Bio-pesticides are registered with CIB&RC under the Insecticides Act, 1968, in the same way as chemical pesticides, but against a distinct set of data requirements covering strain identity, CFU count and viability, infectivity and toxicity, shelf life, and multi-location bio-efficacy. A bio-pesticides registration consultant assembles this package and files it with the Registration Committee.
Why bio-pesticide files are different
A chemical pesticide is defined by its molecule and its impurity profile. A bio-pesticide is defined by a living organism or a natural extract, which means the questions change: which strain exactly, deposited where, identified by what method; how many viable colony-forming units per gram at manufacture and at the end of shelf life; is the organism free of contaminants and of mammalian pathogenicity; does the product still work after three months on a distributor's shelf in Nagpur in May.
Applicants routinely underestimate two of these. Strain identity documentation is often thin — a morphological description where molecular identification and a culture deposit are expected. And shelf-life data is often generated in air-conditioned comfort rather than under the accelerated conditions that reflect Indian distribution.
Bio-pesticides we register
Microbial — fungal
Trichoderma viride, Trichoderma harzianum, Beauveria bassiana, Metarhizium anisopliae, Verticillium lecanii, Verticillium chlamydosporium, Paecilomyces lilacinus, Hirsutella thompsonii, Ampelomyces quisqualis.
Microbial — bacterial and viral
Bacillus thuringiensis var. kurstaki and var. israelensis, Bacillus sphaericus, Bacillus subtilis, Pseudomonas fluorescens, and nuclear polyhedrosis viruses of Helicoverpa armigera and Spodoptera litura.
Botanical and biochemical
Neem-based products across the full azadirachtin range — from 300 ppm EC formulations to 25% w/w extract concentrates — along with pheromone-based products and other biochemical actives.
The data package we build
- Identity and source. Strain designation, molecular and morphological characterisation, culture deposit particulars, and the origin of the mother culture.
- Chemistry and quality. CFU or spore count, purity, absence of specified contaminants, heavy metals where applicable, and batch-to-batch consistency across five batches.
- Toxicity and safety. Acute oral, dermal and inhalation studies, irritation and sensitisation, infectivity and pathogenicity, and ecotoxicity on non-target organisms.
- Bio-efficacy. Field trials on the specific crop-pest combinations claimed, across locations and seasons, at the doses proposed for the label.
- Shelf life and packaging. Viability retention over the claimed period in the proposed pack, under accelerated and real-time conditions.
- Label and leaflet. Claim wording that the Committee will accept and that your marketing team can still use.
The claim question
The single most consequential decision in a bio-input file is what you claim. A product positioned as a plant growth promoter or soil conditioner may sit under the fertiliser framework; the same formulation claiming control of a named pest or disease is a pesticide and must be registered under the Insecticides Act. Companies sometimes try to have both, and end up with a label that is defensible under neither regime. We settle this at the start, in writing, before packaging is printed.
Bio-pesticides are covered by the Schedule to the Insecticides Act, 1968, and are registered under Section 9(3B), 9(3) or 9(4) exactly like chemical pesticides. The lighter data requirement applies to the type of data sought, not to the rigour with which the Committee reviews it.