Dr. Samuel Hahnemann is the originator of homeopathy founded almost 200 years ago. The medicine therapy practitioners or the homeopaths believed that “like cures like”. Being the dark era for medicine the homeopathy was introduced as a light of hope. Homeopathy cures incurable diseases too, as per a few studies “Homeopathic medicine = Energy e.g. E=mc2”
Animal Homeopathy
The human beings with the use of homeopathy were really happy with the
result of homeopathy, so the invention was done for animals as well. Animal
homeopathy or veterinary homeopathy follows the same principle
as in humans. The medicines are available for all the big and small animals.
People want side-effect-free medicine and conventional cures with better
treatment for their animal families.
The regulatory requirement for the Homeopathy
medicines
Homeopathic medicines include drugs that are recorded
in Homeopathic proving and whose therapeutic efficacy has been established
through long clinical experience as recorded in the authoritative Homeopathic
literature of India and abroad. It must be prepared according to the techniques
of homeopathic pharmacy and also includes a combination of drugs.
A license needs to be obtained for manufacturing or selling Homeopathic
medicines wholesale. In 1973, the Government of India recognized Homeopathy as
one of the National systems of medicine and set up the Central Council of
Homeopathy (CCH) to regulate its education and practice. Licenses are valid for
five years.
Applications are made to the State Licensing Authority for the
manufacture of Homoeopathic medicines and to the Central Licensing Authority
for the manufacture of NHMs. Drugs may be manufactured in small quantities for
tests or analyses if the manufacturer holds the appropriate licenses.
What are Regulatory requirements
for over-the-counter (nonprescription) medications?
The D&C Act or the Rules do not specifically mention OTC
drugs. The two broad categories envisaged by the Act are prescription and
nonprescription drugs. Prescription Drugs are those specified in Schedules H, H
(1), and X of the D&C Act, but there is no specific schedule enlisting the
nonprescription drugs. There are certain drugs, however, which can be sold in
non-drug licensed stores i.e., in non-pharmacies. These drugs are specified in
Schedule K of the D&C Act and include drugs such as quinine and other
anti-malarial drugs and household remedies such as Aspirin tablets,
Paracetamol, and Gripe water.
Do you know? OTC homeopathic drugs can be purchased from the
same allopathic chemist shops.
The Centre has amended the Drugs and Cosmetics Rules, 1945 to
allow the sale of homeopathic drugs over the counter from the allopathic
chemist shops.
Now, homeopathic medicines can be purchased over the counter (OTC)
from the common chemist shop selling allopathic drugs in INDIA. Under the
existing laws, the sale of homeopathy and allopathic drugs from the same shop
was not allowed.
On the recommendation of the Drugs Technical Advisory Board
(DTAB), the Union Ministry of Health and Family Welfare, Govt of India, has
amended the Drugs and Cosmetics Rules, 1945. The DTAB had urged the government
to strictly regulate the sale of homeopathic medicines and take efforts to
increase the availability of these drugs to needy patients.
According to the amended rules, allopathic chemist shops are
allowed to sell only over-the-counter (OTC) homeopathic products. Sources said
that currently, the availability of homeopathic pharmacies is an issue in many
parts of the country, particularly in remote villages.
What is the U.S. Food and Drug Administration (FDA) regulating
homeopathic remedies?
Because of their long use in the United States, the U.S. Congress
passed a law in 1938 declaring that homeopathic remedies are to be regulated by
the FDA in the same manner as nonprescription, over-the-counter (OTC) drugs,
which means that most medicines can be purchased without a physician’s
prescription.
Remedies are required to meet certain legal standards for
strength, quality, purity, and packaging. In 1988, the FDA required that all
homeopathic remedies list the indications for their use (i.e., the medical
problems to be treated) on the label. The FDA also requires the label to list
ingredients, dilutions, and instructions for safe use.
The guidelines for homeopathic remedies are found in an official
guide, the Homeopathic Pharmacopoeia of the United States, which is authored by
a nongovernmental, nonprofit organization of industry representatives and
homeopathic experts. Pharmacopoeia also includes provisions for testing new
remedies and verifying their clinical effectiveness. Remedies on the market
before 1962 have been accepted into the Homeopathic Pharmacopoeia of the United
States based on historical use rather than scientific evidence from clinical
trials.
Side Effects due to homeopathy – any reports
It is a safe medicine system and some information has been
reported about the risks and side effects in homeopathy –
The medicine which is consumed in high dilutions taken under the
supervision of trained professionals is considered safe and unlikely to cause
severe adverse reactions.
There have been rare cases where patients are feeling worse for a
short period after starting homeopathic medicine and remedies. The practitioner
believes this as the body temporarily stimulating symptoms while it makes an
effort to restore health. Liquid remedies can contain alcohol and are permitted
to have higher levels of alcohol than conventional drugs for adults – which is
not for all illnesses (in the case of animals it is not added). No adverse
effects from the alcohol levels have been reported either to the FDA or in the
scientific literature.
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