The government will soon make it mandatory for all firms involved in clinical research to maintain minimum quality standards and register themselves with the country’s drug regulator.
Once the law is implemented, the names of all the approved Clinical Research Organisations (CROs) in the country will be uploaded on the website of Drug Controller General of India (DCGI). A violation of the norms could lead to the firm being barred from conducting clinical studies in India.
Several inspectors at the DCGI have been trained by the US Foods and Drug Administration to audit CROs. The country’s highest technical body on medicines, Drug Technical Advisory Board, has approved an amendment to the Drugs and Cosmetics Act to make CRO registrations compulsory.
Industry experts believe that this will regulate the entire clinical protocols, ethical norms and other practices. At present, there are 40-50 CROs in the country, a number that is increasing steadily. All these provide research services to drug companies in developing medicines, especially the clinical trials.
No comments:
Post a Comment