Procedure for Importing Small Quantities of Drugs by a Government Hospital or Autonomous Medical Institution

Deepti Mudgal

Deepti Mudgal

Published on: Mar 30, 2026

Shatakshi Sharma

Updated on: Mar 30, 2026

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Introduction

The import of Small Quantities of Drugs by a Government Hospital or Autonomous Medical Institution is required, as it has a specific streamlined regulatory provision for importing small quantities of new drugs to treat patients with life-threatening conditions, disabilities, or unmet medical needs.

APPLICABLE PROVISIONS

Rule 33A, 34A of Drug Rules,1945

DOCUMENTS REQUIRED

1. Completed Form 12AA: Duly filled and signed by the authorized representative.
2. ID proofs
3. Fee Challan: Original challan showing payment to the government under the specified account head (0210-Medical and Public Health).
4. Hospital/Institution Details: Name, designation, and seal/stamp of the applicant and institution.
5. Undertaking: A declaration to follow the Drugs & Cosmetics Act.
6. Drug Details: List of new drugs, their quantity, and the disease for treatment.

PROCEDURE

Medical Officer of the Government Hospital or Autonomous Medical Institution shall make an application for an import licence for small quantities of a new drug, for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, in Form 12 AA, certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, accompanied by a fee of six hundred rupees (Rs. 600) for a single drug and an additional fee of three hundred rupees (Rs. 300) for each additional drug.

RENEWAL

Applicant shall submit a fresh application in Form 12AA for further import of small quantities of new drugs is required for treatment of patients as per the conditions of the original licence through the CDSCO SUGAM portal along with the prescribed fee of six hundred rupees (Rs. 600) for a single drug and an additional fee of three hundred rupees (Rs. 300) for each additional drug and the required documents.