Plant Growth Regulator Registration
Face up to the regulatory obligations for plant protection products
AGROCHEMICAL & PESTICIDES - Plant Growth Regulator Registration
Cultivating Growth Together
Plant regulators also known as Plant Growth Regulators or Phytohormones or Plant Hormones are natural or
synthetic substances that play a vital role in regulating various aspects of plant growth and development.
Plant growth regulators (PGRs) are organic compound other than nutrients that effect the physiological
process of promoting, inhibiting or modifying growth and development in plants when applied in low
concentration. These act as chemical messengers within plants, controlling processes such as cell division,
elongation, differentiation and flowering. They are applied directly to a target plant to alter its life processes
or its structure to improve quality, increase yields etc.
Plant growth regulators (PGRs) are chemicals used to modify plant growth such as increasing branching,
suppressing shoot growth, increasing return bloom, removing excess fruit, or altering fruit maturity.
PGRs along with pesticides are regulated under the Insecticides Act, 1968 (46 of 1968). It is not categorised as a fertiliser.
Benefits:
To understand PGR regulations, it is important to first understand the terminologies associated with it.
Meaning of Terms- TIM, TI, FIM, FI
PGRs along with pesticides are regulated under the Insecticides Act, 1968 (46 of 1968). It is not categorised as a fertiliser.
Benefits:
- Growth regulators can be used to promote or inhibit certain aspects of plant growth, such as flowering or fruit development.
- Improving crop yields
- Controlling weeds
- Enhancing the appearance of plants
To understand PGR regulations, it is important to first understand the terminologies associated with it.
Meaning of Terms- TIM, TI, FIM, FI
- 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.
CLASSIFICATION OF PGRs
PGRs are broadly classified into two major groups:
Plant Growth Promoters
Plant Growth Promoters
- Auxins
- Gibberellins (GA)
- Cytokinins
- Ethylene
- Abscisic Acid (ABA)
How
Mind Sync
Can Help?
Expertise in agrochemicals is categorized into three broad areas: human health, environmental health, and
chemistry. In each, our associate specializes in areas such as toxicology, environmental chemistry and risk
assessment. Our associate regulatory specialists concentrate on specific regulated areas in their
respective geographies and provide consultancy services to help you with every step of the regulatory
framework process.
Plant Growth Promoters & Plant Growth Inhibitors
Plant Growth Promoter
- The plant growth regulator or hormones which have catalytical effect i.e. take a vital role in plant growth.
- Examples: Auxins, Gibberellins (GA), Cytokinin, etc.
Plant Growth Inhibitor
- The growth regulators which selectively interfere with normal hormonal promotion of growth of the plant without appreciable toxic effects.
- Examples: Malichydrazide (MH), Benzonic Acid, Chlormequat (Chlorocholine) Chloride (CCC), B-9, Triodo Benzoic Acid (TIBA), Abscisic acid (ABA), Chlorpropham (CIPC) etc. act as growth retardants.
REGISTRATION CATEGORIES OF PLANT GROWTH REGULATORS
Permanent Registration u/s 9(3)
All the studies are completed first and then the final
dossier is submitted.
Registrations for:
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
Repeat or ‘Me Too’ registration u/s 9(4)
Anyone wanting to deal in PGR, claiming the chemical
equivalence to already registered products.
Where a PGR 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 PGR was originally registered.
Where a PGR 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 PGR 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 PGR 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)
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 PGR;
- 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 PGR;
- 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 PGR shall make application in Form- II to the Licensing Officer of the concerned State Government for the grant of a license;
- If any PGR 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 PGR 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 PGR are required to obtain a Certificate of Registration from the Registration Committee constituted by Central Government;
- No person shall import any pesticide which is misbranded, whose sale, distribution or use is prohibited u/s 27, any PGR 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 PGR to be registered under the desired category and for the intended purpose.
Following should be clear before data generation:
Generation of Chemistry, Bio-efficacy data, Toxicity (Acute, Sub Acute, Sub-Chronic, Chronic, Genotoxicity, Ecotoxicity) and Packaging and Labelling parameters through GLP and Non-GLP Lab and its evaluation is required.
Following should be clear before data generation:
- Type of PGR 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 PGR 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 and Labelling parameters through GLP and Non-GLP Lab and its evaluation is required.
| Chemistry Parameters | Bio-efficacy Parameters | Toxicity Parameters | Packaging and Labelling |
|---|---|---|---|
|
Source of Supply of
Technical |
Two seasons multi-
location data on bio-
effectiveness and
phytotoxicity. |
Acute oral toxicology
study in rats and
mice. |
Label and Leaflets |
|
Chemical Composition |
Compatibility- If the
product is proposed to
be mixed with other
chemicals, data on
compatibility are
required to be
submitted. |
Acute dermal
toxicology study in
rats and rabbits |
Type of packing |
|
Chemical Identity of
technical
|
Registration status in
other countries
|
Primary skin irritation
|
Manner of Packing
|
|
Physico - Chemical
Properties of adjuvants
|
One season data on
persistence in soil and
plants.
|
Irritation to mucous
membrane
|
Content container
compatibility |
|
Method of extraction in
details (Manufacturing
process)
|
Bio-efficacy claims on the
labels & leaflets as per
guidelines approved by
Registration Committee.
|
Actual oral toxicity to
birds (Chicken &
Pigeons)
|
Manner of Labelling |
|
Specifications
|
|
Toxicity to Honeybees |
Specifications of packing
i. Primary packing
ii. Secondary packing
iii. Transport packing |
|
Chemical method of
analysis only
|
|
Toxicity to fish |
Instructions for storage
and use |
|
Shelf-life
|
|
Data / information on
following parameters
are also required to
be submitted.
Long Term Toxicity-
Neuro-behavior
toxicity
|
Disposal of empty
containers |
|
Test Report
|
|
Data / information on
following parameters
are also required to
be submitted.
Long Term Toxicity-
Mutagenicity |
|
|
|
|
Data / information on
following parameters
are also required to
be submitted.
Long Term Toxicity-
Carcinogenicity
|
|
|
|
|
Data / information on
following parameters
are also required to
be submitted.
Long Term Toxicity-
Effect on
reproduction
|
|
|
|
|
Data / information on
following parameters
are also required to
be submitted.
Long Term Toxicity-
Health records of
workers / spray
operators as per the
protocol. |
|
Do you have any queries?
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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.