Dr Sasitorn Kittivoravitkul, managing director of Bio-Innova and Synchron Co, is bullish about Thailand's prospects to become a regional centre for clinical research, an area in which India is currently the Asian leader.

"While our state universities and medical schools have been doing a lot of clinical trials for new drugs and vaccines over the past decades, the Thai private sector is quite late in grasping business opportunities in this area," said Sasitorn, 35, who holds a PhD in pharmaceutical technology from the University of London.

Bio-Innova, which commenced operations earlier this year, is one of the first privately-owned Thai clinical research organisations (CROs), providing services in clinical research, bio-equivalence, pharmaco-kinetics, bio-availability, blood and urine analysis, statistical analysis, and data management.

The pharmaceutical industry in Thailand is currently worth an estimated Bt56 billion in annual sales. Local and multinational firms register about 1,000 new generic and original drugs with the Food and Drug Administration annually.

Concerning clinical research, Thai scientists, doctors and pharmacists regularly carry out clinical trials (phases one, two, three and four) of new medicines on Thai volunteers at various public hospitals.

"Bio-Innova is a joint venture of Thai investors and Synchron of India, which has been in this business for eight to nine years. India currently has around 30 CROs, making it the largest service provider in Asia for clinical trials of new drugs discovered by Western pharmaceutical giants.

"Taiwan and Singapore have also entered into this business. As for Bio-Innova, we target our services at the vast Asean market, where CROs are still in short supply, especially for bio-equivalence work to produce new generic drugs whose patents have expired.

"These generic products are 40 per cent to 200 per cent cheaper than the originals, making necessary drugs more affordable to lower-income groups.

"We've already conducted clinical trials on two or three drugs for HIV patients and birth control for registration with the Thai Food and Drug Administration, which requires a minimum of 12 volunteers.

"Our facilities include 26 beds for volunteers to stay overnight and state-of-the-art equipment, including the latest UPLC-MS machine worth Bt18 million for very fine measurement of drug delivery.

"Compared to the public sector's services, for which clinical trials may take 24 to 36 months, we could do similar work in a much shorter time. For instance, bio-equivalence work may take just three to six months.

"In India, they can do it in three months and their approval process is now very speedy, taking only 10 days to get the nod to do the work. India now has several established brand names for generic drugs due to its relatively large CRO sector," said Sasitorn.

The Thai Public Health Ministry has also turned to India as a supplier of cheaper drugs for HIV and heart patients after it invoked the right to exercise compulsory licensing on three patented drugs under the rules of the World Trade Organisation.

Compulsory licensing also requires the payment of 0.5-per-cent to 2-per-cent fees on the drug output to the patent holders.

Sasitorn says Bio-Innova also aims its services at the cosmetic, herbal, bio-tech, food and medical-device industries, as they need to test their new products for compliance with international guidelines to ensure faster approval and market launch when these products are exported to foreign countries.

Overall, the global clinical research industry, which is highly knowledge-intensive, is worth around US$10 billion (Bt347 billion), with the US being the world's largest service provider.

Asian countries such as India have enjoyed a competitive edge due to its growing supply of PhD-level scientists who work for less than those in the US and Europe.

To help reduce their drug development costs, US and European pharmaceutical firms have done a significant part of their clinical research in Asia.

Nophakhun Limsamarnphun

nop1122@yahoo.com