India has established a comprehensive regulatory framework for plant biostimulants, detailing the legal requirements, registration steps, and documentation necessary to place these products on the Indian market.

The Legal Basis for biostimulant regulation is the Fertiliser (Control) Order (FCO), 1985, which, back then, did not include the concept of “biostimulants”. It was however amended by Notification S.O. 882(E) on 23 February 2021, which formally brought biostimulants under regulatory oversight via Clause 20C and Schedule VI.

The Competent/Regulatory Authority is the Department of Agriculture and Farmers Welfare, with oversight by the Controller of Fertilisers at the central level. The Central Biostimulant Committee evaluates submissions, advises on standards and testing, and oversees the inclusion of products in Schedule VI.

Plant Biostimulants (under Clause 20C) comprise substances or microorganisms (or both) that stimulate plant physiological processes, improve nutrient uptake, efficiency, stress tolerance, crop quality, or yield, excluding products regulated as fertilizers, pesticides, or plant growth regulators.

Plant biostimulant categories include botanical extracts (including seaweed), biochemicals, protein hydrolysates, amino acids, vitamins, cell-free microbial products, antioxidants, anti-transpirants, humic and fulvic acids, and certain microbials (excluding biofertilizers and biopesticides).

The Indian system works with a positive list approach. It means that only biostimulants listed in Schedule VI of the FCO may be manufactured, imported, sold, or distributed in India; selling unlisted products is prohibited.

Only registered biostimulants (included on Schedule VI) can be sold and the registration process involves submitting a comprehensive dossier to the Controller of Fertilisers, including product identity, composition, manufacturing details, quality specifications, bio-efficacy data, and safety data.

Indeed, Data Requirements include chemistry studies (GLP/NABL-accredited labs (!)), agronomic bio-efficacy trials (minimum three locations, one season, three doses), acute and eco-toxicity studies, heavy metal and pesticide residue analysis, and shelf-life data.

Compliance Obligations require strict adherence to labelling, packaging, and quality standards as specified in the FCO, with enforcement actions including seizure and penalties for non-compliance.

Various affidavit (= a written statement confirmed by oath or affirmation, for use as evidence in court) and declarations must be provided, confirming the product does not contain pesticides or heavy metals beyond permissible limits, and that no adverse effects have been reported; notarized declarations and responsible person acceptance are mandatory.

Application Forms required include Form G2 (state-level certification), Form G1 (application to Controller), and Form G3 (provisional registration certificate).

In the past provisional registrations were allowed to facilitate transition to the new rules. But now, all provisional (G3) certificates expired on 16 June 2025; only products fully registered and listed in Schedule VI are now permitted, which caused about 8000 biostimulant products to vanish from the market.

The timeline for registration typically ranges from 2-3 years, covering regulatory scoping, data generation, field trials, dossier preparation, review, and gazette notification.

The costs to be expected to register a new plant biostimulants are between EUR 150,000–400,000 (INR 1.3–3.5 crore), with major costs in field trials and laboratory studies.

A document checklist could be retrieved and from that, we understood that documents required include sales and GST data (past three years), product labels, technical specifications, safety declarations, affidavits, manufacturing and storage details, and, for importers, foreign registration proof and trial data. Verification and Legal Liability are enforced through signed declarations, affidavits, and acceptance of legal consequences for false information.

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