Registration Procedure for Insecticides in India

Insecticide Registration in India is regulated under the Insecticides Act, 1968 and the Insecticides Rules, 1971. Any person or business intending to import or manufacture an insecticide in India must apply to the Registration Committee for registration. The registration process involves submitting the prescribed application, supporting technical information and documents, payment of the applicable registration fee, evaluation of the product, and issuance of a Registration Certificate subject to the applicable conditions.

1. Application for Insecticide Registration

The first step is to submit an application to the Registration Committee for the registration of the insecticide.

A separate application is required for each insecticide proposed for import or manufacture. The application must contain the prescribed particulars and supporting information required under the applicable regulatory framework.

For businesses dealing with multiple insecticide products, each product should therefore be assessed and prepared for registration separately.

2. Submission of Form I

Applications for insecticide registration are submitted in the prescribed Form I under the Insecticides Rules, 1971.

The form must be completed with the required product, applicant and regulatory details and signed by the appropriate authorised person. The Rules specify who may sign the application depending on whether the applicant is an individual, partnership firm, company or another type of entity.

Any applicable changes relating to the persons responsible for the business or authorised representatives are also required to be communicated to the concerned authorities as prescribed under the Rules.

3. Preparation of Supporting Information

A complete insecticide registration application requires the relevant technical and supporting information for the product.

Depending on the nature of the application, this may include:

• Product and active ingredient details

• Chemical information and specifications

• Technical information and supporting data

• Analytical information

• Proposed labels and leaflets

• Manufacturing or source-related information

• Other documents required for the applicable registration category

The Registration Committee may also require inspection of a testing facility where necessary to establish the authenticity of submitted data.

4. Payment of Applicable Registration Fee

The registration fee for insecticide registration in India depends on the registration provision under which the application is submitted. The applicable fee should be paid as prescribed under the Insecticides Rules, 1971.

As per the Rules hosted by the Directorate of Plant Protection, Quarantine & Storage (PPQS):

• ₹5,000 for applications under Section 9(3) and Section 9(3B)

• ₹2,500 for applications under Section 9(4)

The registration fee is required to be paid through the prescribed demand-draft procedure specified under the Rules.

Before submitting an application, applicants should ensure that the applicable registration category, fee and payment requirements are correctly identified for their product.

5. Review and Evaluation by the Registration Committee

After receiving the application, the Registration Committee may conduct the enquiry it considers necessary to evaluate the insecticide.

The Committee considers whether the insecticide conforms to the claims made by the importer or manufacturer regarding its efficacy and safety to human beings and animals.

Where the Committee considers that the required safety precautions cannot be easily observed, or that the use of the insecticide presents a serious risk despite such precautions, registration may be refused.

6. Registration Number and Certificate

If the Registration Committee is satisfied with the application and the applicable requirements are met, the insecticide may be registered subject to specified conditions.

A registration number is allotted and a Certificate of Registration is issued. The Act provides for a decision within 12 months from the date of receipt of the application. Where the Committee is unable to reach a decision within this period based on the material submitted, the period may be extended by up to six additional months.

Under the Insecticides Rules, the Certificate of Registration is issued in Form II or Form II-A, as applicable.

7. Provisional Registration for New Insecticides

For an insecticide being introduced in India for the first time, the Registration Committee may grant provisional registration for a period of up to two years, subject to the conditions specified by the Committee and pending the required enquiry.

This provision applies to the circumstances specified under Section 9(3B) of the Insecticides Act, 1968.

8. Changes in Registration Conditions

Registration is subject to the conditions specified by the Registration Committee.

The Committee may subsequently vary these conditions after considering the efficacy of the insecticide and its safety to human beings and animals.

Where required, the certificate holder may be asked to submit the Certificate of Registration to the Committee within the specified period for making the relevant changes.

9. Registration of an Already Registered Insecticide

If an insecticide has already been registered, another person or business seeking to import or manufacture the same insecticide may apply for registration under Section 9(4).

Subject to the applicable requirements and payment of the prescribed fee, the applicant may be allotted a registration number and granted a Certificate of Registration on the same conditions under which the insecticide was originally registered.

10. Duplicate Certificate and Certificate Changes

The Insecticides Rules also provide procedures for obtaining a duplicate Certificate of Registration and for making certain additions, deletions or alterations to the Certificate, including labels and leaflets.

The Rules currently hosted by PPQS specify a ₹100 fee for a duplicate Certificate of Registration and a ₹100 fee for each occasion of addition, deletion or alteration to a Certificate, including labels and leaflets, subject to the prescribed procedure.

11. Appeal Against a Registration Decision

A person aggrieved by a decision of the Registration Committee under Section 9 may appeal to the Central Government in the prescribed manner.

Under Section 10 of the Insecticides Act, an appeal is generally required to be filed within 30 days from the date on which the decision is communicated. The Central Government may entertain a delayed appeal where sufficient cause prevented the applicant from filing within the prescribed period.

The Insecticides Rules prescribe Form II-B for such an appeal and specify the applicable procedure and fee.

How OneTouch AgroSolutions Can Help

Navigating insecticide registration requirements can involve extensive documentation, technical information and regulatory procedures. OneTouch AgroSolutions provides regulatory support to businesses looking to register insecticides for import or manufacture in India.

Our support can include:

• Registration requirement assessment

• Applicable registration category guidance

• Form I preparation support

• Technical documentation coordination

• Dossier preparation support

• Label and leaflet documentation

• Application documentation review

• Regulatory submission support

• Registration-related compliance assistance

With 16+ years of experience, OneTouch AgroSolutions helps businesses understand and manage the regulatory documentation and registration requirements associated with insecticides and other agrochemical products in India.

Frequently Asked Questions

What is insecticide registration in India?

Insecticide registration is the regulatory process through which an insecticide is evaluated and registered under the Insecticides Act, 1968 and the Insecticides Rules, 1971 before it can be imported or manufactured in accordance with the applicable requirements.

Who is responsible for registering insecticides in India?

The Registration Committee is responsible for considering applications for registration and evaluating the efficacy and safety of insecticides under the Insecticides Act, 1968.

Which form is used for insecticide registration?

The application for registration is made in Form I as prescribed under the Insecticides Rules, 1971.

Is a separate application required for each insecticide?

Yes. The Insecticides Act requires a separate application for each insecticide proposed for registration.

What is the registration fee for insecticides in India?

The applicable fee is ₹5,000 for applications under Sections 9(3) and 9(3B) and ₹2,500 for applications under Section 9(4), as specified in the Rules hosted by PPQS.

How long does insecticide registration take?

The Act provides a period of 12 months for the Registration Committee to issue a registration decision, with a possible extension of up to six additional months where the Committee is unable to reach a decision within the initial period.

Can a new insecticide receive provisional registration?

Yes. Where the Registration Committee considers that an insecticide is being introduced in India for the first time, it may grant provisional registration for up to two years, subject to the prescribed conditions.

Can registration conditions be changed after registration?

Yes. The Registration Committee may vary the conditions of registration based on considerations relating to the insecticide’s efficacy and safety to human beings and animals.

Can another company register an already registered insecticide?

Yes. Section 9(4) provides for registration of an already registered insecticide by another person seeking to import or manufacture it, subject to the applicable requirements and prescribed fee.

How can OneTouch AgroSolutions help with insecticide registration?

OneTouch AgroSolutions can assist with registration category assessment, Form I preparation, technical documentation, dossier preparation, labels and leaflets, application review and other regulatory documentation related to insecticide registration in India.