Currently Phase I trials are only allowed if the compound was discovered in India or if data from other markets is submitted, which has restricted the outsourcing of early stage research to India.
The CDSCO’s proposals would overturn this and also allow foreign companies to conduct Phase 0 trials in India.
A reversal of the government’s stance would offer another cost-cutting route for pharmaceutical companies and further swell India’s blossoming clinical trials industry.
Surinder Singh, India’s Drug Controller General, revealed the news at the 6th Pharma Summit 2008 and outlined the infrastructure the CDSCO believe needs to be put in place. These proposals fit into a wider overhaul of the way clinical trials are conducted and monitored in India.
Reuters India reported that Singh has proposed making clinical trials monitoring systems more stringent, registering contract research organisations (CROs) and maintaining a database of clinical trial volunteers.
With regard to Phase I the Financial Express reported that Singh has outlined the areas the CDSCO would be prioritising, which fit into the broad aim of establishing an e-governance system.
These include fixed timelines of 2-6 weeks for each application, internet based new drug application (NDA) status and the recruiting subject experts and reviewers.
Improvements to the CDSCO’s working practices are intended to better equip it to deal with the rapidly expanding Indian pharmaceutical industry.
A KPMG report published in January valued India’s clinical research market at $200m in 2007 and went on to predict it could reach $600m by 2010. The opening up of India to early stage contract research would further swell this figure.
Turbulent times
The news comes just weeks after the Indian media and members of its congress expressed their dismay at the state of India’s clinical trials, following the revelation that 49 infants died at the All India Institute of Medical Scientists (AIIMS).
Congress spokesman Manish Tiwari responded to the news by saying that multinational pharmaceutical companies were treating Indian infants like “guinea pigs”.
The CDSCO will have to be careful how it introduces Phase I trials to avoid reigniting a volatile situation. By implementing the raft of improvements it has proposed it may do enough to improve its standing in the eyes of its critics.