Wednesday, 29 August 2012

CHECK LIST FOR SUBMISSION REQUIREMENTS FOR REGISTRATION OF PESTICIDES AND ENDORSEMENTS FOR PRELIMINARY SCRUTINY.

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.

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)

CHEMISTRY

Source of Supply of Technical

Chemical Composition

Chemical Identity of technical

Physico - Chemical Properties of adjuvants

5(a)

Technical Bulletin Copy of RTT permit

Specification

Method of Analysis

Analytical Test Report

Identification& Quantification of identifiable Impurities

10a.

Shelf-life claim

10b.

Shelf-life Data

11.

Establishment of Chemical Equivalance

12a.

Process of Manufacture

12b.

Information about Raw Materials Used

12c.

Their Source of Supply.

12d.

Step-wise Manufacturing Process.

12e.

Chemical Equation

12f.

Formula

12g.

Flow sheet diagram of process of manufacture

12h.

Effluent Treatment method

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

14.

Certificate from manufacturer that the dealer/ trader is an authorised dealer/ trader of the manufa - cturer.

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.

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

17.

Methodology for residue estimation as per BIS format.

BIOEFFICACY & RESIDUES

18a.

Bio-effectiveness

18b.

Phycotoxicity

18c.

Effect on parasites & predators

19.

Translocation in plants

20.

Metabolism in soil

21.

Metabolism in water

22.

Metabolism in plant

23.

Persistence in soil

24.

Persistence in water

25.

Persistence in plant

26.

Compatibility with other chemicals, if claimed

27.

Residues in plant

R/NR

28.

Residues in soil

29.

Residue tolerance limits fixed by foreign countries

30.

Cost benefit ratio

31.

Registration status in foreign countries

32.

M.R.L. Performa in duplicate

TOXICITY

32.

Acute oral in rat & mice

33.

Acute dermal

34.

Acute inhalation

35.

Primary skin irritation

36.

Irritation to mucous membrane

37.

Sub-acute oral rat

NR/R

38.

Sub-acute oral dog

NR/R

39.

Sub-acute dermal

NR/R

40.

Sub-acute inhalation

NR/R

41.

Neuro-toxicity

NR/R

42.

Synergism & potentiation

NR/R

43.

Teratogenicity

44.

Effect on reproduction

45.

Carcinogenicity

46.

Metabolism

47.

Mutagenicity

NR/R

48.

Toxicity to birds

49.

Toxicity to fish

50.

Toxicity to honeybees

51.

Toxicity to live stock

52.

Medical data

53.

Human toxicity information from foreign countries

54.

Observation in man (Health records of spray operators)

55.

Health records of Industrial workers.

56.

Toxicity to live stock (Field trial & observation)

57.

International report on carcinogenicity & genotoxicity status

R/NR

PACKAGING AND LABELLING

58.

Labels and leaflets as per IR-1971 existing norms (i) for size 250 ml & below (ii) for 500 & above.

Labels to contents

Detailed Chemical composition

Purpose for import / manufacture.

Antidot

Toxicity triangle

Cautionary statement

Brief direction concerning usages

Restriction if any

60.

Leaflets to contain

Detailed Chemical composition on leaflets accompanying small labels (upto 250 ml size container)

Introductory para about the pesticide

Detailed directions concerning usages

Time of application

Application equipment

Waiting Period

Symptoms of poisioning

First aid measures

Antidot & treatment

Restriction, if any

Instruction for storage

Information regarding disposal of used packages.

61.

Type of packaging (pkg material + compa- tibility with content)

62.

Manner of packaging

63.

Specification for primary package

64.

Specification for secondary packaging.

65.

Specification for transport packaging.

66.

Manner of labelling

67.

Performance of container during storage stability test

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.

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

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

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

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.

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

CHECKLIST FOR LABEL EXPANSION u/s 9(3)

Name of the Applicant: M/s……………………………………………….

Product :

1. Index

Page Numbering.

Authentication of pages by authorized signatory

Requisite number of stamped envelop

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

Bioeffectiveness
Phytotoxicity
Residue in plant
Persistence in plant
Residue tolerance limits fixed by foreign countries
MRL proforma in duplicate
Registration status in foreign countries
Effect on parasites and predators ( applicable in case of insecticides only)
Seven copies of revised labels/leaflets in English & Hindi

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.

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.

Wednesday, 29 August 2012

CHECK LIST FOR SUBMISSION REQUIREMENTS FOR REGISTRATION OF PESTICIDES AND ENDORSEMENTS FOR PRELIMINARY SCRUTINY.

Bioefficacy

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