What do these guidelines cover?
The data required by the Registration Committee to register herbicides, fungicides, insecticides and plant growth regulators under Section 9(3), and technical indigenous manufacture under Section 9(4), across chemistry, bio-efficacy, toxicity and packaging. They replace earlier guidelines, including those of 05-10-2011.
Registration categories covered
| Category | Meaning |
|---|---|
| TI / TIM | Technical — import / indigenous manufacture, under 9(3) |
| FI / FIM | Formulation — import / indigenous manufacture, under 9(3) |
| TIM vs TI, TIM vs FI*/FIM* | Indigenous technical against an already registered import or formulation |
| TI (New Source) | A new import source of an already registered technical (same or higher purity only) |
| TIM 9(4) | Me-too indigenous technical, relying on chemical equivalence |
Key points
- Bio-efficacy: two seasons from at least three agro-climatic locations where required; residue data for insecticides and fungicides from at least four locations for one season.
- TIM 9(4): most toxicity and bio-efficacy studies are not required, but if chemical equivalence fails, data as for TIM vs TI under 9(3) must be submitted.
- Chemical PGRs follow the same data requirements as chemical pesticides.
- Restrictions: a holder of an indigenous-manufacture registration cannot register the same product under an import category, and FI is not considered where the technical is registered for indigenous manufacture.
- Annexure II lists the mandatory documents for 9(4) FIM, FI and TI applications, including the consent letter, the registration certificate in the exporting country, and the fee.
Registration fees under Rule 6(2) of the Insecticides Rules, 1971, as reproduced in the copy on our Insecticides Rules page: ₹5,000 for Sections 9(3) and 9(3B), and ₹2,500 for Section 9(4). Confirm current amounts before applying.
Read the complete document
Guidelines for Registration of Chemical Pesticides U/S 9(3) & Technical Indigenous Manufacture U/S 9(4)
11 pages · 760 KB
Need help with a filing? See Section 9(3) registration and Section 9(4) me-too registration.