Materia Medica Malaysiana

February 28, 2007

Slash the red tape to make Malaysia a research hub

Filed under: Uncategorized — malaysianmedicine @ 8:17 am

NST: PUTRAJAYA: Millions in pharmaceutical industry money are bypassing Malaysia. And the reason is not hard to find – red tape.
Although Malaysia is ideal for clinical trials for new or improved drugs due to its diverse population, the big players are skirting the country.
They are spending their money in countries such as Singapore, India and China instead.
This year, clinical research on drugs and equipment in Asia is expected to be worth nearly half a billion ringgit.
Last year, the clinical trials industry was worth about RM25 million in Malaysia. The Pharmaceutical Association of Malaysia estimates that this will grow by 20 to 30 per cent this year.
Director-General of Health Tan Sri Dr Mohd Ismail Merican said this was a very small amount compared with the total being spent by the industry in the region.
Dr Ismail said too many ministries and departments were involved in the approval process. There were too many officials to meet, too many forms to fill and a general sense of suspicion of the clinical trial methods.
Giving an example, he said a multinational company, which wanted to set up a research centre in Malaysia, went to Singapore after it was eyed with suspicion.
The company had faced great difficulty in obtaining approvals from various ministries.
“We should not frustrate such efforts. We have to look at the bigger picture. Everyone concerned should walk the extra mile if we want to promote Malaysia as a research hub,” he told the New Straits Times.
On its part, he said, the Health Ministry last week decided to speed up approvals for conducting trials, cutting waiting time from four months to two.
It is also working to improve government hospitals and clinical research centres in the country, some of which have been found lacking in standard operating procedures, facilities and equipment.
This is to assure these firms that they could be certain of high standards and that the centres had been approved by the ministry.
The ministry also plans to make it compulsory for every trial to be registered with the Clinical Research Centre to give the pharmaceutical industry access to expert clinical researchers.
“The online register will contain information on researchers, the number of trials conducted and how many have been completed. If a drug company wants to use a particular researcher, all the necessary information will be available,” he said.
Researchers will be monitored to ensure that funds, especially from the government, were properly utilised.
“Once a trial is registered, the ministry will check with the researchers every three or six months to ensure the trial is on track.
“Millions are spent, but nobody keeps track of the trials and many of these trials are not even published. I’ve always said that if you don’t publish, you perish.”
There are four main phases to a clinical trial. These include testing the drug on a small group, on larger groups and the post-marketing evaluation.
Dr Ismail said the prestigious National Institutes of Health in the United States (NIH) wanted to join forces with Malaysia on cancer research.
“We told them that we were excited to work with them because cancer is high on our priority list. We are planning to visit some of these international centres’ exhibitions to tell them of our capabilities.”
Dr Ismail has been in touch with several NIH directors, including the director of the Cancer Institute.
Meanwhile, Dr Sharmila Ramachandran, the medical director of a pharmaceutical giant, said Malaysia could attract more companies to conduct research and development projects in the medical field.
“Because of its capabilities as a developing country, it is able to cater to those who want to do state-of-the-art research and development.”
Dr Sharmila said clinical trials in Malaysia had become more sophisticated over the last 10 years.

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