Homoeopathic medicines are manufactured on the basis oflong clinical experience in homoeopathy or as recorded in Authoritative Homoeopathic Literature in India and abroad.
Provisions Pertaining to
Homoeopathic Medicines
Homoeopathic
medicines are manufactured on the basis oflong clinical experience in homoeopathy
or as recorded in Authoritative Homoeopathic Literature in India and abroad.
No
parenteral homoeopathic preparations are permitted for manufacture. Import -
The import of homoeopathic medicine is without licence. The licence is
necessary only for new Homoeopathic medicine. i.e., the medicines not specified
in Homoeopathic Pharmacopoeia of India, UK, U.S.A, and Germany.
Manufacture-For
manufacturing each set of Homoeopathic medicine, separate licence is required.
Application for grant or renewal of a manufacturing licence is made in Form
24-C. Licence is issued in for 25 C. Schedule M and GMP should be followed for
manufacture of Homoeopathic drugs. There should be competent staff, facility
for manufacture and analysis, atleast one permanent employee with a minimum of
5 years of experience in manufacturing of Homoeopathic medicines. Factory
premises should be clean and hygienic. The testing facility of Mother Tincture
and facilities for proper storage of Mother Tincture should be provided. Mother
Tincture should be stored in neutral clean glass containers. The manufacturer
should maintain the register with all relevant particulars and allow the
Inspector to inspect the premises and record his observations. The crude drugs
used in preparation of Mother Tincture should be identified for their
authenticity. The total solids and alcohol contents ofHomoeopathic preparations
should be determined, recorded and the records are maintained for 5 years.
No
colour should be added to the preparation except, in combination with syrup
base.
Sale: Application for
licence to sell, stock or exhibit or distribute Homoeopathic medicine is made in Form 19-B. The licence for retail
sale is issued in Form 20-C. The wholesale licence for Homoeopathic medicines
is issued in Form 20-D. Separate licence for separate place of retail is
required. Sale premises should be clean. Incharge of Homoeopathic medicines
should be a competent person with 5 years experience. Homeo-doctor cannot look
after premises for sale. The records of sale should be maintained properly in
accordance with provisions of Rules. The Inspector should be allowed to inspect
premises of sale.
No records of retail
sale are required to be maintained, ifthe container of less than 30 ml of
medicine and Mother Tincture made upto 60 ml potency. The records of sale for
other categories should be maintained with particulars such as percentage of
alcohol in preparation, name and address of manufacturer, date of
manufacturing, manufacturing licence number, Batch number, etc.
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