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 frame- work under the FCO, 1985. Starting with informal discussions in 2019, the govern- ment progressively introduced definitions, registration pro- cesses and quality controls through amendments in 2021 (This amendment officially recognized biostimulants as a distinct category under the FCO, 1985), 2023 (draft guidelines issued), 2024 (added “live microorganisms excluding biofertilizers and biopesticides” and added 11 new biostimulants under Sched- ule VI of FCO), and 2025 (extended the provisional registration period and the Ministry of Agriculture directed all State and Union Territory governments to authorize the sale of biostimu- lants under the FCO). This chronology reflects India’s commit- ment to fostering sustainable agriculture while ensuring prod- uct safety and efficacy, positioning it among the few countries with a dedicated biostimulant regulatory system.

THE REGULATORY FRAMEWORK AND THE KEY COMPONENTS

The Central Biostimulant Committee (CBC)

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:

• Seaweed and Plant Extracts – Includes extracts derived from seaweed and terrestrial plants with biostimulant properties.
• Protein Hydrolysates and Amino Acids – Comprises pep- tides, amino acids and protein-derived compounds bene- ficial for plant growth.
• Vitamins – Essential vitamins that enhance plant metabo- lism and stress resistance.
• Humic and Fulvic Acids and Their Derivatives – Organic substances that improve soil structure, nutrient uptake and plant health.
• Antioxidants – Compounds that mitigate oxidative stress in plants.
• Anti-transpirants – Substances that reduce water loss and improve drought tolerance.
• Biochemicals – Naturally occurring biochemical com- pounds that promote plant growth.
• Cell-free Microbial Products – Includes metabolites, en- zymes and signaling molecules produced by microbes.
• Chitosan and Other Biopolymers – Derived from natural sources to enhance plant immunity and growth.
• Inorganic Compounds – Specific mineral-based com- pounds with biostimulant effects.
• Beneficial Microorganisms (Non-Biofertilizers and Non-Biopesticides) – Includes beneficial bacteria, fungi and other microbes that promote plant growth through non-nutritional means.

The Fertilizer (Inorganic, Organic or Mixed) (Control) (Third) Amendment Order, 2024, issued by the Ministry of Agriculture and Farmers’ Welfare on May 8, 2024, introduced significant changes to regulate biostimulants.

Key Provisions

Tracer Elements: Biostimulant specifications to include “tracer elements” alongside active ingredients, enhancing transparency in composition.

New Category: A category for “live microorganisms excluding biofertilizers and biopesticides” was added to Schedule VI.

Pesticide Limits: The permissible pesticide residue limit in biostimulants was raised from 0.01 ppm to 1 ppm, balancing safety with practical manufacturing realities.

Toxicity Testing: Manufacturers must submit detailed tox- icity data, though exemptions exist for low-risk categories (e.g., seaweed extracts, humic acids) if accompanied by an affidavit affirming safety.

THE REGISTRATION PROCESS

Mandatory Inclusion in Schedule VI: No biostimulant can be manufactured or imported unless approved and listed in Schedule VI by the Central Government. Applications (via Form G) must include the following:

STEP 1: APPLICATION SUBMISSION

• Company Details (FCO license, GST, PAN, manufacturing facility information).
• Product Dossier (composition, active ingredients and scientific justification).
• Manufacturing Process (detailed production methodology).
• Efficacy & Stability Data (shelf-life studies, storage conditions).
• Certificate of Analysis (CoA) from NABL-accredited laboratories.

STEP 2: REVIEW BY STATE & CENTRAL AUTHORITIES

• The application to the Central Biostimulant Committee (CBC) for evaluation.

STEP 3: PRODUCT TESTING & FIELD TRIALS

• Toxicology & Safety Tests: Ensures no heavy metals or harmful contaminants are present.
• ICAR-Approved Field Trials: Multi-location efficacy trials to validate agronomic benefits.
• Shelf-Life & Stability Studies: Ensures consistent product performance over time.

STEP 4: APPROVAL & PROVISIONAL REGISTRATION

• If the field trial results meet the required standards, the CBC grants provisional approval for three years.
• Post-market surveillance is conducted before granting permanent registration.

COMPLIANCE AND QUALITY CONTROL REQUIREMENTS

Biostimulant manufacturers must adhere to strict com- pliance and quality control requirements to ensure product efficacy and regulatory approval. Manufacturing units under- go periodic quality audits conducted to maintain consistency. Labeling and packaging must comply with FCO regulations, including essential details such as trade name, biostimulant category, active ingredients with percentage composition, batch number, manufacturing and expiry dates, storage and handling instructions, recommended dosage, application methods, and safety precautions.

Post-market surveillance plays a crucial role, with regula- tory authorities conducting random quality testing to ensure compliance. Failure to meet standards can result in suspen- sion or cancellation of registration. Manufacturers must also submit annual compliance reports to maintain approval and continue operations in the market.

CHALLENGES IN BIOSTIMULANT REGISTRATION

The registration of biostimulants in India faces several chal- lenges, including lengthy approval timelines, high compliance costs and regulatory misalignment with global standards. The approval process can take 12 to 24 months, delaying market entry for manufacturers. Additionally, the high cost of compli- ance—covering field trials, toxicity testing and certification— poses a significant financial burden, particularly for small and medium enterprises (SMEs).

STRATEGIC RECOMMENDATIONS FOR MANUFACTURERS

To navigate the challenges of biostimulant registration, manufacturers should adopt strategic approaches to stream- line approvals and enhance market competitiveness. Early compliance planning is crucial, ensuring regulatory approvals are initiated well in advance to minimize delays. Collaborating with ICAR and State Agricultural Universities (SAUs) can help fast-track field trials and efficacy studies, expediting product validation. Investing in in-house quality control reduces de- pendency on third-party testing, mitigating potential delays. Engaging with industry associations such as PMFAI, FAI, BASAI,
NBIF and BIPA allows manufacturers to advocate for faster ap- provals and regulatory reforms.
INDUSTRY IMPACT
The stricter regulations aim to weed out substandard products, with estimates suggesting the market (valued at USD 320 million in 2024, growing at a 13.5 percent CAGR) will consolidate as non-compliant players exit. This benefits re- search-driven firms which can leverage their expertise to com- ply and innovate.

The 11 products included under Schedule VI of FCO for which the state governments are to be issued manufacturing and marketing licenses:

• Humic acid 5 percent – powder
• Potassium Humate 49 percent – powder
• Humates and fulvates 22 percent – liquid
• Humates 12.5 percent – liquid
• Humic acid 51 percent – granular
• Seaweed extract – Ascophyllum nodosum 15 percent – liquid
• Sargassum tenerrium 12 percent – granular
• Kappaphycus alvarezi 24 percent – liquid
• Sargassum tenerrium 10 percent – liquid
• Botanical extract Adhatoda vasica – powder
• Mixed formulations of biostimulants – mixture of Humic acid, amino acid, vitamins, and biochemicals – powder

Under these circumstances, the G2 and G3 certificates issued by state and central governments are no longer val- id unless the government grants further extensions for pro- visional registrations. The responsibility now lies with state governments, requiring manufacturers to obtain licenses to produce and market the listed biostimulants. Addition- ally, the government may soon announce the inclusion of other categories.

CHALLENGES IN OBTAINING AUTHORITY LETTERS FOR SCHEDULE VI PRODUCTS

As per the notification dated September 12, 2024, eleven products were included in Schedule VI of the FCO. However,
the State Department of Agriculture is not issuing the required authority letters for the production and sale of biostimulants. Moreover, the industry is yet to know the method of analysis and various equipment required to meet compliance. This is apart from the Government clarification on GST and HSN codes for biostimulant products.

The status on this day (25th March 2025) of writing this ar- ticle, G3 provisional certificates issued by the government will remain valid till June 2025.

India’s regulatory landscape for biostimulants is progres- sively aligning with global standards, such as those in the EU and U.S., while addressing local agricultural needs. Govern- ment support for organic farming and sustainable practices continues to drive this sector, with the market projected to grow significantly in the coming years. However, streamlining registration processes, increasing farmer education and har- monizing definitions with international norms will be critical for unlocking its full potential.

ABOUT BIPA

Bio-Agri Input Producers Association (BIPA) is a not-for profit industry body established in 2023 representing pro- ducers of biological agricultural inputs, including biofertiliz- ers, biopesticides and biostimulants. BIPA advocates for the interests of companies in this sector, particularly in shaping policies that support sustainable agriculture and innovation in microbial and organic products.