Beyond Registration: Regulatory Trends in India and Southeast Asia for Market Access
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By Dr. Piyatida (Tung) Pukclai
The regulatory standards for crop protection products across India and Southeast Asia are shifting quickly—especially for biologicals such as biopesticides and biostimulants. Regulators are tightening quality controls, formalizing more consistent data requirements, and nudging toward regional alignment on residue limits and trade facilitation. For companies operating in (or exporting to) these markets, the next 12–18 months will reward those who invest early in data integrity, digital readiness, and regulatory intelligence.
INDIA
From patchwork to codified standards—especially for biostimulants
India’s legacy framework for chemical pesticides remains the Insecticides Act, 1968, administered by the Central Insecticides Board & Registration Committee (CIB&RC). A long-anticipated overhaul—the Pesticide Management Bill (PMB), 2020—would replace the 1968 Act, expand oversight, and formalize state and national authorities, but as of August 2025 it has not been enacted. Stakeholder debate continues around data protection, risk management, and farmer safety provisions, keeping the sector under the current law for now.
Where India has moved decisively is in the regulation of biostimulants. Following several interim extensions for provisional listings under the Fertilizer (Control) Order (FCO), the Ministry of Agriculture and Farmers Welfare notified the Fertiliser (Inorganic, Organic or Mixed) (Control) Fourth Amendment Order, 2025.
This amendment codifies comprehensive standards for biostimulants, microbial formulations, and biochemical fertilizers—clarifying categories, ingredient specifications, documentation requirements, and quality benchmarks. It closes the era of repeated provisional extensions—last granted through 16 June 2025—and places scientific validation at the center of regulatory decision-making.
Politically, the signal is unambiguous: quality and scientific validation now sit at the heart of biostimulant oversight. In July 2025, India’s Agriculture Minister publicly warned of enforcement against unapproved or ineffective products and stressed the importance of scientific approvals and standard operating procedures (SOPs)—a stance closely aligned with the 2025 FCO amendments. Expect tighter market surveillance and fewer tolerance windows.
What this means in practice (India)
| 1. Treat biostimulants like regulated inputs, not supplements. The 2025 FCO amendment elevates biostimulants to defined, spec-based products. Firms should map formulas against updated Schedule VI categories and specifications, and be ready with identity, safety, and efficacy packages consistent with ministry guidance. |
| 2. Close the gap on “provisional” logic. If you relied on past extensions, assume regulators will now expect full compliance with the new standards and documentation. The 16 June 2025 date marked a line in the sand. |
| 3. Refresh digital filings and KYC details. India’s CIB&RC increasingly relies on the CROP portal and has pushed Know Your Customer (KYC) clean-ups and public notices to streamline interaction. Keep corporate records, manufacturing sources, and import documentation current to avoid administrative delays. |
| 4. Plan for PMB scenarios. Even without enactment, the PMB discussion keeps influencing expectations on stewardship, labeling, and accountability. Build internal readiness for a more risk-based, transparent regime. |
CIB&RC has issued specific guidelines for botanicals and microbials and continues to refine infrastructure expectations for manufacturers. Companies registering new active microbials or botanicals should anticipate dossier reviews focused on quality assurance, manufacturing controls, and reproducible efficacy under Indian agronomic conditions. Public notices in 2024–2025 also signal a queue-management push on 9(3) applications.
Action point: Treat manufacturing site audits and quality system documentation as front-of-dossier content, not appendices. Harmonize your study plans with Indian protocols early to avoid re-work.
SOUTH EAST ASIA
Fragmented today, trending toward alignment
Southeast Asia remains a mosaic of national systems—Indonesia’s MOA requirements, Vietnam’s Plant Protection Department (PPD), the Philippines’ Fertiliser and Pesticide Authority (FPA), Thailand’s Hazardous Substances regime, Malaysia’s Department of Agriculture, and more. Timelines, data packages, and evaluation criteria differ, especially for biologicals. But three trends point to gradual regulatory alignment across the region:
- MRL Harmonization. ASEAN’s Expert Working Group on maximum residue limits (MRLs) continues to meet, and development partners have been active with capacity-building to align with Codex methods, particularly for export crops. Regional workshops in 2024–2025 keep pushing comparable risk assessment approaches and residue evaluation capability.
- Biologicals dialogue. ASEAN’s guidelines on biological control agents and earlier efforts to standardize minimum data requirements provide a reference point that national authorities can adapt. While not a single, binding rulebook, these texts support more predictable expectations for microbials and botanicals.
- Country-level strengthening. In the Philippines, for example, manuals and technical guidance have been co-developed with Centre for Agriculture and Bioscience International (CABI) and United States Department of Agriculture (USDA) to streamline processes at FPA—an example of the practical, country-by-country improvements that collectively lift regional predictability.
What this means in practice (SE Asia)
| 1. Design one ASEAN core dossier, then localize. Develop a core data set (identity, manufacturing quality, tox/eco-tox summaries, efficacy rationale, residue plans) anchored to Codex and Organization for Economic Co-Operation and Development (OECD) principles. Then bolt on country-specific formats, study location preferences, and language or label conventions. This reduces re-work and speeds parallel submissions. (See FPA’s requirement that all pesticides be registered nationally—no regional mutual recognition exists yet.) |
| 2. Build an MRL export strategy. Track target market MRLs and align field trial designs accordingly. The ASEAN harmonization journey is ongoing, but exporters still face mismatches between Codex, importing markets, and national MRLs—plan bridging studies early. |
| 3. For biologicals, anticipate variability. Some authorities readily accept microbials with reduced data sets; others want local efficacy trials and explicit manufacturing QC evidence. Use the ASEAN biological control guidance as a conversation starter, not a substitute for national rules. |
SOUTHEAST ASIA
Biofertilizers and Regulatory Nuances
Not every country in Southeast Asia will accept the registration of biofertilizers. Companies must carefully check local regulations and understand the current enforcement environment. Some countries only allow domestic microorganism strains, while others permit overseas strains, provided they meet national criteria or standards.
Additionally, Pest Risk Analysis (PRA) may be required for the importation of prohibited items, especially those involving plant pests or microorganisms. Early engagement with regulators is therefore essential. Companies should also be prepared for communication in local languages, as not all countries provide guidelines or regulations in English or translated versions. Planning for these differences can significantly reduce delays and compliance risk.
Five Execution Tips for Chemical and Biological Companies
- Elevate quality systems. Whether in India under the 2025 FCO amendment or across ASEAN, regulators are scrutinizing manufacturing consistency for both chemical and biological products. Document batch-to-batch variability, microbial purity, contaminant limits, and shelf-life with GLP/GMP-aligned evidence.
- Pre-align protocols with regulators. Before running local efficacy or residue work, socialize your protocols—crop, pest pressure, application number, and climatic zones—so trial outputs map cleanly to national decision criteria. This is especially important for the Philippines, Vietnam, and Indonesia where local trials are often decisive.
- Digital readiness matters. India’s emphasis on online submissions (CROP) and tighter KYC/portal hygiene is spreading as a general expectation: complete, consistent metadata lowers review friction.
- Watch the policy narrative. Public statements from Indian leadership and partner-led ASEAN workshops indicate a durable trend: “quality, science, and trade readiness.” Expect more enforcement against low-quality biostimulants in India and steady ASEAN progress on Codex-style MRL science.
- Resource for horizon scanning. Track gazette notifications and ministry circulars—especially in India, where FCO amendments and Plant Quarantine updates can appear with near-term effect. Build alerts or assign ownership so nothing is missed.
What to Tell Commercial Leadership
Biostimulants are no longer a lite regulatory path in India. Budget for dossier upgrades (identity & CoA, mode-of-action rationale, efficacy packages) and potential reformulation to meet Schedule VI specs. Lead times will tighten once enforcement scales.
For biopesticides, manufacturing controls are the new differentiator. Data packages that foreground quality control—rather than simply attach it—are moving faster. CIB&RC is sensitive to reproducibility and labelling accuracy for biologicals.
Biofertilizer regulations vary widely in Southeast Asia. Some countries require domestic strains; others allow imported strains with strict criteria. PRA might be needed for importation, especially for microorganisms classified as plant pests. Plan for local-language communication and regulator engagement to avoid delays.
ASEAN is getting easier—slowly. You still need country-by-country registrations, but residue science, drafting practices, and data expectations are converging. A shared core dossier can save 20–30% of time and cost if executed well (internal estimate; validate against your own pipeline).
Invest in regulatory intelligence and local engagement. Monitoring changes, building local contacts, and understanding translation needs can prevent costly missteps in approvals or market access.
Near-Term Outlook (next 12–18 months)
For India, expect additional clarifications and FAQs around the 2025 FCO amendment as industry implements the new biostimulant standards. Given recent ministerial statements, anticipate heightened market surveillance and potential product withdrawals for non-compliance. Keep an eye on any movement of the PMB, but plan operations assuming the 1968 Act remains in force for the short term.
For Southeast Asia, watch for continued technical cooperation on MRLs and gradual improvements in dossier review consistency. Country-specific reforms (e.g., updated manuals or templates) may quietly shorten timelines without headline legal changes—especially in the Philippines and Indonesia. •
Dr. Piyatida (Tung) Pukclai is the Regional Sales & Regulatory Policy Manager (Asia-Pacific) for knoell.