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Bio Stimulants (Manufacturers & Importers)

“Biostimulant” means a substance or microorganism or a combination of both whose primary function when applied to plants, seeds or rhizosphere is to stimulate physiological processes in plants and to enhance its nutrient uptake, growth, yield, nutrition efficiency, crop quality and tolerance to stress, regardless of its nutrient content, but does not include pesticides or plant growth regulators which are regulated under the Insecticide Act, 1968 (46 of 1968).

The biostimulants specified in Schedule VI shall be classified under any of the following categories, namely:

  • Botanical extracts, including seaweed extracts
  • Bio-chemicals
  • Protein hydrolysates and amino acids
  • Vitamins
  • Cell free microbial products
  • Antioxidants
  • Anti-transpirants
  • Humic and fulvic acid and their derivatives

The procedure for obtaining the Provisional Registration of Biostimulant is as follows:

  • Application to State Department of Agriculture for Form G-2;
  • Application to “The Controller of Fertilizer”, INM, New Delhi in Form G-1;
  • Provisional Registration by “The Controller of Fertilizer” in form G-3.

Checklist of documents for obtaining G-2 from State Department of Agriculture

  • Detail of Sales quantity of last 3 Years;
  • Details of the product, its specifications, Chemical Composition and Labels;
  • Self-declaration for no incident has come to its notice about harmful effect of the product;
  • Name of responsible person and his / her acceptance on stamp paper (as per clause 24 of FCO 1985) Notarized
  • Self-declaration for the product is available in the market prior to the publication of the said order

Checklist of documents for obtaining G-3 from Controller of Fertilizer (FCO):

  • G-2 Certificate issued by the State Department of Agriculture;
  • Detail of Sales quantity of last 3 Years;
  • Details of the product, its specifications, Chemical Composition and Labels;
  • Self-declaration for no incident has come to its notice about harmful effect of the product;
  • Name of responsible person and his / her acceptance on stamp paper (as per clause 24 of FCO 1985) Notarized
  • Self-declaration for the product is available in the market prior to the publication of the said order

PERMANENT REGISTRATION

Every manufacturer or importer of a biostimulant is required to make an application to the Controller of Fertilizer (FCO) in Form G along with the required data relating to such product for specifying it as a biostimulant in Schedule VI. JDR (Biostimulant registration Consultant) provides the assistance for generating of data/studies and conducting trails for obtaining the permanent Biostimulant registration. The data under chemistry, toxicity and bio efficacy would be required as below:

  • Chemistry :
    • Source (natural extracts of plant/microbe/animal / synthetic)
    • Product Specification (with analysis from Good Laboratory Practice(GLP) or National Accreditation Board for Testing and Calibration Laboratory (NABL) accredited laboratory, Physical and Chemical properties of active ingredients and adjuvants, if any.
    • Method of analysis conforming to the specifications.
    • Shelf-life;
  • Bio-efficacy Trials:
    • Agronomic Bio-efficiency trials shall be conducted at National Agricultural Research System, including Indian Council of Agricultural Research, State Agricultural Universities.
    • Bio-efficacy trials shall be conducted at minimum three different doses for one season at three agro-ecological locations;
  • Toxicity:
    • Acute oral (Rat)Acute dermal (Rat)
    • Acute Inhalation (Rat)
    • Primary skin Irritation (Rabbit)
    • Eye irritation (Rabbit)
    • Toxicity to bird
    • Toxicity to Fish (Freshwater)
    • Toxicity to honeybee
    • Toxicity to earthworm
  • Heavy metal analysis report
  • Pesticide Residue Report