“The last regulation on health supplements was issued in 2005, therefore the registration has not evolved with the industry developments,” said Patrick Kalona, director of PT Phytochemindo Reksa, which supplies natural ingredients to both functional food and nutraceutical sectors.
“We look into the functional food side more for certain markets, which I think is the faster growing market because the regulation tends to be less,” he said.
In the supplements space, Kalona added that some permitted claims or permitted ingredients have not been updated because regulator BPOM is still using references from the Administration of Health Supplements 2005 rules.
“There are some circulars they use but it is only on a case by case basis.
“The last regulation on health supplements was issued in 2005, therefore the registration has not evolved with the industry developments,” he said.
Meanwhile, Draft Pedoman BPOM Tata laksana Peraturan Periklanan 2014, and the Draft Perka BPOM Tata Laksana Registrasi Suplemen 2015, which include updated guidelines concerning health supplements, are still on hold.
“It has not evolved, it has not progressed, the new drafts are still on hold, and there are still certain restrictions specifically with the use of new ingredients,” said Kalona, who is also chairman of APSKI, Indonesia’s association for health supplement manufacturers.
For example, for a new combination of vitamin or herbal products, the BPOM may require a full clinical trial.
“This is similar to what is required for a new drug discovery. The new drug discovery method may not be the right fit for the purposes of a supplement product,” Kalona explained.
But regulatory challenges aside, the 30-year old company, which has a herbal extraction plant and natural ingredient factory in Bogor, Indonesia, continues to focus on more growth.
“I think the key to any growth is really in the integration, so we invest our time into research development, product development, also in networking and new channels of sales,” said Kalona.
“We diversify our services not only to do ingredients, we also look into toll manufacturing. We do OEM (original equipment manufacturer) toll manufacturing for a number of multinational companies not only in Indonesia, but in other regions.”
The company market its herbal extracts from plants and fruits such as aloe vera, graviola, mangosteen, red rice bran, and java turmeric to 14 countries and has strong networks in the US, Japan, and Korea.
“The key to success in this market is regulatory compliance, and understanding of the ways it is working. And of course the quality, safety and efficacy of the products,” Kalona added.