FDA to revisit the legal position existing since 1938, explore its impact in India and other countries and the possible reasons for such a panic among Homeopaths
The Food and Drug Administration (FDA), USA, issued a public notice, dated March 27th, 2015, expressing their intention to revisit how it oversees homeopathic products, which can be manufactured and marketed without prior approval from regulators. In response to this six presentations/ representations seems to have been received. The public hearing started on 20th – 21st April, 2015. Let us wait for the outcome. An examination of the representations received by the FDA shows that 5 out of six argued for continuing the existing regulatory procedures. The one, who asked for either a ban of Homeopathy or stricter regulation was the one heavily, relied on the NHMRC report of Australia, which itself was flawed in all respects.
The FDA is the regulatory organisation of drugs in USA and is mandated with identical functions of the Drug Control General of India. Several professional organisations in India reacted to the intention of FDA to re visit the existing regulations. A consensus is also building to condemn this effort of the FDA. Many Homeopathic organisations in India see this as a poly of the detractors of Homeopathy to ban Homeopathy in USA. They see an analogy to the Science and Technology report of UK on Homeopathy and National Health and Medical Research Council (NHMRC) report of Australia.
It may be worth examining the genesis of such a move by the FDA, the issues that led the FDA to revisit the legal position existing since 1938, explore its impact in India and other countries and the possible reasons for such a panic amongst Homeopaths.
The Federal Food, Drug, and Cosmetic Act recognizes as official, the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements. In India, similar provision exists in the Drugs and Cosmetic Act, 1940 and Drugs and Cosmetic Rules,1945.
The Federal Food, Drug, and Cosmetic Act define Homeopathy as the practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects and Homeopathic Drug as “Any drug labelled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements. The potencies of homeopathic drugs are specified in terms of dilution, i.e., 1x (1/10 dilution), 2x (1/100 dilution), etc. Homeopathic drug products must contain diluents commonly used in homeopathic pharmaceutics. Drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products”.
Until recently, homeopathic drugs have been marketed on a limited scale by a few manufacturers who have been in business for many years and have predominantly served the need of a limited number of licensed practitioners. Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products.
The legal position on use of Homeopathic remedies in USA is that those products that are offered for treatment of serious disease conditions must be dispensed under the care of a licensed practitioner and the products, offered for use in self-limiting conditions recognizable by consumers, may be marketed as OTC.
Homeopathic Products Vs Homeopathic Medicines- Facts and fiction
If we analyse the position we can see that there are three types of homeopathic preparations in the market in several countries including USA. The first category is classical preparations, manufactured and used on the principles of homeopathy laid down by Hahnemann and meet the Homeopathic concept of Similia. These are the Homeopathic potencies and are safe for human use. These medicines stand the test of time based on similia principles and placed in the Official Pharmacopoeias. The second category is the formulations, where several individual homeopathic remedies in potencies, having certain effect on a specific clinical condition are mixed and marketed by companies. These are marketed more on empirical evidences. These are also labelled as Homeopathic medicine though no drug proving, that is essentially required to brand them as Homeopathic medicine has ever been undertaken.
These products do not find place in the official pharmacopoeias. The manufactures claim these to be safe as these products usually contain Homeopathic medicines beyond a detectable quantity. The third category is preparations containing pharmacologically active ingredients. These are mother tinctures, low potencies and propriety preparations. The propriety medicines are mainly combinations of several pharmacologically active ingredients marketed by companies. These are used on clinical conditions as adjunct to the treatment given by the physicians. Examples are tonics, cough syrups etc. These third category products contain active ingredients and therefore involve safety and shelf life issues. Most of the OTC products flooding in the market are either from the second or third categories. In many countries the concept of OTC do not exist and all the Homeopathic products are freely available.
In the 1970s, lawmakers in USA directed the FDA to review the safety and effectiveness of OTC medications. But the agency deferred reviewing homeopathic treatments at the time and last evaluated its policies in 1988. It has allowed most prescription and non-prescription homeopathic products to go to market without prior approval. It is seen that there are several products coming in the name of homeopathy and some of them are taking public for a ride.
The FDA was issuing warning letters to companies making homeopathic products. The agency warned consumers not to rely on OTC asthma products labelled as homeopathic, saying they have not been evaluated for safety and effectiveness. In 2009, the FDA warned consumers to stop using several types of Zicam cold remedies after reports of more than 130 cases of people losing their sense of smell.
Let us see the Active Ingredient in this and the claim by the manufacturers. One of the Zincom product contains, Zincum Gluconicum 1 X and Zincum Aceticum 2X and the label claim is that it reduces duration of the common cold, reduces severity of cold symptoms, sore throat, stuffy nose, sneezing coughing and congestion.
Zicam® was invented by Robert S. Davidson and Charles B. Hensley in the mid-1990s. The name Zicam comes from a combination of the words “zinc” and “ICAM-1.” Zinc is an essential mineral that has been found to be effective in shortening colds and relieving cold symptoms.1 ICAM-1 is the receptor that the most common cold virus, rhinovirus, binds to in the nose and throat to cause colds.
Another remedy that came under the scrutiny of FDA was “Hyland’s Teething Tablets”. This was recalled after reports of reactions in some children; the tablets later were re introduced with a new formulation.
The ingredients in this product are:
Calcarea Phosphorica 6X HPUS…………………..teething, dentition
Chamomilla 6X HPUS………………………………..irritability
Coffea Cruda 6X HPUS………………………………sleeplessness
Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)…………….redness and teething discomfort
India with its large infrastructure of teaching institutions, number of practitioners, manufacturing units, research facilities and public acceptability is said to be the world leader in Homeopathy. The Homeopathic market is said to be of about 4600 crore by 2017. It is said to be growing at 20 % annually. People know that Homeopathic remedies are safe and effective. There are large numbers of patients who prefer to use Homeopathy as their first line of treatment. The Government on their part has established a net work of research facilities, encourage extramural research, set up a Homeopathic Pharmacopeia Committee, Homeopathic Pharmacopeia Laboratory etc. Our Prime Minister laud the homeopathic treatment and a separate Ministry is established for AYUSH for over all development of its component systems.
On the ground what is happening in the development of Homeopathy in India need a revisit by the professional organisations. They need to have an open approach to lay policy initiatives on what is required and what is not required for scientific development of Homeopathy. There is potential strength in Homeopathy to treat diseases for which there is less or no treatment in other systems. Homeopathy has strength as a standalone treatment and also as an adjunct in certain diseases. There is enormous potential in curative, preventive and promotive care. Homeopathy is found to have potential in veterinary and plant protection. Homeopathic classical medicines have immense scope to take the ever increasing challenges of long term, non communicable diseases, hormonal imbalances, behavioural problems, epidemic controls etc. In allergies and viral infections, homeopathy is the only option. Homeopaths need not shy away from the realities of the combination and formulations flooding in the market in the name of Homeopathy. These may have limited scope on certain conditions and in certain patients. There may be a need to use certain medicines of other systems along with Homeopathic remedies on certain patients. The knowledge about patients and about diseases, as we know, is quite limited. The knowledge about Homeopathy, as we know now is also limited. In that situation, efforts to understand on those areas that we do not know much is better than finding fault on others or rejecting new opportunities without knowing. Practicing medicine and treating the sick are multi dimensional. The requirement of one patient differs from the requirement of another patient.
Having said this, Homoeopathy should not be allowed to go unregulated or Homeopaths should be allowed to prescribe medicines of other systems. Strict regulation is required on the preparation and marketing of classical preparation. Safety and efficacy of every combinations flooding in the market in the name of Homeopathy need to be scientifically established through clinical trials. The formulation coming out from every nook and corner claiming therapeutic efficacy need stricter regulation to qualify as a Homeopathic preparations. A better understanding of practitioners of different medical systems is required to use the strength of different systems for a rational integration of health care delivery.
Solutions to the criticism on Homeopathic Medicine
Operationalisation of the regulation of Homeopathic preparations needs a relook across the world to save the onslaught from its detractors. There should be better understanding as to what is a Homeopathic medicine and preparations coming out in the name of Homeopathic medicine but do not qualify to be called homeopathic medicine, and used in Homeopathic practice. If a distinction can be made, we may be able to overcome many of the unfound criticism that the system facing today.
When we say a remedy as Homeopathic Medicine, it should qualify the strict regime prescribed by Dr Hahnemann- a remedy that undergone through the process of drug proving. Only and only that remedy will qualify the label as Homeopathic medicine in strict sense. In Homeopathic Materia media several medicines are included on empirical, toxicological or pathological evidences. These are all called Homeopathic medicine, though the pharamacodynamics of these remedies as per the Homeopathic principle has not been studied. There are several combinations, formulations available in the market. These are also called Homeopathic Medicine. The external preparations, cosmetics are also marketed as Homeopathic medicine. Homeopathy carry a heavy bundle with less of actual Homeopathic Medicine and more of other’s branded as Homeopathic medicine, but do not qualify to be called under that label. How to come out and justify ourselves is a big challenge.
One possible approach to justify Homeopathic Medicine from situations booming up in USA is to re classify various Homeopathic preparations and prepare a Homeopathic Formulary on the following concepts.
The first step is to filter Homeopathic Materia medica or Pharmacopeia. Under the classical Homeopathic medicines, there are remedies proved as per the Homeopathic principles and remedies less proven. Segregate those remedies whose therapeutic efficacy is established through Hahemanian principle of similia. Qualify only these remedies to be labelled as Homeopathic Medicine and may be kept in Schedule I of the Homeopathic Formulary. The onus of scientific validation of Homeopathy is possible only through Human Pathogenitic Trial (Drug proving) and all these remedies shall stand the test of similia, if Homeopathy is scientific. Reproducibility, evidences etc are possible as per the teachings of Homeopathy with this category of medicines.
All other potentised remedies with empirical evidences and less proven records may be kept in Schedule II of the formulary. An appropriate name may be given to these remedies (these may not be called Homeopathic medicines, but can be used by Homeopaths as these medicines are prepared according to Homeopathic philosophy).
Second step is to collect the commonly available preparations that contain pharmacologically active ingredients such as combinations, propriety medicines, mother tinctures and low potency medicines. These medicines need to undergo shelf life study and also safety masseurs. These may be categorised as Schedule III. Under this, all the mother tinctures may be kept in Schedule III ( a) and the propriety preparations may be kept in Schedule III (b).
The Schedule IV may contain the formulations with multiple Homeopathic medicines in potencies more than 6 C. These may be called Homeopathic formulations.
Another Schedule may be kept (Schedule V) may be kept for external use.
Like this, there can be Homeopathic Cosmetics, Homeopathic veterinary products etc under different Schedules.
Advantage of such a classification
In the name of Homeopathic Medicine, there are different products coming out in the market. There is a larger consensus that the products cited in Schedule I are safe and effective.
When a product in schedule 2, 3 or 4 is found of questionable quality or result, the criticism fall on Homeopathic medicine in general and its practitioners – Homeopathy in general get denigrated. If the above categorisation is adopted the responsibility of validating Homeopathic Medicine shall rest with Schedule I only and the onus of quality assurance and safety of other preparations may lie on the firm manufacturing and marketing the product. This will differentiate Homeopathic Medicine and Homeopathic Products. Homeopathic Medicine is Homeopathic and Homeopathic products need not be Homeopathic!
This is an approach paper only. In order to save the system from within and from outside, we need to re position ourselves with modification and adaptations with the time.
The Author is Former Director, National Institute of Homeopathy, Kolkata and was working in various senior capacities in the Ministry of AYUSH. Now is working as Specialist Validator in Centre for Health Informatics and is the Chairman, Global Homeopathy Foundation.