Draft Medical Devices Bill:
The Union Health Ministry released a draft of the proposed Drugs Medical Devices and Cosmetics Bill, 2022 which would replace the existing Drugs and Cosmetics Act,1940, and other several rules.
- It focuses on creating a separate regulation for medical devices, which makes provision for fines and imprisonment for injury and death related to clinical trials or investigations and seeks to regulate e-pharmacies.
- The medical device industry is a unique blend of engineering and medicine. It involves the creation of machines that are used to support life within the human body.
- Medical devices include Surgical Equipment, Diagnostic equipment like Cardiac imaging, CT scans, X-ray, Molecular Imaging, MRI and Ultrasound-imaging including hand – held devices, Life Support equipment like ventilator, etc. as well as Implants and Disposables.
Highlights of the Draft Bill:
- Provisions for the Clinical Trials and Investigations:
- Compensation to Heir: It makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices.
- The draft also lays the onus on providing medical management for any injury arising due to the trial of the investigators.
- Penalty & Fines: Provision for imprisonment, and fines amounting to double the compensation amount if the compensation is not paid.
- Prohibition of Clinical Trials: It prohibits clinical trials or clinical investigations of drugs and medical devices without permission from the central licensing authority.
- It provides for debarring the investigators and sponsors of a trial or investigation if the laid-down provisions are not followed.
- Medical Devices Technical Advisory Board: The draft bill provides for the creation of a Medical Devices Technical Advisory Board on the lines of the existing drugs technical advisory board, with people who have technical knowledge of the engineering of these devices, and members of the industry.
- Other than officials of the Health Ministry, the board will have officials from the Department of Atomic Energy, Department of Science and Technology, Ministry of Electronics and Information Technology, Defense Research and Development Organization, and experts from the fields of Biomedical Technology, Biomaterials, and Polymer Technology.