Spurious drugs under homeopathic label
In US, many people lost their sense of smell using Zicam nasal spray, a cold remedy they thought would be safer than other medicines because it was sold as homeopathic (!!).
Zicam’s homeopathic label allowed it to be marketed for a decade without a review for safety or effectiveness by the U.S. Food and Drug Administration. Homeopathic products — over-the-counter remedies that use plant, mineral or animal derivatives — don’t need marketing clearance from the FDA under U.S. rules.
Several reports to the FDA and Zicam’s maker, Matrixx International Inc., showed the Zicam nasal sprays and swabs may have caused more than 900 people to lose their sense of smell. The company recalled all such products on June 16, 2009.
This incidence in US has highlighted a need for more stringent checks on homeopathic products… (and homeopathy, homeopaths also)
I would like your attention to the similar situation in India:
- Do we have OTC in homeopathy ??
- What rules govern their sales ??
- How strong GMP regulations are ??
- Clinical trials records of all patents in homeopathy ??
- Effective recall system in India in adverse situation ??
In my early years of private practice, I had communicated with one leading Indian homeopathic pharmaceutical company about one patent preparation. I wanted to know about the details of its clinical trial and effectiveness of the patent in the clinical condition for which this product is sold; and I received a vague reply that it was found effective in few (very low number) of patients in some doctors clinics — do you think this is the right approach to launch a medicinal product in the market.
We know that there are numerous homeopathic patents available in the market, sold without prescriptions. It is estimated that it is more than 200 million dollars market in US, and you can imagine the same potential in India. Therefore, we find hundreds of homeopathic pharmaceutical companies are coming up with their new line of products for acute and chronic health and medical conditions from common cold, obesity, height problems, diabetes, blood pressure to CANCER and all other rare disease conditions, and for wellness and beuty too. Is this Hahnemann’s homeopathy?
These pharmaceutical companies are tarnishing the image of homeopathy system, and finally virtue is at stake for a serious and genuine homeopathic practioner, and eventually homeopathy is blaimed.
In India, I never heard about any recall of any medicine. Medicines are sold without bills to chemists and other stores, and sold to patients without prescriptions and without their details. I believe it is very hard for a company to track its sale to dealers and sub dealers; and, chemists would not be able to trace out the actual users ever !
This is the hightime to brainstorm about the situation of homeopathy in 21st centuary, and first decade gone. We all know it’s time to fix our health care system.
It is the responsibilty of all homeopathic practitioners, homeopathic institues and homeopathic organisations to unite and come foreward to make this homeopathic system a viable genuine therapeutic system as laid down by its originator, inventor Dr. Samuel Hahnemann.
Dr. Anil Singhal, MD(Homeo)
Yes, strict action should be taken against such pharmacetical companies(may be any where in this world) There is no room for patents in Homoeopathy.Stingent law shud be enacted in parliament of each country for such malpractices.
Right Dr Singhal
its really important n serious issue regarding potentiality of homoeopathic medicine, as per my knowledge every homoeopath atleast in india purchase homoeopathic medicine as per faith value from manufacturers of homoeopathic medicines.but now this is the time to assort genuine pharmacies based on certain rules n regulations by Govt. n Homoeopathic community as well.
Hope time will come n do something fare for such great therapeutic system-HOMOEOPATHY.
Such practices will defame homeopathy and it must be stopped.
Dr Anil,
I think this is a very pertinent issue and it has to be discussed on a broadbased platform. Technically, “classical” “pure” homoeopathy has very clear view on this subject but when it comes to a “physician in practice”,it seems like a different ball game. “Integrative Medicine” appears to be an emerging thought and I guess that is worth debating on and perhaps even worth drafting a fundamental policy on that.
Dear Dr Anil,
We have OTC, were in few drugs esp Biochemic tissue salts are allowed to be sold across the counter.
GMP is weakest in case of Homoeopathy though GO has been issued but still lot to be done, there is no strong desire to implement it, our’s is only system where its still to be implemented, we have yet to develop the infrastructure.
On other 2 points less spoken is better there is only one drug inspector for a state who has no time to check up all this
Dr. Anil,
It is a very serious issue that drugs can be marketed as “homeopathic” so freely. Many businesses in the United States are taking advantage of the leeway the FDA gives homeopathic remedies to market exaggeratedly expensive goods which most likely do more harm than good.
In India I imagine the market is just the same; some companies will take a profit at the expense of a legitimate medicine (homeopathy) and people’s health.
definitely the malpractices should be stopped but a question is to be born in the mind that , “Is it justified to use patent homeopathic medicines ? ” see the post : http://drprabhattandon.wordpress.com/2008/09/14/is-it-justified-to-use-patent-homeopathic-medicines/
Wel come to he next question of mixing inimical drugs as is seen in the one of the patent combination of Bakson & Reckweg , In R 23 the ingredients are
even a primary level student of homeopathy knows that Rhus tOX & apis are inimical .
UR EFFORTS R REALLY COMMENDABLE,THE WAY U THINK IS GOOD. IF WE HOMOEOPATHS R UNANIMOUSLY AGREE WITH U ,UPLIFTMENT OF HOMOEOPATHY IS CERTAIN IN COMING DECADE
Dear Dr Prabhat, if you have even primary knowlede of Pharmacokinetics or Pharmacy, you would know that when Medicines are actually mixed, their chemical structure and valency changes and so does their chemical and medicinal action, which is thereafter confirmed through clinical trials before it is being approved as patent medicine to be released for use by medical practicioners
if these patents are efficacious where is the proof….its shameful eading companies manufacture and layman purchases it just reading spondin etc on it
Patents do more of harm than the good they actually hinder the cure of the disease by interfering with the medicine’s action
Tamilnadu, is one place where the rules are being implemented, hats of to the Tamilnadu chemist association and the commisioner, the other states should take a leaf from them, for maintaining and implementing rules and regulation for betterment of HOMOEOPATHY.
You have raised a very important point. I think, Dr. S.K. Vashishth has given a very correct picture. The malpractices in U.S. in relation to the Pharmaceutical Industry, are far more than in India. May be, bigger economy, more malpractices. So far as the Clinical Research goes, if you go through Dr. Vithoulkas Book, titiled “A NEW MODEL FOR HEALTH & DISEASE”, you would find the big hoax behind the so-called research. In India, in Homoeopathy, the clinical trials referred to are on the similar lines. I personally, feel that the situation can be improved only after we are able to improve our education system. The physicians look to the combinations because they lack confidence in handling the cases, possibly because of less exposure to OPD/IPD. The manufacturers prepare combinations because of the economic factors. As Dr. Vashishth has pointed out, the enforcement of the rules, whether relating to manufacturing, or packing, or sale, or even to the implementation of G.M.P., is negligible, not only in Homoeopathy, but also in allopathy. The manufacturers promote the combinations to maintain the economic balance. The best way to curb this practice is the creation of circumstances that would make their demands minimised, and then the manufacturers would find the single drugs mfg. viable. This is possible only by improving overselves, i.e. by education