Provisions Pertaining to Homoeopathic Medicines

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.