1.

2
GUIDELINES FOR REGISTRATION OF PESTICIDES (OTHER
THAN HERBICIDES) U/S 9(3)/ 9(3B) - as on 05-10-2011
Abbreviations :
R
: Required
Technical Indigenous
TIM
:
Manufacture
FI
: Formulation Import

IM
:
CBN :
NOTE

Indigenous Manufacture
Combination

NR

Not Required

TI

Technical Import

FIM

Formulation Indigenous Manufacture

NF
AR

New Formulation
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. The Deemed
Registered Status of technical in such cases shall come into force only
after expiry of 3 years from the date of registration of its formulation for
import and that the norm shall be applicable to all the formulations which
are already registered for import without registering the technical; and in
cases where registration granted for formulations under Section 9(3B) with
commercialization, the period of three years for effecting the deemed
registration of technical will be computed from the date of issuing
registration for formulation under Section 9(3B) with commercialization.
The requirements of data on technical w.r.t. shelf-life & informations on
packaging, as per decision of 313th RC held 8th Nov., 2010, are under Appeal
U/s 10 of the Insecticides Act, 1968.
b.
(ii)

Rationale for importing formulation.

If the applicant does not seek registration for indigenous manufacture of
technical together with Formulation, in such a case the applicant shall be
required to submit complete data as per the requirement of Technical
Indigenous Manufacture in addition to formulation indigenous manufacture
subject to fulfillment of condition that the technical and formulation
products will be manufactured in the same premises. Deemed registration
status of technical shall come into force after expiry of three years from
registration of formulation for indigenous manufacture without registration
of technical U/s 9(3) and other conditions regarding submission of data on
shelf-life & information on packaging etc. shall be same as for the cases
for import of formulation without registration of technical (As per
decisions of 272nd (17-01-2007) & 314th (24/27-01-2011) RC
meetings.

(iii) Data requirements of chemical pesticides are also applicable for registration
of chemical plant growth regulators.

Sl.
No.

Parameter

9(3B)

9(4)

9(3)

T
I

TI
M

FI
M

TI

TIM

FI

FIM

TI
Vs
TIM

TIM
Vs
TI

TI
(New
Sourc
e)

10

11

12

NF**
(IM)

TIM*
(AR)
Vs
TI

13

14

A.

CHEMISTRY

1.

Source of Supply of
Technical

N
R

NR

NR

NR

2.

Chemical Composition

3.

Chemical Identity of
technical

4.

Physico - Chemical
Properties of adjuvants

5.

Technical Bulletin

NR

NR

NR

NR

6.

Specification

7.

Method of Analysis

8.

Analytical Test Report

9.

Identification&
Quantification of
identifiable Impurities

NR

NR

NR

NR

10a. Shelf-life clRm

10b. Shelf-life Data

N
R

NR

NR

Establishment of Chemical N
Equivalence
R

N
R

NR

NR

NR

NR

NR

NR

NR

11.

12a. Process of Manufacture

N
R

NR

NR

NR

NR

12b. Information about Raw

Materials Used

N
R

NR

NR

NR

NR

12c. Their Source of Supply.

N
R

NR

NR

NR

NR

12d. Step-wise Manufacturing

Process.

N
R

NR

NR

NR

NR

12e. Chemical Equation

N
R

NR

NR

NR

NR

NR

NR

NR

12f.

N
R

NR

NR

NR

NR

NR

NR

NR

N
R

NR

NR

NR

NR

12h. Effluent Treatment method N

R

NR

NR

NR

NR

Formula

12g. Flow sheet diagram of

process of manufacture

13.

Documents such as
R
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

N
R

NR

NR

NR

NR

NR

NR

14.

Certificate
from R
manufacturer that the
dealer/ trader is an
authorized dealer/ trader of
the manufacturer.

N
R

NR

NR

NR

NR

NR

NR

NR

15.

A test report about the R

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.

N
R

NR

NR

NR

NR

NR

NR

NR

16.

The
applicant
should R
provide sample alongwith standards technical
sample
from
the
principals/
authorized
dealers
for
chemical
verification. In case of
technical grade pesticides
u/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
with undertaking

17.

Methodology for residue

estimation as per BIS
format.

NR

B.

BIOEFFICACY

18a. Bio-effectiveness

N
R

N
R

R*

NR

R**

R**

R**

R+

R+

R++

R**

NR

18b. Phytotoxicity

N
R

N
R

R*

NR

R**

R**

R**

R+

R+

R++

R**

NR

18c. Effect on parasites &

predators

N
R

N
R

R*

NR

NR

R**

R**

NR

NR

NR

R**

NR

19.

Translocation in plants

NR

NR

NR

NR

NR

NR

NR

NR

20.

Metabolism in soil

NR

NR

NR

NR

NR

NR

NR

NR

21.

Metabolism in water

NR

NR

NR

NR

NR

NR

NR

NR

22.

Metabolism in plant

NR

NR

NR

NR

NR

NR

NR

NR

23.

Persistence in soil

NR

NR

NR

NR

24.

Persistence in water

NR

NR

NR

NR

25.

Persistence in plant

NR

NR

NR

NR

26.

Compatibility with other

chemicals, if clRmed

N
R

N
R

NR

NR

NR

NR

NR

NR

27.

Residues in plant

N
R

N
R

R#

NR

NR

R#

R#

R^

R^

R++

R# /
NR

NR

28.

Residues in soil

N
R

N
R

R#

NR

NR

R#

R#

NR

NR

NR

NR

NR

29.

Residue tolerance limits

fixed by foreign countries

N
R

N
R

NR

NR

NR

NR

NR

NR

30.

Cost benefit ratio

N
R

N
R

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

31.

Registration status in
foreign countries

N
R

NR

NR

NR

NR

NR

NR

NR

R*

: Two seasons/years data generated at minimum two agro-climatic

conditions.

R**

Two seasons/years data generated at minimum three agro-climatic

conditions.

R #: One season / year data generated at minimum four agro-climatic conditions.

Note: Residue data requirements for Insecticides & Fungicides which are
repeatedly used in the same locations is three seasons one location as per old
requirements for herbicides.
Notes:

(i)

R+ : In case of TIM Vs TI and TI Vs TIM under section 9(3), one season

data on bioefficacy including phytotoxicity, if any, on two representative
crops at two climatic zones is required to be submitted.

(ii)

R^ : One season residue data on two representative crops particularly on

fruits and vegetables is required in case of TIM Vs TI and TI Vs TIM under
section 9(3).

(iii)

Data on effect on parasites and predators is not required in case of

fungicides.

(iv) R++: In case of TI (New Source) two seasons data on each crop mentioned in labels/
leaflets at least at two Climatic Zones required on bio-effectiveness and
phytotoxicity and two years or seasons data on Residues in plant on
representative crops of each group on which pesticide is approved.
NOTE: Data on Bioeffectiveness & Phyto-toxicity to be submitted on all registered
formulations of same technical as per RC guidelines on all approved crops at the time
of issue of import permit provided the application for registration is received within 4
years of issue of import Permit as per the decision of 313 th meeting of RC held on 8th
Nov, 2010.
TIM*(AR) Vs TI U/s 9(4): If chemical equivalence fRls in the sample submitted by the
applicant / in-process samples, required to submit data on bioefficacy as per the
guidelines for TIM vs TI U/s 9(3)
C.

TOXICITY

32.

Acute oral in rat & mice

33.

Acute dermal

34.

Acute inhalation

NR

35.

Primary skin irritation

36.

Irritation to mucous
membrane

37.

Sub-acute oral rat

NR
/R

NR/
R

NR/
R

NR

NR

NR/R

NR

38.

Sub-acute oral dog

R* R*

NR
/R*

R*

R*

NR/
R*

NR/
R*

NR

NR

R*

NR/
R*

NR

39.

Sub-acute dermal

NR
/R

NR/
R

NR/
R

NR

NR

NR/R

NR

40.

Sub-acute inhalation

NR
/R

NR/
R

NR/
R

NR

NR

NR/R

NR

41.

Neuro-toxicity

N
R

N
R

NR

NR/
R

NR/
R

NR

NR

NR

NR/R

NR

42.

Synergism & potentiation

N
R

N
R

NR

NR/
R

NR/
R

NR

NR

NR

NR

NR

43.

Teratogenicity

N
R

N
R

NR

NR

NR

NR

NR

NR

NR

NR

44.

Effect on reproduction

N
R

N
R

NR

NR

NR

NR

NR

NR

NR

NR

45.

Carcinogenicity

N
R

N
R

NR

NR

NR

NR

NR

NR

NR

NR

46.

Metabolism

N
R

N
R

NR

NR

NR

NR

NR

NR

NR

NR

47.

Mutagenicity

NR

NR

NR

NR/

NR/

NR

NR

48.

Toxicity to birds (two)

NR

NR

NR

NR

49.

Toxicity to fish (Fresh

water)

NR

NR

NR

NR

50.

Toxicity to honeybees

NR

NR

NR

NR

51.

Toxicity to live stock

NR

NR

NR

NR

NR

NR

NR

52.

Medical data

NR

53.

Human toxicity
information from foreign
countries

NR

NR

NR

NR

NR

NR

NR

54.

Observation in man
(Health records of spray
operators)

N
R

N
R

NR

NR

NR

NR
^^

NR
^^

NR

NR

NR

NR^^

NR

55.

Health records of
Industrial workers.

N
R

N
R

NR

NR

NR

NR

NR

NR

56.

Toxicity to live stock

(Field trial & observation)

N
R

N
R

NR

NR

NR

NR
^^

NR
^^

NR

NR

NR

NR

NR

57.

International report on
carcinogenicity &
genotoxicity status

N
R

N
R

NR

R/N
R

R/N
R

NR

NR

NR

NR

NR

NR

NR

NR^^: Not required as per decision of 318th RC held on 27-04-2011

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 contRning the same a.i.

TIM*(AR) Vs TI U/s 9(4): If chemical equivalence fRls in the sample submitted by the applicant / inprocess samples, required to submit data on toxicity as per the guidelines for TIM vs
TI U/s 9(3)
R*: Any peer reviewed published data/information shall be acceptable (approved in 343 rd and 344th
RC Meeting)
D.

PACKAGING

58.

Labels and leaflets as per R

IR-1971 existing norms (i)
for size 250 ml & below
(ii) for 500 & above.

59

Labels to contents

a.

DetRled Chemical
composition

b.

Purpose for import /

manufacture.

c.

Antidote

d.

Toxicity triangle

e.

Cautionary statement

f.

Brief direction concerning

usages
g.

Restriction if any

60.

Leaflets to contRn

a.

DetRled Chemical
N
composition on leaflets
R
accompanying small labels
(upto 250 ml size
contRner)

N
R

NR

NR

NR

NR

NR

b.

Introductory para about the R

pesticide

c.

DetRled directions
concerning usages

N
R

N
R

NR

NR

NR

NR

NR

NR

d.

Time of application

N
R

N
R

NR

NR

NR

NR

NR

NR

e.

Application equipment

N
R

N
R

NR

NR

NR

NR

NR

NR

f.

WRting Period

N
R

N
R

NR

NR

NR

NR

NR

NR

g.

Symptoms of poisoning

h.

First Rd measures

i.

Antidote & treatment

j.

Restriction, if any

k.

Instruction for storage

l.

Information regarding
R
disposal of used packages.

61.

Type of packaging (pkg

material + compatibility
with content)

NR

62.

Manner of packaging

62.1 Specification for primary

package

62.2 Specification for

secondary packaging.

62.3 Specification for transport

packaging.

63.

Manner of labelling

N
R

NR

NR

64.

Performance of contRner N
during storage stability test R

N
R

NR

NR

65.

Transport worthiness test

N
R

NR

N
R