By Eric L. Foxman, Secretary AAHP
We are very familiar with the regulatory status and acceptance of homeopathic medicines in the United States. We also have an impression of the status of homeopathy in the European Union. But what is the situation in other countries around the world?
I recently returned from the World Integrated Medicine Forum in Goa, India. In attendance were 150 government regulators, pharmacopeia representatives, medical doctors, and industry members from about 20 nations. During the three-day event, reports were given about the status and regulation of homeopathy in various countries. Homeopathy is clearly a part of complementary and integrative medicine around the world.
Planners chose to hold the forum in Goa, not only for its locale, but also because the Federal Representative from Goa State is the Minister of AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathic Medicines). He gives the AYUSH Ministry staff significant support and resources, and provided the Forum with a ceremonial opening. The Governor of Goa State also attended and welcomed the delegates to what she described as a significant and meaningful contribution to the health and welfare of both the Goa State and the Republic of India.
The Homeopathic Pharmacopeia Convention of the United States was a co-sponsoring organization, and its logo was included on all printed materials and signage throughout the conference location and surrounding area. Upon my arrival, I was delightfully surprised to see the familiar logo on 10-foot banners on multiple street corners throughout the area.
In addition to the plenum’s work on the Forum’s theme, I was struck by the incredible diversity in the spectrum of homeopathy’s acceptance around the world. I’d like to share some of the highlights from the various countries’ reports, which were given for the most part by officials from regulating agencies and, in a few instances, by medical doctors from the participating nations.
There are 29 officially-recognized complementary medical practices in Brazil, one of which is homeopathy. Last year, there were 78,000 patient appointments for homeopathic therapies in public National Health Service clinics. Homeopathic Drug Products (HDPs) are made in compounding pharmacies that must be registered and abide by cGMPs. The regulating agency monitors therapeutic claims, stability tests, first safe dilution limits, as well as safety and efficacy evaluations. Marketing authorization is required for attenuations more concentrated than 4X, new HDPs, parenterals, and homeopathic products that are not in strict decimal or centesimal scales. Other products only require the compounding pharmacy to maintain a technical dossier that must be available upon request. Challenges include rigorous inspections, based on allopathic requirements, that can lead to rejections of batches and starting materials. The Brazilian Pharmacopeia would like to find ways to work more closely with our HPUS.
Last year, the Chinese government officially approved the use the word “homeopathy.” That means there is a long way to go to educate the public and academics about homeopathy. But, on the horizon, there is a potential randomized controlled trial on the use of HDPs for sciatica and sprains.
HDPs are overwhelmingly available only from practitioners and cannot have indications on their labeling. Very few HDPs are available in pharmacies, primarily because pharmacists have little knowledge of homeopathy. To overcome this hurdle, the government pharmacy school has begun a course in complementary medicine, and the course will feature HDPs. Challenges include long ministry assessment times, high product registration fees, and little experience in writing the required technical dossiers for registration submission.
The nation has a regulatory system in place, but use is hampered by a lack of available HDPs (there are only 26 “essential” HDPs available). Products are made in both pharmacies and commercial firms. There are over 700 homeopathic specialists in the country (population 11.5 million). There is ongoing work with other Central and South American nations to improve the local situation.
Eurasian Economic Union (Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia)
Regulations say products must be in a homeopathic pharmacopeia, but this is not defined in the law. Thus there is some uncertainty as to what constitutes an HDP. Despite this, throughout the EAEU, there are already 12,000 simplified registrations and 23,000 marketing authorizations (both similar to EU requirements). There is an urgent need for a homeopathic pharmacopeia to standardize and increase the breadth of drug substance choices. (Note: an attendee from Russia asked my colleague, Dr. Todd Hoover, for a written description of the HPUS and the evolving legal situation in the USA; this is for both homeopaths and regulators.)
HDPs are categorized as supplements; none are recognized as drugs by regulators, and insurance does not provide reimbursement for their use. There are no restrictions on the use or practice of homeopathy. The government promotes complementary therapies, but only 0.4% of population have used HDPs. This is, in part, because there are only 220 members of the homeopathic medical group (population 126 million).
HDPs fall into the natural product category. The ministry makes only an abridged evaluation for safety and efficacy in the evaluation of a product dossier. The agency verifies cGMP of manufacture and CoA of finished product. Challenges include incomplete and falsified dossiers. There is an official dialogue with nearby countries on mutual collaborative efforts for the regulation of HDPs.
Interest in homeopathy products has only developed in the last five years. Qatar’s government is just beginning to craft its regulatory efforts for HDPs. They want their regulations to meet worldwide standards. HDPs will likely be classified as herbal medicines so they can be included in an existing category.
The market for HDPs has grown from 900 million to 10 billion rand (US $750 million). The agency has a risk-based approach; high-risk products require both materia medica documentation as well as clinical evidence of efficacy. The agency looks primarily for cGMP compliance. Product dossiers must define how HDPs are manufactured and how they are used. The agency allows shelf life declarations to be based upon diluents/vehicles.
Homeopathy has been legally recognized in Sri Lanka for almost 50 years. There is a government homeopathic hospital that sees 200 outpatients per day and has 20 inpatient beds; it also operates 10 remote clinics. All treatment visits are free for Sri Lankans. A major challenge is that the country needs more education; there are only 55 qualified doctors, who are credentialed from Indian or Pakistani colleges (population 21.5 million). There is no domestic manufacturing of HDPs—all are imported. There is a desire to officially adopt a pharmacopeia to provide standards for HDPs.
In India, there are 10,000 stores licensed to sell HDPs (as compared to 800,000 stores selling allopathic products). Due to new regulations, all licensed stores will be allowed to sell homeopathic products (Indian population 1.3 billion). HDPs can now be covered by insurance when utilized in homeopathic hospitals. Government statistics show the use of HDPs is one-fifth the cost of using conventional medicines.
The government supports homeopathy by enacting regulations, but challenges include specific registration and cGMP regulations that are tailored to allopathic drugs. Manufacturers feel hampered by outdated QC specifications and by monographs identifying subspecies which are no longer available (industry suggestions include reducing number of drugs or expanding usable subspecies). Need more IR, HPTLC, HPLC[BW1] graphs in monographs as well as more officially authorized excipients.
Industry experiences export challenges due to the paucity of US dollars (upon which international trade is based) as well as different dossier format requirements in various countries. Export licenses are difficult to obtain, as the Homeopathic Pharmacopeia of India is not widely accepted outside India, Pakistan, and Sri Lanka. There are import challenges due to agricultural restrictions from government ministries.
The AYUSH Ministry has noted that more contemporary research is needed; the ministry is attempting to fill this gap, but needs more participation and support from industry.
During my visit to the AYUSH analytical lab outside New Delhi, I passed through the first-floor homeopathic clinic that sees 450 to 500 patients per day by a group of doctors (about 150,000 patient visits per year). Patients pay 20 to 30 Rupees ($0.28 to $0.42) per treatment, no matter how many visits are involved. This facility also operates five once-a-week satellite clinics in the surrounding area with additional patients. This particular clinic is only one of many government clinics throughout India with similar caseloads.