India: Import License for Custom Clearance

ARQon
May 6, 2022
2 min read

The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India released a gazette draft notification, G.S.R. 23(E)., on 18 January 2022 about the cancellation or suspension of import license used during custom clearance.

The rules enforce the circumstance and process in which the MOH has the authority to cancel or suspend an Import License in India. As per G.S.R. 23(E)., the following of certain rules further to amend the Medical Device Rules, 2017, is hereby given that the said draft rules shall be taken into consideration of after the forty-five days expiry period from 18 January 2022. This draft is released with the consideration of the wider public views.

Before this draft notification, there were no existing rules which explicitly explains the cancellation or suspension of the import license in any cases of violation by the license holder while such conditions are included within the manufacturing license in the MDR 2017. With the new Rule 43A being proposed, after Rule 43 – Import of medical device for personal use, the CDSCO is improving on the MDR 2017.

Interpretation

According to the latest draft notification, if the license holder/manufacturer fails to obey the conditions or any provisions of the rules stated, the Central Licensing Authority (CLA) has the authority to cancel the license issued to them or suspend it for a duration in which they deem fit. However, the CLA will also give them the opportunity to clarify on their reasons of cause in which an appeal to reason with them. In a worse case scenario, the termination of license will lead to stoppage of import, sale, or distribution of the said medical device or even the destruction of medical device stocks.

Provided that the person wishes to appeal to the CLA and the Central Government, they can do so within thirty days of the serving of the order.

The draft notification covers the following license:

Form Form MD-15- License to Import Medical Device
Form MD-17- License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training
Form MD-19- License to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients
Form MD-21- Permission to import of small quantity of medical devices for personal use

Sources:

Central Drugs Standard Control Organization (Gazette Notifications)