Is a Narcotics License mandatory for exporting cough syrups containing codeine?

Yes, absolutely. Any pharmaceutical formulation containing Schedule I, II, III, or IV narcotic drugs (including codeine-based syrups) requires a valid Narcotics License from the NCB before the DGFT will authorize export. Operating without it is a criminal offense under NDPS Act Section 23.

Can I export narcotic substances if I have only a CDSCO certificate and no Narcotics License?

No. CDSCO certification covers manufacturing quality and safety standards but does not authorize handling of narcotic substances. The Narcotics License is a separate mandatory authorization from the NCB. The DGFT will reject export applications unless both the CDSCO/state drug license and the Narcotics License are submitted.

What happens if NCB inspection finds my storage facility non-compliant?

The application is rejected, and you are given 60 days to remediate deficiencies (upgrade locks, install surveillance, etc.). Resubmit with updated facility photographs and re-inspection documentation. If deficiencies are serious, the application may be permanently rejected, and regulatory action may follow.

Can the Narcotics License be transferred to another entity or location?

No, the Narcotics License is non-transferable and location-specific. If you relocate your facility or change ownership, a new application must be filed with the NCB. The old license is cancelled, and a fresh inspection of the new facility is mandatory before issuance.

How often must I report to the NCB after obtaining the Narcotics License?

You must submit quarterly inventory returns to the NCB detailing receipts, consumption, and closing stock of all controlled substances. The Responsible Person must file monthly reports in some states. Additionally, any loss, theft, or significant deviation from forecasts must be reported within 24 hours. Annual audits by NCB are also mandatory.

Narcotics License

Obtain NCB Narcotics License for exporting pharmaceutical products with controlled substances. Process, eligibility, documents & compliance guide for Indian EXIM traders.

Verify IEC and drug manufacturing/trading license from state authority; prepare Form NCB-1 and supporting documentation
Submit application package to NCB regional office in your jurisdiction with organized filing and checklist verification
Facilitate on-site NCB inspection of storage facilities, security systems, and Responsible Person qualifications (15-30 days)
Receive NCB approval letter and Narcotics License specifying authorized substances and stock limits
Present Narcotics License to DGFT when applying for export authorization; maintain compliance through quarterly reporting

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What is Narcotics License?

A Narcotics License is a mandatory authorization issued by the Narcotics Control Bureau (NCB) under the Ministry of Home Affairs to entities engaged in the manufacture, possession, import, export, or trade of narcotic drugs and psychotropic substances in India. This license regulates controlled substances listed under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, ensuring compliance with international drug control treaties and domestic statutory requirements.

The license operates within the framework of the NDPS Act and its rules, specifically the Narcotic Drugs and Psychotropic Substances Rules, 1985. It applies to pharmaceutical manufacturers exporting medicinal products containing controlled substances, research institutions, and chemical manufacturers supplying precursor chemicals. The NCB maintains strict oversight to prevent diversion of licensed substances to illicit channels.

Pricing

Package	Price	Details
Standard	On request	Including document prep

Process

📋
Verify IEC and drug manufacturing/trading license from state authority; prepare Form NCB-1 and supporting documentation
🔍
Submit application package to NCB regional office in your jurisdiction with organized filing and checklist verification
📝
Facilitate on-site NCB inspection of storage facilities, security systems, and Responsible Person qualifications (15-30 days)
✅
Receive NCB approval letter and Narcotics License specifying authorized substances and stock limits
📤
Present Narcotics License to DGFT when applying for export authorization; maintain compliance through quarterly reporting

Documents Required

Form NCB-1 (Narcotics License Application Form) completed and signed
Valid IEC (Importer-Exporter Code) certificate issued by DGFT
Drug manufacturing or trading license from State Drug Controller or state pharmacy licensing authority
Business registration/incorporation documents (Memorandum of Association, Partnership Deed, or sole proprietorship proof)
Storage facility blueprint/layout plan with security specifications (locks, vaults, surveillance systems, fire safety)
Curriculum vitae and qualification proof of Responsible Person (pharmacist/chemist with 2+ years narcotics experience)
List of narcotic substances to be handled with intended quarterly usage/manufacturing quantities and forecasts
Board resolution (for companies) authorizing narcotics license application and appointing Responsible Person
No-criminal-history affidavit and undertaking to comply with NDPS Act rules and NCB regulations
Proof of financial solvency (bank statements, audited financial statements for preceding 2 years)

Frequently Asked Questions

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Narcotics License

Obtain NCB Narcotics License for exporting pharmaceutical products with controlled substances. Process, eligibility, documents & compliance guide for Indian EXIM traders.

Verify IEC and drug manufacturing/trading license from state authority; prepare Form NCB-1 and supporting documentation

Submit application package to NCB regional office in your jurisdiction with organized filing and checklist verification

Facilitate on-site NCB inspection of storage facilities, security systems, and Responsible Person qualifications (15-30 days)

Receive NCB approval letter and Narcotics License specifying authorized substances and stock limits

Present Narcotics License to DGFT when applying for export authorization; maintain compliance through quarterly reporting

Google VerifiedBusiness

500+Export Clients Served

End-to-EndEXIM Support

What is Narcotics License?

Package

Price

Details

Standard

On request

Including document prep

Process

📋

Verify IEC and drug manufacturing/trading license from state authority; prepare Form NCB-1 and supporting documentation

🔍

Submit application package to NCB regional office in your jurisdiction with organized filing and checklist verification

📝

Facilitate on-site NCB inspection of storage facilities, security systems, and Responsible Person qualifications (15-30 days)

✅

Receive NCB approval letter and Narcotics License specifying authorized substances and stock limits

📤

Present Narcotics License to DGFT when applying for export authorization; maintain compliance through quarterly reporting

Documents Required

Form NCB-1 (Narcotics License Application Form) completed and signed

Valid IEC (Importer-Exporter Code) certificate issued by DGFT

Drug manufacturing or trading license from State Drug Controller or state pharmacy licensing authority

Business registration/incorporation documents (Memorandum of Association, Partnership Deed, or sole proprietorship proof)

Storage facility blueprint/layout plan with security specifications (locks, vaults, surveillance systems, fire safety)

Curriculum vitae and qualification proof of Responsible Person (pharmacist/chemist with 2+ years narcotics experience)

List of narcotic substances to be handled with intended quarterly usage/manufacturing quantities and forecasts

Board resolution (for companies) authorizing narcotics license application and appointing Responsible Person

No-criminal-history affidavit and undertaking to comply with NDPS Act rules and NCB regulations

Proof of financial solvency (bank statements, audited financial statements for preceding 2 years)

Frequently Asked Questions