Pulling In 10 Different Directions – The Challenge Of Harmonizing Asia’s VMS Market
A lack of regulatory harmonization for dietary supplements in Asia is a big challenge facing companies operating in the region, according to experts from the Asia Regulatory Professionals Association. The ARPA is looking to start a conversation on the issue which the association hopes will lead to regulatory change.
Demand is surging for dietary supplements in markets across Asia as consumers with more disposable income become increasingly health conscious.
In the 10 countries that make up the Association of Southeast Asian Nations (ASEAN), supplement sales are growing mid-single-digits annually, with around 40% of the population consuming a nutraceutical product every day.
The COVID-19 pandemic has only accelerated this growth – with immune health products increasingly popular – making it the perfect time for consumer healthcare companies to enter the region.
However, a lack of harmonization of regulatory and technical standards for supplements in ASEAN is a big challenge facing companies operating in the region, according to Srilatha Sreepathy of the Asia Regulatory Professionals Association (ARPA).
Sreepathy, chair of ARPA’s recently-formed Vitamins, Minerals and Supplements (VMS) Chapter, tells HBW insight that a manufacturer looking to launch a supplement in five markets across the region will likely be faced with five different sets of regulatory requirements. National rules on labelling, stability data, and maximum limits for vitamins and minerals mean a new product must be tailored for each individual market, she points out, which is a time consuming and expensive process.
To tackle this issue by effectively creating a single market for supplements, ASEAN has been working since 2004 on harmonizing standards across its 10 member states. While a draft agreement on a regulatory framework for supplements has been drawn up – based on guidelines covering 10 different areas including health claims, labelling and establishing maximum levels of vitamins and minerals – this is yet to be agreed by the members.
ARPA Working To Raise Awareness
While there is a tentative plan to sign an agreement by 2021, Sreepathy fears that the COVID-19 pandemic might push the issue further down ASEAN’s agenda.
Recognizing the need for action, APRA’s VMS Chapter is championing the harmonization issue and looking to raise awareness among industry, regulators, healthcare professionals and consumers. Sreepathy is supported in this endeavor by Geeta Pradeep, a pharmacy academic and Dr. A.V. Rukmini, a medical doctor and research scientist. The three are part of a network of over 4,000 ARPA members, an organization established in 2010 to raise the standard and social recognition of regulatory professionals.
ARPA founder Jack Wong explains that the organization is looking to start a conversation on VMS which will potentially lead to regulatory change. “Hopefully by raising awareness we can facilitate harmonization, because more people will talk about the issue and find solutions,” he says.
Sreepathy – who has over 15 years’ experience working for consumer health multinationals in regulatory affairs – says ARPA has an important role to play in educating national regulators that are often stuck in their ways.
ARPA has to encourage regulators to think in a much more broader sense so they are at the very least willing to accept other countries requirements for supplements, Sreepathy says, which will reduce the burden on industry to prepare so many dossiers for the same product.
“It is an opportunity for us closely engage the regulators and help them,” she notes. “Regulators are very keen to understand how other markets are looking at the same product.”
10 Different Countries, 10 Different Views
Given that harmonization has been on ASEAN’s radar since 2004 what is holding it back?
“It’s hard to get just two countries to harmonize, getting 10 to agree is a big challenge,” Sreepathy admits, pointing to a similar plan by Australia and New Zealand to create a joint regulator for healthcare products which was discontinued after disagreements between the countries.
At meetings of ASEAN’s Traditional Medicines and Health Supplement Product Working Group – the committee working on harmonizing standards – members will align on certain aspects of the guidelines but disagree on others, she notes.
“Though they have come up with the standards, some member countries will not agree to them,” Sreepathy explains. For example, when it comes to setting maximum limits for vitamins and minerals members often want to stick to their existing national limit. “They want to have certain country specific requirements, which defeats the whole purpose of doing this harmonization.”
Sreepathy notes that it is a small number of member states often holding back progress. “We have six or seven of the countries that are more relaxed and more lenient towards the standard, whereas others are more stringent.”
Asked why she thinks certain members are less in favor of harmonization, Sreepathy says these countries don’t want to change national legislation as it’s such a big undertaking. “They have to get industry feedback, public feedback and then they have to convince the government. So it takes anywhere from two to five years to change the legislation. And that’s just one country.”
Highlighting the divergence of approach by ASEAN members, Sreepathy gives the example of Indonesia and Singapore.
Indonesia – which Sreepathy describes as a “very tough market” for supplement players – has a strict pre-market approval process for supplements, with a “big checklist” of requirements, such as stability data and strict labelling rules, which can take six to nine months to navigate.
By contrast, in Singapore there is no pre-market approval process, so companies are not forced to jump through hoops. For example, supplements sold in Singapore include English on the label, whereas in Indonesia everything must be written in Bahasa and no other languages are permitted.
While ARPA is looking to raise awareness of all aspects of ASEAN’s harmonization plans, the VMS Chapter has a particular focus on the issue of setting of maximum limits for vitamins and minerals in supplements.
ARPA’s research highlights the difference in maximum upper limits for four vitamins in five ASEAN member states, making it virtually impossible for a manufacturer to sell the same product formulation in all markets under the health supplement classification (see table, which also includes rules in Australia and New Zealand for comparison purposes).
As the table shows, the maximum daily dose for vitamin B12 permitted by each of the ASEAN members shown varies from just 2mcg in Thailand up to 600mcg for Malaysia and Singapore. Complicating this further, Indonesia and the Philippines also set maximum limits for different population groups, such as babies and pregnant women.
Wong points out that individual countries base these limits on different rationales. “Some might be based on the limit in the EU or the US, others on the local population, considering diet. Certain limits might also be influenced by an adverse event in past, leading to a particular vitamin being controlled stringently.”
Some of these countries have had these maximum levels in place for many years, Wong says. “Sometimes regulators don’t even know why the limit for a vitamin is set at a certain level. Even with scientific data it can be hard to convince a regulator to change long established limits.”
ASEAN Using WHO Model
To tackle this issue, ASEAN has based its harmonization efforts on the World Health Organization’s nutrient profile model, Sreepathy explains, plus the nutrient risk management model developed by the European Responsible Nutrition Alliance, which sets out low, medium and high risk populations based on adverse effects.
These efforts have produced a set of upper limits for over 20 common vitamins and minerals when used in supplements. However, ASEAN is not making this mandatory, which Sreepathy says creates a whole new challenge. The guideline notes that members states “may consider exemption in their countries under special circumstances such as national requirements based on country exposure assessment/consumption survey or product classification type.”
With ASEAN’s upper limits largely based on a western model, ARPA is encouraging further scientific research of vitamin and mineral needs among the Asian population, Dr. Rukmini explains.
“All the research on vitamin levels has been done on western populations, so we don’t really know what is required for an Indian, Chinese or Vietnamese person, for example. Diets vary from country to country which will influence how much supplementation of a vitamin a person would require. So no one knows what is the right dose for the patient in one given country or area.”
Pradeep notes that such research is important as consuming high doses of certain vitamins could cause toxic effects. “While water soluble vitamins such as B12 and C may not cause major problems, fat soluble vitamins such as A, D, E and K, can definitely lead to adverse effects, particularly when taken alongside certain medication. So consumers need to know, and stick within, the maximum limit.”
There is also a lack of knowledge on the appropriate dosage and use of supplements among health prescribers and pharmacists, Pradeep points out, who are the most common healthcare professionals consumers approach for advice on usage. This is further compounded by the fact that most of products are available in pharmacies for self-selection, she adds, and with the advent of online pharmacies, consumers can purchase supplements which are not always sourced within their local jurisdiction, which is another reason for having harmonized standards. With the debate around harmonization ongoing, Pradeep says it must be remembered that consumers continue to have easy access to supplements.
Change Won't Happen Overnight
While ARPA is committed to raising awareness of the variation in maximum vitamin limits across ASEAN and the wider harmonization issue, Wong accepts that legislative change will not be easy.
Progress has been slow, he admits, but things are moving in the right direction. “Even though harmonization hasn’t happened yet, the member states are still sharing good practice. They know they can’t change the regulations just like that, but they are building the network, sharing knowledge, it’s still a good thing to do.”
From ARPA’s point of view, the more people are aware of the issue the more questions governments will face about how they regulate supplements and the vitamins they take every day, Wong insists.
“It is technically possible to set maximum limits for vitamins, but the real difficulty is political,” he argues. “Every country has their own situation, to see change you need political power behind it.”
For more information on ARPA visit: arpaedu.com
Jack Wong has over 25 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Nutritional, Pharmaceuticals, Medical Devices, Consumer Healthcare and Biological products. He plays a leading role among all the Regional Regulatory professionals in Asian Harmonization Working Party and developed the First Asia Regulatory Affairs Certificate course since 2007 with over 3800 students in industry, government and universities. Wong founded ARPA in 2010 which has over 4,800 members and wrote the first Asia Regulatory Book, Handbook of Medical Device Regulatory Affairs in Asia, now in its 2nd edition.
Srilatha Sreepathy, M.Pharm has over 15 years’ experience in Regulatory Affairs, Pharmacovigilance, Drug Safety, Quality Compliance and Product Development in Australia & Singapore. Her experience in Regulatory Affairs includes OTC, Health Supplements, Medical device & Ethical products across Asia. Sreepathy’s interests are in down scheduling and evidence-based use of Complementary and Alternative Medicines.
Geeta Pradeep, M.Pharm, MPS is a clinical pharmacist and educator with over 18 years of experience teaching pharmacotherapeutics, pharmacy practice and clinical pharmacy content for undergraduate and postgraduate pharmacy courses in Australia and India. She is experienced in use of curriculum development and design suitable for flexible learning environments, supervision of undergraduate pharmacy honours projects and maintaining an active research profile. Research interests are in medicines safety, collaborative medicines management, pharmaceutical care and evidence-based use of Complementary and Alternative Medicines (CAMS).
Dr. A.V. Rukmini is a Research Fellow at the Chronobiology and Sleep Laboratory, Duke-NUS Medical School. Her work experience includes teaching, laboratory management, and clinical research. Currently, Dr. Rukmini works on the effect of sleep and circadian rhythms on cognition, metabolism, physical and mental health. She has a PhD in Neuroscience and Behavioural Disorders from Duke-NUS, for which she received the Wang Gungwu Medal and award for the Best thesis in Natural Sciences from NUS. Dr. Rukmini subsequently worked at Singapore Eye Research Institute in Visual Neurosciences before joining Duke-NUS as a Research Fellow.