Review of pesticides Regulation in India: 2018

Overview:

India is one of the most dynamic generic pesticide manufacturers in world and is fourth largest pesticide manufacturer after China, United States of America and Japan.

Manufacture, Import, Registration, Sale, Transport, Distribution and use of pesticides in India is regulated by The Insecticides Act, 1968 and Insecticides Rules, 1971. All pesticides (Insecticides, Fungicides, Herbicides, Public health insecticides) must be registered with Insecticides Board & Registration Committee (CIB & RC), ministry of agriculture under various sections of Insecticides Act before they can be imported/manufactured for sale and distribution.

Once a crop protection product is approved by CIB&RC, it will be further approved by state governments of each state.

As per Insecticides Act pesticides are defined as those substances that are listed on the "Schedule" of the Insecticides Act, 1968. List of Insecticides in schedule can be obtained from the official website of CIB&RC. If there is any pesticide other than listed in schedule then it must be included in Schedule before it can be applied for registration with CIB & RC.

Registration process:

Registration is done under various sections of Insecticides act 1968 those are 9(3)B for pesticides being introduced first time in India, 9(3) for manufacture/import of already existing pesticides with different impurities or higher
purity and 9(4) for indigenous manufacture of Active Ingredients and formulations under me too category. Each section has different set of data requirements, application for the registration is prepared in Form -1 and submitted online along with the required data. Final approval from CIB&RC may take from 2 months to 1 year depending upon the category of requested registration.

Once a pesticide product is approved by CIB&RC it must be registered with government of the state where product is supposed to be distributed or sold.


Fig: Central Insecticides Board & Registration Committee (CIB&RC) working structure

Stages in pesticides registrations:
1. Study of guidelines displayed on official website of CIB&RC.
2. Generation of chemistry, toxicological, packaging, bio-efficacy data as per latest guidelines.
3. Submission of online form 1 along with required data.
4. Preliminary scrutiny by CIB&RC for application and data completeness.
5. Sampling and verification of manufacturing site by government authorities.
6. Testing of collected samples if same are as per specifications.
7. Scrutiny of submitted data by concerned sections of CIB&RC.
8. Approval in CIB&RC monthly meeting.
9. Issuance of Registration certificate on Form -II.
10. Application for manufacturing license from state government on Form –III.
11. Issuance of manufacturing license on Form –V.
12. Application for stock and sale of Insecticides on Form –VI.
13. Approval by state governments if to be sold and distributed in India.


Data requirement:

Data requirement varies vastly depending upon the category of application. Least data (AMES test report) is required for registration under me too category under section 9(4) while 9(3)B and 9(3) applications may require Physico - Chemical Properties of adjuvants, Analytical Test Report, Identification& Quantification of identifiable Impurities, , Shelf-life Data, Establishment of Chemical Equivalence, Acute six pack toxicology studies, Sub-acute toxicity, Neuro-toxicity, Synergism & potentiation, Teratogenicity, Effect on reproduction, Carcinogenicity, Metabolism, Mutagenicity, Toxicity to birds, Toxicity to fish, Toxicity to honeybees,Toxicity to live stock, Toxicity to live stock,Bio-effectiveness, Phytotoxicity, Translocation in plants, Metabolism in soil, Metabolism in water, Metabolism in plant, Persistence in soil, Persistence in water, Persistence in plant, Compatibility with other chemicals, Residues in plant, Residues in soil, MRLs, Transport worthiness test, Container compatibility test.

Appeal against rejection/cancellation of approval:

Application for registration may be rejected by CIB&RC if precaution claimed by applicant posses serious risk to human beings, animals or environment.

Any person aggrieved by a decision of the Registration Committee may appeal on Form II-B, within a period of thirty days from the date on which the decision communicated to him,to the Central Government in the ministry of agriculture whose decision thereon shall befinal. Central Government may entertain an appeal after the expiry of the said period, if it is satisfied that the appellant was prevented by sufficient cause from filling the appeal in time.

Focus on make in India:

In recent times CIB&RC has made many changes to existing guidelines to promote government’s initiative of “Make in India”.

Most notable changes are as follows:
1. If a product is registered under indigenous manufacture then no certificate for import will be granted in any case and under any category.
2. Existing import registrations to be cancelled in case firm is holding certificate for indigenous manufacture of same product.
3. Five batch samples in case of Technical Import/Formulation Import without Registering Technical have to be drawn from the commercial plant as per FAO guidelines for Pre-registration verification (PRV) purposes.
4. Applicant for new application of will have to declare that he does not possess any certificate for indigenous manufacture of that particular product.
5. Toxicological studies for Acute oral (Mice), Acute inhalation (Rat), Primary skin irritation, Irritation to mucous membrane in case of TIM category u/s 9(3) shall not be required where chemical equivalence is established, Ames test (First tier) shall replace all toxicology data requirement in case of application for A.I. indigenous manufacturing under section 9(4).
6. Toxicology studies conducted by Non-GLP laboratories shall also be accepted for two years from the date of approval these new guidelines are to encourage indigenous manufacturing and ease out in the process under indigenous manufacturing category.

Proposed Pesticide Management Bill 2017:

Insecticides Act 1968 is expected to be replaced by proposed Pesticide Management Bill 2017 with more focus to protect farmers and promote safe use of pesticide. Data requirements and  guidelines for registration under this bill expected remain almost same with major changes for punishment and fines for misbranded products and handing over more powers to state governments in dealing with such issues. Bill also proposes extension of data protection to 5 years with application not to be reused by another applicant for three years. Draft copy of the bill has been released in February, 2018 for comments from representatives of industry, farmers, retail sector, environmental groups and central and state. Proposed Pesticide Management Bill may come in effect from December, 2019.



The article is from 2018 INDIA PESTICIDE SUPPLIERS GUIDE magazine, download for more articles here: