By SHAHEERA AZNAM SHAH / Pic By MUHD AMIN NAHARUL
A NEW set of guidelines for clinical trials in alternative medicine will be established to spur more regulatory approved products, the Ministry of Health (MoH) announced.
Its Deputy Minister Datuk Seri Dr Hilmi Yahaya said at present there are no guidelines that are compatible for alternative medicine, which comprises formulas that are made of herbals and natural ingredients.
“We noticed the existing regulations for medicine at the moment, such as the US’ Food and Drug Administration (FDA) approval, are far too stringent for the herbal and complementary medicine.
“Thus, the herbal medicine producers had to rely on their own research to avoid the government’s involvement, as medicine registered with the ministry needs to comply with certain standards,” he said at the 10th Herbal Asia — Asia’s Premier Herbal, Green and Natural Trade Show and Conference in Kuala Lumpur recently.
He said the new guideline would expedite the clinical trials process for herbal and complementary medicine, as the current regular process usually takes a longer time.
“The new guideline would allow alternative medicine industry players to get their products approved without having to comply with the stringent FDA regulations.
“Usually, it will take years to get a medicine approved and at an expensive cost. Via this guideline, we hope to ease the process,” Hilmi said.
He added that the introduction of the guideline will also promote the growth of herbal and complementary medicine that could penetrate the pharmaceutical market.
“For herbal medicine, there are 2,000 out of 20,000 species of plants in the country that have potential to be developed by alternative medicine producers.
“If we do not do this, many of the potential herbal medicine would not be able to enter the pharmaceutical market,” he said, adding that the guideline is planned to be effective next year.
The MoH established the traditional and complementary medicine division in 2007 to promote the co-existent between modern and herbal medicine.
The division has classified the alternative medicine into six categories — traditional Malay medicine, traditional Chinese medicine, traditional Indian medicine, homeopathy, complementary medicine and Islamic medical practice.
“The ministry also established a council to oversee the production of traditional and complementary medicine and how they can support the modern medicine.
“The existing as well as new herbal and natural medicine regulated under the guideline will be available at government hospitals that provide alternative treatment.
“At present, there are 12 government hospitals in Malaysia that provide alternative treatments, according to the degree of illness and treatment suitability,” he said.