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Regulation of Insecticides / Pesticides in India

Regulation of Insecticides / Pesticides in India

India is one of the most dynamic generic pesticide manufactures in the world and it is the fourth largest producer of the agrochemical after USA, Japan & China. The import, registration process, manufacture, sale, transport and distribution are regulated by The Insecticides Act, 1968 and Insecticides Rules, 1971.

All insecticides /pesticides have to register with the Central Insecticides Board & Registration Committee (CIB & RC) before use or sale.

Registration of Pesticides / Insecticides:
  • Any person desiring to import or manufacture any insecticides (pesticides) may apply to the Registration Committee for the registration.

  • On receipt of such application, the Committee will make an inquiry and will conform to the request made by the importer and after payment of a fee may prescribe the insecticide (Pesticide), allot a registration number and issue a certificate of registration in token thereof within a period of twelve months.

  • The application shall be refused by the committee that the precaution claimed by the application involves serious risk (human beings or animals)

  • An appeal against any decision of the Registration Committee shall be made in writing in duplicate to the Central Government in the Department of Agriculture.

  • Every appeal shall be followed by a challan evidencing the payment of relevant fee and a copy of the decision appealed against.

  • Online registering facility is also available to help the applicant. The applicant needs to put in his PAN number to prove his credibility.

Registration of Insecticides/ Pesticides is controlled at central Government level and implementation of the Act including manufacturing license is done at the state level. Registration is a multidisciplinary endeavor cover following schedule:

The Technical Grade Products Registration Can be Obtained in Three Ways:
  • Provisional Registration u/s 9(3b)

For the new molecule introduced first time in India. Usually granted for a period of 2 years

  • Regular Registration u/s 9(3)

Subject to the submission of complete data

  • “Me-Too” Registration u/s 9(4)

After 9(3) registration of a molecule, any other person can apply for registration

Activity9(4)-“ME too” registration9(3) and 9(3b)- Fresh registration
  1. Documentation & Form I & other documents verification by legal
0.5 Month1 Month
  1. CIB & R  Analysis , Covering:
  • Chemistry
  • Bioefficacy
  • Toxicology
  • Packaging
1 – 3 Month6-12 Months
  1. Sample Submission , collection & Analysis
2-6 Months2-6 Moths
  1. MRL- Fixation (Ministry of Health)
1-2++ Months3-12 Months
  1. Registration certificate Issuance
2 Months2 Months
Overall ProcessMinimum 6 MonthsMinimum 12-36 Months

An application for the technical import requires data on physical-chemistry, eco toxicological, toxicological studies:

CHEMISTRY
Parameter9(3B)9(3)9(4)
Chemical CompositionRRR
Chemical Identity of technicalRRR
Physico – Chemical Properties of adjuvantsRRR
SpecificationRRR
Method of AnalysisRRR
Analytical Test ReportRRR
Identification& Quantification of identifiable ImpuritiesRRR
Shelf-life claimRRR
Shelf-life DataNRRNR
Establishment of Chemical EquivalenceNRNRR
Process of ManufactureNRNRR
Information about Raw Materials UsedNRNRR
Their Source of Supply.NRNRR
Step-wise Manufacturing Process.NRNRR
Chemical EquationNRNRR
FormulaNRNRR
Flow sheet diagram of process of manufactureNRNRR
Effluent Treatment methodNRNRR

In case of u/s 9(3) submissions, samples of std. impurities are also to be provided for chemical verification.

BIOEFFICACY
Parameter9(3B)9(3)9(4)
Translocation in plantsRRNR
Metabolism in soilRRNR
Metabolism in waterRRNR
Metabolism in plantRRNR
Persistence in soilRRNR
Persistence in waterRRNR
Persistence in plantRRNR
Registration status in foreign countriesRRNR
TOXICOLOGY
Parameter9(3B)9(3)9(4)
Acute oral in rat & miceRRR
Acute dermalRRR
Acute inhalationRRNR
Primary skin irritationRRR
Irritation to mucous membraneRRR
Sub-acute oral ratRRNR
Sub-acute oral dogRRNR
Sub-acute dermalRRNR
Sub-acute inhalationRRNR
Neuro-toxicityNRRNR
Synergism & potentiationNRRNR
TeratogenicityNRRNR
Effect on reproductionNRRNR
CarcinogenicityNRRNR
MetabolismNRRNR
MutagenicityNRRNR
Toxicity to birds (two)RRNR
Toxicity to fish (Fresh water)RRNR
Toxicity to honeybeesRRNR
Toxicity to live stockRRNR
Medical dataRRR
Human toxicity  information from foreign countriesRRNR
Health records of Industrial workers.NRRNR
International report on carcinogenicity & genotoxicity statusNRR/NRNR
Abbreviations:

(R) – Required

(TIM)- Technical Indigenous Manufacture

(FI) – Formulation Import

(IM) – Indigenous Manufacture

(CBN) – Combination

(NR) – Not Required

(TI) – Technical Import

(FIM) – Formulation Indigenous Manufacture

(NF)- New Formulation

(AR) – Already Registered

Online registration for Pesticides:

Computerized Registration of Pesticides (CROP) is a web-based application for Registration of Pesticides developed for the (CIBRC). The application is supposed to automate the whole registration procedure.

The main features of the application are summarized below:
  • Online Application for Registration of Pesticides under 9(3) & 9(3b)
  • On line status checking.
  • Frequent email notification
  • Online application for the grievances.
Online registration Procedure:
Applicant Login:

Any registered user can log into the CIBRC portal by providing the user credentials. The login Page of an applicant is different from that of a (CIBRC) Central Insecticides Board and Registration Committee.

  1. Applicants, who have already registered to (CIBRC) can use CIBRC services by log into the homepage.
Procedure for homepage login:
  1. Open URL official site of pesticide regidtration page.
  2. Enter the User Name
  3. Enter the Password
  4. Enter the Security Code as shown in the screen
  5. Click Login to access your homepage
  1. Applicants, who have not already registered to CIBRC, need to register themselves before using CIBRC services by clicking New User Register Here link on the login page.
Step1:  New User Registration:
  • The form contains following mandatory text fields: First Name, Middle Name, Last Name, E-mail, Password, and Confirm Password.
  • E-mail address is a unique field and must not have been used by any existing user.
  • Password should be min. 8 and max. 14 characters long and have at least 1 alphabet, 1 numeric and 1 special character
  • On clicking Submit, user receives following e-mail containing user credentials and an activation link (click here)
Step2:  New User Register:

User is required to enter the e-mail address and password communicated to him via e-mail, and click Login.

Step3:  New User Register:

Next step, the user has to fill a registration form and to enter the personal details as well as the company details for all mandatory fields.

  • PAN number is unique and must not have been used by any existing user.
  • If Contact number is landline number / mobile number it should of prescribed format and only Indian numbers are allowed.
  • If the applicant’s company has already been registered, Use search for the registered company.
  • If the applicant’s company has not been registered, click ‘click here’ to register your company. A form is displayed where the user can enter the mandatory company details.
  • User must install Hindi fonts and GIST Hindi Typing Tool before filling his/her details.
  • Only Indian companies are allowed to register. If address other than that of India is provided the user should not be able to register.
  • Successful submission of this form will activate this new user account.

The user receives an e-mail on completing registration.

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