Bio-Stimulant Registration

The Indian government has recently introduced an amendment to the Fertilizer Control Order 1985, allowing for the registration of bio-stimulants in the country. This opportunity is open to both Indian and foreign companies. According to the FCO, compliance with approved specifications is mandatory, and for new products, inclusion in the schedule requires an application, followed by data generation.


At Lead Agri Venture, we possess the knowledge and expertise required to guide you through the process of registering your bio-stimulant product in India. Our team of regulatory experts will collaborate closely with you to develop a comprehensive registration strategy that fulfills all necessary requirements. We are committed to assisting you in swiftly and seamlessly bringing your innovative product to the market.

Navigating the regulatory landscape can be complex, but with our guidance, you can confidently pursue the bio-stimulant registration process in India. Contact us today to learn how our team can support you in achieving your registration goals.

Govt has allowed following categories of products.

Botanical extracts

Seaweed extracts

Protein Hydrosylate

Amino acids

Humic Acid

Anti-oxidents

Anti Transpirants

Stress busters

The Present application system is

  • G Form – For inclusion in Schedule
  • G1 Form – Application to State Govt
  • G2 Form – Certificate issued by State Govt
  • G3 Form – Provisional for On going sale
  • G3 Form – Final Certificate (Complete Registration)

For Foreign Companies (Outside India)

  • GLP –Toxicology data is acceptable from any country
  • You can include your own composition in Schedule for exclusiveness
  • We give Marketing support services
  • Suggest you Indian Formulation Plant
  • Give back office support

Chemistry:
The Source, Chemical composition, Method of analysis and Impurities studies under GLP/NABL accredited labs

Toxicology Studies:
Only Acute Toxicological studies are required.

Bio-Efficacy & Residue Studies:
One season 3 location/Agro climatic studies from Agriculture Universities and four location Residue studies to generate

Packaging:
Transport worthiness, Container compatibility and Shelf life studies

The Data Requirement

Chemistry Studies:

  • Source (natural extracts of plant/microbe/animal/ synthetic)
  • Chemical composition (chemical analysis from GLP/NABL accredited lab)
  • Physical & Chemical properties of active ingredients and adjuvants, if any
  • Method of analysis conforming to the specifications
  • Shelf-life claim

Acute Toxicology Studies

Acute Toxicity Studies ECOTOXICOLOGY – AQUATIC STUDIES* ECOTOXICOLOGY - TERRESTRIAL STUDIES
Acute Oral Fish Acute Toxicity Test Earthworm Acute Toxicity Test
Acute Dermal Daphnia Sp. Acute Immobilisation Test Honeybees Acute Oral Toxicity Test
Acute Inhalation Freshwater Alga and Cyanobacteria, Growth Inhibition Test Honeybees Acute Contact Toxicity Test
Acute Dermal irritation/Corrosion Daphnia magna Reproduction Test Avian Acute Oral Toxicity Test
Acute Eye Irritation/Corrosion Fish Embryo Acute Toxicity (FET) Test
Skin Sensitization Need in special case