This article is about Import License for Drugs and Cosmetics in India.

Import License:

Import of medical devices is regulated in India that any industry or an individual having license (wholesale and/or manufacturing license) issued under Central Drug Standard Control Organization (CDSCO), Drugs and Cosmetics Act, 1940 and Rules 1945 can import medical devices into India.

An applicant can submit an application for Registration Certificate (Form 41) and Import License (Form 10) together at the same time, on condition that Indian agent and importer remain same

Import of medical devices in India Requirements:

  • Form 41 (Registration Certificate) is required as per requirements of the Drugs & Cosmetic Act &
  • Wholesale Drug License in Form 20B & 21B
  • The firm must be registered with the CDSCO SUGAM Online System

Procedure for Obtaining Import License:

For obtaining an Import License in Form 10, an application in Form 8 and Form 9 is required. Since 1st April 2016, all applications should be made through the CDSCO’s SUGAM portal. For more information on the CDSCO’s Portal – Portal for Import License and Registration Certificate.

Rule 24 of the Drugs and Cosmetics Rules deals with the procedural requirements for obtaining an Import License.

  1. The application may be made either: By the Manufacturer himself having a valid wholesale license of Drugs under the Drugs and Cosmetics Rules, 1945, or
  2. By the Manufacturer’s agent in India either having a valid license under the Drugs and Cosmetics Rules, 1945 or having a valid wholesale License for sale or distribution of Drugs.
  3. In a power of attorney, the agreement by the Manufacturer to his Indian agent has to be documented and verified either in India before a First-Class Magistrate, or in the country of origin.
  4. The application for an Import License has to be followed by a copy of the Registration Certificate issued in Form 41 issued under Rule 27A.

Requirements for Grant of Import License: 

As per rule 25A of the Drugs and Cosmetics Rules, 1945, the following conditions must be complied by the applicant

  1. Whether the site, imported substances will be stored properly for maintaining the properties of the Drugs applies for import License.
  2. Where any such change in the constitution of the manufacturer site and/or address takes place, the current Registration Certificate is considered to be valid for a maximum period of 3 months from the date, in the mean time a fresh Registration Certificate will be issued from the licensing authority with the changed details.

Time period for Grant of Import license:

If the application is proper, within three months from the date of receipt of an application, the licensing authority will issue an import license in Form 10.

Validity of Import License:

As per the Drugs and Cosmetics Rules Import License shall be valid for a period of three years (Until Registration Certificate is valid). To know more about cosmetics read – Cosmetics Registration in India 

Renewal of Import License:

Applications for Import License should be submitted along with the application for renewal with importer and Indian Agent are remain same or minimum three months ahead of the expiry of the Import License.


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