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

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

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C. Keswani, et al. 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
Fig. 1. Industry-wise Distribution of microbial biopesticides. Sectoral dis-
drastically reduce the product's microbial count, thereby severely re-
tribution based on data from Directorate of Plant Protection, Quarantine &
ducing its effectiveness in field conditions (Alam, 2000; Evans et al.,
Storage, Department of Agriculture, Cooperation & Farmers Welfare, Ministry
of Agriculture & Farmers Welfare, Government of India (http://ppqs.gov.in/
1993). It all stalls before due to lack of funding for the next steps:
divisions/cib-rc/biopesticide-registrant Accessed on: March 01, 2019). meeting regulatory criteria, scaling-up for shipping and application,
marketing-commercialization.

commercial companies and 32 IPM centers to produce biopesticides

since 2010 (Keswani et al., 2016a). Some other advances have also been 4. Further work required
observed, such as the establishment by the State Departments of Agri-
culture and Horticulture of Gujarat, Uttar Pradesh, Karnataka, Tamil India still faces major challenges in terms of agricultural sector
Nadu, Andhra Pradesh and Kerala of advanced biocontrol laboratories, development, to meet its demographic challenges to provide food se-
as well as the production of microbial pesticides (Pathak et al., 2017) by curity in the next 20–50 years. It is therefore high time that, in order to
the Institutions of the Indian Council of Agricultural Research (ICAR) coordinate an integrated federal action plan, internally consistent, with
and a few State Agricultural Universities (SAUs) (Rabindra, 2005) realistic funding and administrative mechanisms for registration and
(Supplementary Data Tables 2–7). marketing. In addition, farmers should be properly trained to use bio-
Another limitation is the requirement to verify the microorganism pesticides, for harvesting maximum benefits. . These major constraints
for biosafety prior to registration and propagation of biopesticides. include: creating a thorough awareness among farmers on biopesticides
Some incidences report health hazards if the product is not used in storage and use, farmers should be properly trained to use these eco-
accordance with the above guidelines (Doekes et al., 2004). Likewise, friendly alternatives to pest control in their agricultural fields effi-
allergies have been reported in immunocompromised patients with ciently. Prior to the development of biopesticides and their use in field
entomopathogenic fungi such as Trichoderma, Metarhizium anisopliae applications, stringent techniques for accurate identification of species
and Beauveria bassiana (Darbro and Thomas, 2009; Iida et al., 1994; of biopesticides and strain levels with respect to DNA barcoding should
Keswani et al., 2014). Even if the strains proposed for biopesticide be performed to avoid the possibility of erroneous microbes entering
development are safe, their introduction might create alterations in the the environment. Biopesticides production is a high-risk venture, as an
soil community (Singh et al., 2013a). Universities and research in- initially high investment in capital, needs to be made right from the
stitutions where biopesticides are developed cannot bear these costs, screening stage to select potential strains for production and their
therefore there is no commercialization, and many strains with all packaging, storage, and distribution.
public research support remain on research laboratory shelves (Singh
et al., 2017; Keswani, 2015).
Acknowledgments

CK is grateful to Banaras Hindu University for providing financial

support through the DST-PURSE (5050) programme.

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doi.org/10.1016/j.rhisph.2019.100155. Singapore, pp. 3–12.
Keswani, C., Singh, S.P., Singh, H.B., 2013. A superstar in biocontrol enterprise:
Trichoderma spp. Biotech. Today 3, 27–30.
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