CHECK LIST FOR SUBMISSION REQUIREMENTS FOR REGISTRATION OF PESTICIDES AND ENDORSEMENTS FOR PRELIMINARY SCRUTINY.
Table 1. |
CHECK LIST FOR REGISTRATION OF PESTICIDES UNDER
SECTION 9(3)/ 9(3B)
|
Table 2. |
CHECK LIST
FOR EXTENSION OF PROVISIONAL REGISTRATION UNDER SECTION 9(3B)
|
Table 3. |
CHECK LIST FOR 9 (4) TIM CASES UNDER INSECTICIDES ACT, 1968
|
Table 4. |
CHECK LIST FOR UNDER SECTION 9 (4 ) FIM/RSF/CBN/NF
CATEGORY OF THE INSECTICIDES ACT, 1968
|
Table5. |
CHECK LIST FOR UNDER SECTION 9
(4 ) TI/FI CATEGORY OF THE INSECTICIDES ACT, 1968
|
Table 6. |
CHECK LIST FOR REGISTRATION OF PESTICIDES FOR
EXPORT UNDER SECTION 9(3)/ 9(3B)/ 9(4)
|
Table 7. |
CHECKLIST FOR LABEL EXPANSION u/s 9(3) |
Table 8. |
CHECKLIST
FOR LABEL EXPANSION OF INSECTICIDE FOR HOUSEHOLD USE u/s 9(3)
|
Table 9. |
CHECK LIST FOR ENDORSEMENT OF
BIOEFFICACY CLAIM ON LABEL/LEAFLET OF REGISTRATION CERTIFICATE U/S 9(4 ) OF THE INSECTICIDES ACT, 1968
|
Table 10. |
CHECKLIST FOR ENDORSEMENT OF NEW/ALTERNATE PACKAGING |
Table 11. |
CHECKLIST FOR ENDORSEMENT OF CHANGE OF NAME OF THE
COMPANY/FIRM
|
Table 12. |
CHECKLISTFOR ENDORSEMENT OF
FACTORY ADDRESS FOR THE FIRST TIME/SHIFTING OF FACTORY AND ESTABLISHMENT OF
SECOND FACTORY ADDRESS
|
Table 13. |
CHECKLIST FOR TRANSFER OF
CERTIFICATE OF REGISTRATION OF ONE PERSON/UNDERTAKING IN THE NAME OF ANOTHER
PERSON/UNDERTAKING
|
Table 14. |
CHECK LIST FOR ENDORSEMENT OF
CHANGE OF NAME OF SOURCE OF IMPORT OF CHEMICALS DUE TO DISINVESTMENT.
|
Table 15. |
CHECKLIST FOR CHANGE OF NAME OF SOURCE OF IMPORT. |
1.
CHECK LIST FOR
REGISTRATION OF PESTICIDES UNDER SECTION
9(3)/ 9(3B)
NAME OF THE APPLICANT :- M/S
--------------------------------------------------------
---------------------------------------------------------
PRODUCT :-
-------------------------------------------------------------------------------------
TYPE OF THE PESTICIDE & ITS USE
:------------------------------------------------------
A. Administration / Legal : Complete / Deficient
i) Index
ii) Page Numbering
iii) Authentication of pages by authorized
signatory
iv) Form – I duly signed
v) Demand draft as registration Fee
v) Requisite number of stamped envelops
vi) Notarized copy of BOD
Resolution/Affidavit/Partnership Deed.
S.
No. |
Parameter
|
9(3B)
|
9(3)
|
||||||||||||||
|
|
TIT
|
TIM
|
FIM
|
TIT
|
TIM
|
FIT
|
FIM
|
TIT
Vs TIM |
TIM
Vs TIT |
TIT
(New Source) |
CBN
(IM) |
RSF
(IM) |
NF
(IM) |
|||
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
|||
A.
|
CHEMISTRY
|
||||||||||||||||
1.
|
Source of Supply of
Technical
|
R
|
NR
|
R
|
R
|
NR
|
R
|
R
|
R
|
NR
|
R
|
R
|
R
|
R
|
|||
2.
|
Chemical Composition
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
3.
|
Chemical Identity of
technical
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
4.
|
Physico - Chemical
Properties of adjuvants
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
5.
5(a)
|
Technical Bulletin Copy of RTT permit
|
R
R
|
NR
NR
|
NR
NR
|
R
R
|
NR
NR
|
R
R
|
NR
NR
|
R
R
|
NR
NR
|
R
R
|
NR
NR
|
NR
NR
|
NR
NR
|
|||
6.
|
Specification
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
7.
|
Method of Analysis
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
8.
|
Analytical Test Report
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
9.
|
Identification&
Quantification of identifiable Impurities
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
|||
10a.
|
Shelf-life claim
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
10b.
|
Shelf-life Data
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
11.
|
Establishment of Chemical
Equivalance
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
12a.
|
Process of Manufacture
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
12b.
|
Information about Raw
Materials Used
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
12c.
|
Their Source of Supply.
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
12d.
|
Step-wise Manufacturing
Process.
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
12e.
|
Chemical Equation
|
NR
|
R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
NR
|
|||
12f.
|
Formula
|
NR
|
R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
NR
|
|||
12g.
|
Flow sheet diagram of
process of manufacture
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
12h.
|
Effluent Treatment method
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
|||
13.
|
Documents such as
registration certificate / Certificate of DNA/manufacturing licence or any
other approval under any Govt. regulation will be acceptable to support that
manufacturer is actual producer
|
R
|
NR
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
NR
|
NR
|
|||
14.
|
Certificate from
manufacturer that the dealer/ trader is an authorised dealer/ trader of the
manufa - cturer.
|
R
|
NR
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
15.
|
A test report about the
quality of the product from a laboratory as per GLP scheme or from a company
of ISO-9000. This requirement will be provided along with first consignment.
Thereafter,each consignment should have proper analytical test report of the
manufacturer.
|
R
|
NR
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
16.
|
The applicant should
provide sample along- with standards technical sample from the principals/
aut- horized dealers for chemical verification. In case of techni - cal grade
pesti- cidesu/s 9(3), samples of std. impurties are also to be provided for
chemical verification. In process sample to be provided in case of indigenous
manufacture of technical u/s 9(3) TIM & 9(4) TIM withundertaking
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
17.
|
Methodology for residue
estimation as per BIS format.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
B.
|
BIOEFFICACY & RESIDUES
|
||||||||||||||||
18a.
|
Bio-effectiveness
|
NR
|
NR
|
R
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
18b.
|
Phycotoxicity
|
NR
|
NR
|
R
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
18c.
|
Effect on parasites & predators
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
19.
|
Translocation in plants
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
20.
|
Metabolism in soil
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
21.
|
Metabolism in water
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
22.
|
Metabolism in plant
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
23.
|
Persistence in soil
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
|||
24.
|
Persistence in water
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
|||
25.
|
Persistence in plant
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
|||
26.
|
Compatibility with other
chemicals, if claimed
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
27.
|
Residues in plant
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R/NR
|
|||
28.
|
Residues in soil
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
|||
29.
|
Residue tolerance limits
fixed by foreign countries
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
R
|
R
|
|||
30.
|
Cost benefit ratio
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
|||
31.
|
Registration status in
foreign countries
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
R
|
|||
32.
|
M.R.L. Performa in
duplicate
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
C.
|
TOXICITY
|
||||||||||||||||
32.
|
Acute oral in rat &
mice
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
33.
|
Acute dermal
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
34.
|
Acute inhalation
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
35.
|
Primary skin irritation
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
36.
|
Irritation to mucous
membrane
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
37.
|
Sub-acute oral rat
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR/R
|
|||
38.
|
Sub-acute oral dog
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR/R
|
|||
39.
|
Sub-acute dermal
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR/R
|
|||
40.
|
Sub-acute inhalation
|
R
|
R
|
NR/R
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
R
|
NR
|
NR
|
NR/R
|
|||
41.
|
Neuro-toxicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR/R
|
|||
42.
|
Synergism &
potentiation
|
NR
|
NR
|
NR
|
R
|
R
|
NR/R
|
NR/R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
43.
|
Teratogenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
44.
|
Effect on reproduction
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
45.
|
Carcinogenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
46.
|
Metabolism
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
47.
|
Mutagenicity
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR/R
|
NR/R
|
R
|
NR
|
NR
|
NR
|
|||
48.
|
Toxicity to birds
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
|||
49.
|
Toxicity to fish
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
|||
50.
|
Toxicity to honeybees
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
|||
51.
|
Toxicity to live stock
|
R
|
R
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
|||
52.
|
Medical data
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
NR
|
NR
|
|||
53.
|
Human toxicity
information from foreign countries
|
R
|
R
|
R
|
R
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
|||
54.
|
Observation in man (Health
records of spray operators)
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
|||
55.
|
Health records of
Industrial workers.
|
NR
|
NR
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
R
|
NR
|
NR
|
NR
|
|||
56.
|
Toxicity to live stock
(Field trial & observation)
|
NR
|
NR
|
NR
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
NR
|
NR
|
|||
57.
|
International report on
carcinogenicity & genotoxicity status
|
NR
|
NR
|
NR
|
R/NR
|
R/NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
NR
|
|||
D.
|
PACKAGING AND LABELLING
|
||||||||||||||||
58.
|
Labels and leaflets as per
IR-1971 existing norms (i) for size 250 ml & below (ii) for 500 &
above.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
59
|
Labels to contents
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
a.
|
Detailed Chemical
composition
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
b.
|
Purpose for import /
manufacture.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
c.
|
Antidot
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
d.
|
Toxicity triangle
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
e.
|
Cautionary statement
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
f.
|
Brief direction concerning
usages
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
g.
|
Restriction if any
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
60.
|
Leaflets to contain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
a.
|
Detailed Chemical
composition on leaflets accompanying small labels (upto 250 ml size
container)
|
NR
|
NR
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
NR
|
R
|
R
|
R
|
|||
b.
|
Introductory para about the
pesticide
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
c.
|
Detailed directions
concerning usages
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
d.
|
Time of application
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
e.
|
Application equipment
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
f.
|
Waiting Period
|
NR
|
NR
|
R
|
NR
|
NR
|
R
|
R
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
|||
g.
|
Symptoms of poisioning
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
h.
|
First aid measures
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
i.
|
Antidot & treatment
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
j.
|
Restriction, if any
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
k.
|
Instruction for storage
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
l.
|
Information regarding
disposal of used packages.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
61.
|
Type of packaging (pkg material
+ compa- tibility with content)
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
62.
|
Manner of packaging
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
63.
|
Specification for primary
package
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
64.
|
Specification for secondary
packaging.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
65.
|
Specification for transport
packaging.
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
66.
|
Manner of labelling
|
NR
|
R
|
R
|
NR
|
R
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
67.
|
Performance of container
during storage stability test
|
NR
|
NR
|
NR
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
R
|
|||
Abbreviations :
|
|||||
R
|
:
|
Required
|
NR
|
:
|
Not
Required
|
TIM
|
:
|
Technical
Indigenous Manufacture
|
TIT
|
:
|
Technical
Import
|
FIT
|
:
|
Formulation
Import
|
FIM
|
:
|
Formulation
Indigenous Manufacture
|
CBN
|
:
|
Combination
Formulation
|
RSF
|
:
|
Relatively
Safer Formulation
|
IM
|
:
|
Indigenous
Manufacture
|
NF
|
:
|
New
Formulation
|
AR
|
:
|
Already
Registered
|
|
|
|
|
|
|
|
|
|
|
i.
|
For
Import of formulations under section 9(3) :
|
|||
|
|
a.
If the applicant does not seek registration for import of technical
together with formulation, in such a case the applicant shall be required to
submit complete data as per requirement of import of technical.
|
|||
|
|
b.
Rationale for importing formulation.
|
|||
|
ii.
|
Data
on effect on parasites and predators is not required in case of fungicides
and herbicides.
|
|||
|
iii.
|
In
case of relatively safer formulations two consecutive seasons data on
bioeffectiveness indicating phytotoxic effects, if any, on two representative
crops at two agro-dimatic zones of the country or one season / year
multilocation data generated under different agro-climatic zones is required
to be submitted.
|
|||
|
iv.
|
In
case of TIM Vs TIT and TIT Vs TIM under section 9(3), one season data on
bioeffecacy including phytotoxicity, if any, on two representative crops at
two climatic zones is required to be submitted.
|
|||
|
v.
|
One
season residue data on two representative crops particularly on fruits and
vegetables is required in case of relatively safer formulation, TIM Vs TIT
and TIT Vs TIM under section 9(3).
|
|||
|
vi.
|
In
case of herbicides data on effect on soil physico-chemical properties, soil
flora and fona and succeeding crops is
required alongwith the long term residue studies.
|
|||
|
vii.
|
Data
requirements of chemical pesticides are also applicable for registration of
chemical plant growth regulators.
|
|||
|
viiii.
|
NF: In
case of wettable powder, if toxicological data is generated for EC
formulation applicable as per guidelines, then there is no need to generate
data on wettable powder containing the same a.i. |
|||
|
ix.
|
RSF :
The need for additional toxicity data will be determined on case to case
basis. |
2.
CHECK LIST FOR EXTENSION OF PROVISIONAL
REGISTRATION
UNDER SECTION 9(3B)
NAME OF THE APPLICANT: M/s……………………………………………………..
…………………………………………………………….
NAME OF THE PRODUCT:
………………………………………………………...
A. Administration/legal
i)
Index
ii)
Page numbering
iii)
Authentication of pages by authorized signatory
iv)
Authorization for the signatory (Notarized copy of BOD
resolution/affidavit/partnership deed)
v) Form-I duly signed
vi) Demand draft as registration fee
vii)
Requisite number of stamped envelops
viii)
Justification for extension
ix)
Copy of all earlier CRs for the product
x)
Details of data generated to fulfill the conditions of
provisional registration.
a.
Chemistry
b.
Bioefficacy
c.
Toxicity
d.
Packaging
3.
CHECK LIST FOR 9
(4) TIM CASES UNDER INSECTICIDES ACT,
1968
NAME OF THE APPLICANT: M/S……………………………………………………..
…………………………………………………………….
PRODUCT : ………………………………………………………………………
Administration/Legal:-
1. Index
2. Page
numbering
3.
Authentication of pages by authorized signatory.
4. Demand
draft.
5.
Requisite number of stamped envelopes
6. Form-I
duly signed
7. Authorization for the signatory
(Notarized copy of BOD
resolution/affidavit/partnership deed)
Chemistry:-
1. Chemical Composition
2. Chemical Identity/Structural
formula
3. Physico-Chemical properties
4. Specification
5. Method of analysis
6. Analytical Test Report from an
independent laboratory
7. Identification and
quantification of associated standard identifiable
8. Shelf- life claim and Products
Quality undertakings
9. Establishment of chemical
equivalence
10. Process of manufacture
11. Information about raw material
12 Source of supply
13. Step-wise manufacturing process
14. Step-wise chemical equations
15. Flow –sheet diagram of
manufacturing process
16. Effluent treatment method/flow –
sheet diagram, and
17. Drawl of in-process sample and its
Analysis Test Report (ATR) from CIL
Toxicology
1. Acute oral in rat & mice
2. Acute dermal
3. Primary skin irritation
4. Irritation to mucous membrane
Packaging
1. Seven copies Label/leaflets as
per IR 1971 existing norms
2. Manner of packaging
3. Manner of Labeling
4.
CHECK LIST FOR
UNDER SECTION 9 (4 ) FIM/RSF/CBN/NF CATEGORY OF THE INSECTICIDES ACT, 1968
NAME OF THE APPLICANT:
M/S……………………………………………………..
…………………………………………………………….
NAME OF THE PRODUCT :……………………………………
1. Index
2. Page numbering
3. Authentication of pages by
authorized signatory.
4. Demand draft.
5. Requisite number of stamped
envelopes
6. Form-I duly signed
Notarized copies of the following:-
1. BOD Resolution/Partnership
Deed/Affidavit
2. SSI Certificate, if SSI Unit
3. PAN NO.
4. Incorporation Certificate
5.
CHECK LIST FOR UNDER SECTION 9 (4 ) TI/FI CATEGORY OF THE
INSECTICIDES ACT, 1968
NAME OF THE APPLICANT:
M/S……………………………………………………..
…………………………………………………………….
PRODUCT :
………………………………………………………………………
1. Index
2. Page numbering
3. Authentication of pages by
authorized signatory.
4. Demand draft.
5. Requisite number of stamped
envelopes
6. Form-I duly signed
Notarized copies of the following:-
1. BOD Resolution/Partnership
Deed/Affidavit
2. SSI Certificate, if SSI Unit
3. PAN NO.
4. Incorporation Certificate
5. Letter of consent, duly legalized
from Indian Embassy/High Commission/
Consulate in the Country of
origin.
6.
CHECK LIST FOR REGISTRATION OF PESTICIDES FOR
EXPORT UNDER SECTION 9(3)/ 9(3B)/ 9(4)
NAME OF THE APPLICANT: -
M/s.--------------------------------------------------------
---------------------------------------------------------
PRODUCT AND ITS CATEGORY: - ---------------------------------------------------------
A. Administration / Legal
:
i) Index
ii) Page Numbering
iii) Authentication of pages by authorized
signatory
iv) Demand draft as registration Fee
v) Requisite number of stamped envelops
vi) Authorization for the signatory.
B. Chemistry
Already registered
molecule
a) Chemexcil certificate
b) Form – I duly signed
6(i)-Chemical composition
10(i)- BIS no/specification &
method of analysis.
c) 7 copies of Labels/leaflets
d) For category I and VI- “Source of
Import.”
e) “Process of manufacture” (Indigenous
manufacture) for category I and II
New molecule, not registered for use in the
country.
a) Chemistry-information as in (B) above.
b) Toxicity information
(i) Acute oral in rat
(ii) Acute dermal
(iii) Acute inhalation
(iv) Primary skin irritation
(v)
Irritation to mucous membrane
For
Technical Additional Requirement
(vi)
Effect on reproduction
(vii)
Carcinogenicity
(viii)
Mutagenicity.
Bt. & Neem: As per guidelines for export-Chemistry + Toxicity
information
7.
CHECKLIST
FOR LABEL EXPANSION u/s 9(3)
Name of the Applicant: M/s……………………………………………….
Product :
1. Index
5.
Copy of Registration Certificate
6.
Authorization for the signatory(Notarized copy of BOD
resolution/affidavit/partnership deed)
7.
Affidavit duly notarized
regarding label expansion made
earlier in respect of certificate
for which the present request
is
being made.
Bioefficacy
|
8.
CHECKLIST FOR
LABEL EXPANSION OF INSECTICIDE FOR HOUSEHOLD USE u/s 9(3)
Name of the Applicant:
M/s……………………………………………….
Name of the product :
- Index
- Page Numbering.
- Authentication of pages by authorized signatory
- Requisite no. of stamped envelopes
- Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)
- Bioeffectiveness data of minimum two repeated trials from three National Laboratories
- Information on secondary pest outbreaks particularly of ticks & mites where residual pyrethroids are being used.
- Data on persistence on different type of surfaces generated under Indian conditions from three laboratories (except coil/mats/liquid vaporizer).
- Data on concentration in air in case of coil/mats/liquid vaporizer.
- Seven copies of Label/leaflets in Hindi and English.
- Affidavit duly notarized regarding label expansion made earlier in respect of certificate for which the present request is being made.
9.
CHECK LIST FOR ENDORSEMENT OF BIOEFFICACY CLAIM ON LABEL/LEAFLET OF
REGISTRATION CERTIFICATE U/S 9(4 ) OF
THE INSECTICIDES ACT, 1968
NAME OF THE APPLICANT:
M/s.……………………………………………………..
…………………………………………………………….
PRODUCT:
………………………………………………………………………
1. Index
2. Page
numbering
3.
Authentication of pages by authorized signatory.
4.
Notarized copy of BOD Resolution/Affidavit/Partnership Deed
5. Notarized copy of Registration
Certificate of the product with approved
label/leaflet.
6. If Registration Certificate is
more than 2 years old, a certificate from the
concerned State/UT Govt. as a proof of commencement of actual production
of the pesticide.
7. Affidavit duly notarized regarding
endorsement made earlier in respect of certificate for which the present
request is being made.
10.
CHECKLIST FOR
ENDORSEMENT OF NEW/ALTERNATE PACKAGING
Name of the Applicant:
M/s……………………………………………….
1. Index
- Page Numbering.
- Authentication of pages by authorized signatory
- Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)
- Justification for change
- Copy of Certificate of Registration
- Details of system of packaging w.r.t. Primary, secondary and transport packaging
- Data supporting the suitability of the content with the container
- Affidavit duly notarized regarding endorsement made earlier in respect of
Certificate for
which the present request is being made.
11.
CHECKLIST FOR
ENDORSEMENT OF CHANGE OF NAME OF THE COMPANY/FIRM
Name of the Applicant:
M/s……………………………………………….
- Index
- Page Numbering.
- Authentication of pages by authorized signatory
- Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)
- Affidavit duly notarized regarding endorsement made earlier in respect of certificates for which present request is being made.
- Copy of Certificate of registration
- In case of shifting of factory premises, a No Objection Certificate from the Director of Agriculture of the State/UT for setting of the factory at the newly proposed site. In case of shifting of office premises, full and complete address of the Head Office including the branch office
- In case of firm, copy of the Partnership Deed/ in case of Company, (a) Memorandum of Articles & Association (b) fresh Certificate of Incorporation consequent on change of Name, approved by Registrar of the Company, Ministry of Law, Justice & Company Affairs.
- An affidavit regarding no court case is pending under any provisions of the Insecticides Act and Rules framed there under.
12.
CHECKLISTFOR ENDORSEMENT OF FACTORY ADDRESS FOR THE FIRST
TIME/SHIFTING OF FACTORY AND ESTABLISHMENT OF SECOND FACTORY ADDRESS
NAME OF THE APPLICANT: M/S……………………………………………………..
…………………………………………………………….
I Factory Address
for the first time:-
1. Index
2. Page numbering
3. Authentication of pages by
authorized signatory.
4. Authorization for the signatory
(Notarized copy of BOD resolution/affidavit/partnership deed)
5. Affidavit, duly notarized,
regarding endorsement made earlier in respect of
Certificate for which present
request is made.
6. Copy of Certificate of
Registration
7. Copy of approved labels and
leaflets or 7 copies of labels and leaflets
(If not approved earlier)
II Shifting of
Factory and endorsement of second
Factory Address:-
(A) All above from 1-6
(B) ‘No Objection Certificate’ from the State
Director of Agriculture for
shifting of the factory/endorsement of
second address.
13.
CHECKLIST FOR
TRANSFER OF CERTIFICATE OF REGISTRATION OF ONE PERSON/UNDERTAKING IN THE NAME
OF ANOTHER PERSON/UNDERTAKING
Name of the Applicant:
M/s……………………………………………….
- Index
- Page Numbering.
- Authentication of pages by authorized signatory
- Authorization for the signatory (Notarized copy of BOD resolution/affidavit/partnership deed)
- Affidavit duly notarized regarding endorsement made earlier in respect of certificates for which present request is being made
- Joint application signed by both the parties in respect of each registration certificate on a non-judicial stamp paper duly Notarized with the following details:
(i)
Date of commissioning the unit/Accepted date of
commissioning of unit
(ii)
Complete address of the manufacturing unit
(iii)
Details of production of different products for last
one year
- Attested copy of the manufacturing licence issued by the State Licensing Authority containing the name of products for which a requests for transfer of certificate have been made.
- Certificate of incorporation issued by the Registrar of Companies in case of Private/Public Ltd. Companies together with copies of Memorandum and articles of association.
- Attested copies of the Deed for dissolution of partnership or deed of partnership as the case may be.
- Attested copies of the registered sale deed/gift/inheritance
- No Objection Certificate from the competent court towards its transfer, in case of any Court case is pending under any provisions of the Insecticides Act and Rules framed there under against the transfer.
14.
CHECK LIST FOR
ENDORSEMENT OF CHANGE OF NAME OF SOURCE OF IMPORT OF CHEMICALS DUE TO
DISINVESTMENT.
Name of the applicant: - M/s
--------------------------------------------------------
Name of the product: -
-------------------------------------------------------------------
i) Index
ii) Page Numbering
iii) Authentication of pages by authorized
signatory
iv)
Authorization for the signatory (Notarized copy of BOD
resolution/affidavit/partnership deed)
v)
Formal request letter by the disinvestor
vi)
Copy of Certificate of Registration
vii)
Certificate with reference to disinvestments along with
other relevant supporting documents.
viii)
Undertaking from the buyer with reference to
maintenance of same quality, specification, process of manufacture of technical
product
ix)
Analytical test report of the technical product being
manufactured by the buyer with reference to quality specification as well as
purity, impurity profile of these batch samples.
x)
Consent letter to supply the product to India
xi)
Affidavit with reference to earlier endorsement being
made.
15.
CHECK LIST FOR CHANGE OF NAME OF SOURCE OF IMPORT
NAME OF THE APPLICANT:
M/s.……………………………………………………..
…………………………………………………………….
Name of the Product :…………………………………………………………..
Administration/Legal
1. Index
2. Page
numbering
3. Notarized
copy of BOD Resolution/Affidavit/Partnership Deed
4
Authentication of pages by authorized signatory.
5. Affidavit duly notarized regarding
endorsement made earlier in respect of
Certificate for which the present request is being made
6. Documentary proof of change of name
applicable in respect of country duly authenticated by Consulate/Embassy/High
Commission
i.
Documentary proof as per change of manufacturing
premises duly authenticated
by Consulate/Embassy/High
Commission.
ii.
Copy of certificate of Registration
CHEMISTRY
1.
Reason/justification for the change in name clarifying
whether it is a case of merger/taking over of company/internal
rearrangement/shifting of manufacturing unit.
2.
Analytical test
repot from the approved source as well as from the newly named source alongwith
undertaking w.r.t. quality specification and process of manufacture
3.
Supportive
document from the designated National Authority/Registration Document
4.
Letter of consent, duly legalized from Indian
Embassy/High Commission
/Consulate in the country of origin
5. Any other additional relevant
document/information.
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