Plant
genetic resources were considered to be heritage of mankind and was shared
freely among nations, till the concern for conservation of biological diversity
were raised by the Convention of Biological Diversity (CBD), 1993. India being
a signatory to CBD, enacted the Biodiversity (BD) Act in 2002, (hereinafter
referred as “Act”) with three main objectives:
- conservation
of biological diversity,
- sustainable
use of its components, and
- equitable
sharing of benefits arising out of the use of biological resources.
For
the effective implementation of the Act, a three-tier system was established
with a National Biodiversity Authority (NBA) at the Centre, State Biodiversity Boards
(SBBs) in each of the Indian states and local-level Biodiversity Management Committees
(BMCs) functioning with both municipalities and panchayats. Further, India
adopted Nagoya Protocol (2014) on
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization to the Convention on Biological Diversity,
a supplementary provision in compliance with the third objective of CBD, 2002. In
pursuance of the Nagoya Protocol, NBA published Guidelines on Access to Biological
Resources and Associated Knowledge and Benefits Sharing Regulations, 2014, popularly
known as ABS guidelines, 2014. These guidelines provide a detailed procedure for
determination and sharing of benefits arising out of the use of biological
resources obtained from India.
The
provisions of the BD Act, 2002, have differential restrictions and exemptions,
depending on the person involved or the activity envisaged with respect to
bio-resources. Foreign nationals or Indian citizen or body corporate falling
under Section 3 (2) of the Act, are required to obtain prior approval of NBA
for obtaining any biological resource occurring in India or knowledge
associated thereto for research or for commercial utilization or for bio-survey
and bio-utilization. Provided that under Section 5, collaborative research
projects are exempted from prior-approval of NBA. In case of obtaining
intellectual property rights (IPR) on research results involving biological
resources obtained from India, prior NBA approval is required under Section 6,
irrespective of the category of the person. Further, under Section 7, Indian
nationals or a body corporate, association or organization which is registered
in India shall not obtain any biological resource for commercial utilization,
or bio-survey and bio-utilization for commercial utilization, except after
giving prior intimation to the concerned State Biodiversity Board in the
prescribed manner. Provided that the provisions of this section shall not apply
to the local people and communities of the area, including growers and
cultivators of biodiversity, and vaids and hakims, who have been practicing
indigenous medicine.
As
per NBA official records, thousands of notices were issued by SBBs under Section
7 of the Act to various Indian companies including those of pharmaceuticals,
ayurvedic, coal extracting, liquor, sugar, oil as well as food and industrial
processors using bio-resources, for deposition of a “benefit sharing” amount as
per ABS guidelines, 2014. Several times this issue got media attention and
various reports were published in leading newspaper where the companies
challenged the vires of the state rules and ABS Guidelines, which ask for
benefit sharing upon access by Indian entities. One of the leading case in this
regard is the Uttarakhand HC case, filed in 2016
by Ramdev’s Hardiwar-based Divya Yoga Mandir Trust when the Uttarakhand State
Biodiversity Board (SBB) asked its pharma unit, Divya Pharmacy, to share INR
20.4 million of its INR 4.21-billion revenue in 2014-15 with farmers as benefit
sharing under the BD Act, 2002. Patanjali pleaded in the Court that it being an
Indian company hence, ABS compliance is not applicable to it. In 2015,
the Ayurvedic Drug Manufacturers Association (ADMA) approached government
officials for modification in provisions of ABS guidelines, 2014, but the
response was not favorable to them. As per official records, only a handful of
companies are sharing their profits as per ABS guidelines, 2014. Hence, at present,
the effectiveness of the regulatory regime on benefit sharing is not very
promising in herbal sector.