HOMEOPATHIC MEDICINE

REGULATIONS IN INDIA, USA

AND GERMANY
Presented by:
Shaik Shabrin,
618209507005,
M.Pharmacy 2nd year,
Drug Regulatory Affairs.
 Introduction to Homeopathy
• Homeopathy definition:
• Homeopathy is the practice of medicine that embraces a holistic, natural
approach to the treatment of sick.
– The word homeopathy which comes from the greek, through latin into english,
literally means “like disease”.
– A homeopathic dose is defined as a particular preparation of medicine used, the
quantity and form of that preparation of the medicine.
• Types of doses
– Maximum dose
– Lethal dose
– Booster dose
– Fractional dose
– Physiological dose
– Minimum dose
• Types of potencies
• Low potency
• (Below 30C)
• Medium potency
• (Between 30C and 1M)
• High potency
• (Above 1M)

 Types of homeopathy
Auto isopathy
Classical homeopathy
Complex homeopathy
Homotoxicology
Isopathy
Pluralistic homeopathy
 Potency and potentisation
• POTENCY
• The denominated degree of serial trituration or dilution and succussion that is
reached for each homeopathic medicine.
• The degree of dilution are normally indicated by the letters D, DH, or X for
successive 1 to 10(decimal) dilutions, the letters C, CH,K or CK(centesimal)
dilutions while Q or LM denote succussive 1 to 50,000 dilutions.
• POTENTISATION
 Potency table
S.No. Dilution Ratio Common Designation Examples
1. 1:10ᵃ X 1X, 2X, 3X....
2. 1:10ᵃ D D₁, D₂, D₃....
3. 1:10ᵃ DH DH₁, DH₂, DH₃....
4. 1:100ᵇ C 1C, 2C, 3C....
CH₁, CH₂, CH₃....

5. 1:100ᵇ CH 1CH, 2CH, 3CH....

CH₁, CH₂, CH₃....

6. 1:100ᵇ K 1K, 2K, 3K....

K₁, K₂, K₃....

7. 1:50,000ᵃ LM 1LM, 2LM, 3LM....

8. 1:50,000ᵃ Q Q₁, Q₂, Q₃....
 REGULATIONS OF
HOMEOPATHY IN INDIA
Import of new homeopathic medicines
• The importer of a new homeopathic medicine when applying for
permission shall produce before the licensing authority such documentary
and other evidence as may be required by the licensing authority for
assessing the therapeutic efficacy of the medicine including the minimum
provings carried out with it.
• No new homeopathic medicines shall be imported except under accordance
with the permission in writings of the licensing authority.
 Labelling and packing of Homeopathic
medicines
• Manner of labelling of Homoeopathic medicines.-
• The following particulars shall be either printed or written in indelible ink and
shall appear in a conspicuous manner on the label of the innermost container of
any Homoeopathic medicine and on every other covering in which the
container is packed:-
• (i) The words „Homoeopathic medicine‟.
• (ii) In case of Homoeopathic medicine containing two or more ingredients the
name of each ingredient together with its potency and proportion expressed in
metric system shall be stated on the label.
• (iii) Name and address of the manufacturer when sold in original containers of
the manufacture.
 Sale Of Homeopathic Medicine
• Application for the grant or renewal of a licence to sell, stock, exhibit or offer for
sale or distribute Homoeopathic medicines shall be made in Form 19-B to the
Licensing Authority and shall be accompanied by a fee of rupees two hundred and
fifty.
• If the original licence is either defaced, damaged or lost, a duplicate copy thereof
may be issued on payment of 3 a fee of rupees fifty.
• If drugs are sold or stocked for sale at more than one place, a separate application
shall be made and a separate licence shall be obtained in respect of each place.
• Duration of licences.- An original licence or a renewed licence unless it is sooner
suspended or cancelled shall bevalid for a period of five years on an from the date
of which] it is granted or renewed.
• Prohibition of quantity and percentage.-No Homoeopathic medicine containing
more than 12% alcohol v/v (Ethyl Alcohol) shall be packed and sold in packing or
bottles of more than 30 millilitres, except that it may be sold to
hospitals/dispensaries in packings or bottles of not more than 100 millilitres.
 Manufacture of homoeopathic medicine
• If Homoeopathic medicines are manufactured in more than one set of
premises a separate application shall be made and a separate licence shall
be obtained in respect of each such set of premises.
• Application for grant or renewal of licences of manufacture for sale [or for
distribution] of Homoeopathic medicines shall be made to the Licensing
Authority appointed by the State Government.
• Licence for manufacture of Homoeopathic medicines is a licence to
manufacture potentised preparations from back potencies by Pharmacies
who are already licensed to sell Homoeopathic medicines by retail and
shall be granted in Form 25-C.
 Good manufacturing practices
(schedule M-I)
• The factory buildings for manufacture of drugs shall be so situated and shall have
such measures as to avoid risk of contamination from external environment
including open sewage, drain, public lavatory or any factory which produces
disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemical or
biological emissions.
• The premises used for manufacturing, processing, warehousing, packaging, labeling
and testing purposes shall be:
• (i) compatible with other drug manufacturing operations that may be carried out in
the same or adjacent area / section;
• (ii) adequately provided with working space to allow orderly and logical placement
of equipment, materials and movement of personnel .
 REGULATIONS OF
HOMEOPATHY IN GERMANY
• In Germany, the legislation for homeopathic remedies follows European Union
(EU) regulations. Homeopathic remedies are subject to registration, but they need
not be tested. However, homeopathic remedies are less diluted than D4. They can
be sold over-the-counter in pharmacies. Germany is the only member state of the
EU in which homeopathic remedies based on minerals or plants, and produced only
in very low quantities, do not need to be registered.
• In Germany, there is no legal monopoly on the practice of medicine. Both medical
doctors and non-medically qualified practitioners (Heilpraktiker) are allowed to
practice medicine. Only medical doctors are allowed to treat sexual diseases, treat
communicable and epidemic diseases, deliver specific medications, give or provide
anaesthetics and narcotics, practice obstetrics and gynaecology, take X-rays,
perform autopsies, and deliver death certificates. Infringement may result in penal
punishment.
• Directive 2001/83/EC of the European Parliament and of the Council on the
Community code relating to medicinal products for human use, which includes
homeopathic medicinal products.
• SCOPE:
• This guidance is intended for those companies wishing to obtain registration for the marketing
of homeopathic medicinal products for human use in Ireland. It covers the criteria for
registration as set out in the EC Directives(92/73/EC and 2001/83/EC, as amended) and
includes information taken from other EC Directives as appropriate. It provides advice on the
administrative aspects of the registration scheme and gives guidance on how the application
should be made.
• Purpose of the registration:
• The homeopathic medicines registration scheme is a simplified regulatory
procedure, which enables companies to market certain homeopathic medicinal
products in Germany.
• Products outside the scheme of registration:
• Products for use in the treatment of animals.
• Products those prepared in a pharmacy in accordance with a prescription for an
individual patient.
• Products supplied in response to unsolicited orders.
• Products eligible for registration:
• It must be prepared from homeopathic stocks in accordance with a
homeopathic manufacturing procedure described by the German
Pharmacopoeia.
• It must be for oral or topical use.
• There must be no specific therapeutic indication included in the labelling or
in any information relating to the product.
• The product must bear the scientific name of the stock or stocks from
which it is prepared; if the product is composed of two or more stocks, the
scientific names of the stocks may be supplemented by an invented name.
• It must be sufficiently dilute to guarantee safety.
• It must contain no more than one part per 10,000 of the mother tincture or
not more than 1/100th of the smallest dose where the active principle is a
prescription only medicine contained in Schedule 1 of the medicinal
Products.
• Companies should also be aware of the need
for the following authorisations:
• Manufacturers:
– A company which manufactures homeopathic medicinal products must
hold a manufacturer‟s authorisation. „Manufacture‟ includes all
processes carried out in the course of making the product, including
diluting, mixing and quality control.
• Importers:
– A company which imports homeopathic medicinal products from countries
outside the EEA needs a manufacturer‟s authorisation.

• Wholesalers:
– A company which acts as a wholesaler for the supply of homeopathic
medicinal products needs a wholesaler‟s authorisation in accordance with the
requirements of the wholesale distribution regulations.
• APPROVAL PROCESS:
•Assessment of the application

•Issue of registration certificates

•Timescales for approval

• ACCOMPANYING DATA:
•Data required

•Presentation of data

•Format of presentation

•Homeopathic stocks

•Stability

•Dosage form
 MANUFACTURE AND WHOLESALE:
• Manufacturer‟s authorisation
• Compliance with Good Manufacturing Practice
• Import authorisation
• Qualified persons
• Inspection
SALE AND SUPPLY

•Route of sale and supply

•Classification of registered products

VARIATION, RENEWAL AND SUSPENSION OF CERTIFICATION:
•Application for variations
•Duration of certificates
•Renewal of certificates
•Refusal
•Suspension and revocation
•Withdrawal from the market
LABELLING
•Small containers
•Leaflets
•Changes to approved labelling
•Labelling of registered products