BIOSTIMULANT REGISTRATION SERVICES IN INDIA
Auxilife provides scientific services for the registration of bio-stimulant products in India, following the new Gazette Notification Guidelines “The Ministry of Agriculture and Farmers Welfare issued the Fertilizer (Inorganic, Organic, or Mixed) (Control) Amendment Order, 2021, on February 23, 2021”, to further amend the Fertilizer (Inorganic, Organic, or Mixed) (Control) Order, 1985. Any novel bio-stimulant product must be listed in Schedule VI of the regulations. No individual may manufacture or import any bio-stimulant unless it is duly included.
The definition of plant bio-stimulant according to the new Gazette Notification is defined as “a substance or microorganism or a combination of both whose primary function when applied to plants, seeds, or the rhizosphere is to stimulate physiological processes in plants and to enhance their nutrient uptake, growth, yield, nutrition efficiency, crop quality, and tolerance to stress, regardless of their nutrient content.” Bio-stimulants should be used for pesticidal use and nutrient use.
Data requirements:
• Chemical composition analysis
• Bio-efficacy assessment trials
• Toxicological evaluation studies
• Heavy metal limit adherence
• Pesticide limit analysis obligation
Bio-stimulant shall be classified under any of the following categories, namely:
a) Botanical extracts, including seaweed extracts
b) Biochemicals
c) Protein and amino acid hydrolysates
d) Vitamins
e) Cell-free microbial products
f) Antioxidants
g) Antiperspirants
h) Humic and fulvic acid and its derivatives
i) Live micro-organisms excluding biofertilizers and biopesticides.
If the product is already available in the Indian market, the manufacturer or importer must have obtained a provisional certificate to continue selling it. The deadline for obtaining the provisional registration from the state agriculture department was March 31, 2022.
Provisional Registration (G3) Extension: According to the most recent gazette notification from February 20, 2024, the Indian government has decided to extend the deadline for bio-stimulant registration until February 22, 2025, providing companies an extra year to comply.
Key Services
• Data Generation Support
Auxilife offers comprehensive support for generating data required for regulatory submissions. Our services include identifying necessary studies, managing their implementation, and ensuring compliance with Indian regulatory standards.
• Placement, Monitoring, and Evaluation of Bio-efficacy, Toxicological, and Chemistry Studies
We provide services like placement, monitoring, and evaluation of bio-efficacy trials, as well as toxicological and chemistry studies, essential for regulatory compliance. We coordinate the execution of these studies with State Agricultural Universities, ensuring regulatory guidelines.
• Legal and Technical Documentation Guidance
Auxilife offers guidance in the preparation, compilation, and management of all necessary legal and technical documents for regulatory submissions. This includes ensuring that all documentation complies with the Indian Regulation (FCO).
• Product Label Preparation and Support
Auxilife provides specialized assistance in the preparation and support of product labels ensure that labels accurately reflect the product’s classification and efficacy standards.
