Rhizosphere 11 (2019) 100155

Contents lists available at ScienceDirect

Rhizosphere
journal homepage: www.elsevier.com/locate/rhisph

Regulatory barriers to Agricultural Research commercialization: A case T

study of biopesticides in India
Chetan Keswani∗, Hagera Dilnashin, Hareram Birla, Surya Pratap Singh
Department of Biochemistry, Institute of Science, Banaras Hindu University, Varanasi, 221005, India

A R T I C LE I N FO A B S T R A C T

Keywords: Since the Indian green revolution in agriculture, the intensification of pesticide uses has brought into focus the
Biopesticides long-term hazardous impact of such practices to public health and the environment. To ensure sustainable long
Bioinoculants term food security , India is trying to shape a second green revolution with alternative technologies that are
Biofertilizers ecofriendly to reduce the nefarious environmental impacts. Application of microorganisms of agricultural im-
Research development
portance for sustainable crop production and disease management is an effective strategy for replacing con-
Sustainable agriculture
ventional agrochemicals. These have been variously called plant growth promoting bacteria (PGPB) or rhizo-
bacteria (PGPR), with biofertilizer and biopesticide properties. Yet, despite two decades of intensive research by
universities and the private sector, and the accumulation of countless potentially beneficial microbes across
India, there has as yet not been any transforming discoveries or commercialization. Several regulatory and
commercialization barriers causing slow market growth and poor acceptance of biopesticides in India are dis-
cussed here

1. Introduction
The green revolution in India introduced enhanced agricultural
technologies, in particular, the use of chemical pesticides to increase
production and yield (Bisen et al., 2015; Singh et al., 2017). However,
over the years, the rampant and continuous use of pesticides and fer-
tilizers has not only posed an imperative risk to human health and
ecosystems but has also been catastrophic for soil microbiota (Bisen
et al., 2015; Keswani et al., 2014; Mishra et al., 2015). Large-scale
chemical inputs into the soil have made many areas unproductive,
especially in Uttar Pradesh, Punjab, and Haryana, which has become a
matter of genuine concern (Planning Commission, Government of India,
2013; Singh et al., 2013b). Furthermore, xenobiotic pesticides are de-
signed to have slow or very slow degradation rates due to their struc-
ture, which promotes their bioaccumulation and biomagnification
across the food-web, causing loss of biodiversity and contamination of
groundwater. The continuously growing human population (current
annual growth rate is 1.6% (James and Goli, 2016)), together with a
constant threat of abiotic stress and the loss of fertile soils (NAAS, 2013;
2017), especially from the Indian perspective, made the search for
plausible eco-friendly alternatives extremely imperative, mainly to
ensure food safety (Keswani, 2015).
The Indian economy is predominantly agro-based with about 70%
of the population of the country being linked to agriculture in some
ways. India is the leading producer of cereals, cash crops, and some
horticultural crops, according to reports (www.fao.org; www.agricoop.
nic.in). In the context of eco-friendly solutions, plant breeds that are
tolerant or that have improved resistance to pathogens may be con-
sidered an alternative to xenobiotic or plant-extract derived pesticides.
But these economically unsustainable techniques cannot be con-
templated seriously due to their exorbitant costs to Indian farmers, and
due to the length of time required for the development, licensing, and
commercialization of these varieties. This opens the way for plausible
cost-effective, eco-friendly and sustainable yield improvement alter-
natives, such as the use of agriculturally important microbes (AIM),
including rhizobacteria, which have attracted the attention of agri-
culturalists for a long time. Extensive research on sustainable agri-
culture using AIM has been carried out globally for at least two decades
(Ahmad et al., 2008; Ram et al., 2018; Singh et al., 2019a,b). Biopes-
ticides, an AIM subclass (Table 1), are naturally occurring biologically
safe microorganisms that can be used to control and regulate outbreaks
of pests in agriculture (Singh et al., 2016). Considering the significant
role of biopesticides and biofertilizers in promoting sustainable agri-
culture that mainly encompasses target-specificity, environmental se-
curity and biodegradability (Bisen et al., 2016; Keswani et al., 2013;
Kumar and Singh, 2015), several government agencies such as the In-
dian Ministry of Agriculture and Farmers Welfare, Department of Bio-
technology (DBT) and the Indian Ministry of Science and Technology

∗
Corresponding author.
E-mail address: chetan.keswani4@bhu.ac.in (C. Keswani).

https://doi.org/10.1016/j.rhisph.2019.100155
Received 11 April 2019; Received in revised form 15 May 2019; Accepted 16 May 2019
Available online 25 May 2019
2452-2198/ © 2019 Published by Elsevier B.V.
C. Keswani, et al. Rhizosphere 11 (2019) 100155

Table 1
List of Microorganisms Permitted for Commercialization for Agricultural Application Included in the Gazette of India on January 26, 1999. Data in the brackets
represent the number of registered Indian companies (with license) involved in the production of microbial biopesticies.
Fungi Bacteria Virus

Trichoderma viride (285) Pseudomonas fluorescens (176) Nuclear polyhedrosis virus of:
(a) Helicoverpa armigera (24)
(b) Spodoptera litura (3)
Trichoderma harzianum (53) Agrobacterium tumefaciens Granulosis viruses
Beauveria bassiana (97) Agrobacterium radiobacter strain 84
Gliocladium sp. Bacillus subtilis (5)
Metarhizium anisopliae (35) Bacillus thuringiensis (5)
Verticillium lecanii (84) Bacillus thuringiensis var. israelensis (13)
Verticillium chlamydosporium Bacillus thuringiensis var. kurstaki(40)
Fusarium oxysporum Bacillus thuringiensis var. galleriae (1)
(nonpathogenic)
Penicillium islanidicum (for groundnut) Bacillus sphaericus (2)
Aspergillus niger—strain AN27 Streptomyces lydicus
Paecilomyces lilacinus (36) Streptomyces griseoviridis
VAM (fungus) Erwinia amylovora
Nomuraea rileyi Alcaligenes sp.
Candida oleophila Serratia marcescens GPS 5
Hirsutella sp. Burkholderia cepacia
Pythium oligandrum
Photorhabdus luminescences akhurustii strain K-1
Chaetomium globosum
Myrothecium verrucaria
Ampelomyces quisqualis (2)
Piriformospora indica
Coniothyrium minitans
Phlebia gigantean

Source: Directorate of Plant Protection, Quarantine & Storage, Department of Agriculture, Cooperation & Farmers Welfare, Ministry of Agriculture & Farmers
Welfare, Government of India (http://ppqs.gov.in/divisions/cib-rc/biopesticide-registrant Accessed on: March 01, 2019).

actively promote research and improve the development and com-
mercialization of such “ecological” input. Despite strong Government
support in India, North American Free Trade Agreement (NAFTA)
countries (USA, Canada, and Mexico) are the world's major biopesti-
cides consumer and uses approximately 45% of all globally sold bio-
pesticides (Vílchez et al., 2017), the European Union uses 20%, Oceanic
countries use 20%, South and Latin Americas use 10%, and Asia (in-
cluding China and India) use only 5% of the world's biopesticides
(Bailey et al., 2010; Marrone, 2009).
2. Biopesticide registration
The current status of the Indian Biopesticides Market and
Regulatory Bodies involves a series from the biopesticides manu-
facturing process. The Central Insecticides Board and the Registration
Committee (CIBRC) are the primary bodies involved in screening po-
tential biopesticides based on their biosafety. The Central Insecticide
Board's Gazette Notification dated March 26, 1999, put biopesticides
under the 1968 Indian Insecticide Act. Biopesticides registration be-
came mandatory prior to marketing (Kumar et al., 2018). Newly de-
veloped biopesticides should be temporarily (under section 9(3B)) or
permanently (under section 9(3)) registered with the CIB as settled by
the RC on October 05, 2011 (Keswani et al., 2016; Kulshrestha, 2004).
In this context, manufacturers are required to provide basic information
on their product, such as moisture content, shelf life, product potency in
terms of LC50, toxicity, secondary non-pathogenic microbial load,
packaging, labeling, etc., and to register their product for provisional
registration under either 9(3B) or 9(3) for regular registration under the
1968 Insecticide Act (Rabindra, 2005) (http://ppqs.gov.in/divisions/
cib-rc/guidelines). The Ministry of Agriculture and Farmers Welfare
and the Department of Biotechnology (DBT) are responsible for the
marketing of biopesticides among farmers, in addition to the Central
Integrated Pest Management Centre (CIPMC), Faridabad, the National
Centre for IPM (NCPM) under the Indian Agricultural Research Council
and the Directorate of Biological Control (Alam, 1994). The Department
of Biotechnology (DBT) finances research for the development of
biopesticides in addition to the aforementioned regulatory bodies
(Sinha and Biswas, 2008). Similarly, the National Agricultural Research
System (NARS) and the National Accreditation Board (NBA) perform
biopesticidal quality control testing and provide training in quality
control protocols to state agricultural departments. The latter plays an
essential role in conducting biopesticide distribution to farmers at a
reasonable rate in this regulatory chain (Kabaluk et al., 2010).
However, despite the regulatory bodies' tremendous efforts, the
slow permeation of biopesticides into agricultural applications remains
a major constraint. On the other hand, demand for biopesticides does
increase at the national level due to the initiatives taken by federal and
state governments to promote biopesticides as an alternative to che-
mical pesticides, thereby also stimulating the marketing of spurious
biopesticides that are nefarious to the respectability of this bio-
technology sector. Increased market penetration of spurious biopesti-
cide products was the primary reason for the failure of the 2008
Pesticide Management Bill (by an implementation) which included:
• Monitoring and regulating pesticide manufacturing
• Licensing of pesticide registration, manufacture, and sale
• Access to the effectiveness and safety of pesticides through labora-
tories of pesticide testing
• Indian scenario challenges posed by biopesticides
The currently available mass production technology is the major
constraint of limited production of large-scale biopesticides, especially
in the Indian context. Only 14 biopesticidal formulations were regis-
tered under the 1968 Insecticide Act, which primarily catalogs certain
criteria related to pesticide biosafety, according to literature until
October 2013 (Singh et al., 2016). A total of 970 biopesticides com-
panies are registered by CIBRC and the details are given in the sup-
plementary data (http://ppqs.gov.in/divisions/cib-rc/biopesticide-
registrant). The number of bioproduction units has currently in-
creased to 410, of which 130 are in the private sector (Desai et al.,
2016; Singh et al., 2013; Singhal, 2004) (Table 1 and Fig. 1). Moreover,
the Ministry of Agriculture and Farmers Welfare has assisted about 35

2
C. Keswani, et al.
Fig. 1. Industry-wise Distribution of microbial biopesticides. Sectoral dis-
tribution based on data from Directorate of Plant Protection, Quarantine &
Storage, Department of Agriculture, Cooperation & Farmers Welfare, Ministry
of Agriculture & Farmers Welfare, Government of India (http://ppqs.gov.in/
divisions/cib-rc/biopesticide-registrant Accessed on: March 01, 2019).
commercial companies and 32 IPM centers to produce biopesticides
since 2010 (Keswani et al., 2016a). Some other advances have also been
observed, such as the establishment by the State Departments of Agri-
culture and Horticulture of Gujarat, Uttar Pradesh, Karnataka, Tamil
Nadu, Andhra Pradesh and Kerala of advanced biocontrol laboratories,
as well as the production of microbial pesticides (Pathak et al., 2017) by
the Institutions of the Indian Council of Agricultural Research (ICAR)
and a few State Agricultural Universities (SAUs) (Rabindra, 2005)
(Supplementary Data Tables 2–7).
Another limitation is the requirement to verify the microorganism
for biosafety prior to registration and propagation of biopesticides.
Some incidences report health hazards if the product is not used in
accordance with the above guidelines (Doekes et al., 2004). Likewise,
allergies have been reported in immunocompromised patients with
entomopathogenic fungi such as Trichoderma, Metarhizium anisopliae
and Beauveria bassiana (Darbro and Thomas, 2009; Iida et al., 1994;
Keswani et al., 2014). Even if the strains proposed for biopesticide
development are safe, their introduction might create alterations in the
soil community (Singh et al., 2013a). Universities and research in-
stitutions where biopesticides are developed cannot bear these costs,
therefore there is no commercialization, and many strains with all
public research support remain on research laboratory shelves (Singh
et al., 2017; Keswani, 2015).
3
Rhizosphere 11 (2019) 100155
3. Three major constraints for increase in use of biopesticides
Biopesticide production is a high-risk venture as an initially high
investment in capital needs to be made right from the screening stage to
select potential strains for sales and then also packaging, storage, and
distribution. Apart from the aforementioned issues, the single biggest
constraint to biopesticides' development and growth is the rampant sale
of sub-standard (low CFU count), spurious biopesticides (no CFU count
products) (Alam, 1994), and misbranded (pesticide-laced bioproducts-
pseudo-biopesticides) (Keswani et al., 2016b). Moreover, unregulated
organic bio-inputs (not approved CIBRC) sold under the guise of or-
ganic bio-inputs certified by APEDA (Ministry of Commerce) also pose
as serious competition for high quality biopesticides. The organic bio-
input products are not subjected to any CIBRC mandated bio-efficacy/
safety trials. Over 65% of biopesticides' total sales volume belongs to
these categories (Singh et al., 2016). Strict adherence to mandatory
licensing and quality controls for biopesticides should be enforced by
all Agriculture Departments to make biopesticide, a successful tool for
IPM/Sustainable Agriculture.
Another constraint for enhancing research and development and use
of biopesticides in IPM/Sustainable Agriculture is the highcosts for the
registration of biopesticides (Directorate of Plant Protection,
Quarantine & Storage (http://ppqs.gov.in/divisions/cib-rc/
guidelines)). To facilitate the registration of a large number of biopes-
ticides, relaxed guidelines for registration with CIBRC should be framed
on the basis of the Global Harmonized System (GHS). Imposition of
12% Goods and Services Tax (GST) on microbial products and also on
the botanical product (neem), are the biggest obstacle to the promotion
of the use of biopesticides/biofertilizers/botanicals (same GST rate as
for toxic/hazardous conventional chemical pesticides).
Biopesticides' low shelf life is a major concern for farmers. Because
biopesticides consist primarily of living microbes, temperature fluc-
tuations, humidity or even ultraviolet radiation exposure dampen their
efficacy (Arora et al., 2010). In addition, any contamination may
drastically reduce the product's microbial count, thereby severely re-
ducing its effectiveness in field conditions (Alam, 2000; Evans et al.,
1993). It all stalls before due to lack of funding for the next steps:
meeting regulatory criteria, scaling-up for shipping and application,
marketing-commercialization.
4. Further work required
India still faces major challenges in terms of agricultural sector
development, to meet its demographic challenges to provide food se-
curity in the next 20–50 years. It is therefore high time that, in order to
coordinate an integrated federal action plan, internally consistent, with
realistic funding and administrative mechanisms for registration and
marketing. In addition, farmers should be properly trained to use bio-
pesticides, for harvesting maximum benefits. . These major constraints
include: creating a thorough awareness among farmers on biopesticides
storage and use, farmers should be properly trained to use these eco-
friendly alternatives to pest control in their agricultural fields effi-
ciently. Prior to the development of biopesticides and their use in field
applications, stringent techniques for accurate identification of species
of biopesticides and strain levels with respect to DNA barcoding should
be performed to avoid the possibility of erroneous microbes entering
the environment. Biopesticides production is a high-risk venture, as an
initially high investment in capital, needs to be made right from the
screening stage to select potential strains for production and their
packaging, storage, and distribution.
Acknowledgments
CK is grateful to Banaras Hindu University for providing financial
support through the DST-PURSE (5050) programme.
C. Keswani, et al.
Appendix A. Supplementary data
Supplementary data to this article can be found online at https://
doi.org/10.1016/j.rhisph.2019.100155.
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