Drug Regulation India Takes Bold Steps in Inspections for Medical Devices and CROs
Drug Regulation India Expands Inspections
India's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has broadened its scope of surprise audits, now including medical devices, contract research organisations (CROs), and drug testing private laboratories. This expansion follows the success of risk-based inspections in the pharmaceutical sector, designed to enhance compliance and quality.
Implementation of Risk-Based Inspections
The CDSCO's inspections, known as Risk Based Inspections (RBIs), target firms manufacturing medical devices and conducting drug tests across India. Over 400 pharma companies have been audited in the past two years, leading to a decrease in complaints and sub-standard products.
- Focus on medical device firms and CROs
- Inspections undertaken by qualified experts
- Emphasis on data integrity and compliance
Rajiv Nath from the Association of Indian Medical Device Industry (AiMeD) highlights the need for such audits to include foreign manufacturers, due to the high volume of import licenses.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.