India’s MOH Issues New Draft Guidance for Suspending or Cancelling an Import License

Draft Covers Process for Cancelling an Import License

The Department of Health and Family Welfare has issued the DRAFT NOTIFICATION on 18 January 2022 announcing the provisions and process under which the MOH could cancel or suspend an Import License in India. Per G.S.R. 23(E)., the following draft of certain rules further to amend the Medical Device Rules, 2017, is hereby published for information of all persons likely to be affected thereby and notice is given that the said draft rules shall be taken into consideration or after the expiry of a period of forty-five days from the date of publication, i.e. 18 January 2022. Draft is being released for wider stakeholder consideration.

Prior to this draft notification, there was no explicit rule providing clarity about the cancellation or suspension regarding the import License in case of any violation of the conditions by the license holder while such provisions were included for a manufacturing license in the MDR 2017.

New Rule 43A is proposed to be inserted after the current Rule 43 – Import of medical device for personal use.

43A. Suspension and cancellation of license. — (1) If the manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules, the Central Licensing Authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a license issued under rules, or suspend it for such period as it thinks fit either wholly or in respect of any of the part of medical device to which it relates or direct the licensee to stop import, sale or distribution of the said medical device and, thereupon, order the destruction of medical device and the stock thereof in presence of officer authorized by Central Licensing Authority, if in its opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or Rules made thereunder:

Provided that a person who is aggrieved by the order passed by the Central Licensing Authority under this rule may, within thirty days of the serving of the order, may file appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for hearing, pass such order as it thinks fit.”

Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed to drugsdiv-mohfw@gov.in. Last date to submit feedback is 4^th March 2022.

Asia Actual’s Interpretation

As per the current draft notification, if the manufacturer or licensee fails to comply with the conditions of the import license or any provisions of the Act and the MDR 2017, the Central Licensing Authority (CLA) may cancel or suspend the license and import of such medical devices.

This draft notification will have coverage over the following import licenses –

• 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

Draft notification can be found here.

Proposed Process for Cancelling an Import License

The CLA may give an opportunity to the Licensee to explain in writing the reason for not following the conditions. If CLA is not satisfied with the reasons provided by the Licensee, then they may ask to stop the import sale or distribution of the said medical device or may ask to destroy the medical device in presence of officer authorized by Central Licensing Authority. The aggrieved party may within a period of thirty days of passing the order by the CLA, file an appeal to the Central Government and after enquiry, the CLA may pass the suitable order.