The Ministry of Agriculture has recently published draft guidelines that outline the efficacy data and trial reports necessary for the registration of various categories of bio-stimulants under Schedule-VI of the FCO Amendment order 2021. The guidelines aim to establish a framework for the regulation and registration of bio-stimulants in India, making it one of the few countries with specific regulations for these products.
Bio-stimulants are substances, microorganisms, or combinations thereof that enhance the physiological processes in plants, leading to improved nutrient uptake, growth, yield, nutrition efficiency, crop quality, and stress tolerance. Unlike pesticides or plant growth regulators, which fall under the Insecticides Act, 1968, bio-stimulants serve to stimulate plant processes without directly providing nutrients.
The FCO Amendment order, issued in 2021, mandated the registration and demonstration of efficacy before bio-stimulants can be introduced into the market. The newly released draft guidelines provide detailed instructions for stakeholders seeking registration of these products. Authenticity, replicability, utility, and good quality of the submitted data are essential requirements, and complete study reports must be included.
Manufacturers and importers must submit data and information related to the proposed application, identity and composition of the bio-stimulant, risk assessments for humans and the environment, efficacy studies, packaging details, and labeling requirements. Chemistry data, bio-efficacy trials, and toxicity data are also mandatory for each product seeking registration.
Regarding toxicity data, the Central Bio-stimulant Committee (CBC) will review cases based on the product's history of safe use and accepted bio-safety data from the Indian government or any developed country. Additionally, the guidelines emphasize the importance of complying with the requirements specific to the bio-stimulant category and intended purpose during the data generation and registration process.
The draft guidelines also acknowledge the possibility of utilizing data generated by recognized scientific research organizations and industry associations under accepted procedures and protocols. Multiple manufacturers can use such data under legally acceptable terms and conditions while ensuring product equivalence.
For generating bio-efficacy data, trials should be conducted at a minimum of three agro-ecological locations under the National Agricultural Research and Education System, which includes ICAR Institutions, central and state agriculture universities, and recognized organizations and institutions.
Toxicity data generation should be approached through a robust weight-of-evidence analysis, and whenever possible, animal testing should be avoided. The guidelines suggest accepting scientifically validated in-vitro methods and data on toxicity from a single species of birds and fish to reduce the need for experimental animals.
Shelf life studies should adhere to standard testing protocols and norms, and fortification of bio-stimulants with additional nutrients or chemicals is strictly prohibited. However, naturally occurring beneficial elements resulting from the extraction process can be considered on a case-by-case basis.
The draft guidelines also address the tolerance limits for naturally occurring phyto-hormones, which will be defined based on their availability in raw natural products used to derive the bio-stimulant. Applicants are not required to resubmit data previously submitted for provisional registration if the composition and other claims remain unchanged when applying for regular registration. However, for inclusion in the FCO, a complete dataset, including bio-efficacy and toxicity data, must be provided.
The guidelines also stress the importance of adhering to standard packaging designs prescribed for agro-chemicals and bio-fertilizers.
