World Health Organisation to setup Global Ayurveda Center in India

Policy planning

To accomplish its duties regarding health through incorporation and strengthening of TRM, in 2003, at the 56^th Session of the WHO Regional Committee for South-East Asia, member states requested for inter-country collaboration to develop and enhance health research efforts, human resources and exchange of information in TRM. They decided that measures should be taken to protect, preserve and improve traditional knowledge and medicinal plant resources for sustainable development of TRM, and that there was a need to promote the safety and efficacy of drugs belonging to TRM. Yet again in 2003, WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) was formed. This Commission is examining contribution of TM in improving healthcare and suggesting developmental measures for the same.

In the 9^th meeting of health secretaries in July 2004 (convened by WHO), the focus was on globalization, trade, intellectual property rights (IPR) and health. Member states endorsed and appreciated the work of the CIPIH. It was recommended that SEARO facilitate the preparation of a common regional perspective focusing on the burden of disease and related health research and development, IPR and public health, other incentives for innovation, traditional systems of medicine and capacity building, to be presented to the CIPIH.

In compliance with this resolution in which the role of TRM has been duly appreciated in the service of humanity, WHO Strategy for Traditional Medicine (2002–2005, 2005–2010) has been framed which acknowledges the widespread use of TM, not merely in the region but worldwide. World Health Assembly resolution (WHA 56.31) assigned specific roles/activities for countries and WHO, which form the basis of this working group for the strengthening of TM globally and for Ayurveda in the Indian context.

The role for WHO has been identified which is as follows:

1. To facilitate the efforts of interested member states in formulating national policies and regulations on traditional, complementary and alternative medicine, and promoting the exchange of information and collaboration on national policy and regulation of TRM among member states;

2. To provide technical support for the development of methodologies to monitor or ensure product quality, efficacy and safety, preparation of guidelines, and promotion of exchange of information; and

3. To provide technical support to member states in defining indications for the treatment of diseases and conditions by means of TM.

Rules for regulation of herbal medicine

WHO has always emphasized upon institution of proper rules and regulations for the practice of TM in the country of origin as well as for its global accreditation among the member countries. Since the dawn of human civilization in this geographical part of the world, viz., Indian subcontinent, Ayurveda has got the distinction of being the first indigenous medical system. Therefore, the Government of India has already recognized Ayurveda as one of the official systems of medicine to be practiced in this country. Rules for education and practice of Ayurveda in India have been laid out in the Indian Medicine Central Council Act, 1970, whereas herbal medicines of Ayurveda are regulated by the provisions of chapter IV A of Drugs and Cosmetics Act, 1940 and rules instituted in part XVI-XIX of Drugs and Cosmetics Rules, 1945, along with relevant schedules for Ayurveda.[

Criteria for classification of herbal medicines

As per the WHO guidelines, for all practical purposes, herbal medicines can be classified into four categories, based on their origin, evolution and the forms of current usage. While these are not always mutually exclusive, these categories have sufficient distinguishing features for a constructive examination of the ways in which safety, efficacy and quality can be determined and improved.

Scheme for standardization of herbal medicine

WHO has observed that quality assurance of herbal medicinal products is the shared responsibility of manufacturers and regulatory bodies. National drug regulatory authorities have to establish guidelines on all essentials of quality assurance, evaluate dossiers and data submitted by the producers, and check post-marketing compliance of products with the specifications issued by the producers as well as compliance with Good Manufacturing Practices (GMP).

WHO has declared that the purpose of quality control is to ensure quality of the products by adhering to appropriate specifications and standards. Information on appropriate standards can be found in official pharmacopoeias, monographs, handbooks, etc. In choosing analytical methods, the availability, robustness and validity of the methods must be considered and if such advanced methods are used, a full validation for each test would be necessary.

To comply with the spirit of WHO regulations, Department of AYUSH, Government of India, took several measures to standardize Ayurvedic medicines. Some of these schemes are implemented with WHO assistance, such as the first workshop on “Production of ISM Drugs with Current Good Manufacturing Practices” organized in April 2001 covering different aspects of GMP, which was highly appreciated by those concerned with this subject. The second workshop in October 2001 was organized exclusively to throw light on the need for isolation and characterization of the active chemical constituents that should have the desired therapeutic action to cure different ailments as evidenced by various marker compounds, that can be used as an important tool for testing /analysis of single and compound formulations (whether “Classical” or “Patent Proprietary” medicines) available in the market.

In addition to these activities, WHO also impressed upon Central Council of Research in Ayurveda and Siddha (CCRAS) to prepare HPTLC-Fingerprint atlas of Ayurvedic single plant drugs which are mentioned in Ayurvedic Pharmacopoeia Vol. III and IV as a published document for standardization purposes.

Reason for rational use of herbal medicine

Rational use of medicines is essential in today’s situation, especially in a country like India, where there is a wide disparity in the availability of medicines between cities and villages. The concept of rational use of medicines has not yet fully penetrated into the minds of healthcare providers or the public, and as a result there is large scale irrationality seen in availability and prescription of medicines.

Therefore, Department of AYUSH has launched a few projects in association with WHO under APW and DFC programs to address this issue, and several documents are being prepared which will promote rational use of herbal medicines of Ayurveda. Institute of Post Graduate Teaching and Research in Ayurveda, Gujarat Ayurved University, as well as WHO country office have published two documents which are serving the purpose.But still much more needs to be done in this arena.

Projection of pharmacovigilance program for herbal medicine

The recommended approach of WHO is to include herbal medicines in the existing national pharmacovigilance programs. However, in view of the unique characteristics of the Ayurvedic medicines, there are several technical issues that need to be addressed along with basic fundamentals of Ayurveda if adequate and effective monitoring is to be done. Any pharmacovigilance program should identify the inherent challenges faced in monitoring the safety of herbal medicines effectively and propose adequate measures for overcoming them. Special attention has to be paid toward the reporting system for adverse reactions of herbal medicines and to the causality analysis of the reported adverse reactions.

The increasing international acceptance of Ayurveda has led the regulators of Department of AYUSH to implement a similar program for Ayurveda, particularly after some medical professionals, scientists and citizens reported adverse reactions upon consuming Ayurvedic formulations. Hence, the WHO persuaded the Department of AYUSH, Ministry of Health and Family Welfare, Government of India, to implement a comprehensive pharmacovigilance program for Ayurveda, as a means to ensuring the safety and efficacy of Ayurvedic medicines which was launched nationally on 29 September 2008. This program is running successfully at present.

Commencement of consumer guidelines of herbal medicines

Most recently, WHO country office agreed to sponsor a short-term project meant to prepare consumer guidelines for appropriate use of Ayurvedic medicines on recommendations of the Department of AYUSH, Government of India.

Safety status

Traditional medicines, an age-old heritage inherited from years of experience, are bound to contain some valuable elements but inevitably they also contain some ingredients which are no longer useful. It is therefore necessary to carry out scientific research in order to separate the grain from the chaff and to develop and improve the useful elements.

Therefore, safety is a primary concern regarding traditional and complementary therapies. There are two aspects of safety evaluation: First, to ensure that the right quality of material and appropriate processes are used from source till marketing and secondly ensuring that there is no contamination, adulteration or spiking.

Safety and efficacy studies of Ayurvedic medicines presently going on may overcome the lacunae indicated in the observations made under WHO global survey on the national policy and regulation of TM, which has identified three common difficulties and challenges, viz., lack of information sharing, lack of safety monitoring for herbal medicines and lack of methods to evaluate their safety and efficacy.