NBA for clarification on whether the 
licensor or licensee would be responsible for paying 
royalties to the NBA. 
 
¶28. (U) Another major unresolved issue for the NBA is 
developing guidelines to deal with materials transferred 
prior to the existence of the CBD, BDA, and NBA.  While this 
applies primarily to UK researchers who collected significant 
numbers of samples during their stewardship of India, it may 
also apply to materials shared with the U.S. either 
independently or through institutes in the U.K. and other 
countries. 
 
¶29. (SBU) Patent applications in India are required to 
specify the source and origin of biological materials, and 
NBA approval is required before a patent can be granted. 
However CSIR's Mr. Gupta indicated that at the moment, only 
the Mumbai patent office was verifying NBA approval prior to 
issuing a patent.  Mr. Gupta also said the rules regarding 
the timing for filing both patent and NBA applications was 
unclear, and so CSIR was erring on the side of filing first 
for patent protection and immediately thereafter filing for 
NBA approval.  His logic was that filing first for the patent 
provides some protection of the information since the NBA 
application is publicly available. 
 
¶30. (U) In regard to IPR-related applications, the NBA is 
supposed to conduct a review of traditional knowledge before 
providing approval.  People's Biodiversity Registers are 
intended to be one mechanism for review of traditional 
knowledge.  In fact, our contacts told us that patent offices 
in Indonesia, the EU, and other unspecified countries were 
recently granted restricted access to the PBR databases for 
that purpose.  A second mechanism is the "Wealth of India" 
compendium which catalogues colloquial and technical 
information on India's natural resources.  It is not clear 
whether these sources, or any others, are routinely consulted 
by the NBA. 
 
¶31. (U) There is also conflicting information about 
negotiation of PIC.  Despite claims that PIC is supposed to 
be negotiated with the local organizations by the Indian 
sponsor, our Delhi-based contacts suggested that the NBA 
retains control.  Regardless of whether or how the 
negotiations take place, additional NBA approvals and fees 
are required any time Indian biological resource materials or 
information are to be transferred to a party not explicitly 
named in an original NBA-approved agreement. 
 
-------- 
COMMENTS 
-------- 
 
¶32. (SBU) Despite nearly a month of requests A. K. Goyal, 
MoEF Joint Secretary and India's designated point of contact 
for the Convention on Biological Diversity, refused to meet 
with us and claimed various excuses from involvement in 
Parliamentary sessions to being too busy.  This unwillingness 
to engage is unprecedented and we suspect stems from a desire 
to avoid discussing a process MoEF knows is severely flawed. 
Our other contacts, including those at the NBA, were happy to 
discuss the issues and provide copies of related 
documentation.  They were, however, hesitant to give us 
definite answers and conceded uncertainty about many of the 
processes and requirements as they are constantly changing. 
Indian sponsors are intended to provide guidance to foreign 
parties, though in many cases they appear not to be aware of 
the various requirements and processes.  The bottom line is 
that there is no one-stop-shop for a researcher interested in 
accessing biological resources in India. 
 
¶33. (SBU) The BDA and NBA, in theory and especially in 
 
NEW DELHI 00000421  008 OF 008 
 
 
practice, appear to be more focused on IPR and financial 
considerations than on conservation or biodiversity.  Though 
the NBA allegedly has responsibility for ensuring compliance 
with the BDA and Rules, our contacts were unable to provide 
any information on specific penalties or enforcement 
authorities for violations of research, IPR, transfer, or 
royalty payments.  In addition, India has not even begun to 
address the management and sharing of genetic sequences or 
the structures of compounds derived from biological resources 
- both of which could be used to recreate Indian biological 
resources or their derivatives outside of India. 
 
¶34. (U) Post's contact for further inquiries is EST Officer 
Heather Broman (email: bromanhw@state.gov). 
WHITE