Status of Homeopathic Medicine in Drugs and Cosmetic Act, 1940 & Rules, 1975

A brief overview of status of homeopathic medicines in Drugs & Cosmetics Act 1940 (XXXIII of 1940) &  Drugs and Cosmetics Rule 1975 with latest changes made therein .

Homeopathy is specified method of Drugs therapy, a therapeutic method of curing natural suffering of a man by  administration of Drugs which have been experimentally proved to possess powers of producing similar, artificial suffering in a healthy human being.

Keeping in view the current awareness of the general public and inclusion of Medical Practice in Consumer Protection Act, the homoeopathic physician should know the rules and laws by which there is governed. Even the slightest fault, mismanagement or negligence at their and may result in severe punishment under CPA.There exists a provision of Homeopathic Medicines in Drugs and cosmetics Rules in the Schedule under 4-A Drugsand Cosmetic Act. The definition of Homeopathic Medicines is prescribed which is as under:

1. Drugs included in the Homeopathic Pharmacopoeia of India. Standards of identity, purity and strength specified in the edition of the Homeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
2. Drugs not included in the Homoeopathic Pharmacopoeia of India, but which are included in theHomoeopathic Pharmacopoeia of United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia. Standards of identity, purity and strength prescribed for the Drugs in the edition of such Pharmacopoeia for the time being in which they are given and such other standards may be prescribed.
3. Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the Germany Homoeopathic Pharmacopoeia. The formula or list of ingredients displayed in the prescribed on the label of the container and such other standards as may be prescribed by the Central Government.

The definition of Homoeopathic Medicines as per Rules 2(dd) of Drugs and Cosmetic Rules is as follows:-

Homoeopathic Medicines include any drug which is recorded in Homeopathic proving or therapeutic efficacy of which has been established through ling clinical experience as recorded in authoritative Homeopathic literature of India and abroad which id prepared according to techniques of Homeopathic   Pharmacy and covers combination of the ingredients of such Homeopathic Medicines but does not include a medicine which is ministered by parental route.

Homeopathic Pharmacopoeia

Homoeopathic Medicines are covered under Second Schedule of the Drugs and Cosmetics Act, 1940. The standards are worked out by the Homeopathic pharmacopoeia laboratory and then approved by the Homeopathic pharmacopoeia committee and published in the form of Homeopathic pharmacopoeia of India (HPI).

So far eight volumes of HPI have been published consisting of standards on 916 basic drugs and standards on 159 finished products. Apart from this the Standards of 101 Homeopathic drugs has also been published in form of Homeopathic Pharmaceutical Codex. Standards in HPI include information on characterization, identification, testing of standards and preparation of the various provisions under drugs and Cosmetics Rules,    1945 are as follows:-

Rules: -

30 AA       Import of New Homeopathic medicine- seeking permission from licensing Authority- Definition on New Homeopathic Medicine.

32 A        No Homeopathic Medicine shall be imported unless it is packed and labeled in conformity with rules under part IX-A-Rules 106(A) and 106(B).

PART VI-A SALE OF HOMEOPATHIC MEDICINE

67 C        Form of license to sale, stock or exhibit or distributed by retail or wholesale Homeopathic Drugs-Form-20 C or Form 20-D is required.

67 D        Sale at more than one place - separate application is needed and separate license is to be obtained for each place.

67 E         Duration of license- the original or renewed license is valid up to 31 st December of following year. The application for renewal is to be made before expiry or within six months of paying additional fee.

67 EE     Conditions to satisfied for a license in form 20 C or Form 20 D (to sell, stock, exhibit Homeopathic Medicine). The form is issued in 20- E.

67 G        Conditions of license- the Homeopathic Medicine to be stocked under clean condition and under supervision of competent persons etc. The license provides inspection to inspect the premises.  The record of sale and purchase to be maintained.

67 GG       Additional information to be furnished by an application for licenses or licensee to the licensing authority.

67 H        Cancellation and suspension of license – The license may be suspended or cancelled after so cause     notice and the applicant may appeal to State Government within three months.

PART–VII A  Manufacture for Sales or for distribution of Homeopathic Medicine

85 A        manufacture on more than one set of premises, separate application for each set of premises.

85 B         Application for license to manufacture Homeopathic Medicines – request is to be made in Form 24 –C.

85 C        Application to manufacture "New Homeopathic Medicines"– may be read with rule 30AA, Therapeutic efficacy is to be ascertained by applicant.

85 D        Form of license to manufacture Homeopathic Medicine – required in Form 25- C.

85 E         Conditions for the grant or renewal of license in form 25 C- the manufacturing shall be conducted under the direction and supervision of competent staff.

85 EA       Inspection before grant or renewal of license- The licensing authorities may inspect the establishment before granting or renewing the license.

85 EB       Report by inspection- Inspector to forward the report to licensing authority.

85 EC       Grant or refusal of license- The licensing authority may be refused for license and further inspection may be conducted after depositing requisite fee.

85 ED       Further application after rejection- the application may be resubmitted within six months of rejection.

85 EE       Appeal to State Government- The applicant may appeal to state Government after rejection by licensing authority.

85 F         Duration of license- valid up to 31 st December for following year unless suspended or cancelled in the year in which it is granted or renewed.

85 G        Certificate of renewal of license is to be issued on Form 25-C and Form 26-C.

85 H        Various conditions of license to be issued in a Form 25-C under the prescribed conditions.

85 HH       Additional information to be furnished by an applicant for license or licenses to the licensing authority.

85 I         Cancellation and suspension of license- The licensing authority may cancel or suspend the license. The applicant may appeal to State Government within three months.

PART IX – A Labeling and packing of Homeopathic Medicines      

106 A       Manner of labeling Homeopathic Medicines- the process of labeling of Homeopathic Medicine is prescribed like indicating the name and potency of Homeopathic Medicine etc.

106 B       Prohibition of quality and percentage- No Homeopathic Medicine containing 12% along with V/V (Ethyl Alcohol) shall be packed and sold in packing or more than 30 ml. Homeopathic Medicines. These  are statutory  requirements to be followed by all the manufacturers of  Homeopathic Medicines for maintenance of quality   under item 4A of the Second Schedule, under section 8 and 16 of Drugs and Cosmetics Act,1940 and Rules,  1945.