Drug Export
NOC & Certificates
from CDSCO
Complete regulatory support for obtaining Drug Export NOC, Certificate for Export (CoPP/CFE), and related clearances from CDSCO — enabling Indian pharmaceutical companies to legally export drugs to regulated and semi-regulated markets worldwide.
What is a Drug Export NOC?
A Drug Export NOC (No Objection Certificate) is a CDSCO authorisation confirming that the drugs being exported from India comply with Indian regulatory standards and are free for export to the destination country. It is mandatory for exporting drugs that are not registered in the importing country or for specific regulatory requirements.
Mandatory for Many Export Markets
Several countries require CDSCO-issued export certificates as a pre-condition for drug import registration. Regulated markets (EU, USA, UK) and semi-regulated markets (Africa, Southeast Asia, Latin America) have different NOC and certificate requirements.
Multiple Certificate Types
CDSCO issues different certificates — Drug Export NOC (Form 12AA), Certificate of Pharmaceutical Product (CoPP/WHO-type), Certificate for Export (CFE/Form 12B) and Dual-Use NOC — depending on the destination country's import authority requirements.
Manufacturing Licence Required First
A valid Drug Manufacturing Licence (Form 25) is a prerequisite for most export certificates. The exporter must be the licensed manufacturer or hold an authorisation from the manufacturer. CDSCO verifies licence validity before issuing any export certificate.
Country-Specific Requirements
Each destination country may require different export documentation formats. We advise on exactly which CDSCO certificate the importing country's regulatory authority needs and prepare the application in the required format with all supporting documents.
Drug Export NOC & Certificate Services
We handle all CDSCO export certificates and NOCs — from routine export shipments to complex multi-country regulatory filing packages.
Form 12AA⏱ 7–15 daysThe primary CDSCO export NOC confirming the drug is manufactured in India as per approved specifications and is free for export. Required by many semi-regulated markets and by Indian Customs for drug export consignments.
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CoPP / WHO⏱ 15–30 daysWHO-format certificate confirming a drug product is licensed and manufactured under GMP in India. Required by regulated export markets for import registration. Issued by CDSCO on the WHO recommended format with GMP status attestation.
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Form 12B / CFE⏱ 10–21 daysCertificate for export of drugs that are not registered / approved for sale in India but are being manufactured specifically for export. Required for drugs whose formulations are not in the Indian market but are registered abroad.
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Dual-Use NOC⏱ 10–20 daysSpecific NOC required for exporting drugs that have both legitimate pharmaceutical use and potential for misuse (e.g., psychotropic precursors, controlled substances for medical use). Involves additional CDSCO review and documentation requirements.
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ADC NOC⏱ 15–30 daysNo Objection Certificate from the Narcotics Commissioner / ADC for export of narcotic drugs, psychotropic substances and their preparations. Required in addition to CDSCO NOC for Schedule W and Schedule X drugs being exported.
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Multi-Country⏱ 15–45 daysFor pharmaceutical exporters supplying to multiple countries simultaneously — we prepare coordinated NOC, CoPP and CFE applications for different destination countries with unified timelines and a single point of contact for tracking.
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Prerequisites for Drug Export NOC
All conditions below must be satisfied before CDSCO will process your export NOC application. We review and confirm eligibility before filing.
Valid Manufacturing Licence (Form 25)
The applicant must hold a current, valid Drug Manufacturing Licence (Form 25) for the drug product being exported. CDSCO cross-checks licence status before processing any export certificate application.
WHO-GMP / Schedule M Compliance
The manufacturing facility must comply with Schedule M GMP for Indian market drugs. For regulated-market CoPP applications, WHO-GMP inspection or equivalent international GMP certification is typically required.
Drug Approved in India or Export-Specific
For Form 12AA, the drug must be approved for sale in India. For Form 12B (CFE), the drug can be manufactured specifically for export — not required to be approved in India — but must comply with the destination country's standards.
No Pending Enforcement Actions
No active show-cause notices, market recalls, or ongoing CDSCO enforcement actions against the manufacturer or the product. CDSCO checks the product's regulatory history before issuing export certificates.
Valid Drug Registration in India
The product must have a valid drug registration / new drug approval from CDSCO if the drug is a new drug under Indian law. Older drugs (approved before 2019) may be exempt from this requirement depending on category.
How to Obtain a Drug Export NOC / Certificate
Our 5-step process takes your export certificate application from eligibility check through CDSCO review to certificate issuance — with SUGAM portal management and proactive follow-up included.
We review your manufacturing licence status, product registrations, destination country requirements and determine the exact CDSCO certificate type needed — Form 12AA, CoPP, Form 12B or Dual-Use NOC. This prevents filing the wrong application type, which wastes time and fees.
Documents Required for Drug Export NOC
The document requirement varies by the certificate type. Select the tab for your specific export certificate or NOC type.
Drug Export NOC — Fees & Timelines
CDSCO charges fees per product and per certificate type. Below is an indicative guide — timelines depend on CDSCO workload and completeness of documents submitted.
| Certificate / NOC | Issuing Authority | Approx. Govt. Fee | Validity | Timeline | Form |
|---|---|---|---|---|---|
| Drug Export NOC | CDSCO — Central | ₹ 500 – ₹ 5,000 | Per shipment | 7–15 days | Form 12AA |
| Certificate of Pharma Product (CoPP) | CDSCO — Central | ₹ 2,000 – ₹ 10,000 | 1–2 years | 15–30 days | CoPP Form |
| Certificate for Export (CFE) | CDSCO — Central | ₹ 1,000 – ₹ 8,000 | Per shipment | 10–21 days | Form 12B |
| Dual-Use NOC | CDSCO — Central | ₹ 1,000 – ₹ 5,000 | Per shipment / Annual | 10–20 days | CDSCO Form |
| ADC NOC (Narcotics) | Narcotics Commissioner | ₹ 500 – ₹ 2,000 | Per shipment | 15–30 days | ADC Form |
| CoPP Renewal | CDSCO — Central | ₹ 1,000 – ₹ 5,000 | 1–2 years | 10–20 days | Renewal Form |
| Multi-Country NOC Package | CDSCO — Central | Combined fees | Varies | 15–45 days | Multiple |
Why Choose RegPath for Drug Export NOCs?
500+ drug export NOCs and certificates obtained for Indian pharmaceutical exporters across 80+ destination countries — from generic API exporters to finished formulation exporters targeting regulated markets.
Fastest Turnaround — As Low as 7 Days
Our pre-built Form 12AA / CoPP application templates, established CDSCO SUGAM relationships and complete document preparation consistently achieve NOC certificates faster than the standard CDSCO processing time.
80+ Country Requirements — All Covered
We know exactly what each destination country's health authority needs from CDSCO — whether it's a WHO-format CoPP, legalised/apostilled documents, specific product information formats or additional government attestation.
CoPP + WHO-GMP Coordination
For regulated-market exports (EU, USA, UK, Canada, Australia), we coordinate CoPP applications with WHO-GMP inspection scheduling, ensuring your CoPP and GMP certificate timelines align with your export requirements.
Bulk Export NOC Management
For pharmaceutical companies with high-volume exports to multiple countries, we provide subscription-based export NOC management — tracking, renewal, and batch-wise NOC filing with consolidated monthly reporting.
Drug Export NOC — FAQs
Common questions from Indian pharmaceutical exporters, API manufacturers and finished formulation companies about export NOCs and certificates from CDSCO.
Get Your Drug Export NOC
— Any Country, Fast
Book a free consultation. We'll determine the exact CDSCO certificate you need for your destination country and drug — at zero cost to you.