Pesticide Registration in India: Overview and Opportunities

Release Date:

2019-11-05

India ranks first in the world in terms of total cultivated land area, at approximately 1,891,761 square kilometers. However, it only comes in fourth place globally in terms of gross agricultural output. One of the key reasons behind this disparity is the relatively low level of purchase and use of agrochemical products. India’s total consumption of agrochemicals ranks tenth, averaging about 40 million kilograms per year—far below China’s 1.806 billion kilograms.

To boost agricultural productivity, the Indian government is working to raise farmers’ awareness of the proper use of agrochemicals. To ensure fair pricing and high‑quality products, the government is committed to eliminating counterfeit pesticides and non‑compliant agrochemicals from the market. In line with this objective, the government, through its regulatory body—the Central Insecticides & Registration Committee—issued new registration guidelines in 2017. These guidelines aim to verify the authenticity of agrochemical sources and ensure proper registration; they also seek to encourage reputable companies to enter the Indian market and to strengthen oversight of imported agrochemicals, thereby curbing the circulation of illegally imported pesticides.

Registration Process Overview

The entry into force of the new registration guidelines will make import registration more challenging. However, this presents an opportunity for legitimate suppliers, as it will become more difficult for counterfeit and substandard manufacturers to enter the market. Under the new regulations, entities holding the following valid Registration Certificates (RCs) are permitted to market agrochemical products in India;

• TIM – Local Technology Manufacturing

• TI – Technology Import

• FIM – Formulation Local Manufacturing

• FI – Formula Import

The aforementioned registration certificates can be categorized into two main types of registration:

• 9(4) Me‑too registration: This applies to products and active ingredients that are already registered in India. 9(4) is the simplest registration route; if all documents submitted to the CIB are complete and accurate, the registration process will be finalized within six months of filing the application.

• 9(3) New Registration: This applies to products or raw materials that have not yet been registered in India. Any ingredient or raw material being registered for the first time falls under this category. New registrations may include:

o 9(3) – New Ingredient under the TI: Technical import registration for a new ingredient that has never been registered for import in India.

o 9(3) – New raw material for TI: To import into India, this technology has already been registered in India; however, a new overseas manufacturer also seeks to register as a legally authorized export entity to export the ingredient to India.

o 9(3) – New ingredient for FI: preparations imported directly into India in their finished form.

Registration Process 9(3) – TI New Raw Material

If the technology has already been registered in India, TI New Ingredient 9(3) represents the most effective pathway to enter the Indian market. Manufacturers are willing to obtain registration by using alternative raw materials and exporting the ingredient directly to India. The registration process requires at least two companies: an Indian company serves as the primary applicant for import registration, while the manufacturer registers the raw material and will continue to be the supplier of that product to the Indian company going forward. Under the new guidelines, manufacturers or raw material suppliers must hold valid registration with the regulatory authority in the country of origin (e.g., ICAMA in China) and possess a manufacturing license; otherwise, CIB will not process the registration application.

Completing the registration of TI raw materials typically takes 45 to 54 months. The full registration process can be divided into the following stages, accompanied by a tentative timeline.

1. Application for a Sample Import License (RTT): The first step is to obtain a Sample Import License (RTT) to import a specified quantity of samples and generate data in India. The authorization letter and the ICAMA certificate must be authenticated by the Embassy of India in China before the application can be submitted. Obtaining the RTT typically takes about 2 to 4 months.

2. Data Generation: After obtaining the RTT, import the product and conduct field trials across all registered crops over two growing seasons. From the initiation of these field trials, it typically takes approximately 24 to 30 months to generate reports on all biological efficacy endpoints. Additionally, an extra 32 months are required to complete shelf-life data; thus, a full dataset and a complete set of trials collectively demand nearly 32 months. Concurrently, other chemical and toxicity assessments are carried out. GLP-compliant data from any laboratory worldwide is acceptable. However, once the RTT is obtained, all field trials, efficacy studies, and chemical analyses must be conducted in India.

3. Application for Assessment: After submitting all required data to the TI, the CIB will evaluate it and review the registration dossier. If any information is missing, it must be completed. Typically, the entire process takes approximately 12 to 18 months, depending on the completeness of the submitted data. Once all deficiencies have been addressed, the TI registration will be approved at a committee meeting.

Apart from requiring additional information for registration, the new guidelines are largely similar to the previous ones. Furthermore, both Indian importers and overseas exporters must keep the following key points in mind to successfully complete the registration process and submit their applications.

- An Indian company may not simultaneously hold both a TIM and a TI registered for the same chemical substance. If the company already holds both, the TI registration will be cancelled. Similarly, if the company obtains a TIM after acquiring a TI, the TI registration will also be cancelled.

- The raw materials shall be duly registered in the country of origin (e.g., ICAMA in China) and obtain a manufacturing license.

- Previously issued TI registrations were invalid. However, the validity of TI registrations is now aligned with that of ICAMA. Upon renewal of the ICAMA, a new ICAMA will be submitted to the CIB to extend the validity of the TI registration.

- Prior to obtaining the RTT and upon compliant importation of samples into India, any data generated by either the Indian importer or the Chinese raw material supplier will not be deemed valid by the CIB during the registration process. However, GLP‑compliant data generated outside India may be considered valid and included in the dossier.

There is no doubt that the new registration rules have made the TI registration process more costly and time‑consuming. However, the revised regulations are clearly defined, helping to reduce confusion about India’s registration procedures. That said, there is still room for improvement, and CIB is working to make the registration process more transparent and streamlined. For companies planning to enter the Indian market and invest in registration, now is an opportune moment. These transparent and well‑articulated requirements make it easier for legitimate raw‑material suppliers to obtain TI registration, while the stringent new rules will make it more challenging for entities sourcing products from illicit channels to register new products or renew existing registrations.

P.S.: In the draft of the new registration regulations, an early proposal suggested halting the registration of imported products under the TIM scheme in India. This recommendation was later removed from the final version of the policy. Regardless of its effectiveness, all products currently covered by the TIM scheme can still apply for TI registration, after which they may be imported into and sold in India.

Source: AgroPages (World Agrochemical Network)

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