Central Biostimulant Committee (CBC)
The Central Biostimulant Committee (CBC) is a statutory‐level body established under the Ministry of Agriculture & Farmers’ Welfare to regulate, guide and supervise the use, approval, and standards of biostimulant products in India. Its formation marks a key step in India’s endeavour to formalise the regulation of biostimulants under the Fertiliser Control Order (FCO), 1985.
Purpose and Legal Basis
- In 2021, the Government of India amended the FCO, 1985, to include biostimulants as a regulated class under a new clause (Clause 20C).
- Under this regulatory framework, the CBC functions as the central advisory and decision-making authority for evaluation, approval, specification setting, and quality control oversight of biostimulant products.
- The CBC thus formalises the governance of what was previously an unregulated or loosely regulated sector, ensuring that only scientifically validated and safe biostimulants enter the Indian market.
Composition & Term
- The CBC was constituted in April 2021 for a term of five years.
- The Agriculture Commissioner (Government of India) serves as the Chairperson of the CBC.
- The Committee comprises seven additional members (total eight), drawn from various stakeholder, scientific, and regulatory domains.
Functions and Responsibilities
As laid out in the amended FCO and draft guidelines, the CBC performs multiple functions:
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Product inclusion and approval
- Deciding whether a new biostimulant product may be included in Schedule VI of the FCO (i.e. be accepted for manufacture, sale, import).
- Granting exemptions or waivers in special cases (for toxicity data, history of safe use, etc.) based on scientific merit.
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Specification setting and standards
- Defining specifications (active ingredients, permissible limits, tracer elements) for different categories of biostimulants.
- Determining sampling methods, testing protocols, analytical methods, and laboratory requirements for compliance.
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Advisory role to Government
- Advising the central government on any matter referred to it concerning biostimulants.
- Issues such as revisions to registration procedures, regulatory updates, or changes in safety norms.
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Oversight and quality assurance
- Ensuring post-market surveillance, periodic review of approvals, and enforcement of quality and safety.
- Cancelling or suspending approval if products are found noncompliant.
Registration & Regulatory Process
The CBC plays a central role in the mechanism for registering biostimulant products under FCO:
- Manufacturers or importers must submit product dossiers (composition, manufacturing process, label, toxicology, bio-efficacy data) to the Controller of Fertilisers for evaluation by CBC.
- Products must undergo bio-efficacy trials (across agro-ecological zones, multiple doses) under institutions like ICAR or State Agricultural Universities.
- Toxicity and ecotoxicity tests are required: acute oral, dermal, inhalation, skin irritation, eye irritation, and ecotoxicity tests on birds, fish, honeybees, earthworms.
- CBC may consider waivers of certain tests if the substance has history of safe use.
- Provisional registrations (G3 certificates) were given earlier to allow time for data generation; these expired in 2025, after which only products included in Schedule VI remain valid.
Challenges & Recent Developments
- With the expiry of provisional registrations (June 16, 2025), many biostimulant products lacking permanent certification cannot be legally sold.
- As of now, only 146 products have been included in Schedule VI.
- Some industry bodies warn of a regulatory impasse, citing delays in permanent approvals, burdensome data requirements, and uncertainty over state-level licensing.
- States have been urged by the central government to cease forced bundling of biostimulants with subsidised fertilisers (a practice in some regions).
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