Bangkok--27 Apr--PR Associates
Bio-Innova and Synchron Co. Ltd. (Bio&S) is the first joint venture in Thailand to provide clinical research services, testing new medical treatments on human volunteers in Thailand, and with technological support from the global-level expert research company, Synchron.
Bio-Innova & Synchron will also join government agencies to help push forward the potential of Thailand’s research facilities and expand across the Asian region.
Dr. Sasitorn Kittivoravitkul, Managing Director of Bio-Innova and Synchron Co. Ltd., said Bio-Innova is the first private sector Contract Research Organization (CRO) to concentrate on providing services in the areas of clinical research, bio-equivalence, pharmacokinetics, bio-availability, blood and urine analysis, statistical analysis and data management. Bio-Innova has a state-of-the-art clinical research facility, with laboratories and well-trained medical professionals to care for the volunteers. The Thai investors joined Synchron of India to set up the company with a registered capital of 50 million baht.
At present the pharmaceutical industry in Thailand, comprising the output of local pharmaceutical producers and multinational pharmaceutical firms, is worth about 56 billion baht in annual sales. Each year local pharmaceutical companies introduce an average of 1,000 new generic drugs, with 800 new drugs also being launched by the multinational pharmaceutical industry. Local and international pharmaceutical companies register an average of 1,000 new products with the Thai Food and Drug Administration each year.
As for clinical research in Thailand, scientists, doctors and pharmacists are already routinely carrying out phases 1, 2, 3 and 4 clinical trials to test new medications on Thai volunteers at various public hospitals. As a private sector company with an advanced data system and efficient methods for analyzing research results, Bio-Innova & Synchron will be able to help to speed up and improve the efficiency of Thailand’s medical research, in both clinical research and bio-equivalence services.
Each year the Thai government has to spend an enormous budget on buying medicines, especially patented drugs, which are very expensive. Producing generic drugs, which are not covered by patents, can greatly help reduce public health costs. To make sure that generic drugs can be produced at reasonable prices, but with the same quality as the original drugs, the Food and Drug Administration in 2000 introduced a rule requiring manufacturers of generic drugs to submit the results of their bio-equivalence studies when submitting a request to register their products. This helps to raise quality standards and provide quality insurance for consumers.
The FDA has now raised the standards further by implementing Good Clinical Practice (GCP) standards to make sure that the data from bio-equivalence studies is reliable. This also can make the volunteers confident that their rights will be protected.
Dr. Sasitorn said, “Our country is doing extremely well in such sectors as agriculture, tourism and food. The pharmaceutical industry is also growing rapidly in Thailand but at present we lack clinical research companies that can help our pharmaceutical, cosmetics, herbal or biotech industries to test their products as per international guidelines — ensuring faster approval and market launch. . This will help industries to grow domestically and also they can now look beyond our borders and export to other countries”.
Bio-Innova & Synchron will also provide research services for companies in other fields, such as the biotechnology, food and medical device industries.
The global clinical research market is worth some 10 billion US$ (360 billion baht) and many countries, such as China, Taiwan, India, Korea, Hong Kong, Singapore, The Philippines and Malaysia, are all vying to become a center of excellence in the clinical research organisation industry. This is a field offering considerable promise as clinical research costs in Asia are lower than in North America, Europe or Japan.
India is now playing a significant role in the global pharmaceutical industry, including in clinical research, because it is well prepared in terms of having PhD-level scientists who were trained in using technology from the USA, low labor costs and a domestic pharmaceutical market worth about 175 billion baht a year. Many of the leading multinational innovative pharmaceutical companies from the US and Europe have set up factories and laboratories in India, as well as leading international research companies. This gives India an advantage over other Asian countries in promoting its clinical research industry.
Dr. Shivprakash Rathnam, Managing Director of India’s Synchron Company, said, “With Synchron’s clinical research experience, combined with the capabilities of the Bio-Innova & Synchron staff, I am confident that the joint venture will be at the forefront of the clinical research services, pharmacokinetics research and other important services. We can cooperate with other agencies in Thailand to see that the clinical research industry advances so that Thailand can be a leader in this field.”
Synchron was the first private sector company in India to begin providing clinical research services in 1998 and in 2006 partnered with PAREXEL, one of the largest clinical research organizations in the USA. Synchron became widely accepted as the largest clinical research services provider in India by providing drug development services to local and multinational pharmaceutical companies with consistent quality and capabilities.
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