Gel preparations designed to be used in human or veterinary medicine as a lubricant for parts of the body for surgical operations or physical examinations or as a coupling agent between the body and medical instruments

Medical gel preparations for surgical or examination use

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 3006 70 00 (gel preparations for surgical operations, physical examinations, or medical-instrument coupling) is subject to Central Drugs Standard Control Organisation (CDSCO) registration and import licensing under the Drugs and Cosmetics Act, 1940. Where the preparation is listed as a medical device under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW), compliance with the registration conditions notified therein is additionally required.

What this is

HSN code

3006 70 00

Chapter

30 · Pharmaceutical products

Primary regulator

CDSCO · Drugs and Cosmetics Act, 1940 (drug/medical-device import registration regime)

Customs documentation

Registration certificate from CDSCO
Import licence for drugs from CDSCO
Batch release certificate from CDSCO

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain a valid registration certificate for the drug or medical device (document code 101dc1) and an import licence for drugs (document code 9111dc) from the Central Drugs Standard Control Organisation before the bill of entry is filed. Both documents must be uploaded in e-Sanchit prior to customs out-of-charge.
CDSCO registration regime · document codes 101dc1, 9111dc · e-Sanchit mandatory upload per CCR
2
Upload the Certificate of Analysis (document code 0010dc), Batch Release Certificate (document code 0030dc), and Label of Consignment (document code 0110dc) in e-Sanchit at the bill of entry stage. The proper officer will verify all five mandatory documents before granting out-of-charge.
Document codes 0010dc, 0030dc, 0110dc · e-Sanchit mandatory upload per CCR
3
Where the gel preparation is classified as a medical device listed in G.S.R. 102(E) dated 11-02-2020, confirm compliance with the specific registration conditions issued by the Ministry of Health and Family Welfare. Non-compliance with those conditions constitutes a separate contravention independent of the drug-import licence.
G.S.R. 102(E) dated 11-02-2020 · Ministry of Health and Family Welfare notification

A word of counsel

The most common error on this tariff line is presenting a drug import licence (9111dc) without an accompanying product-specific registration certificate (101dc1), treating the two as interchangeable. They are separate instruments: the registration certificate is product- and manufacturer-specific, while the import licence covers the authorised importer. A consignment with one but not the other will be detained at the port of entry pending CDSCO rectification, accruing demurrage and ground rent with no assured resolution timeline.

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Frequently asked

Does HSN 3006 70 00 require BIS certification?

No, gel preparations for surgical or examination use fall outside the BIS Quality Control Order regime. Import is governed by the Central Drugs Standard Control Organisation under the Drugs and Cosmetics Act, 1940, with additional compliance obligations under G.S.R. 102(E) dated 11-02-2020 where the product qualifies as a medical device.

Which five documents must be uploaded in e-Sanchit before out-of-charge is granted?

The mandatory documents are: Certificate of Analysis (0010dc), Batch Release Certificate (0030dc), Label of Consignment (0110dc), Registration Certificate for Drugs (101dc1), and Import Licence for Drugs (9111dc); all five must be present in e-Sanchit before the proper officer issues out-of-charge.

Does the G.S.R. 102(E) medical-device notification apply to all gel preparations under this HSN?

Only those gel preparations that are listed as medical devices in G.S.R. 102(E) dated 11-02-2020 attract the additional MOHFW registration conditions; preparations used purely as coupling agents or lubricants and not so listed remain subject to the standard CDSCO drug-import registration and licensing requirements.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / MOHFW / Indian Customs CUSDATA.