Check list for application under Section for 9(4) Technical Import/Formulation

Sl.No.

                  Section

Description

1.

Fee

    a.  Amount

    b.  Validity

    c.  In favour of







   
   d.  Payable at

 

As prescribed in Insecticides Act, 1968

Valid draft only

Accounts Officer,

Directorate of Plant Protection, Quarantine & Storage,

N.H. IV,

Faridabad-121 001(Haryana)

State Bank of India, Faridabad

2.

Legal

a)Form-I

 

 

 




b) BOD Resolution

/Partnership Deed/ Authority of the Proprietor

 

Any person desiring to import or manufacture any insecticide may apply to the Registration Committee for the registration of such insecticide and there shall be a separate application for each such insecticide. As per sub-section (42) of Section (3) of General Clauses Act, the word "person" shall include any company or association or body of individuals whether incorporated or not .

An application for registration of insecticides under the Insecticides Act shall be made in Form-I, which is a legal document prescribed under Rule 6(1) (a) of the Insecticides Rules, 1971. The Form-I including the verification portion shall be signed in case of an individual by the individual himself or a person duly authorised by him; in case of partnership firm by the managing partner; in case of a company by any person duly authorised in that behalf by the Board of Directors and in any other case by the person in charge of or responsible for the conduct of the business. Any change in members of Hindu undivided family or partners or board of directors or the person in charge, as the case may be, shall be forthwith intimated to the Secretary, Central Insecticides Board & Registration Committee and the States/UTs Licencing Officer.

  1. Board of Directors Resolution (BOD): In case of company the applicant should submit BOD  Resolution to be signed by the  Managing Director/chairman of  the Company, along with  attested signature of Form – I  Signatory.

ii. Partnership Deed: In case of Partnership Firm, the applicant should submit an attested copy of partnership deed alongwith attested signature of managing partner and witnesses.

  1. In case of Proprietorship, a declaration duly signed by the Proprietor attested by the Notary Public should be submitted.

By virtue of the laws of the land, the company or firm etc. are artificial entities. Such company or firm etc. cannot be convicted since they are not natural persons. Therefore, it is just necessary to launch prosecution, if any, against the company or firm etc. represented by its natural person. In law, such natural person is responsible for its conduct of business. The procedural laws contemplates that the prosecution should prove, as to who is the person in charge of company or firm are responsible for its conduct of business. Launching prosecution against a person representing a company or firm by his name is more appropriate and legally justified.

3.

Chemistry

a)Source


b)Chemical Composition

 



c)Adjuvants


d)Shelf Life


e)Specification/BIS No.

 

f)Method of analysis


g) Label and leaflet should include (chemical composition, source, mesh size for granules)

 

Manufacture’s and supplier’s name and address

To be on w/w basis and not on w/v basis Details for large size container of capacity 500 ml and above and in brief for small size container of size 250 ml or below

To be based on type of formulation and kind of active ingredients.

In years, subject to the maximum life approved by Central Insecticides Board and/or Registration Committee

BIS specification number and year other wise manufacture’s specification in BIS format

Routine and referee method in BIS format

        a.  Common name – approved
             common name in form I,
             label and leaflet

        b.  Chemical composition – on
             w/w basis

c.  mesh-size – within 1:3 ration in case of granules. The chemical composition shall be given in detail for large size container of capacity 500 ml / grams and above. And in brief for small size container of capacity 250 ml / grams and below.

d.  Leaflet Detailed chemical composition shall be given for small size container of capacity of 250 ml/grams and below

4.

Bioefficacy:

(a)Introduction

 


(b)Recommendations

 


(c) Plant Protection Equipment

 



(d)Direction for use

 


(e) Specific condition, if any.

 

Information about the nature of the product i.e. whether it is insecticide, fungicide or herbicide together with specific characteristics of the product.

Information should be given in tabular form indicating the crops, pests, diseases and weeds and doses, dilution in water, interval between the two sprays and/or the waiting period.

Names of the plant protection equipment to be used for the application of the product together with type of nozel specially in case of herbicides.

Crop stage depending upon the infestation / infection / appearance of the weeds, time of application, dose response with different types of soils

Some products have got toxicity to honey bee, fish, silk worm and drift hazards. For use of such product precaution has to be given.

5.

Toxicity

Form-I – should include:

a) Acute oral LD 50 rat

b) Acute Dermal LD(50) rat or rabbit

Label – should include:

a)Toxicity triangle with prescribed colour, signal words, symbol and warning statement

 

b)Antidote statement

 

 

Leaflet - should include:

a) Symptoms of poisoning

 

 

 


b) First Aid Measures

 

 

c) Precautionary statement

 

 

 


d)Anti-dote statement / treatment

 

 



Only LD 50 value in mg / kg. of tehnical ingredient is required to be submitted.

-do-

 


It is required to be submitted as per the provisions of the Insecticides Rules 1971 (Rule No. 19 – manner of labelling).

Given only specific antidote – name, doses, manner of administration and duration. If specific antidote is not known then indicate "no specific antidote. Give symptomatic and supportive treatment".

 

Indicate all symptoms of poisoning. Do not make any unwarranted claims for the safety of the product or its ingredients. This includes statements such as "safe", "non-poisonous", "non-injurious" or "harmless" with or without such qualifying phrase as "when used as directed"

 

First aid treatment to be undertaken before the Physician is called should be given for all possible routes of exposure of pesticide viz. oral, dermal and inhalation.

In addition to the precautions to be undertaken under sub-rule (3, 4 and 5) of the Rule 19 of the Insecticides Rules, 1971, the directives with reference to inflammability or any other directive as deemed fit as per the biological / chemical nature of the pesticide or as recommended by the Registration Committee should be indicated on leaflets.

In addition to the information as indicated under (b) of the label, the treatment for the other specific ailments of poisoning by the particular pesticide may be indicated. For example, for convulsions in case of organo-chlorine pesticides, for allergic manifestations in case of pyrethroids.

6.

Packaging 9 (4):

a) Form-I

b)IS No.


c)As approved under section 9(3)


d)Manner of packing

 

 

Labels(Bilingual Hindi and English) for 500 gms and above size - should include:

a. Batch No.

b. Registration No.

c. Manufacturing licence No.

d. Net content/volume

e. Maximum retail price

f. Date of manufacture

g. Date of expiry

h. Manufactured/

imported/ Marketed by

i. Other requirements as per

IR 71 rule 18, 19 (Chapter V)

Leaflet – should include:

a. Detailed chemical

composition (for small size

container upto 250 ml/gm)

b. Storage condition

c. Disposal of used container

d. Manufacture/imported/

marketed by

e. Direction for use in case of

House-hold product.

 

Form-1, Coloum 12

The relevant IS standard for the packaging requirements of the product.

If the product/packaging system not yet included/published in the relevant IS.

In case of new packaging system which do not include on the above mentioned packaging requirements




Common name and type of formulation.


These information are to be printed on leaflet.



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