INDIA TO AGREE NEW CLINICAL TRIAL PROTOCOL WITH US

India's Science and Technology Ministry has requested that the US authorities consider accepting clinical research data generated in India for US FDA drug approvals.

At present, Indian officials envisage adopting a special bilateral protocol, to be finalised between the US FDA and the Drugs Controller General of India. However, this will depend on an agreement on mutually acceptable data, and Indian research firms' ability to abide by any subsequent protocol.

The proposals form the second phase of plans by the Indian authorities to set up a new regulatory system modelled on the US FDA. Senior Indian officials have stressed the need to make drug regulations in the country more stringent, as reform of the country's drug market continues.

In many respects, India offers one of the most attractive overseas locations for clinical trial activity, although some observers have pointed to lingering weaknesses in data protection. India's large pool of qualified, English-speaking personnel, the country's new patent laws and an abundance of genetically diverse "treatment naïve" volunteers all bode well for the sector. However, much still depends on the success of the new co-operation initiative with the US, with the R&D sector key to the authorities' ambitions for the local drug industry.