Clinical Research

Regulations & Guidelines of Complementary / Alternative Medicine in South East Asia:

The evolution of traditional medicine has taken place since thousands of years. This form of medicine has been very dominant in most of parts of South East Asia. In today’s world this form of practicing medicine is called Traditional Medicine or Complementary/Alternative medicine (TM/CAM). TM/CAM is monitored in this region under the regulations of WHO (World Health Organization) South-East Asia Region (SEAR). Many countries from this region have developed extensive systems of Traditional Medicine health services. In many parts of South East Asia, countries such as India,¬†Indonesia, Nepal and Sri Lanka, a large population use traditional medicines to meet their primary health care needs. Given the role of TM along with its rich history, Traditional Medicine and its practitioners have been recognized by the governments and are regulated by national policies which are implemented under WHO (World Health Organization) South-East Asia Region (SEAR).

CAM (Complementary/Alternative Medicine) practitioners include Ayurvedic practitioners, homeopaths, naturopaths, acupuncture and Unani practitioners. These therapies are practiced as ‘Evidence Based’ by these practitioners. They are also used as self-care or as an alternative form of treatment to conventional medicines and hence generate a large market and demand for medicinal plants and herbal products. Due to large base of Traditional Medicine, many countries in SEAR need expertise and guidance to develop national regulations and safety monitoring systems.
According to the WHO global survey on the national policy and regulation of Traditional Medicine, there are three common difficulties and challenges: lack of information sharing; lack of safety monitoring for herbal medicines; and lack of methods to evaluate their safety and efficacy.

To overcome such challenges governments in the South-East Asia Region are encouraging medical doctors to work with traditional practitioners at the hospital level, and to support research on Traditional Medicine. This has created a new model which uses the best from each therapy for the betterment of patients. For example, in India there are 2860 hospitals providing Ayurvedic medicines. In Bhutan, in the national health centre, patients can receive both conventional and Traditional Medicine treatments based on their needs. Among the 11 Member States in SEAR, there are five with national research institutes of Traditional Medicine.

WHO hence created a set of guidelines not only to support Member States in renewing or updating their regulations on traditional medicines, but also to meet technical requirements for evaluating the safety, efficacy and quality control of herbal medicines.

Some major highlights of these guidelines are:

1) They classify herbal medicines
2) It states minimum requirements for assessment of safety of herbal medicines
3) It proposes minimum requirements for assessment of efficacy of herbal medicines
4) Quality Assurance of Herbal Medicine is discussed
5) There is a section on Pharmacovigilance, &
6) Control over advertisement of Herbal Medicines

Few Recommendations to Member States by WHO SEAR are as follows:

  • Member states should develop national regulations on herbal medicines based on the WHO guidelines;
  • Member states should establish a national advisory committee for herbal medicines;
  • Member states should adopt requirements for the registration of herbal medicines as proposed during this workshop;
  • Member states should establish coordination agencies to implement GACP;
  • Member states should establish an ADR monitoring centre and system for conventional medicines and herbal medicines, and develop necessary linkages with other ADR monitoring centres in the Region and with WHO collaborating centres;
  • Member states should work to strengthen the regional network in all possible aspects of herbal medicines, particularly with regard to their safety, efficacy and ADR;
  • Member states should develop and strengthen herbal medicine education and training, practice and research;
  • Members states should work at facilitating harmonization among those countries that have common systems of herbal medicines

1) Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region (SEAR) by WHO (World Health Organization), Jan 28th 2012,

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