PLANT PROTECTION PRODUCTS REGULATORY SERVICES

Auxilife takes pride in having the best strength of knowledge to offer the pesticide registration in India. The regulatory body Central Insecticide Board and Registration Committee (CIBRC) listed wide categories of PPP registrations in India such as Pesticides, Insecticides, Bio pesticides, Seed treatment and Plant growth regulators etc. And CIBRC also regulates vector control, LLIN and household pesticides registrations in India. There are major and subcategories of registration in India.

Registration Categories

• CIBRC Registration under the major categories:
  o 9(3) registrations
  o 9(4) registrations

Original Registration under section 9(3)

• Technical import-TI. Technical import-new source.
• Technical indigenous manufacture -TIM. Technical indigenous manufacture - new source. Formulation import-FI.
• Formulation Import-FI (without registering its technical).
• Formulation Indigenous manufacture-FIM. Formulation Indigenous Manufacture-FIM (without registering its technical).

Me-Too Registration under section 9(4)

Key Services

• • Strategic planning to identify best suitable category of agrochemical registration in India.

India's plant protection product registration is intricately challenging task due to various categories of registration. Identifying a suitable category for your product needs to be established and it sometimes happens with the conformity of regulatory authority. Our team has abundant Indian regulatory compliance experience and expertise gained from closely working with regulatory authority, industry and CROs and some other key stake holders. Our proven track record by successfully supporting our client to get product approval and final authorisation tag us as the only agrochemical regulatory consultants in India. Indian authorities many a take a product-to-product approach basis for the initial evaluation phase hence back and forth communication with authority becomes mandatory in nature.

• • Advice on data requirements and data gap analysis.

Our technical team are well experience and equipped with required knowledge to guide you for the data requirements and most of the time we guide you to minimise the data generation as many a time the data is available with client and that needs to be brought into authorities’ attention. We identify gap in the data if any and support you for India specific data generation.

• • Guidance and assistance for experimental use permit (RTT).

Guiding you for bringing your active or product into India for certain testing requirements or at the time of efficacy data generation. Getting a successful RTT permit is in itself a paramount achievement and led to the beginning of regulatory compliance journey. Our regulatory team will strongly support you and guide at all the stages.

• • Study management support and selection of the best testing laboratory.

Study management and monitoring is one of the most robust tasks in the whole application process. Our team is highly qualified and extensively experienced in study management. We identify and already have associated with the network of best GLP certified labs in India for data generation. We support you in best testing laboratory selection, the study placement, monitoring studies, and proofreading the report. Our main task is to maintain a constant check with the labs that the studies must fulfil the regulatory requirement. And can be used for registration purpose. We also support you in identification of Indian specific required studies for registering your products. And at last, to utilising the end points and studies in dossiers. Moreover, managing efficacy field trial according to Indian climatic condition is one of a key area of our bio-efficacy department. Our team helps you in designing trial programs and developing study plans. For more information on efficacy field trial.

• • Placing efficacy trials and monitoring.

We help you in conducting exploratory trials via our own access to various farm lands and established support mechanism from our experienced farmers. We support you to test your product in Indian climatic condition at multiple location where your target crops can be grown and your GAP can be proven. We also support you for regulatory trial at State Agriculture Institutes and connect you with SAUs. On behalf of you we manage your trail at SAU and monitor all the steps and report by constantly being in touch with study directors.

• • Dossier preparation and submission.

The data requirements are set out in respective Regulation for the active substance and for the product formulation. Writing regulatory dossiers is one of the most important tasks. Therefore, we completely support you in dossier preparation, submission and post submission. Data must be provided via online portal yet coordination with authorities must be maintain in order to check that all data is being submitted. Below are some of the key solution:

• • 1. Compilation and preparation of dossier
    2. Authority comment’s reply with scientific justification
    3. Communication with authorities
    4. Support you for online portal submission.
    5. Management of the entire dossier preparation and submission process

Our specific support consists:

• • Advice & support on classification & labelling.
  • Preparation of product labels.
  • Preparation of MSDSs.
  • Liaison with Regulatory Authorities.
  • Keep updated with the everchanging regulations.