Regulatory requirement of Biopesticides and Insecticides Act, 1968

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Biopesticides
Regulation
requirements in
India
Presented by
Subhash Chand
Deputy Director(Chem)
Govt. of India
Ministry of Agriculture
Department of Agriculture & Cooperation
Central Insecticide Board & Registration

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THE INSECTICIDES
ACT, 1968
2
….With a view to prevent
risk to Human beings,
Animals and matters
connected therewith.
Import
Use
Manufacture
Distribution
Transport
Stocking/
Sale
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Insecticides Act 1968
implemented by
• CENTRAL GOVERNMENT –
• REGISTRATION
• QUALITY CONTROL
• STATE GOVERNMENTS –
• MANUFACTURING LICENCES
• SALE PERMIT/LICENSE
• QUALITY CONTROL
• USE

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STATUTORY BODIES UNDER
THE INSECTICIDES ACT
CENTRAL LEVEL
• CENTRAL INSECTICIDES BOARD
• REGISTRATION COMMITTEE
• CENTRAL INSECTICIDES LABORATORY
• Regional Pesticides Testing Laboratories
STATE LEVEL
• LICENSING OFFICERS
• INSECTICIDE INSPECTORS
• INSECTICIDE ANALYST
• PESTICIDE POISONING REPORTING

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CENTRAL INSECTICIDES
BOARD
Constituted Under Section 4
Of The Insecticides Act,
1968

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COMPOSITION OF CENTRALCOMPOSITION OF CENTRAL
INSECTCIDES BOARDINSECTCIDES BOARD
7
•Director General of Health Services
as Chairman.
• 28 Members from different Ministries.
(16 ex-officio and 12 nominated)
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Insecticides Act implemented
by
• CENTRAL GOVERNMENT –
• REGISTRATION
• QUALITY CONTROL
• STATE GOVERNMENTS –
• MANUFACTURING LICENCES
• SALE PERMIT/LICENSE
• QUALITY CONTROL
• USE

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FUNCTIONS OF THE BOARD
• To Advise Central Government and State Governments
(a) Technical matters arising out of administration of the Act.
(b) The risk to human beings or animals involved
in the use of insecticide and safety measure.
(c) The manufacture, sale, storage, transport and
distribution of insecticides with a view to ensure safety
to human beings or animals.
(D) Specify the shelf-life of insecticides
(E) Specify the uses of classification of insecticides on the
basis of their toxicity as well as their being suitable for
aerial application.
(F) Inclusion of insecticides in schedule to the Act.
(G) Carry out such other functions as are supplemental,
incidental or consequential to any of the functions
conferred by the Act or these rules.
(H) Advice tolerance limits of Insecticides, residues and
minimum internal between the application and harvest.

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REGISTRATION COMMITTEE
(RC)
• Constituted under Section 5
of Insecticides Act, 1968

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FUNCTIONS OF THE
REGISTRATION cOMMITTEE
• To register pesticides after
scrutinizing their formulae and
• Verify claims regarding Efficacy And
Safety to human beings and Animals
• Specify Dosage, Manner of Use
Application time and technique,
Precautions against Poisoning etc to
be printed on Labels and Leaflets.
• Any other Function Incidental to
these Matters.

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BIOPESTICIDES INCLUDED IN THE
SCHEDULE TO THE INSECTICIDES
ACT, 1968
A- Microbial Pesticides
I. Antagonistic fungi and Bacteria
Bacillus Species (B.t., B.s.,
Bacillus subtilis, etc.)
Gliocladium species
Pseudomonas sp.
Trichoderma species
Contd…

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II. Entomopathogenic Fungi
Beuveria bassiana
Metarrhizium anisopliae
Nomuraea rileyi
Verticillium lecanii
Hirsutella species
III. Viruses
Granulosis viruses (GV)
Nuclear polyhedrosis virus
(NPV)
Contd…

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B - Pesticides of Plant Origin
–Pyrethrum
–Karanjin
–Herbal Extract (mixture of
diallyl disulphide, allyl
propyl disulphide and allyl
isohiocyanate)
–Neem based Pesticides
–Cymbopogon extract
–Eucalyptus leaf extract.

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Microbial pesticides included in the schedule to
the Insecticide Act, 1968
 Bacillus species
I Bacillus thuringiensis var.israelensis
II Bacillus thuringiensis var.kurstaki
III Bacillus thuringiensis var.galleriae
IV Bacillus sphaericus
 Bacillus subtilis
 Gliocadium species
 Pseudomonas species
 Trichoderma species
 Beauveria bassiana
 Metarrhizium anisopliae
 Nomurea rileyi
 Verticillium lacanni
 Granulosis viruses (GV)
 Nuclear polyhetrosis viruses (NPV)
 Hirsutella species
 Verticillium chlamydosporium
 Streptomyces griseoviridis
 Streptomyces lydicus
 Ampelomyces quisqualis
 Candida oleophila
• Fusarium oxysporum (non pathogenic)
• Burkholderia cepacia
• Coniotyrium minitans
• Agrobactarium radiobacter strain 84
• Agrobactarium tumefaciens
• Pythium oligandrum
• Erwinia amylovora (hairpin protein)
• Phlebia gigantean
• Paecilomyces lilacinus
• Penicilliuim islanidicum (for groundnut)
• Alcaligenes spp.
• Chaetomium globosum
• Aspergillus niger – strain AN27
• VAM – Vesicular arbuscular
mycorrihizal (fungus)
• Myrothecium verrucaria
• Photorhabdus luminescences akhurustii
strain K-1
• Serratia marcescens GPS 5 (Bacteria)
• Piriformospora indica
• Total -38

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REGISTRATION OFREGISTRATION OF
PESTICIDESPESTICIDES
• Provisional Registration for two
years [Section 9 (3B)] for first time
introduction.
• Regular Registration [Section
9(3)].
• Me-Too Registration [Section 9(4)].
(Applications could be for import or manufacture.)

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12
INCLUSION IN THE SCHEDULE TO THE ACT
SAMPLE IMPORT PERMIT/Manufacture
DATA GENERATION UNDER INDIAN CONDITION
SUBMISSION OF APPLICATION FOR
REGISTRATION
REGISTRATION UNDER SECTION 9 (3B) OF
THE ACT - PROVISIONAL
REGISTRATION UNDER SECTION 9 (3) OF
THE ACT – PERMANENT
REGISTRATION UNDER SECTION 9(4) OF
THE ACT ME-TOO
STEPS TO PESTICIDE REGISTRATIONSTEPS TO PESTICIDE REGISTRATION
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4 . Central Insecticides
Laboratory (PRV)
2. Sectt. CIB & RC
1. Applicant
Administratio
n/ office Chemistry
Toxicology
Packaging
Registratio
n Committee
Submits
applicati
on along
with data
Deficienc
y report
a) For Products Manufactured in India
Team visits
site and
collects
the sample
Sample
analysis
b) For Imported Technicals/formulations
Applicant
Submits
sample
Sample
analysis
Bio-efficacy
Legal
5. Ministry of Health And Family Welfare (MRL)
Secretariat
scrutinizes
data and
sends it to
FSSAI
FSSAI
fixes
MRL’s
3. ICAR
REGISTRATION PROCEDUREREGISTRATION PROCEDURE
13
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LIST OF BIOPESTICIDES REGISTERED
FOR USE IN INDIA
• Microbial Biopesticides Registered U/s 9(3)
• Bacillus sphaericus
• Bacillus thuringiensis var. galleriae
• Bacillus thuringiensis var. israelensis
• Bacillus thuringiensis var. kurstaki
• Beauveria bassiana
• Metarhizium anisopliae
• Nuclear polyhyderosis virus of Helicoverpa
armigera
• Nuclear polyhyderosis virus of Spodoptera litura
• Pseudomonas fluorescens
• Trichoderma harzianum
• Trichoderma Viride
• Verticillium chlamydosporium
• Verticillium lecanii

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Continue…
• Botanical Pesticides (Biopesticdes)
Registered U/s 9 (3)
• Azadirachtin
• Pyrethrins (pyrethrum )
• Spinosad
• Tricontanol
• Microbial Biopesticides Registered U/s 9(3B)
only
• Ampelomyces quisqalis
• Bacillus subtillis
• Hirsutella thompsonii
• Paecilomyces lilacinus
• Photorhabdus luminescences akhurustii strain K-1
• Botanical Biopesticides Registered U/s 9(3B)

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Data Requirements for
Registration of Biopesticides
• Chemistry
• Bioefficacy
• Toxicity
• Packaging and Labelling

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Chemistry & biological
characteristics
• Systemic name, strain
• Detail composition
• Test procedure
• Specifications
• Contaminants
• Process of manufacture
• Shelf-life
• Coding (in case of formulation)

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Bioefficacy
• Laboratory Tests.
• Field Trials with proposed
formulation (ICAR, SAU, CSIR, ICMR)
• Phytotoxicity
• Effect on non-target organisms (Two
season/Two year data on natural
parasites and predators)

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Toxicity
• Single exposure studies
• Skin and mucous membrane
irritation
• Toxicity to birds, fish, honey
bees, silk worm, earthworm with
formulation only

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Packaging & Labeling
• Type of packaging
• Manner of packaging
• Container contents
compatibility
• Labels and leaflets
• Instruction for storage and
use
• Disposal of empty containers

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Data Requirements for
Neem based Pesticides
•Chemistry
•Bioefficacy
•Toxicity
•Packaging & Labelling

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Chemistry
• Name of part of plant
• Process of manufacture
• Chemical identity of ingredients
• Physiochemical properties
• Specifications
• Method of analysis
• Analytical test report
• Shelf life claim/data

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Bioefficacy
• Bioeffectiveness
• Phytotoxicity
• Compatibility with other
chemicals
• Label information: Purpose of
manufacture, direction for use
(dosage), time of application,
waiting period, application
equipments

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Toxicity
• Acute toxicity studies (except inhalation)
• Skin & mucous membrane irritation
• Neurobehavioral toxicity
• Mutagenicity
• Reproduction toxicity
• Carcinogenicity
• Health monitoring studies in applicators

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Packaging & Labeling
• Type of packaging
• Manner of packaging
• Container contents compatibility
• Labels and leaflets
• Instruction for storage and use
• Disposal of empty containers

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Market of Bio-Pesticides in India
and its Scope of Business
Opportunities
• Current market for Bio-Pesticides in India is approx.
INR 10.0 billions and estimated to grow at a CAGR of
18% per annum.
• Although there are > 350 producers of these Bio-
agents in India, the formulated product available
for farmers for various treatments is about 30000
MT only.
• Total combined production is just enough to meet
the requirement of 4% of arable land of Indian
Agriculture. Huge gap exists in demand and supply
of quality products.

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Government efforts to
promote Biopesticides
• Registration guidelines
simplified
• Applications processed on
priority
• Commercialization is permitted
during provisional registration

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Commercial Products Based on Bio-Pesticides Registered with
Central Insecticides Board & Registration Committee,
Faridabad, u/s 9(3B) and 9(3)

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Market of Bio-Pesticides in India
and its Scope of Business
Opportunities
• Current market for Bio-Pesticides in India is
approx. INR 10.0 billions and estimated to grow
at a CAGR of 18% per annum.
• Although there are > 350 producers of these
Bio-agents in India, the formulated product
available for farmers for various treatments is
about 30000 MT only.
• Total combined production is just enough to
meet the requirement of 4% of arable land of
Indian Agriculture. Huge gap exists in demand
and supply of quality products.

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Status of RegistrationStatus of Registration
* PesticidesincludedinSchedule ofInsecticidesAct 1968 : 901
* ActiveingredientsregisteredforuseinIndia : 281
formulationsregisteredforusein India : 648
* Bannedfrommanufacture/import/use : 28
* Banned fromdomesticuse,allowedforexport : 02
* Formulationsbanned : 04
* Refusedregistration : 18
* Restricteduse : 13
• Withdrawnforuse : 07

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NUMBER OF CERTIFICATES
ISSUED
Year Category wise Certificate or Registration
issued/approved
Total
Export Biopesticides 9(3)
Chemical
9(4)
TIM
9(4) &
others
2005-2006 442 56 44 44 2915 3501
2006-2007 498 81 31 48 3722 4380
2007-2008 373 146 27 68 3756 4370
2008-2009 363 220 43 17 3557 4200
2009-2010 371 137 24 20 2772 3324
2010-2011 379 262 22 22 1456 2141
2011-2012 545 295 25 15 2890 3770
2012-2013 402 305 22 85 4993 5807
2013-2014 1073 240 20 66 8624 10023
2014-2015 1409 703 72 171 33741 36096
2015-2016 1003 351 90 156 16351 17951
TOTAL 6858 2796 420 712 84777 95563

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Please visit us at:
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