India has emerged as one of the world’s fastest-growing markets for biological inputs, with biostimulants playing a central role in enhancing soil health, nutrient efficiency and crop resilience. Recognizing both the promise and the risks, the Government of India has brought biostimulants under formal regulation through amendments to the Fertilizer (Control) Order (FCO, 1985). A dedicated Schedule VI now defines permissible categories, imposes standards on composition, pesticide residues, heavy metals and mandates rigorous bio-efficacy trials under the national agricultural research system. While the intent is to protect farmers from spurious products and ensure quality is well founded, the policy transition has exposed tensions between regulation and innovation. Large multinational companies with deep regulatory resources are better positioned to navigate the new compliance framework. By contrast, Indian MSMEs face high costs for multi-location trials, dossier preparation and repeated compliance updates—risking disadvantage to genuine local producers even as stricter enforcement responds to farmer complaints.

India’s evolving regulatory journey offers valuable lessons for the Global South: the need for robust but proportionate compliance pathways, transparency in product approvals, pooled trial infrastructure and support mechanisms for MSMEs. As global agriculture transitions toward biologicals, India’s experience highlights the fine balance between safeguarding farmer interests, nurturing domestic innovation and integrating into international markets.

What is the Latest?

• Biostimulants under FCO, 1985: Product-wise specs in Schedule VI. 2025 saw multiple amendments expanding the list and tightening bio-efficacy/quality requirements.
• Provisional registration timelines (Form G-3) were extended to June 16, 2025; enforcement has since tightened, and some states acted strictly on non-compliant sales.
• Centre’s stance: standardize, stop fakes and insist on science-backed products; states directed to operationalize licensing under FCO.
• Industry stance: welcomes clarity but flags compliance burden, analysis-method gaps and state-level inconsistencies; associations have sought interim relief.
• Farmers: short-term disruptions in a few states; longer-term benefit is cleaner labels and crop-specific recommendations once compliant products are in place.

What Changed Recently?

• February 23, 2021 – FCO amendment formalized the biostimulant pathway, including Form G-3 provisional registration.
• September 12, 2024 (S.O. 3922(E)) – Schedule VI, Part A substantially updated; biostimulants given category-wise specifications (e.g., humic/fulvic, seaweed, botanical extracts, etc.).
• March 2025 – Centre directs States/UTs to authorize sale under FCO and extends provisional window to June 16, 2025 to complete compliance.
• May 26, 2025 (S.O. 2346(E)) – Further additions/clarifications to Schedule VI, Part A (specifications) notified.
• August 13, 2025 – 6th–8th Amendment Orders add more entries and tighten rules, including bio-efficacy trials at ICAR/SAUs across three agro-ecological regions with multi-dose designs; more product types (incl. cell-free microbial products, vitamins/antioxidants) and crop-wise doses added.

Total Number of Biostimulants in Schedule VI of FCO

• As of July 2025: only 45 products officially approved and included under Schedule VI.
• May 2024: first 11 products registered under Schedule VI.
• June 2025: 34 new products added, bringing the total to over 45.
• More recent update: an additional 101 biostimulants notified under the FCO, taking the grand total to 146 formulations.

The Government’s Perspective

• Quality + farmer protection first: warnings against fake/forced sales; only scientifically validated biostimulants permitted; stricter SOPs and enforcement expected.
• Uniform roll-out: states/UTs asked to authorize sale under FCO (licensing, stocking, distribution) to end the grey zone.
• Evidence requirements: standard bio-efficacy trials (ICAR/SAUs) and clear composition/tolerance specs in Schedule VI.

The Industry’s Perspective

• Clarity welcomed, execution hard: compliance costs/time (trials, lab methods, documentation, re-labelling) are heavy—especially for MSMEs.
• Gaps to fix: regulatory gridlock, uneven state actions, and pending method-of-analysis/lab capacity; calls for interim relief and fast-track pathways.
• State divergence: examples include stricter temporary halts vs. controlled liquidation—creating uncertainty.
• Recent relief: Delhi High Court (August 18, 2025) allowed manufacturers/importers to continue operating while applications are processed.

Farmers’ Perspective

• Short-term: stock movement pauses and availability confusion in stricter states; clampdown aims to reduce spurious/over-sold products.
• Medium-term: clearer labels and crop/dose-specific recommendations under Schedule VI, improving consistency and reducing misleading claims.
• Adoption pain points: awareness, pricing and trust highlighted in field research; stronger extension and proof-on-farm are needed.

Key Takeaways

• Regulation has shifted from a grey zone to a full compliance regime under FCO.
• The government focuses on farmer protection and scientific validation.
• Industry faces compliance pressure but gains credibility for genuine products.
• Farmers should ultimately benefit through better quality, safer and more effective biostimulants—with strong extension and demonstrations.

If you are a manufacturer/importer

• Map your SKUs against Schedule VI entries; where a product isn’t listed, plan reformulation or dossier for inclusion.
• Ensure bio-efficacy trials meet ICAR/SAU + three-region + multi-dose design before seeking/maintaining approvals.
• Tighten QC to Schedule VI spec/tolerance limits; prepare for audits and method-of-analysis queries.
• Keep state authorizations current (manufacture/sale/stock) and maintain traceable labels with category, composition, crop and dose as notified.

Conclusion: India’s biostimulant regulation marks a decisive step toward farmer protection and product credibility. While it strengthens quality and trust, the high compliance burden risks sidelining MSMEs that drive local innovation. Balancing strict standards with supportive measures will be key to ensuring both farmer welfare and a thriving, competitive biostimulant industry.

Bio-Stimulants FCO Approved Grades

A. Humic Acid and Fulvic Acid and their derivatives

• Humates (12.5%) (Liquid)
• Humates and Fulvates -22% (Liquid)
• Humic Acid 1.5% (Granules)
• Humic Acid 5% (Powder)
• Humic Acid 51% (Granular)
• Humic Acid 6% (Liquid)
• Humic and Fulvic Acid 25.05% (Liquid)
• Humic and Fulvic Acid 76% (Powder)
• Potassium Humate 49% (Powder)
• Humalite 100% (Granular Powder)
• Humic Acid and Fulvic Acid 19.5% (Liquid)
• Humalite 82% (Powder)
• Humic Acid and Fulvic Acid 85% (Powder)
• Humic Substance 16% (Liquid)
• Humic Substances 6% (Liquid)
• Humic Acid 0.27% (Liquid)
• Humic Acid 1% (Liquid)
• Humic Substances 1.5% (Granular)
• Humic Substances 6% (Liquid)
• Humic Acids 40% (Powder)
• Humic Acid 1.2% (Granules)
• Humic Acid 4% (Liquid)
• Humic Acid 50% (Powder)
• Humic