In the recent past, India has been engaged in improving the overall drug regulatory environment. Not long back, clinical trial regulation has been strengthened in the country. India added 12 new Drug Advisory Committees (NDACs) and six Medical Device Advisory Committees (MDACs) to evaluate clinical trial proposals.

By the way, India is not the only country engaged in effecting regulatory improvement in the Asia Pacific region. China, too, is laboring over it, as is another leading country in the region - Australia. In Australia, the industry association AusBiotech is urging the government to complete the Clinical Trials Action Group (CTAG) change program. The 20 CTAG recommendations, accepted by the government, have not been implemented in a timely manner. And the industry in Australia is pushing for it in order to leverage Australia as a destination for efficient and effective clinical services.

Most Asian countries face similar regulatory challenges and should look at coming together to face it jointly. Experience sharing between regulatory authorities of countries in Asia is much required.