Amitryptyline HCl

Amitriptyline hydrochloride, tricyclic antidepressant active pharmaceutical ingredient

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2942 00 25 (Amitriptyline HCl) is subject to drug-import controls under the Drugs and Cosmetics Act, 1940, with mandatory registration certificate and import licence documents verified at the bill of entry through e-Sanchit. The Narcotic Drugs and Psychotropic Substances (NDPS) regime under Chapter VII-A of the NDPS Rules, 1985 applies as a concurrent overlay, requiring an import certificate under Rule 53 where the substance is scheduled. Central Board of Indirect Taxes and Customs (CBIC) Circular 23/2023-Cus and the ITC (HS) Restricted-import policy under Chapter 29 condition no. 2 administered by the Directorate General of Foreign Trade (DGFT) apply as additional clearance requirements.

What this is

HSN code

2942 00 25

Chapter

29 · Organic chemicals

Primary regulator

CDSCO/Drugs · Drugs and Cosmetics Act, 1940 (drug import licence and registration)

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Import certificate from NDPS

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, ensure the registration certificate (drugs) (document code 101dc1) and import licence for drugs (document code 9111dc) are current and uploaded in e-Sanchit. Also upload the certificate of analysis — drug (document code 0010dc), batch release certificate (document code 0030dc), and label of consignment (document code 0110dc); out-of-charge will be withheld until all five documents are verified.
e-Sanchit document codes 101dc1, 9111dc, 0010dc, 0030dc, 0110dc · Drugs and Cosmetics Act, 1940
2
If the consignment is imported for medical or scientific purposes and Amitriptyline HCl is scheduled under the NDPS Act, obtain an import certificate under Rule 53 of the NDPS Rules, 1985 before shipment. Imports not falling within the medical/scientific category are governed by Appendix-I to the ITC (HS) Schedule per ITC (HS) policy condition no. 2 of Chapter 29.
Rule 53 of the NDPS Rules, 1985 · Chapter VII-A of the NDPS Rules, 1985 · ITC (HS) policy condition no. 2, Chapter 29
3
Comply with CBIC Circular 23/2023-Cus dated 30-09-2023 by including mandatory additional qualifiers in the import declaration for Chapter 29 commodities as stipulated in paragraphs 4.1 and 4.2, effective 15 October 2023. Verify also whether the consignment quantity triggers the Public Liability Insurance Act, 1991 insurance obligation per S.O. 227(E) dated 24-03-1992.
CBIC Circular 23/2023-Cus dated 30-09-2023 · S.O. 227(E) dated 24-03-1992 · PLI Act, 1991

A word of counsel

The most common error on this tariff line is treating the drug-import documentation bundle as exhaustive and overlooking the independent NDPS import-certificate requirement: the two regimes operate in parallel, and a consignment cleared under the drug-import licence alone — without the Rule 53 NDPS import certificate where the substance is scheduled — remains liable to detention and seizure under the NDPS Act, 1985. Additionally, the Chapter 29 mandatory qualifiers under CBIC Circular 23/2023-Cus are a bill-of-entry-level declaration requirement entirely separate from the PGA documents and omission draws a CBIC show-cause notice independent of PGA clearance status.

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Frequently asked

Does HSN 2942 00 25 require BIS certification?

No, Amitriptyline HCl is not subject to any BIS Quality Control Order. Import is governed by drug-import licensing under the Drugs and Cosmetics Act, 1940, with a concurrent NDPS import-certificate requirement under Rule 53 of the NDPS Rules, 1985 and the ITC (HS) Restricted-import overlay administered by DGFT under Chapter 29 policy condition no. 2.

Which e-Sanchit document codes are mandatory at the bill of entry for this tariff line?

Five documents must be uploaded: certificate of analysis — drug (0010dc), batch release certificate (0030dc), label of consignment (0110dc), registration certificate for drugs (101dc1), and import licence for drugs (9111dc); out-of-charge is withheld until all are verified by the proper officer.

Does the CIB&RC insecticide-registration requirement apply to Amitriptyline HCl?

The Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit under Rule 45 of the Insecticides Rules, 1971 applies only if the specific substance or formulation figures in the Schedule to the Insecticides Act, 1968; importers should verify the Schedule before shipment and obtain CIB&RC clearance if the substance is listed.

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