In an effort to make India a hub for clinical research, the Union Government will be announcing shortly a slew of policy measures that will strengthen the clinical research infrastructure already present in the country.
The first among them will be the announcement of revised Schedule Y, which will be notified in November, said Ashwini Kumar, Drugs Controller General of India. Besides, the DCGI is working towards enforcing the regulatory capacity for inspection of clinical trials conducted by CROs.
"We have made revision in the Schedule Y norms, which will be officially notified in November. For the purpose of inspection of clinical trials, we are in the process of recruiting medical professionals, who will be trained in the role of inspecting and monitoring the procedure of clinical trials. By 2005, DCGI office will come up with a clear cut policy on this," said Kumar.
Ashwini Kumar was addressing the inaugural session of "Confronting the Challenges of Global Clinical Trials in India," a two-day conference organized by the Mumbai-based Chemtech Foundation.
According to Kumar, although India would like to study the clinical trials guidelines adopted by the ICH or the US or European authorities, it will eventually frame its own guidelines taking into account the country's socio-environmental concerns. Accordingly, the country will be adopting its own standard operating procedures (SOPs) and timelines in the end.