Tilidine (INN) and its salts

Tilidine and its salts, opioid analgesic compound

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2922 44 00 (Tilidine (INN) and its salts) is governed by the Narcotic Drugs and Psychotropic Substances (NDPS) regime under Chapter VII-A of the NDPS Rules, 1985, requiring an import certificate under Rule 53 before any consignment may be cleared. Items falling within the schedule to the Insecticides Act, 1968 additionally require registration and an import permit from the Central Insecticides Board and Registration Committee (CIB&RC) under Rule 45 of the Insecticides Rules, 1971; the tariff line is Restricted under the ITC (HS) import policy administered by the Directorate General of Foreign Trade (DGFT).

What this is

HSN code

2922 44 00

Chapter

29 · Organic chemicals

Primary regulator

NDPS · NDPS Rules, 1985 (Chapter VII-A, Rule 53 import certificate)

Customs documentation

Import certificate from NDPS
Registration certificate from CIB&RC
Import permit from CIB&RC

Applicable Partner Government Agencies

CIB&RCCIB&RC·Central Insecticides Board and Registration Committee

NDPSNDPS·Narcotics Control Bureau

Procedural directions for customs clearance are issued by: Directorate General of Foreign Trade, Central Board of Indirect Taxes and Customs.

Compliance steps

1
Before filing the bill of entry, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 from the Central Bureau of Narcotics (cbn.nic.in) covering the specific quantity and purpose. Import for medical and scientific purposes is permitted under the special provisions of Chapter VII-A of the NDPS Rules; all other imports are governed by Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition 2 of Chapter 29.
NDPS Rules, 1985 · Rule 53 · Chapter VII-A · ITC (HS) policy condition 2 to Chapter 29
2
If the consignment falls within the schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of CIB&RC before dispatch. Import is permitted only at ports notified under Rule 45 of the Insecticides Rules, 1971; deviation to an unnotified port renders the consignment liable to seizure.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971
3
Upload all mandatory documents in e-Sanchit before out-of-charge: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc). Ensure the bill of entry carries the additional Chapter 29 qualifiers mandated under paragraphs 4.1 and 4.2 of CBIC Circular 23/2023-Cus dated 30-09-2023, applicable with effect from 15-10-2023.
CBIC Circular 23/2023-Cus dated 30-09-2023 · document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc

A word of counsel

The most common error on this tariff line is assuming that a valid NDPS import certificate under Rule 53 discharges all regulatory obligations, while overlooking the parallel CIB&RC registration and permit requirement where the substance is also scheduled under the Insecticides Act, 1968. Both regimes operate independently: an NDPS-compliant consignment without CIB&RC clearance will be detained at the notified port, and the converse is equally true. The Public Liability Insurance requirement under S.O. 227(E) dated 24-03-1992 must also be confirmed before import of specified hazardous substances exceeding threshold quantities.

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Frequently asked

Does HSN 2922 44 00 require BIS certification?

No. No BIS Quality Control Order covers tilidine or its salts. Import is governed by the NDPS Rules, 1985 — requiring an import certificate under Rule 53 from the Central Bureau of Narcotics for medical and scientific use — with a parallel CIB&RC registration and permit obligation where the substance is scheduled under the Insecticides Act, 1968.

Are all five e-Sanchit document codes mandatory at the bill of entry?

Yes. The certificate of analysis (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc) must all be uploaded in e-Sanchit before customs out-of-charge; a missing document code triggers detention of the consignment regardless of physical NDPS or CIB&RC clearances.

What happens if imports of tilidine are not for medical or scientific purposes?

Imports outside the Chapter VII-A medical and scientific purpose category are governed by Appendix-I to the ITC (HS) Schedule under ITC (HS) policy condition 2 of Chapter 29, and unauthorised import of an NDPS-scheduled substance attracts confiscation and criminal liability under the Narcotic Drugs and Psychotropic Substances Act, 1985.

Last verified against gazette notifications: 2026-05-16. Source: CIB&RC / NDPS / DGFT / CBIC / Indian Customs CUSDATA.