Status of Homeopathy in the Drugs and Cosmetic Act and rules

Status of Homoeopathic Medicines under

Drugs & Cosmetic Act, 1940 & Rules 1945

Homoeopathic medicines are covered under the provisions of Drugs & Cosmetic Act, 1940 and the Rules made there under: Some Important Provisions are:

1. Homoeopathic medicines are defined under Rule 2(dd) of Drugs and Cosmetics Rules, 1945.
2. Standards of Homoeopathic medicines to be complied for manufacture, for sale, distribution or import are defined under Second Schedule of the Drugs and Cosmetics Act(item N.4a).
3. New Homoeopathic medicines are covered under Rule 30 aa.
4. Minimum requirement for good manufacturing are included in Schedule m-1.
5. Ophthalmic preparations, standards and conditions for preparation thereof are covered under Schedule ff (Rule 126 a).
6. Homoeopathic Pharmacopoeia Laboratory, Ghaziabad is to function as Central Drugs Laboratory w.r.t. Homoeopathic drugs, under section 6 of the act under sub-rule 7 of rule 3-a.
7. Anybody can get medicines tested under Section 26.
8. Under Section 26-a, Central Government can cancel licence of manufacturing a drug, if therapeutic claims are not genuine.
9. Procedures for labelling and packing of Homoeopathic medicines are covered under Rule 32 a, Rule 106 a and 106 b(Part ix-a).
10. Rule 85 b covers manufacture of mother tinctures, potencies or potencies from back potencies. Application for which is made under form 24 c.
11. Rule 85 c and 30 aa covers manufacture of new Homoeopathic drugs.
12. Individual pharmacists (shop keepers) are allowed to manufacture of potencies only and, that only from back potencies, under Rule 85 d.
13. Retail is covered under Rule 67 c. Application be made under form 20 c. Single drugs.
14. Though whole sale is covered under Rule 67 c, but application is made under form 20-d. Single drugs.
15. Licensing authority for issue of licence for Homoeopathic medicines lies with the State Government as per Rule 67 a and 85 b.