Herbal Research in India @ Crossroads
Dr Gopakumar G Nair
CEO
Gopakumar Nair Associates

This article is a brief review of the herbal research in India and the regulatory guidelines in relation to research applications and commercialisation of biological resources.

The Convention on Biological Diversity signed by more than 150 governments at 1992 Rio Earth Summit is dedicated to promoting sustainable development. It has been acknowledged that biodiversity is more than plants, animals and micro-organisms and their ecosystems-it is about people and our need for food security, medicines, fresh air and water, shelter, and a clean and healthy environment in which to live.1

On 17 February, 2014 South Sudan became the 194th member country to the global treaty on biodiversity and sustainable development. United Nations has also announced a "Decade on Biodiversity, living in harmony with nature ." Strategic goals of 20 ambitious yet achievable targets, collectively known as the "Aichi Targets" have been identified to be achieved by 2020. The main goals are as follows:

GOAL A: Address the underlying causes of biodiversity loss by mainstreaming biodiversity across government and society.

GOAL B:Reduce the direct pressure on biodiversity and promote sustainable use.

GOAL C: Improve the status of biodiversity safeguarding ecosystems, species and genetic diversity.

GOAL D: Enhance the benefits to all from biodiversity and ecosystem services.

GOAL E: Enhance implementations through participatory planning, knowledge management and capacity building.2

India was one of the first Countries to implement the Bio-Diversity Act. India's 'The Biological Diversity Act, 2002' was enacted on 5th February, 2003. In the preamble to the Act conservation of biodiversity, sustainable use, fair and equitable sharing of benefits were highlighted as the objectives in line with the United Nations Declaration.3

"Biological resources" has been defined under section 2(c) of the Act. The 2 (c) reads as follows-"biological resources" means plants, animals and micro -organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material.

Further, "sustainable use" is defined under section 2(o) as follows-it means the use of components of biological diversity in such manner and at such rate that does not lead to the decline of the biological diversity thereby maintaining its potential to meet the needs and aspirations of present and future generations.

Section 2(p) defines "value added products" as follows- it means products which may contain portions or extracts of plants and animals in unrecognisable and physical inseparable form.

However, the sections of the Bio Diversity Act and the rules, thereof (Bio Diversity Rules, 2004) leaves much to be desired in promoting sustainable development and benefit sharing.

The Bio Diversity Authority (BDA) has recently celebrated its 10th Anniversary. In the preamble the BDA states as follow;

"The Act covers conservation, use of biological resources and associated knowledge occurring in India for commercial or research purposes or for the purposes of bio-survey and bio-utilisation. It provides a framework for access to biological resources and sharing the benefits arising out of such access and use. The Act also includes in its ambit the transfer of research results and application for intellectual property rights (IPRs) relating to Indian biological resources.

The Act covers foreigners, non-resident Indians, body corporate, association or organisation that is either not incorporated in India or incorporated in India with non-Indian participation in its share capital or management. These individuals or entities require the approval of the National Biodiversity Authority when they use biological resources and associated knowledge occurring in India for commercial or research purposes or for the purposes of bio-survey or bio-utilisation. Indians and Indian institutions do not require the approval of the National Biodiversity Authority when they engage in the above mentioned activities. However they would need to inform the State Biodiversity Boards prior to undertaking such activities. However, any commercial application related to use of biological resources should be approved by the Authority. The Act excludes Indian biological resources that are normally traded as commodities. Such exemption holds only so far the biological resources are used as commodities and for no other purpose. The Act also excludes traditional uses of Indian biological resources and associated knowledge and when they are used in collaborative research projects between Indian and foreign institutions with the approval of the central government."

However, the definition on the website of the Biological Diversity Act differs substantially from the definition in the Act itself. Unfortunately while the BDA emphasises on prevention and regulation of use of biological resources, there appears to be no effort for encouraging sustainable development or for benefit-sharing. The entire emphasis of Biological Diversity Act as interpreted and implemented by the BDA appears to be directed towards preventing access to Indian Researchers and use of national biological resources for Research and Protection of research funding. This leads to prevention of research and bio-utilisation including commercialisation or licensing thereof, in a sustainable manner, which alone can generate results both tangible and intangible, intellectual or financial , for benefit-sharing. While there is no dispute with regard to the need of biodiversity preservation, the emphasis should shift from excessive policing to encouragement of sustainable development and benefit generation for sharing.

The Nagoya Protocol on Access and Benefit-Sharing
The initiative on Convention of Bio-Diversity has received a boost on 2014 through the Nagoya Protocol on Access and Benefit-Sharing. The Nagoya Protocol come into effect on October 12, 2014. The Honourable Cabinet Minister of India on Environment, Prakash Javadekar had announced this development in the Indian Parliament. It is earnestly hoped that the Indian Bio Diversity Acts and Rules as well as the procedures and approaches for the implementation of the same will be reviewed under the context of Nagoya Protocol of 2014 for better capacity-building and awareness-raising.

It is further hoped that Indian researchers will get opportunities for research in biological resources including herbals and in protecting their research findings for improved benefit-sharing with the Indian communities in a fair and equitable basis.

The need for reviewing the current working of the BDA and the procedures adopted to interpret the Acts and the Rules will become clear on an audit of the performance of BDA as available from the statistics of the benefit generated and shared till date, from the records of BDA itself.

The Patents Act, 1970 & Biodiversity Act
The footnote in Form 1 under Patents Act, 1970 for filing of Patent Applications, states as follows with reference to declarations.

"The invention as disclosed in the specification uses the biological material from India and the necessary permission from the competent authority shall be submitted by me/us before the grant of patent to me/us" .

The Patent Controller should exercise his discretion for evaluation of applicability of Biodiversity Act for cases not involving exportation of Natural or biological resources.

Section 3 (p) and TKDL
Section 3 (p) of the Patents Act, 1970 states as follows:
(Inventions not patentable/ What are not inventions)
"an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components".

Inventions which are not traditional knowledge and which have novelty and inventive step of their own, should be eligible for grant of Patents. Patent should not be denied to otherwise patentable subject matter, only because there is mention of the item in TKDL.

References
1) www.cbd.int/convention/
2)www.cbd.int/sp/targets/
3)www.nbaindia.org/text/12/1 TheBiologicalDiversityAct2002.html