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:
-
Homoeopathic medicines are defined under Rule 2(dd) of Drugs and Cosmetics Rules, 1945.
-
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).
-
New Homoeopathic medicines are covered under Rule 30 aa.
-
Minimum requirement for good manufacturing are included in Schedule m-1.
-
Ophthalmic preparations, standards and conditions for preparation thereof are covered under Schedule ff (Rule 126 a).
-
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.
-
Anybody can get medicines tested under Section 26.
-
Under Section 26-a, Central Government can cancel licence of manufacturing a drug, if therapeutic claims are not genuine.
-
Procedures for labelling and packing of Homoeopathic medicines are covered under Rule 32 a, Rule 106 a and 106 b(Part ix-a).
-
Rule 85 b covers manufacture of mother tinctures, potencies or potencies from back potencies. Application for which is made under form 24 c.
-
Rule 85 c and 30 aa covers manufacture of new Homoeopathic drugs.
-
Individual pharmacists (shop keepers) are allowed to manufacture of potencies only and, that only from back potencies, under Rule 85 d.
-
Retail is covered under Rule 67 c. Application be made under form 20 c. Single drugs.
-
Though whole sale is covered under Rule 67 c, but application is made under form 20-d. Single drugs.
-
Licensing authority for issue of licence for Homoeopathic medicines lies with the State Government as per Rule 67 a and 85 b.
- PUBLISHED DATE : Feb 05, 2016
- PUBLISHED BY : Zahid
- CREATED / VALIDATED BY : Dr. Eswara Das
- LAST UPDATED ON : Feb 05, 2016
Discussion
You would need to login or signup to start a Discussion