Biostimulants are emerging as a crucial category of agricultural inputs that enhance plant growth, resilience, and productivity through biological and biochemical mechanisms. The Indian government, recognizing their importance, introduced a regulatory framework for biostimulants under the Fertilizer Control Order (FCO) 1985 (Amendment 2021) which mandates a structured registration process, field validation, and post-market surveillance for all biostimulant products.

Biostimulants are substances or microorganisms that enhance plant growth, nutrient uptake, stress tolerance and yield without being fertilizers, pesticides or plant growth regulators. They include seaweed extracts, humic acids, fulvic acids, amino acids, protein hydrolysates, microbial inoculants and other organic compounds.

Under the new regulations, manufacturers must register their products with the Integrated Nutrient Management (INM) department of the Ministry of Agriculture under FCO by submitting scientific data on efficacy and safety, and adhering to labeling and packaging norms. This ensures that only standardized and scientifically validated products enter the market.

Additionally, the framework mandates periodic quality testing, and non-compliance can lead to penalties or product recalls, enhancing market credibility and farmer confidence. This regulatory shift is expected to drive innovation, investment, and market expansion in India’s biostimulant sector while phasing out unregulated or misleading products. Clear guidelines encourage R&D in advanced formulations, particularly in microbial and sustainable agriculture technologies, positioning India as a key player in global biological inputs.

CHRONOLOGY OF THE BIOSTIMULANT REGULATION IN INDIA
The regulation of biostimulants in India has evolved from an unregulated market to a structured framework under the FCO, 1985. Starting with informal discussions in 2019, the government progressively introduced definitions, registration processes and quality controls through amendments in:

• 2021 – Officially recognized biostimulants as a distinct category under FCO, 1985
• 2023 – Draft guidelines issued
• 2024 – Added “live microorganisms excluding biofertilizers and biopesticides” and 11 new biostimulants under Schedule VI
• 2025 – Extended provisional registration period and directed State/UTs to authorize sales under FCO

This chronology reflects India’s commitment to fostering sustainable agriculture while ensuring product safety and efficacy.

THE REGULATORY FRAMEWORK AND THE KEY COMPONENTS
The Central Biostimulant Committee (CBC) is the Governing Authority under the Department of Agriculture and Farmers’ Welfare. The CBC plays a pivotal role in reviewing applications, setting guidelines and deciding data exemptions. This committee ensures that biostimulants meet efficacy and safety standards, fostering trust among farmers.

Biostimulants approved under Indian regulations fall into the following categories:

1. Seaweed and Plant Extracts
2. Protein Hydrolysates and Amino Acids
3. Vitamins
4. Humic and Fulvic Acids and Their Derivatives
5. Antioxidants
6. Anti-transpirants
7. Biochemicals
8. Cell-free Microbial Products
9. Chitosan and Other Biopolymers
10. Inorganic Compounds
11. Beneficial Microorganisms (Non-Biofertilizers and Non-Biopesticides)

The Fertilizer (Inorganic, Organic or Mixed) (Control) (Third) Amendment Order, 2024 introduced significant changes:

• Tracer Elements: Must be disclosed for better transparency
• New Category: Live microorganisms excluding biofertilizers and biopesticides
• Pesticide Limits: Raised from 0.01 ppm to 1 ppm
• Toxicity Testing: Required, with exemptions for low-risk categories upon affidavit

THE REGISTRATION PROCESS
Mandatory Inclusion in Schedule VI: No biostimulant can be manufactured or imported unless approved and listed.

Step 1: Application Submission
Submit application via portal with:

• Company details (FCO license, GST, PAN)
• Product Dossier
• Manufacturing Process
• Efficacy & Stability Data
• Certificate of Analysis (CoA)

Step 2: Review by State & Central Authorities
The CBC evaluates the application.

Step 3: Product Testing & Field Trials

• Toxicology & Safety Tests
• ICAR-Approved Field Trials
• Shelf-Life & Stability Studies

Step 4: Approval & Provisional Registration
Provisional approval granted for three years; permanent registration after post-market surveillance.

COMPLIANCE AND QUALITY CONTROL REQUIREMENTS
Manufacturers must undergo regular audits, adhere to packaging norms, and submit compliance reports. Post-market surveillance ensures accountability, and violations may result in registration cancellation.

CHALLENGES IN BIOSTIMULANT REGISTRATION
Approval timelines (12–24 months), high testing and compliance costs, and lack of global alignment pose hurdles, especially for SMEs.

STRATEGIC RECOMMENDATIONS FOR MANUFACTURERS

• Plan early compliance
• Collaborate with ICAR/SAUs for faster field trials
• Invest in in-house quality control
• Engage with associations like PMFAI, FAI, BASAI, NBIF and BIPA

INDUSTRY IMPACT
With the market growing at 13.5% CAGR and valued at USD 320M in 2024, the sector is consolidating as substandard players exit. This benefits research-driven and compliant innovators.

11 Biostimulants under Schedule VI:

1. Humic acid 5% – powder
2. Potassium Humate 49% – powder
3. Humates and fulvates 22% – liquid
4. Humates 12.5% – liquid
5. Humic acid 51% – granular
6. Seaweed extract – Ascophyllum nodusum 15% – liquid
7. Sargassum tenerrium 12% – granular
8. Kappaphycus alvarezi 24% – liquid
9. Sargassum tenerrium 10% – liquid
10. Botanical extract Adhatoda vessica – powder
11. Mixed formulations (Humic acid, amino acid, vitamins & biochemicals) – powder

G2/G3 Certificates: These will remain valid only until June 2025 unless extended. State governments are now responsible for licensing. Clarifications are awaited on analytical methods, equipment, GST and HSN codes.

CHALLENGES IN OBTAINING AUTHORITY LETTERS
Despite inclusion in Schedule VI, authority letters for manufacturing/sale are pending in some states, slowing progress.

India’s regulatory framework for biostimulants is evolving toward global alignment, backed by sustainability goals and organic farming support. To unlock its full potential, India must streamline registration, align with global definitions, and raise awareness.

ABOUT BIPA
Bio-Agri Input Producers Association (BIPA) is a non-profit industry body (est. 2023) representing producers of biological agri-inputs like biofertilizers, biopesticides and biostimulants. BIPA advocates policy shaping, innovation, and sustainable agriculture through microbial and organic products.