|•Evolving Clinical Development Regulatory Framework in India|
India is emerging as a country with tremendous potential to contribute to the national and international clinical trial platforms. The Central Drugs Standard Control Organization (CDSCO) is the national regulatory authority of India managed by the Drug Controller General of India (DCGI). The DCGI is responsible for the coordination of inspections of the sponsors, manufacturing units, as well as the trail sites.
Early Years in Clinical Development:-
In 2000, the Indian Council of Medical...
•Challenges in Biosimilars Development
With patents expiring for many successful biologic drugs, researchers are focusing on developing drugs that are competitive in pricing and affordable to patients who require critical medications for managing chronic diseases.
A biosimilars medicinal product is a replica of the innovator medicinal product with similar safety and efficacy profiles .1,2. Some of the popular biosimilars studies are monoclonal antibodies for cancer therapeutics, erythropoietin, insulin, interferon, granulocyte...