The Hindu Business Line : `Clearance for clinical trials quicker in India'

India trials
Regulatory timeline now 2-3 months after overseas study.
6% of patients required for global trials came from India
Indian clinical trial market estimated at $100-$200 m.
Quintiles conducted about 180 trials in India over the last 10 yrs.

MR DENNIS GILLINGS

Mumbai April 6 Ten years ago, it took contract research organisation (CRO) Quintiles eight to nine months to get regulatory clearance to do a clinical study in India, though the same study had just been started in the US, observes Dr Dennis Gillings, Chairman and Chief Executive Officer of Quintiles Transnational Corp.

Now the regulatory timeline in India is about two to three months after the study starts overseas, he said, adding that he hoped the time-lag would be brought down to zero. Regulatory timelines in India are competitive when compared to other Asian countries, he said, with China for instance taking six to 12 months to approve a similar study.

There may have been concerns of safety from a regulator's point of view and issues on making local people "guinea pigs" for trials. But since the safety of the drug molecule is established in preliminary studies overseas, that need not be an issue, he said.

10-year stay

Dr Gillings was in the country to open a global central laboratory network at Mumbai, a development that coincided with 10 years of operations in India for Quintiles. No financials were divulged regarding the revenues of the India operations and the investment in the new laboratory.

He also indicated that the CRO looked to partner with Indian companies in the future. The model usually followed by the CRO when it partners is to pick up equity in the company or have a royalty payment.

Head-quartered in the United States, Quintiles is a $2billion company. In 2004, the multinational CRO had revenues of about $1.78 billion and company top-brass had then said that India contributed one per cent of these revenues. They had also projected that India would contribute 5 per cent of global revenues in the forthcoming years. Dr Gillings, responding to repeated queries on revenues said that Quintiles was close to the half-way mark of that projection.

Market worth

Clinical trials involved the testing of drugs on humans for a period of time before they are brought into the market. In India, the clinical trials market is estimated to be between $100 and $200 million with varying projections touching between $300 million and $1.5 billion by 2010.

While he was happy with the local regulatory response to international requirement, he pointed out that markets like East Europe were also extremely competitive. Pointing out the importance of the India operations, he said that six per cent of patients required for global trials came from India and this could become 10 per cent in future. However, this stands compared to East Europe that provides 29 per cent of the patients.

India trials

Meanwhile, Dr Ferzaan Engineer, Chief Executive Officer of Quintiles in India said that the CRO had conducted about 180 trials in India over the last 10 years. Every year it does between 20 and 30 trials. Globally, Quintiles has done about 700 global trials and 30 of the world's top-selling drugs have been developed or commercialised by Quintiles, he said.

In India, the CRO employs more than 1,400 people.

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