India faces a complex challenge in regulating biopesticides, which are living organisms that require adaptive governance.
Unlike chemical pesticides, biopesticides demand continuous learning and monitoring due to their evolving nature.
Effective regulation must include post-market surveillance, adaptive authorisations, and a balance between central and state roles, ensuring farmer welfare and ecological sustainability.
Governing biopesticides without continuous learning is like navigating with an outdated map while the terrain shifts beneath you. Microbes adapt and evolve. Environmental interactions change with season and climate. New strains arise and long-term consequences may surface only years after introduction.
Ecological science and microbiome research constantly produce new knowledge, while field experience reveals patterns laboratory studies cannot anticipate. For this reason, post-market surveillance must be mandatory. Monitoring in regions of widespread use should track soil microbial communities, non-target organisms, crop performance, water quality and biodiversity over multiple seasons.
Epidemiological research on applicators and nearby communities is essential. Resistance surveillance in pest populations should provide early warnings and environmental fate studies across diverse agro-climatic conditions must test how products behave in practice.
Crucially, regulatory systems must specify how new evidence triggers action. Predefined thresholds for intervention, rapid response mechanisms for emerging risks and periodic reassessments of approvals should be standard. Regulation has to be adaptive.
Permanent approvals make little sense for living organisms. Time-limited authorisations, conditional registrations requiring additional research and mandatory reporting should replace the “approve once and forget” model inherited from chemical pesticide governance.
None of this is possible without funding. Industry levies, public budgets and carefully structured partnerships can sustain independent research. Without continuous investment, regulation becomes obsolete while biology keeps moving.
Designing institutions for biopesticide governance involves foundational choices. One option is to adapt existing pesticide law, which benefits from established procedures but risks forcing biological products into frameworks meant for chemicals.
Another option is to formulate separate legislation tailored to biological realities, though this demands new infrastructure. A comprehensive pesticide management approach might allow integration while acknowledging differences.
Jurisdiction is equally important. Agriculture authorities understand farming systems and farmer welfare, but may lack specialised biosafety expertise. Environmental institutions bring ecological competence, yet may remain distant from day-to-day agricultural practice. Joint mechanisms could combine strengths, though they may introduce bureaucratic friction.
India’s federal structure adds another layer. Central standards can ensure uniformity and economies of scale, but may ignore regional variation. States can adapt rules to local contexts but differ widely in capacity. A hybrid approach of central norm-setting with state implementation and monitoring may best reflect agricultural realities.
Across all designs looms the risk of regulatory capture, where industry interests shape rules to exclude smaller actors and privilege corporate models. Warning signs include compliance costs affordable only to large firms, standards biased toward industrial production, revolving doors between regulators and companies and procedural complexity requiring expensive intermediaries.
Preventing capture requires structural safeguards: Representation of farmer organisations, open consultations, periodic review of regulations, explicit protection for small-scale and farmer production, independent scientific advice and strong whistleblower protections. Transparency is not cosmetic; it is defense against distortion.
Regulating microbes is fundamentally different from regulating chemicals. It demands expertise in microbiology, molecular biology, and ecology, along with laboratories capable of culturing organisms, verifying purity and conducting biosafety analyses. Field evaluation of living agents requires ecological understanding far beyond residue chemistry.
Expecting existing pesticide bureaucracies to perform these tasks without new investment is unrealistic. Just as cybercrime required specialised investigative systems, biopesticides require dedicated technical capacity — trained personnel, diagnostic infrastructure, genetic analysis tools, and standardised protocols. Building this capacity must be integral to regulatory reform.
The aim is not regulation for its own sake but protection without suffocation. Farmers need defense against fraudulent commercial products, yet their own innovations must remain free. Markets require quality assurance, but rules should not create barriers that destroy decentralized production. High-risk technologies deserve strict precaution; low-risk traditional practices deserve space.
An evolutionary path makes sense. Begin by establishing definitions and baseline norms for categories of products. Develop flexible model guidelines, clarify documentation expectations, and strengthen institutional capacity. Only then should comprehensive mandatory systems emerge, informed by learning from earlier stages.
A practical boundary can be drawn at commercialisation. Products that are packaged, branded and sold with standardised claims fall under regulation. Preparations made by farmers or communities for their own use or local exchange remain outside formal licensing. This protects grassroots knowledge while ensuring accountability where money changes hands.
For commercial goods, regulation should include clear shelf-life standards based on Indian climatic conditions, contamination and composition testing, independent verification of efficacy, and transparent labeling in local languages. Maximum retail price mechanisms can prevent exploitation. Because microbial viability depends on handling, requirements for temperature control, realistic expiry dating, and encouragement of regional production units are essential.
Genetically modified organisms or species introduced from other ecosystems occupy an entirely different category of risk — one that warrants not merely a more stringent regulatory pathway, but a serious examination of whether they should be permitted at all. Unlike conventional inputs, their release into open environments is largely irreversible; once a transgene spreads or an invasive species establishes itself, there is no meaningful recall. Where permission is even considered, the burden of proof must be firmly reversed — manufacturers demonstrate safety, not regulators or the public prove harm — with independent oversight, longer evaluation periods, and mandatory continuous monitoring. Automatic suspension, not prolonged review, should follow any warning signs. For ecologically sensitive regions or crops of cultural significance, a blanket prohibition may be the only defensible position.
Openness must be explicit. Disclosure should be the default, with secrecy the rare exception justified by the applicant. Regulatory bodies should publish applications, data, review outcomes, meeting records and conflict-of-interest declarations. Adverse effects, complaints, and enforcement actions should be visible in real time. Legal mechanisms must allow challenges to decisions that hide information. Without such provisions, even well-designed systems risk losing credibility.
Continuous study is not an accessory but a condition of authorisation. Industry contributions and public funding should support long-term surveillance lasting decades where necessary. Independent institutions must have authority to initiate reviews when evidence demands. Adaptive management — learning and adjusting — should define the culture of regulation.
The shortcomings of chemical pesticides created the opportunity for biological alternatives. Wise governance can help this transition deliver safer agriculture, stronger biodiversity, and greater farmer autonomy. Poor governance — whether careless, opaque, or overly restrictive — could reproduce old failures under new labels.
India has the opportunity to craft a framework that reconciles innovation with precaution, science with traditional knowledge, and enterprise with public interest. Doing so means privileging farmer welfare and ecological sustainability over narrow commercial convenience.
Regulation should standardise where markets operate, yet leave room where communities innovate. It should monitor risk without criminalizing tradition. Above all, it should remember that farmers are not the threat requiring control; they are partners in building resilient agriculture.
As biopesticides move from margins to mainstream, choices made today will shape decades of practice. The central question is simple: Will regulation empower those who cultivate the land, or those who sell to them? The answer will determine whether biological pest management becomes a pathway to sustainability or merely another marketplace.
Narasimha Reddy Donthi is a public policy expert and consultant at the Pesticide Action Network India and a visiting faculty (honorary) at Delhi-based Impact and Policy Research Institute. Views expressed are the author’s own and don’t necessarily reflect those of Down To Earth.
This is the second of a two-part series on the framework for biopesticide regulation in India. Read the first part.