Regulatory changes in India have contributed to lengthening and inconsistency in the time taken to have a trial approved. The uncertainty has challenged contract research organisations (CRO) but, having heard from the Drug Controller General of India, Quintiles expects timeframes to improve.

“It should settle down in the next two to three months”, Anand Tharmaratnam, head of Asia markets at Quintiles, told Outsourcing-Pharma. Quintiles always expected the delays to be a short-term issue, Tharmaratnam said, which would settle down after India had made revisions to its regulatory system.

The latest of the changes is the draft guidance on clinical trial compensation. Quintiles is among the CROs to have paid compensation but Tharmaratnam said it would be wrong for him to comment on the merits of the guidelines.

India is trying to protect its population while realising the benefits of clinical trials, Tharmaratnam said, and has now done what it set out to achieve. Throughout this process Quintiles has tried to help where it can.

“We’re able to constructively work with governments in the region to drive thinking”, Tharmaratnam said. In China this approach has seen Quintiles work with the State Food and Drug Administration (SFDA) on training programmes and accreditation of clinical research associates (CRA).

Despite the recent uncertainty in India and the long-standing problem of approval times in China, both are among Quintiles’ highest growth markets in Asia. Quintiles is also experiencing strong growth in Korea, Taiwan and Japan.

Japanese changes

To tackle bottlenecks causing drugs to be introduced in Japan years after other markets regulations were changed to allow data from some other Asian countries. These revisions have changed the clinical research sector and created business for multi-national CROs.

In April Alan Morgan, the then president of global clinical development services at Icon, said changes to regulations in Japan had made Korea a “very, very strong” market for the CRO. Quintiles is also benefiting from regulatory liberalisation and subsequent rise of pan-Asian studies.

“It’s an opportunity”, Tharmaratnam said. Quintiles is seeing Japan being included in more clinical development programmes and this trend will continue as biopharm adopt simultaneous global development. This change in approach could help Japan get medicines to patients sooner.

“I expect the drug lag to reduce over the next five to 10 years”, Tharmaratnam said.