NDPS Licence in India: Manufacture, Import and Export Permissions
An NDPS licence is the permission the law requires before you manufacture, import or export narcotic drugs or psychotropic substances for medicine and science. Depending on the activity, the Narcotics Commissioner or the State Drugs Controller grants it. We prepare the file and follow it through.
What it is
The Narcotic Drugs and Psychotropic Substances Act, 1985 bars the production, manufacture, possession, sale, transport, import and export of these substances, except for medical or scientific purposes and as the Act, its Rules and licence conditions allow. An NDPS licence is that permission in practice. Think of a Faridabad formulation unit that has just added a psychotropic tablet to its range. Its drug licence alone no longer covers what it makes.
There is no single licence. The Narcotics Commissioner licenses the manufacture of synthetic narcotic drugs under Rule 37 of the NDPS Rules, 1985. Psychotropic substances are manufactured under a licence from the State Drugs Controller under the Drugs and Cosmetics Rules, 1945, with registration under Rule 65. The Rules are amended from time to time, so we check the current text before filing. Imports and exports need a consignment-wise certificate or authorisation from the Narcotics Commissioner.
Who it applies to
Manufacturers of narcotic drugs
Pharmaceutical units that make synthetic narcotic drugs need a licence under Rule 37 of the NDPS Rules, in addition to their drug manufacturing licence. See our manufacturing drug licence page for the drug side.
Makers of psychotropic substances
Units whose products contain psychotropic substances need a manufacturing licence from the State Drugs Controller and have to register with the Narcotics Commissioner.
Importers and exporters
A company bringing in raw material or shipping finished formulations needs an import certificate or export authorisation for each consignment.
Why it matters
Legal clearance for the product line
Without the licence, a plant has no lawful basis to produce or move a narcotic or psychotropic formulation, whatever its Schedule M standing.
Cleaner customs and transport
Consignments move with the import certificate, export authorisation and consignment notes the Rules prescribe. Papers that match the licence mean fewer holds at ports.
Lower risk of suspension
The Rules allow licences to be suspended or cancelled for breach of conditions. Timely returns and accurate records keep that risk away.
Documents required
Entity and site
- Certificate of incorporation or partnership deed
- Proof of premises and site plan
- Existing drug manufacturing licence (Form 25 or Form 28)
- Pollution control board consent where applicable
Product and quota
- List of narcotic or psychotropic drugs with composition
- Quantity requirement and quota or allotment papers where applicable
- Technical staff details
- Storage and security arrangements
For import or export
- Importer or exporter code and GST registration
- Order, invoice or contract with the overseas party
- State excise permit where the Rules ask for one
- Draft import certificate or export authorisation application
Which authority grants what
| Activity | Authority | What you receive |
|---|---|---|
| Manufacture of synthetic narcotic drugs | Narcotics Commissioner (Rule 37) | Licence; government fee ₹5,000 under Rule 38 |
| Manufacture of psychotropic substances | State Drugs Controller (Rule 64) | Licence under the Drugs and Cosmetics Rules, plus registration with the Narcotics Commissioner under Rule 65 |
| Import | Narcotics Commissioner (Rule 55) | Import certificate on Form No. 4 or 4A; fee ₹1,000 per certificate |
| Export | Narcotics Commissioner (Rule 59) | Export authorisation for each consignment |
Import and export of the substances listed in Schedule I to the NDPS Rules is prohibited, and the export of certain psychotropic substances to specified countries is not permitted. We check your product against these lists before filing anything.
How it works
Map the activity to the right authority
We list what you will do, whether manufacture, import or export, and which substances are involved. Here is the catch: one company can need all three permissions. That decides whether the file goes to the Narcotics Commissioner, the State Drugs Controller or both.
Prepare the application set
We draft the application with the site, staff, product and quantity details, and match the papers to your existing drug licence.
File and answer queries
We file with the right authority, reply to queries and coordinate any inspection. The Narcotics Commissioner decides licence and import applications within the time the Rules set.
Set up records and returns
After grant, we help you keep the accounts and file the returns the Rules require, including quarterly returns for psychotropic substances.
Timelines
Manufacture licence
Rule 38 of the NDPS Rules provides for issue within thirty working days of receipt of the application. A drug manufacturing licence must also be in place before production begins.
Import certificate
Rule 56 sets twenty-one working days for the Narcotics Commissioner to issue or refuse, from an application complete in all respects. A fresh certificate is needed for every consignment.
Quarterly returns
For psychotropic substances, Rule 65 requires a return for each quarter before the last day of the month that follows it. Diarise all four. Missing one is the commonest slip.
What happens if you get it wrong
Prosecution under the Act
Contravention involving manufactured drugs falls under Section 21 of the NDPS Act. Punishment rises with quantity: up to one year for a small quantity, up to ten years in between, and ten to twenty years for a commercial quantity.
Licence suspension or cancellation
Rule 48 allows suspension or cancellation for breach of licence conditions, transfer without approval or a conviction under narcotics law, after giving you a reasonable opportunity to be heard.
Revocation for missed returns
Under Rule 65, failure to file quarterly returns can lead to notice of revocation of the registration. An appeal against an order lies within 30 days under Rule 49.
Frequently asked questions
What is an NDPS licence?
It is the permission under the NDPS Act, 1985 and the NDPS Rules, 1985 to manufacture, import or export narcotic drugs or psychotropic substances for medical or scientific use. There is no single licence; the authority depends on the activity. We prepare the file for the right authority and follow it up.
Who issues the NDPS manufacturing licence?
For synthetic narcotic drugs, the Narcotics Commissioner issues the licence under Rule 37, with a government fee of ₹5,000 under Rule 38. For psychotropic substances, the State Drugs Controller issues a licence under the Drugs and Cosmetics Rules, and the unit registers with the Narcotics Commissioner. We handle both filings.
How long does the Narcotics Commissioner take?
Rule 38 provides for licence issue within thirty working days of receiving the application, and Rule 56 allows twenty-one working days for an import certificate. These periods run from a complete application, so missing papers pause the clock. We check completeness before filing so queries stay few.
Do I need an import certificate for each shipment?
Yes. A separate import certificate on Form No. 4 or 4A is required for each consignment, with a fee of ₹1,000 under Rule 55. Exports need a separate export authorisation for each consignment too. We prepare and track each application so shipments are not held at the port.
Can I import or export any NDPS substance?
No. Import and export of substances listed in Schedule I to the NDPS Rules is prohibited, and some psychotropic substances cannot be exported to certain countries listed in Schedule II. Always check the substance first. We screen your product against the schedules before any application goes in.
Is a drug manufacturing licence enough for narcotic drugs?
No. Rule 37 requires a separate NDPS licence from the Narcotics Commissioner on top of your drug manufacturing licence, and Rule 39 expects both to be in place before manufacture begins. Keep the two licences aligned on products and site. We prepare them together to avoid mismatches.
What records and returns are required?
Licensees must keep true accounts of every transaction and furnish returns in the forms prescribed, and officers can inspect stocks and records under Rule 47. Psychotropic substance units also file quarterly returns under Rule 65. We set up the formats and a calendar of due dates.
Will Taxhint represent me in a criminal case?
No. Taxhint prepares applications and records and coordinates with the authority. If a case or a notice leads to court, a practising advocate appears and signs the pleadings, and we can organise the documents for that advocate. We keep the licensing side clean to avoid that situation.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Ready to begin?
Tell us the substance, the activity and your existing licences, and we will map the NDPS permissions you actually need.