Is WHO-GMP Certification mandatory for all pharmaceutical exports from India?

WHO-GMP Certification is mandatory for exports to stringent regulatory authority (SRA) countries including USA, EU, UK, Canada, Japan, and Australia. However, it is highly recommended for other export destinations to ensure market acceptance and regulatory compliance. The FTP 2023-28 encourages WHO-GMP certification as it facilitates faster customs clearance and supports export incentive schemes like RoDTEP.

How long does the WHO-GMP Certification process take?

The entire process typically takes 4-8 months from application submission to certificate receipt. This includes pre-inspection preparation (2-4 weeks), inspection scheduling (1-2 weeks), on-site inspection (3-5 days), and remedial action plan closure (4-8 weeks). Timelines may extend if significant deviations are identified during inspection.

What happens if a manufacturer fails the WHO-GMP inspection?

If major deviations are identified, CDSCO issues an inspection report with a detailed list of observations. The manufacturer must submit a Remedial Action Plan addressing each observation within 30-45 days. CDSCO may conduct a follow-up inspection to verify corrections. Only upon satisfactory closure of all observations is the certificate issued. Persistent non-compliance may result in denial of certification and regulatory action.

Can WHO-GMP Certificate be renewed after expiry?

Yes, the certificate can be renewed by submitting a renewal application 90-120 days before expiry. However, operating without a valid certificate after expiry is non-compliant and may result in suspension of export licenses and customs clearance restrictions. Renewal inspection follows the same process as initial certification and typically takes 3-4 months.

Does WHO-GMP Certification guarantee export eligibility under FTP 2023-28?

WHO-GMP Certification is a critical requirement but not the sole factor for export eligibility. Manufacturers must also maintain valid IEC, comply with FTDR Act provisions, meet product-specific regulatory requirements, and ensure accurate customs documentation. However, WHO-GMP certification significantly facilitates faster CBIC clearance and supports RoDTEP and other incentive scheme benefits under the FTP 2023-28.

WHO-GMP Certification

Get WHO-GMP Certification for pharmaceutical exports from India. Comply with global standards, access SRA markets, and strengthen EXIM operations with CDSCO-approved quality certification.

Verify manufacturing license validity and IEC registration; compile all required documentation including facility layout, quality procedures, and batch records
Submit formal application to the relevant CDSCO Zonal Office with prescribed fees and complete documentation package
Receive inspection schedule notification from CDSCO; conduct internal audit to identify and address any potential deviations before the scheduled inspection
Undergo on-site WHO-GMP inspection by CDSCO team; receive inspection report with observations and prepare detailed Remedial Action Plan if required
Submit RAP within stipulated timeframe; obtain CDSCO approval and final certificate issuance valid for three years with periodic compliance monitoring

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What is WHO-GMP Certification?

WHO-GMP (World Health Organization - Good Manufacturing Practice) Certification is an international quality standard for pharmaceutical manufacturing facilities. It is a prerequisite certification that demonstrates a manufacturer's compliance with global standards for production, quality control, and safety of pharmaceutical products intended for export to regulated markets.

Under India's FTP 2023-28 and the Drugs and Cosmetics Act, 1940, pharmaceutical manufacturers seeking export licenses must obtain WHO-GMP certification from the Central Drugs Standard Control Organization (CDSCO). This certification is mandatory for exports to WHO-member countries, stringent regulatory authorities (SRAs), and several other international markets where pharmaceutical products must meet internationally recognized manufacturing standards.

Pricing

Package	Price	Details
Standard	On request	Including document prep

Process

📋
Verify manufacturing license validity and IEC registration; compile all required documentation including facility layout, quality procedures, and batch records
🔍
Submit formal application to the relevant CDSCO Zonal Office with prescribed fees and complete documentation package
📝
Receive inspection schedule notification from CDSCO; conduct internal audit to identify and address any potential deviations before the scheduled inspection
✅
Undergo on-site WHO-GMP inspection by CDSCO team; receive inspection report with observations and prepare detailed Remedial Action Plan if required
📤
Submit RAP within stipulated timeframe; obtain CDSCO approval and final certificate issuance valid for three years with periodic compliance monitoring

Documents Required

Valid Manufacturing License issued by State Drugs Controller or CDSCO under the Drugs and Cosmetics Act, 1940
IEC (Importer Exporter Code) certificate issued by DGFT/CBIC with active export status
Detailed facility description including site plans, equipment list, quality control laboratory capabilities, and storage infrastructure
Quality Management System documentation, Standard Operating Procedures (SOPs), and Master Batch Records for at least one product manufactured in the preceding 12 months
Environmental clearance certificate, labour licenses, and ISO certifications (ISO 9001 or equivalent) demonstrating quality systems
Testing reports from CDSCO-recognized laboratories showing compliance with pharmacopeial standards for representative product batches

Frequently Asked Questions

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WHO-GMP Certification

Get WHO-GMP Certification for pharmaceutical exports from India. Comply with global standards, access SRA markets, and strengthen EXIM operations with CDSCO-approved quality certification.

Verify manufacturing license validity and IEC registration; compile all required documentation including facility layout, quality procedures, and batch records

Submit formal application to the relevant CDSCO Zonal Office with prescribed fees and complete documentation package

Receive inspection schedule notification from CDSCO; conduct internal audit to identify and address any potential deviations before the scheduled inspection

Undergo on-site WHO-GMP inspection by CDSCO team; receive inspection report with observations and prepare detailed Remedial Action Plan if required

Submit RAP within stipulated timeframe; obtain CDSCO approval and final certificate issuance valid for three years with periodic compliance monitoring

Google VerifiedBusiness

500+Export Clients Served

End-to-EndEXIM Support

What is WHO-GMP Certification?

Package

Price

Details

Standard

On request

Including document prep

Process

📋

Verify manufacturing license validity and IEC registration; compile all required documentation including facility layout, quality procedures, and batch records

🔍

Submit formal application to the relevant CDSCO Zonal Office with prescribed fees and complete documentation package

📝

Receive inspection schedule notification from CDSCO; conduct internal audit to identify and address any potential deviations before the scheduled inspection

✅

Undergo on-site WHO-GMP inspection by CDSCO team; receive inspection report with observations and prepare detailed Remedial Action Plan if required

📤

Submit RAP within stipulated timeframe; obtain CDSCO approval and final certificate issuance valid for three years with periodic compliance monitoring

Documents Required

Valid Manufacturing License issued by State Drugs Controller or CDSCO under the Drugs and Cosmetics Act, 1940

IEC (Importer Exporter Code) certificate issued by DGFT/CBIC with active export status

Detailed facility description including site plans, equipment list, quality control laboratory capabilities, and storage infrastructure

Quality Management System documentation, Standard Operating Procedures (SOPs), and Master Batch Records for at least one product manufactured in the preceding 12 months

Environmental clearance certificate, labour licenses, and ISO certifications (ISO 9001 or equivalent) demonstrating quality systems

Testing reports from CDSCO-recognized laboratories showing compliance with pharmacopeial standards for representative product batches

Frequently Asked Questions