The Ministry of Health and Family Welfare on 18th January 2022 has notified the Medical Devices (Draft Amendment) Rules, 2021 to further amend the Medical Device Rules, 2017.
Through this amendment a new rule 43A which deals with suspension and cancellation of license has been inserted as follows:
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.”
The Ministry has invited Objections/suggestions from the public on the above draft rules, which shall be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at drugsdiv-mohfw@gov.in.
