Procedure for Import License for Examination, Test and Analysis

Deepti Mudgal

Deepti Mudgal

Published on: Mar 13, 2026

Shatakshi Sharma

Updated on: Mar 13, 2026

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INTRODUCTION

Import License for Examination, Test or Analysis of Drugs is a mandatory permit issued under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, authorising the import or manufacture of small quantities of drugs, medical devices, or in-vitro diagnostics for examination, research, or analysis. Such products are strictly prohibited from being used for commercial sale or distribution. It ensures products meet safety and quality standards before market entry.

Applicable Provisions

Rules: 34, 34, 35 of Drugs and Cosmetics Rules, 1945

Mandatory Requirements

1. Form 12: The formal application for the license must be submitted in Form 12 and must be signed or countersigned by the Head of the Institution or by a Proprietor/Director of the company or firm responsible for conducting the examination, test, or analysis.
2. T.R. 6 Challan: Payment must be made via a T.R. 6 Challan. The fee is Rs. 100 for the first product and fifty rupees (Rs. 50) for each additional product, regardless of dosage form or pack size.
3. Covering Letter: Must include the firm’s name/address, purpose of submission, a list of attachments, and the authorized signatory’s stamp.
4. Notarized Undertaking/Affidavit: Since the term “small quantity” is not clearly defined under Rule 33, the pplicant must provide a notarized undertaking or affidavit stating that the imported drugs will be used only for examination, test, or analysis and will not be used for commercial purposes.
5. DSIR Approval: If the applicant is a research or R&D institution, a valid recognition certificate from the Department of Scientific and Industrial Research may be required.
6. BE NOC (No Objection Certificate): If importing for Bioequivalence (BE) studies, submit the Bioequivalence (BE) protocol. If the drug is intended for Bioavailability/Bioequivalence (BA/BE) studies, the Bioequivalence (BE) NOC from CDSCO along with the study protocol must be submitted
7. Form 29: If drugs are to be manufactured in India for examination, test, or analysis, a licence in Form 29 must be obtained from the State Licensing Authority through an application in Form 30.
8. Testing Agreements: If using a third-party testing facility, provide a notarized agreement plan between your firm and the testing laboratory.

PROCEDURE

1. The applicant shall register and create a user account on the official CDSCO SUGAM platform.
2. The applicant shall make an application in Form 12 for a license for examination, test or analysis and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.
3. All supporting documents, including testing details, drug list, and premises proof, shall be uploaded to the portal.
4. Application in Form 12 shall be accompanied by a fee of one hundred (Rs 100) for a single drug and an additional fee of fifty rupees (Rs. 50) for each additional drug.
5. The CDSCO reviews the application and verifies documents and premises through inspection if required.
6. Once approved, the licensing authority issues Form 11, granting permission to import or manufacture drugs for testing or analysis.

As per Rule 33 of the Drugs and Cosmetics Rules, 1945, the following conditions are to be considered by the applicant, or else the license can be cancelled:

1. No drug shall be imported for any other commercial purpose.
2. The licence shall use the substances imported for the purpose of test analysis.
3. Drug Inspector authorised by the licensing authority will inspect the premises with or without prior notice.
4. The licence shall keep a record and report to the licensing authority.
5. Technical literature /package inserts of drugs.

RENEWAL

The Applicant shall make an application in Form 12 with T R 6 challan and documents as per the checklist for renewal of license for examination, test or analysis and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.

REJECTION

Application for grant of the test licence in Form 11 for Examination Testing and analysis cannot be considered in case of banned drugs, starting material, Herbal/agricultural products, excipients.

VALIDITY

The validity period of the Test License is 1 year from the date of its issue.