How to get manufacturing & import certificate for a new insecticide

Introduction

• India operates one of the most comprehensive and scientifically driven regulatory systems for pesticides and insecticides globally. The framework is designed to ensure that only those products which meet stringent standards of safety, efficacy, and environmental compatibility are permitted for use within the country. When an insecticide is introduced in India for the first time, particularly for the purpose of import, it is legally classified as a “New Insecticide” under Indian regulatory provisions.
• Such insecticides are subject to an extensive and multi-layered evaluation process before they can be approved for importation, manufacture, sale, or distribution. This process involves a detailed assessment of the product’s chemical composition, toxicological profile, bio-efficacy, residue behavior, and environmental impact, all evaluated under Indian agro-climatic and use conditions. Until regulatory approval is granted, the import of these products is strictly restricted to research, testing, and trial purposes, and commercial use is expressly prohibited.
• The registration and approval process is governed by the Insecticides Act, 1968 and the Insecticides Rules, 1971, which together form the statutory backbone of pesticide regulation in India. These laws are aimed at safeguarding human and animal health, protecting agricultural crops, and minimizing adverse impacts on the environment and biodiversity, while simultaneously promoting the responsible introduction of innovative and effective crop protection solutions into the Indian mark.

Regulatory Authority

• The Central Insecticides Board & Registration Committee (CIB&RC), functioning under the Ministry of Agriculture & Farmers Welfare, Government of India, is the statutory apex body entrusted with the regulation of insecticides and pesticides in the country. The CIB&RC derives its authority from the Insecticides Act, 1968, and is responsible for ensuring that insecticides introduced into the Indian market meet prescribed standards of quality, safety, efficacy, and environmental protection.
• The Registration Committee (RC), a statutory committee under the CIB, plays a critical role in the approval and control of insecticides intended for import, manufacture, sale, distribution, and use in India. Its regulatory oversight encompasses the entire lifecycle of an insecticide, from initial evaluation to post-approval compliance.

Key responsibilities of the CIB&RC include:

• Scientific and technical evaluation of new insecticides, including assessment of chemical identity, toxicological profile, bio-efficacy data, residue behavior, and environmental impact under Indian conditions.
• Grant of registration certificates for the import and/or manufacture of insecticides, whether provisional or regular, in accordance with Sections 9(3) and 9(4) of the Insecticides Act, 1968.
• Approval of product labels and leaflets, ensuring compliance with statutory labeling requirements, toxicity classifications, precautionary statements, usage directions, and antidote information.
• Authorization of approved uses and application patterns, including crops, target pests, dosage, method of application, and safety intervals, to ensure safe and effective field use.
• Issuance of regulatory guidelines and clarifications, and coordination with State Licensing Authorities to support uniform enforcement of insecticide regulations across India.

What Is a “New Insecticide” Under FCO / Indian Law?

Under the Insecticides Act, 1968 and the regulatory framework administered by the Central Insecticides Board & Registration Committee (CIB&RC), the term “New Insecticide” has a specific legal and regulatory meaning. Any insecticide falling under this category is subject to rigorous evaluation and mandatory registration before it can be manufactured, imported, or sold in India.

An insecticide is classified as new in India under the following circumstances:

1. Insecticide Never Registered in India

If an insecticide—irrespective of its approval or usage status in other countries—has never been registered by the CIB&RC, it is considered a new insecticide in India.

• The product must undergo Indian data evaluation, including toxicology, bio-efficacy, and environmental safety
• Import or manufacture is permitted only for trial or research purposes until full registration is granted

2. New Molecule / New Active Ingredient

Any insecticide containing a novel chemical entity or biological active ingredient not previously evaluated in India is treated as a new insecticide.
This includes:

• Completely new chemical molecules
• New biological agents, microbial strains, or plant-derived actives
• Actives with a new mode of action not previously assessed in the Indian agro-ecosystem

Such products require:

• Comprehensive toxicological, eco-toxicological, and residue studies
• Multi-location bio-efficacy trials under Indian conditions
• Risk assessment specific to Indian crops, climate, and farming practices

3. New Combination or Co-Formulation

Even if individual active ingredients are already registered, a product will be classified as a new insecticide if it involves:

• A new combination of two or more active ingredients
• A new ratio or synergy claim
• A combination likely to alter toxicity, efficacy, or environmental behavior
• Each combination is evaluated as a distinct product, not merely as an extension of existing registrations.

4. New Formulation or Dosage Form

A change in formulation can also render an insecticide “new,” such as:
Introduction of a novel formulation type 

• Use of new solvents, adjuvants, or delivery systems
• Modified release or enhanced penetration formulations
• Even with a registered active ingredient, the formulation safety and performance must be re-validated.

5. Novel Use Pattern or Crop–Pest Claim

An insecticide treated as new if it proposes:

• A new crop not previously approved
• A new target pest
• A different method of application (e.g., seed treatment, soil application, drone spraying)
• Changes in dosage, frequency, or pre-harvest interval (PHI)

These changes can significantly impact residue behavior and environmental safety, requiring fresh evaluation.

Regulatory Implications 

New insecticides cannot be imported or marketed commercially in India without prior registration under Section 9(3) of the Insecticides Act.
Before commercial approval, such products typically require:

• Import permission under Section 9(4) for trial or testing
• Submission of complete scientific dossiers
• Approval of labels and leaflets
• Compliance with post-registration conditions, including restricted use classification 

Conclusion

Introducing an insecticide into India for the first time involves compliance with a robust and precaution-driven regulatory system established under the Insecticides Act, 1968. Any product categorized as a New Insecticide is subject to detailed scrutiny by the Central Insecticides Board & Registration Committee (CIB&RC) to verify its safety, performance, and environmental suitability for Indian conditions.
Commercial import or sale is not permitted without prior registration under Section 9(3). Before this stage, limited import may be allowed solely for research and field trials under Section 9(4), supported by comprehensive scientific data. While the approval process is intensive and time-consuming, it serves as a critical safeguard to ensure that only scientifically validated and responsibly assessed insecticides enter the Indian market, thereby protecting farmers, consumers, and the environment
 

For more details, please contact Metacorp