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
Activity | 9(4)-“ME too” registration | 9(3) and 9(3b)- Fresh registration |
|
0.5 Month | 1 Month |
|
1 – 3 Month | 6-12 Months |
|
2-6 Months | 2-6 Moths |
|
1-2++ Months | 3-12 Months |
|
2 Months | 2 Months |
Overall Process | Minimum 6 Months | Minimum 12-36 Months |
An application for the technical import requires data on physical-chemistry, eco toxicological, toxicological studies:
CHEMISTRY | |||
Parameter | 9(3B) | 9(3) | 9(4) |
Chemical Composition | R | R | R |
Chemical Identity of technical | R | R | R |
Physico – Chemical Properties of adjuvants | R | R | R |
Specification | R | R | R |
Method of Analysis | R | R | R |
Analytical Test Report | R | R | R |
Identification& Quantification of identifiable Impurities | R | R | R |
Shelf-life claim | R | R | R |
Shelf-life Data | NR | R | NR |
Establishment of Chemical Equivalence | NR | NR | R |
Process of Manufacture | NR | NR | R |
Information about Raw Materials Used | NR | NR | R |
Their Source of Supply. | NR | NR | R |
Step-wise Manufacturing Process. | NR | NR | R |
Chemical Equation | NR | NR | R |
Formula | NR | NR | R |
Flow sheet diagram of process of manufacture | NR | NR | R |
Effluent Treatment method | NR | NR | R |
In case of u/s 9(3) submissions, samples of std. impurities are also to be provided for chemical verification.
BIOEFFICACY | |||
Parameter | 9(3B) | 9(3) | 9(4) |
Translocation in plants | R | R | NR |
Metabolism in soil | R | R | NR |
Metabolism in water | R | R | NR |
Metabolism in plant | R | R | NR |
Persistence in soil | R | R | NR |
Persistence in water | R | R | NR |
Persistence in plant | R | R | NR |
Registration status in foreign countries | R | R | NR |
TOXICOLOGY | |||
Parameter | 9(3B) | 9(3) | 9(4) |
Acute oral in rat & mice | R | R | R |
Acute dermal | R | R | R |
Acute inhalation | R | R | NR |
Primary skin irritation | R | R | R |
Irritation to mucous membrane | R | R | R |
Sub-acute oral rat | R | R | NR |
Sub-acute oral dog | R | R | NR |
Sub-acute dermal | R | R | NR |
Sub-acute inhalation | R | R | NR |
Neuro-toxicity | NR | R | NR |
Synergism & potentiation | NR | R | NR |
Teratogenicity | NR | R | NR |
Effect on reproduction | NR | R | NR |
Carcinogenicity | NR | R | NR |
Metabolism | NR | R | NR |
Mutagenicity | NR | R | NR |
Toxicity to birds (two) | R | R | NR |
Toxicity to fish (Fresh water) | R | R | NR |
Toxicity to honeybees | R | R | NR |
Toxicity to live stock | R | R | NR |
Medical data | R | R | R |
Human toxicity information from foreign countries | R | R | NR |
Health records of Industrial workers. | NR | R | NR |
International report on carcinogenicity & genotoxicity status | NR | R/NR | NR |
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.
- Applicants, who have already registered to (CIBRC) can use CIBRC services by log into the homepage.
Procedure for homepage login
- Open URL http://www.pesticides-registrationindia.nic.in/
- Enter the User Name
- Enter the Password
- Enter the Security Code as shown in the screen
- Click Login to access your homepage
- 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.