How to import Germplasm, Transgenics & Genetically Modified Organisms (GMOs) for research

The import of plant germplasm, transgenic materials and genetically modified organisms (GMOs) plays a pivotal role in advancing agricultural research, crop improvement and biotechnology development. To ensure the safe introduction of such materials into the country, India has established a robust regulatory framework under the Plant Quarantine (Regulation of Import into India) Order, 2003, supported by biosafety rules under the Environment (Protection) Act, 1986.
This guide provides a professional, detailed and structured overview of the legal requirements, eligibility criteria, approval workflow and compliance obligations for researchers and institutions intending to import germplasm and GMOs for non-commercial, research-oriented purposes.

1. Introduction

Agricultural innovation relies heavily on access to diverse genetic resources and improved germplasm. However, the importation of plant genetic material carries inherent risks, including the potential introduction of exotic pests, diseases and unregulated genetic traits. To mitigate these risks, India mandates that all imports of germplasm, transgenic and GMOs for research must be authorized and carefully monitored by designated national authorities.
The regulatory mechanism ensures that scientific research can progress while safeguarding national biosecurity, biodiversity and environmental health.

2. Regulatory Framework

Imports of germplasm and GMOs are governed by the following legislations and rules:

• Primary Regulations
• Plant Quarantine (Regulation of Import into India) Order, 2003
• Destructive Insects and Pests Act, 1914
• Environment (Protection) Act, 1986
• Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/GMOs, 1989

Competent Authorities

This multi-tiered structure ensures coordinated phytosanitary and biosafety management throughout the import cycle.

3. Eligibility to Apply

The following entities are eligible to apply for permits:

• Government research institutions, including Indian Council of Agricultural Research (ICAR),  Council of Scientific and Industrial Research (CSIR), Department of Biotechnology (DBT)
• State Agricultural Universities (SAUs)
• Accredited private research organizations
• Multinational and domestic biotechnology companies involved in R&D
• Any authorized importer/agent engaged exclusively in non-commercial research

4. Applicability of the Approval

Import approval is required when importing any of the following for research, experimentation, breeding or evaluation:

• Plant germplasm (seeds, tissues, propagules, clones, wild accessions)
• Transgenic lines or genetically modified organisms
• DNA constructs, gene-editing materials or modified cell lines
• Any material listed under Schedule V, VI or XII of the PQ Order

5. Designated Port of Entry

As per the PQ Order, all germplasm, transgenic and GMO imports must enter exclusively through New Delhi Airport, ensuring direct scientific handling under the supervision of NBPGR. No other port is authorised for such material.

6. Step-by-Step Procedure for Obtaining an Import Permit

Below is the standardized, institution-grade procedural workflow:

Step 1: Submission of Application (Form PQ-08)

The importer must apply using Form PQ-08, providing complete technical details including:

• Botanical name, variety and type of material
• Origin and exporting institution
• Purpose of import and research justification
• GMO/Transgenic status supported by scientific documentation
• Containment facility details (for GMOs)
• Prior import record 

All information must be scientifically accurate and verifiable.

Step 2: Obtain RCGM/GEAC Approval (For GMOs and Transgenics Only)

RCGM Approval
Mandatory for:

• Genetically engineered plants
• Gene-edited materials
• Transgenic seeds or tissues

GEAC Approval
Required for:

• Higher-risk GMOs
• Materials with environmental implications
• Imports intended for contained field trials

These approvals must accompany the PQ application and are essential for biosafety compliance.

Step 3: Technical Evaluation by NBPGR

NBPGR conducts a comprehensive review based on:

• Phytosanitary risk assessment
• Biosafety approval validity
• Purpose and national relevance of the import
• Availability of Post-Entry Quarantine (PEQ) facilities
• Conformity to schedules of the PQ Order

Step 4: Issuance of Import Permit (Form PQ-09)

Upon satisfactory evaluation, NBPGR issues:

• Import Permit (Form PQ-09)
• Official identification tags, colour-coded as:

--    Red/Green for germplasm
--    Red/White for transgenics/GMOs
The permit includes the approved quantity, validity period, and mandatory conditions for import.

Step 5: Pre-Shipment Requirements

The exporter must provide a valid Phytosanitary Certificate with necessary additional declarations, certifying:

• Freedom from regulated pests
• Absence of soil and weed seeds
• Completion of prescribed treatments

These requirements must strictly align with the PQ Order and the conditions listed in the import permit.

Step 6: Arrival and Handling at Port

• The consignment must remain sealed at the port.
• It must not be opened under any circumstances.
• Customs forwards the sealed shipment directly to NBPGR for scientific handling.

This ensures secure and contamination-free transfer.

Step 7: Quarantine Inspection and Laboratory Testing

At NBPGR, the material undergoes:

• Visual inspection
• Seed health testing
• Pest and pathogen detection
• Molecular identification (as required)
• GMO verification (for transgenic imports)

Appropriate measures such as treatment, rejection or destruction are applied if contamination or pest detection occurs.

7. Importer Obligations and Compliance Requirements

The importer must ensure:

• Accurate and complete documentation
• Adherence to permit conditions
• Restricted use strictly for research
• Non-distribution before quarantine clearance
• Proper scientific handling and containment
• Reporting of any pest/disease detection
• Maintenance of PEQ documentation for audit

8. Summary of the Approval Workflow

1.    Prepare application in PQ Form–08
2.    Obtain RCGM/GEAC approval (for GMOs)
3.    Submit application to NBPGR
4.    Technical evaluation and verification
5.    Issuance of permit (PQ Form–09)
6.    Pre-shipment compliance by exporter
7.    Import through New Delhi Airport
8.    Quarantine inspection at NBPGR
9.    Post-entry quarantine (if applicable)
10.    Final clearance

Conclusion

India’s regulatory framework for the import of germplasm, transgenics and GMOs is designed to enable scientific progress while ensuring national biosecurity and environmental protection. By adhering to the approval process, complying with biosafety standards and cooperating with regulatory authorities, research institutions can responsibly access international genetic resources essential for innovation in agriculture.