Timolo maleate

Timolol maleate, ophthalmic beta-blocker active pharmaceutical ingredient

CIB&RC CLEARANCE · NDPS CLEARANCE

HSN 2942 00 21 (Timolol maleate) is subject to Central Insecticides Board and Registration Committee (CIB&RC) registration and import permit under the Insecticides Act, 1968, where the substance figures in the Schedule to that Act, with import restricted to notified places under Rule 45 of the Insecticides Rules, 1971. The Narcotic Drugs and Psychotropic Substances (NDPS) regime applies for any scheduled substance imported under Chapter VII-A of the NDPS Rules, 1985, and mandatory Chapter 29 additional qualifiers under CBIC Circular 23/2023-Cus are required at the bill-of-entry stage.

What this is

HSN code

2942 00 21

Chapter

29 · Organic chemicals

Primary regulator

CIB&RC · Insecticides Act, 1968 and Insecticides Rules, 1971

Customs documentation

Registration certificate from CIB&RC
Import permit from CIB&RC
Chapter 29 qualifiers from CBIC

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
If the consignment falls within the Schedule to the Insecticides Act, 1968, obtain registration and an import permit from the Secretariat of the Central Insecticides Board and Registration Committee before dispatch. Ensure the consignment arrives only at a notified place of import as prescribed under Rule 45 of the Insecticides Rules, 1971.
Insecticides Act, 1968 · Rule 45 of the Insecticides Rules, 1971 · ITC (HS) policy condition 2 to Chapter 29
2
Upload the mandatory e-Sanchit documents before the bill of entry is given out-of-charge: Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc). For any NDPS-scheduled substance, an import certificate under Rule 53 of the NDPS Rules, 1985 is additionally required.
NDPS Rules, 1985, Rule 53 · ITC (HS) policy condition 2 to Chapter 29 · CCR document codes 0010dc, 0030dc, 0110dc, 101dc1, 9111dc
3
Comply with CBIC Circular 23/2023-Cus dated 30-09-2023 by including the mandatory additional qualifiers in the import declaration for all goods under Chapter 29, as stipulated in Paragraphs 4.1 and 4.2, with effect from 15 October 2023. Non-compliance triggers assessment scrutiny and may result in consignment detention.
CBIC Circular 23/2023-Cus dated 30-09-2023, Paragraphs 4.1 and 4.2

A word of counsel

The most common error on this tariff line is assuming that drug-channel document codes (101dc1, 9111dc) alone satisfy customs clearance without verifying whether the substance also attracts CIB&RC registration as an insecticide or NDPS import-certificate requirements as a scheduled psychotropic substance. Timolol maleate can present across multiple regulatory tracks simultaneously; a single missing clearance — particularly the NDPS import certificate under Rule 53 or the CIB&RC permit — results in consignment detention and potential seizure regardless of the completeness of the pharmaceutical regulatory record.

Need a regulatory steer on this product?

Speak to a regulatory counsel about your specific HSN, IS, and supplier situation.

Speak to an Expert

Frequently asked

Does HSN 2942 00 21 require BIS certification?

No, no BIS Quality Control Order covers this tariff line. Import of Timolol maleate is governed by the Central Insecticides Board and Registration Committee under the Insecticides Act, 1968, with an NDPS overlay under the NDPS Rules, 1985 for any scheduled substance, and CBIC Chapter 29 qualifier requirements.

Which document codes must be uploaded in e-Sanchit for this HSN?

The mandatory documents are Certificate of Analysis — Drug (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate — Drugs (101dc1), and Import Licence for Drugs (9111dc); all must be uploaded before out-of-charge is granted.

When does the NDPS import certificate requirement apply to this consignment?

Where Timolol maleate or a co-formulated substance is scheduled under the NDPS Act, import for medical and scientific purposes is permitted only after obtaining an import certificate under Rule 53 of the NDPS Rules, 1985; imports outside that category are governed by Appendix-I to the ITC (HS) Schedule under policy condition 2 to Chapter 29.

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