AGROCHEMICAL & PESTICIDES > Pesticides / Insecticides Registration
Creating a resource-efficient agriculture
Insecticides Act, 1968 and Insecticides Rules 1971 regulates the import, manufacture, storage, sale, transport, distribution and use of insecticides/pesticides with a view to prevent risk to human beings or animals. All insecticides/pesticides have to be registered with the Central Insecticides Board & Registration Committee (CIB & RC) under the Ministry of Agriculture and Farmers Welfare before use or sale. The Central Government has constituted a Registration Committee (RC) which has the mandate to register insecticides after scrutinising the formulae and verifying claims made by an importer or manufacturer, as regards its efficacy and safety to human beings and animals.
The Central Government’s primary responsibility is to grant registration and quality control. After getting registration from the Central Government through the regulatory body, then manufacturing, sale, transport, distribution and use lies with the State Government. The State Government has major component of quality control through State Pesticides Testing Laboratories. Here, the State Governments, if they find any safety issue and efficacy issue, can prohibit the sale, distribution and use of Pesticides for two months which can be extended further.
To understand Pesticides regulations, it is important to first understand the terminologies associated with it.
Meaning of Terms-
- Technical Import (TI): Import of technical insecticide for manufacture of formulated insecticide.
- Technical Indigenous Manufacture (TIM): Manufacture of technical insecticide in India.
- Formulation Indigenous Manufacture (FIM): Manufacture of formulation from technical insecticide manufactured in India or from imported technical.
- Formulation Import (FI): Formulations, which are to be directly imported to India in finished form for direct marketing.
- Bio-Pesticides: A naturally occurring or derived substance or an organism that controls pests by non-toxic means.
TYPES OF PESTICIDES
- Bio-Pesticides- They are Pesticides of biological origin, i.e., derived from animals, plants, bacteria etc.
- Insecticides- The chemicals that are used to protect plants from insects and pests are known as Insecticides.
- Herbicides/Weedicides- Herbicides are chemicals that kill or control the growth of weeds in the cultivation area.
- Fungicides- This class of crop protection chemicals are used to control the spread of fungal diseases in plants.
- Others- This includes Plant Growth Regulators, Nermaticides, Rodenticides and Fumigants
How
Mind Sync
Can Help?
Our expert associates can help you identify whether your products fall within the scope of pesticideS
legislation and support you in becoming compliant. We have vast experience resolving complex issues faced
to register products and active ingredients. Whether you need assistance with sustainability strategy,
regulatory compliance, or environmental impact assessment, our experts are ready to collaborate with you.
We provide registration and notification services, regulatory compliance support to our clients across India.
Registration Categories
Permanent Registration u/s 9(3)
All the studies are completed first and then the final dossier is submitted.
Registrations for:
- Technical Indigenous Manufacture (TIM)
- Technical Import (TI)
- Formulation Indigenous Manufacture (FIM)
- Formulation Import (FI)
- Technical Import (TI) from New Source
- Formulation Import (FI) from New Source
- Bio-Pesticides
Repeat or ‘Me Too’ registration u/s 9(4)
Anyone wanting to deal in insecticides, claiming the chemical equivalence to already registered products.
Where an insecticide has been registered on the application of any person and some other person desires to manufacture or import the same insecticide or engage in the business of import or manufacture thereof shall be granted a Certificate of Registration on the same conditions on which the insecticide was originally registered.
Technical Import (TI);
Formulation Import (FI);
Technical Indigenous Manufacture (TIM);
Formulation Indigenous Manufacture (FIM).
Provisional Registration u/s 9(3B)
Where the insecticide is being introduced for the first time in India, it is registered provisionally for a period of 2 years. During provisional registration, the distribution or sale of such pesticides shall not be permitted.
It includes first time introduced:
- Technical Import (TI)
- Formulation Import (FI)
- Technical Indigenous Manufacture (TIM)
- Formulation Indigence Manufacture (FIM)
- Bio-Pesticides.
QUICK ANSWERS
- Conducting a feasibility study;
- Pre-registration analysis of data;
- Applying for Research, Test and Trial (RTT)- We guide you to bring your active ingredient or product in India for certain testing requirements or at the time of efficacy data generation. Obtaining a successful RTT permit is a major accomplishment, marking the outset of our regulatory compliance journey;
- Registration and Data generation as per CIB guidelines- We work closely with GLP (Good Laboratory Practice) labs and consistently communicate with the scientists at (Contract Research Organisations). We rigorously examine the data before presenting it to the appropriate authorities.
- Separate application shall be made to CIB & RC for each such insecticide;
- Dossier Submission;
- Scrutiny by CIB & RC;
- Approval by CIB&RC and issuance of Registration Certificate;
- State Regulatory compliance for approval to sell.
- BIS and FSSAI compliance, wherever required.
- A manufacturer, who holds a valid Certificate of Registration granted by CIB & RC is also required to obtain License in Form- II from the Licensing Officer of the concerned State Government for manufacturing the pesticide;
- The manufacturer shall meet requirements relating to qualifications, infrastructure, manufacturing premises, storage and transport etc.
- Any person desiring to only sell, stock or exhibit for sale or distribute any pesticide shall make application in Form- II to the Licensing Officer of the concerned State Government for the grant of a license;
- If any insecticide is proposed to be sold or stocked for sale at more than one place, separate applications shall be made in respect of every such place;
- The seller must procure pesticides from a valid holder of Certificate of Registration;
- Obtaining license is a State subject matter and differs from State to State.
- Persons seeking to import pesticides are required to obtain a Certificate of Registration from the Registration Committee constituted by Central Government;
- In case of import of pesticides, only certificate of registration is required to be obtained;
- No person shall import any pesticide which is misbranded, whose sale, distribution or use is prohibited u/s 27, any insecticide other than conditions specified or in violation of any other provision.
- Central Insecticides Board & Registration Committee (CIB&RC)
- Respective State Governments
Before data generation, the applicant should ensure that the requirements are being complied correctly for
the type of pesticide to be registered under the desired category and for the intended purpose.
Following should be clear before data generation:
- Type of pesticides to be registered;
- Type of material to be registered i.e. Technical or Formulation or Manufacturing Use Product (MUP) etc.,
- Type of formulation i.e. Solid (WP, granules, powder) etc. Liquid (EC, EW, SC etc.) or Vapor (vaporizer, fumigants etc.);
- Category of registration i.e. Provisional [u/s 9(3B)], Permanent [u/s 9(3)] or Me-too [u/s 9(4)];
- Purpose of registration- Domestic use/Import/Export;
- Intended use of the pesticide to be registered and its label claims etc. Generation of Chemistry, Bio-efficacy data, Toxicity (Acute, Sub Acute, Sub-Chronic, Chronic, Genotoxicity, Ecotoxicity) and Packaging parameters through GLP and Non-GLP Lab and its evaluation is required.
| Chemistry Parameters | Bio-efficacy Parameters | Toxicity Parameters | Packing |
|---|---|---|---|
|
Source of Supply of
Technical |
Bio-effectiveness |
Acute oral in rat &
mice |
Manner of labelling and
leaflets |
|
Chemical Composition |
Phytotoxicity |
Acute dermal |
Cautionary statement |
|
Chemical Identity of
technical |
Effect on parasites &
predators |
Acute inhalation |
Brief direction concerning
usages |
|
Physico - Chemical
Properties of adjuvants
|
Translocation in plants |
Primary skin
irritation
|
Information regarding
disposal of used packages. |
|
Technical Bulletin |
Metabolism in soil |
Irritation to mucous
membrane
|
Type of packaging |
|
Specification |
Metabolism in water |
Sub-acute oral rat |
Manner of packaging |
|
Method of Analysis |
Metabolism in plant |
Sub-acute oral dog |
Specification for primary package |
|
Analytical Test Report |
Persistence in soil |
Sub-acute dermal |
Specification for secondary
packaging. |
|
Identification&
Quantification of
identifiable Impurities
|
Persistence in water |
Sub-acute inhalation |
Specification for transport
packaging. |
|
Shelf-life Data |
Persistence in plant |
Neuro-toxicity |
Performance of contender
during storage stability test |
|
Establishment of
Chemical Equivalence
|
Compatibility with other
chemicals
|
Synergism &
potentiation
|
Transport worthiness test |
|
Process of Manufacture |
Residues in plant |
Teratogenicity |
|
|
Information about Raw
Materials Used
|
Residues in soil |
Effect on
reproduction |
|
|
Their Source of Supply |
Residue tolerance limits
fixed by foreign countries
|
Carcinogenicity |
|
|
Step-wise
Manufacturing Process
|
Cost benefit ratio |
Metabolism |
|
|
Chemical Equation |
|
Mutagenicity |
|
|
Formula |
|
Toxicity to birds
(two) |
|
|
Flow sheet diagram of
process of manufacture
|
|
Toxicity to fish
(Fresh water) |
|
|
Effluent Treatment
method
|
|
Toxicity to
honeybees |
|
|
A test report about the
quality of the product
from a laboratory as per
GLP scheme or from a
company of ISO-9000.
|
|
Toxicity to live stock |
|
|
Standards technical
sample from the
principals/ authorized
dealers for chemical
verification.
|
|
Medical data |
|
|
Methodology for
residue estimation as
per BIS format.
|
|
Human toxicity
information from
foreign countries |
|
|
|
|
Observation in man
(Health records of
spray operators)
|
|
|
|
|
Health records of
Industrial workers
|
|
|
|
|
Toxicity to live stock
(Field trial &
observation)
|
|
|
|
|
International report
on carcinogenicity &
genotoxicity status |
|
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This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.