ABSTRACT
The Drugs & Cosmetic act is meant to regularize safety & quality of medical devices, which is applied to all medical devices, implemented from 1st April 2020. Earlier 37 medical devices were regulated/ notified in India. The present study focuses on the devices which require regulations but still lack the quality check points for scrutiny from Central Drug standard control organization (CDSCO), Delhi. Furthermore, it aims to provide quality checklist for two upcoming devices (Ventilator) which is neither categorized nor regulated by Central Drug standard control organization, Delhi. Since the medical devices aid in diagnosing, treatment and palliative care, it is essential to check the quality such that it matches with the International standards. Post covid-19 outbreak ventilators have come under surveillance and notified as medical devices. The present study monitors all parameters for regulation of the ventilator. The survey based quality & regulation standards for ventilator as medical devices has been incorporated in this study.
ABSTRACT
The central drugs standard control organization (CDSCO), Indian national regulatory authority under the Ministry of Health and Family Welfare have revised the clinical trial regulations in 2019 and there was a tremendous change in the approach for regulatory approvals due to the COVID-19 pandemic. A tremendous strain has been observed on the clinical research activities due to the COVID-19 pandemic which involves the redirection of resources and avoidance of personal meetings. Therefore, an urgent need of innovative solution was identified to enhance the overall performance clinical research during this pandemic. The innovative solutions include involvement of digital biomarkers, digital information consent form, digital health record and digital case report form. In the present study, impact of new drugs and clinical trials rules 2019 and COVID-19 pandemic on clinical trials applications received by CDSCO and evaluated by Subject Expert Committees (SEC) have been analyzed retrospectively. The author concluded that new drugs and clinical trials rules were enforced recently by the regulatory bodies to meet the requirement of emergency medical conditions. A large number of variations in the clinical trials application were observed in terms of the types of trial and the procedure after the implementation of new clinical trial rules.