Fungicides are registered with CIB&RC under the Insecticides Act, 1968. The file must establish identity and specification through five-batch analysis, demonstrate efficacy against the named disease on the named crop across seasons and locations, and support the declared waiting period with residue data. A fungicides registration consultant plans, compiles and files that package.
Where fungicide files get difficult
Fungicide efficacy trials are unforgiving because they depend on disease pressure that may or may not appear in the season you booked. A trial year lost to a dry spell is a real risk, and it is why we plan fungicide bio-efficacy across more locations than the minimum, and why we advise on hot-spot site selection rather than convenient site selection.
The second difficulty is residue. Fungicides are frequently applied close to harvest, so the waiting period is short and must be supported by residue data that stands up. Where the intended market is export-oriented produce, the Indian waiting period also has to be reconciled with the maximum residue limits of the destination market — a commercial issue that is best identified before the label is fixed, not after.
Fungicides we register
Protectant and contact chemistry including mancozeb, copper oxychloride, copper hydroxide, chlorothalonil, captan, thiram, ziram, propineb and sulphur formulations. Systemic chemistry including carbendazim, thiophanate methyl, metalaxyl and metalaxyl-M, hexaconazole, propiconazole, difenoconazole, tebuconazole, myclobutanil, penconazole and tricyclazole. Strobilurins including azoxystrobin, pyraclostrobin, kresoxim-methyl and picoxystrobin. Plus the combination products that dominate current registrations — strobilurin plus triazole, systemic plus contact, and carboxin-thiram type seed treatment mixtures.
Scope of work
- Route selection under Section 9(3B), 9(3) or 9(4), and category selection between TI, FI, TIM and FIM
- Data gap analysis against the exact crop-disease claims proposed
- Bio-efficacy trial design, site selection in disease hot-spots, and monitoring across seasons
- Phytotoxicity observations, particularly for copper and sulphur formulations on sensitive crops
- Residue, persistence and waiting-period studies, with an eye on export MRLs where relevant
- Five-batch analysis, specification, method of analysis and shelf-life studies
- Seed treatment specifics: adhesion, flowability, seed germination and vigour data
- Draft label and leaflet, filing, query replies and grant follow-up
Combination fungicides
Most new fungicide registrations in India today are ready-mixes. The Committee examines a combination on its own merits: the ratio must be justified, the mixture must be shown to work better than or at least differently from the components at the proposed doses, the specification must be set for the combined product, and the toxicology and residue position of the mixture must be addressed. Filing a combination as though it were two registered products in one pack is the most common reason these files are deferred.