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‘World Integrated Medicine Forum on the Regulation of Homeopathic Medicinal Products: National and Global strategies’
New Delhi: 23-24 February 2017
In the presence of 50 delegates from 24 countries, the World Integrated Medicine
Forum on regulations of homoeopathic medicinal products opened on 23rd February
2017. The two-day forum, organised by Central Council for Research in
Homoeopathy in collaboration with Dr. Robbert van Haselen, Director, World
Integrated Medicine Forum, was inaugurated by the Hon’ble Minister of State (I/C)
Sh. Sripad Yesso Naik, Ministry of AYUSH, Government of India. Sh. Naik, while
praising the efforts of Council for arranging such a forum, expressed that the
regulation of homoeopathic medicinal products (HMPs) is an important requirement
for the worldwide promotion of Homoeopathy. In today’s era, when the demand for
traditional and integrated medicine systems is on the rise, it is important that quality-
assured HMPs are made legally accessible, which is only possible via a well
developed regulatory framework.
The inaugural ceremony was also graced by Sh. Ajit M. Sharan, Joint secretary,
Ministry of AYUSH, Sh. A.K. Ganeriwala, Joint Secretary, Ministry of AYUSH and Dr.
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S.S. Handa, Chairman, Scientific Body, Pharmacopeia Commission for Indian
Medicine & Homoeopathy.
LMHI actively participated in World Integrated Medicine Forum (WIMF) on
regulations of homoeopathic medicinal products (HMPs) held in New Delhi, India on
23rd-24th February 2017. The two-day forum, organised by Central Council for
Research in Homoeopathy in collaboration with Dr. Robbert van Haselen, Director,
World Integrated Medicine Forum. The forum had representations from regulators,
manufacturers and pharmacopeia experts from 24 countries, as well as from World
Health Organization (WHO). Heads of reputed international industries including Heel,
DHU, Reckweg, Wala, Hevert, Boiron, Hyland’s, Labolife, C4C Group of Companies
and Living and leading Indian industries like SBL, Bakson, Willmer Schwabe (India),
B. Jain, New Life, HAPCO etc. actively participated in the forum.
The highlight of the
inaugural ceremony was
signing of a
Memorandum of
Understanding (MoU) on
cooperation in the field
of Homoeopathic
Medicine between the
Homoeopathic
Pharmacopoeia
Convention of the
United States (HPCUS)
and Indian bodies –
Pharmacopoeia
Commission for Indian
Medicine &
Homoeopathy
(PCIM&H) and Central
Council for Research in
Homoeopathy (CCRH). It is hoped that this agreement will be a benchmark for many
more agreements to follow with the aim to develop and harmonise homoeopathic
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pharmacopoeias of various countries and to strengthen and/or enable regulatory
provisions for homoeopathy worldwide.
Dr. Alok Pareek, LMHI
President, elaborately
presented physicians’
perspectives towards
regulations of HMPs from
world over. He expressed the
need to address the
discrepancies arising out of
non-standardization of
production of HMPs. The lack
of confidence in certain production methods leads to a bias from the physician’s side
towards only choosing the scale of dynamisation he trusts. He further pointed out
that liberal rules for products not following the homeopathic cardinal principles of
simplex or a thorough Hahnemannian proving and their labelling as “Homeopathic
medicine” is causing deterioration in classical homeopathic practice. Standardisation
is necessary in every aspect, right from proving to pharmacopeias, manufacturing,
and dispensing. He informed the audience that LMHI is taking initiatives in bringing
about this standardization and stressed that the definition of ‘homoeopathic
medicine’ also needs to be unanimously decided for uniformity. Finally, he urged for
coordination among all the stakeholders from producers to end users regarding use
of HMPs.
Dr. Todd A. Hoover, Member,
Research Working Group, LMHI
and Dr. Robert van Haselen,
Diurector, WIMF, jointly
presented on modernizing
monograph evaluation while
respecting homeopathic
principles. They illustrated how
the review of monographs by
HPCUS is both a technical and clinical process.
HPCUS is constantly updating its proving and clinical evidence standards to assure
Dr. Todd Hoover
Dr. Alok Pareek
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quality of monographs included in HPUS. Premarket approval needs of allopathic
and homeopathic drugs are different: while the former depends on a single
diagnostic indication, the latter presents a clinical composite picture. Therefore, the
drug discovery and clinical verification approaches have to be different for the two.
Information was presented on the current HPCUS and Vithoulkas Compass joint
research effort to investigate the validity of provings.In next 1-2 years, HPCUS will
publish a new matrix of evidence requirements for monographs. An outline of this
matrix and the accompanying monograph review process was presented. They
recommended additional research and harmonization of the monograph (new drug
evaluation) process across pharmacopeias.Dr. Heike Gypser, Secretary of
Pharmacy, LMHI, could not attend the forum despite her willingness to do so.
However, her views on the subject were communicated to the forum through other
representatives of LMHI.
Over a billion patients worldwide are demanding safe and effective medicines for
their conditions. In this era of growing adverse drug reactions and auto-immune and
lifestyle-related illnesses, Homeopathy has a crucial role to play in the well-being of
mankind. Being gentle, safe as well as cost-effective, Homoeopathy is gaining
popularity across the globe and is one of the most followed medical systems in India.
The use of homoeopathy is steadily growing in India and as per an analysis by
Ministry of AYUSH, this sector exhibited an annual growth rate of 26.3% in the past
year, the highest among the other AYUSH modalities.
Homeopathic medicines have a different history, background and mode of utilization
compared to conventional medicines. Also the integration of homeopathy in public
healthcare system ranges from a fully accepted medicinal speciality – such as in
India- to a complete absence. The regulation of homeopathic medicines reflects this
variability. The homeopathic industry collaborates on regulatory issues in certain
domains, but this collaboration is fragmented at best. It is with the aim of bringing the
homoeopathic industry and regulatory sector on a common platform for strategic
discussion that this ‘World Integrated Medicine Forum on the Regulation of
Homeopathic Medicinal Products: National and Global strategies’, has been
conceived jointly by Central Council for Research in Homoeopathy, Ministry of
AYUSH, Govt. of India and by World Integrated Medicine Forum (WIMF), an
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international firm that organises, and provides consultation for arranging such fora.
The event is supported by Ministry of AYUSH, Government of India, as well as other
government organisations, Pharmacopoeia Commission for Indian Medicine &
Homoeopathy (PCIMH) & Central Drugs Standard Control Organization (CDSCO).
Through this forum, regulators from more than 15 countries including France,
Germany, Switzerland, Sri Lanka, Bangladesh, India etc. shared the current status,
challenges and outlook with regard to the regulation of homeopathic products. At
least 15 international industries manufacturing homoeopathic medicines and more
than 30 Indian industries participated and interacted with the drug regulators and
controllers. Among the delegates were also included the regulators and drug
controllers of various states of India. Forum discussions explored the commonalities
as well as differences in regulatory affairs among various countries. The common
concern was how to promote regulatory practices that met the highest modern
standards, whilst at the same time respected the unique tradition of homeopathy
worldwide.
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While appreciating the effort of CCRH and WIMF, Minister of AYUSH in his inaugural
address remarked that there is clearly a need for a high-level strategic exchange
platform, where stakeholders can meet outside their immediate work related context,
and this forum could address that need. Sh. Ajit M. Sharan, Secretary, Ministry of
AYUSH also expressed his delight that the Ministry, through CCRH, could
demonstrate global leadership by hosting this unique event at the Ashoka Hotel in
Delhi. He said that in view of the efficacy of homoeopathy especially in non-
communicable and lifestyle-based diseases, there is a need to address the
challenges pertaining to regulations and/or distribution of homoeopathic medicinal
products.
In his interaction with the delegation, Sh. A.K. Ganeriwala, Joint
Secretary, Ministry of AYUSH, opined that is important that such meets are
organised more frequently as strategies for strengthening regulatory provisions
for homoeopathic medicines deliberated upon in such platforms, would ensure wider
and easier access to quality homoeopathic medicines, which, in turn, would mean a
healthier world through the gentle touch of Homoeopathy.
Dr. Raj K. Manchanda, Director
General, CCRH, hoped that this
forum could provide impetus to
further dialogues for strengthening
regulatory framework worldwide,
to assure that the users of
Homoeopathy could have wider
access to quality-assured
homoeopathic medicines. Dr.
Robbert van Haselen, Director of the WIMF and
also the international consultant for the forum, thanked
the Government of India for spearheading this challenging task of bringing together
the regulators and homeopathic industrialists from so many countries on a common
platform to exchange their concerns and issues.
Dr. Anil Khurana, Deputy Director General, CCRH, wrapped up the inaugural
ceremony of the forum by expressing gratitude to the Ministry of AYUSH, dignitaries,
resource persons and delegates on behalf of CCRH, for making this forum a global
Dr. Raj K. Manchanda
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event by their participation and hoped that the two-day interactions will be the
opening platform for more regulations-oriented interactions in future.
The Forum had eight interactive sessions, followed by panel discussion on second
day. These sessions were:
1. Setting the scene: Practitioners' perspectives
2. Regulators' perspectives
3. Pharmaceutical Industry perspectives
4. Regulatory status and outlook in various countries
5. Homeopathic pharmacopoeias: Status in main countries
6. Monograph/regulatory requirements: Strategic aspects
7. Homeopathic Drug Development, Regulatory innovation
8. Enhancing synergies with traditional and conventional medicine systems
Various presentations on the above topics during the two days explored how the
regulation of homeopathic medicines can be further modernized and advanced. This
included exploring the possibilities of synergies with other traditional and integrated
systems of medicine. The latter discussion also included the WHO traditional
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medicine strategy. Further forum discussions explored the possibilities and
limitations with regard to harmonization and collaboration among countries and the
future strategic priorities with regard to the regulation of homeopathic medicines. The
Indian industrialists hoped that the forum would deliver direct benefits for the
regulation of homeopathic medicines in India, via increased co-operation and
adoption of best practices developed elsewhere. Promotion of exchange between
the private and public sector and fostering increased trade between India and the
rest of the world is expected to be another lateral outcome of the forum.
A cultural dinner accompanied with folk instrumental was organised on the night of
23rd February 2017.
The unanimous recommendations that were made during the concluding forum
session included:
• Harmonisation, or at least, collaboration, convergence and reliance on
regulations of HMPs,
• Encouraging Good Pharmacacopeial Practices,
• Exchange of information for harmonisation and for collaborating for research
on mapping the diversity in pharmacopeial standards, and
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• Finding out ways to evaluate and compare points of convergence and
divergence across various countries, in terms of: HMPs regulations,
pharmacopoeia and industry standards.
• Exchange of more MoUs among countries on the lines of the one signed
among HPCUS and Indian bodies CCRH and PCIMH.
• All countries agreed to meet more often to discuss further on specific areas
related to drug regulations and harmonisation of pharmacopeias.
Much acclaim was won by the organisers of the forum for materialising this unique
forum which proved to be an apt platform for rigorous discussions on lesser
discussed but very vital points like: regulations of HMPs, harmonisation of
pharmacopeias and linking industry and regulators’ sectors for unified efforts for
global development of Homoeopathy.
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