Standardization of Homoeopathic Drugs

For laying down standards for identity, purity and testing of homoeopathic drugs, Govt. of India, Ministry of Health & Family Planning had constituted a Homoeopathic Pharmacopoeia Committee in 1962 with objectives:-

1.  

To preserve a Pharmacopoeia of Homoeopathic drugs whose therapeutic usefulness have been proved on lines of the American, German and British Homoeopathic Pharmacopoeia. .

2. To lay down principles and standards for preparation of Homoeopathic Drugs.
3. To lay down tests of identity, quality & purity.
4. Such other matters as are identical and necessary for preparation of Homoeopathic Pharmacopoeia.

Functions of the Homoeopathic Pharmacopoeia Committee were further enlarged by the ministry of Health & Family Planning also to prepare.

     1.  

A pharmaceutical codex in order to give such detailed information on drugs which are normally not given in pharmacopoeias e.g. constituents, uses etc and

2.

To prepare standards on nosodes.

For laying down standards for identity and purity and for testing of homoeopathic drugs, Govt. of India had set up a Homoeopathic Pharmacopoeia Laboratory at Ghaziabad in the year 1975. Important functions which Homoeopathic Pharmacopoeia Laboratory is to discharge include:

1.  

Laying down of standards for identity and purity of Homoeopathic Drugs. Finding out indigenous substitutes for foreign Drugs.

2.

Verification of pharmacopoeial standards, done elsewhere, for adoption or improvement of standards or updation of standards.

3.

Testing of samples of Homoeopathic Drugs for identity and quality under different provisions of Drugs and cosmetics act and rules. Testing of samples referred by drug control authorities, port authorities, state Government etc.

4.

Survey and collection of samples of Homoeopathic Drugs for verification of quality and adulteration trends of drugs marketed.

5.

Maintenance of a medicinal plants garden with preference to plants used in Homoeopathy. Cultivation and introduction of medicinal plants.

6.

Survey and collection of Medicinal Plants.

7.

Maintenance of a preference herbarium and a museum.

8.

To import orientation to all India state / central Government Drug Authorities, Drug inspectors, Drug Analysts, Pharmacists etc. In methods of standardization, identification and testing of Homoeopathic Drugs and application of various provision of Drugs Act.

9.

To act as central drugs laboratory for Homoeopathic Drugs for whole of India.

10.

To perform functions of Government analyst for state Government and when desired by them.

For correct identity, enforcement and maintenance of quality of Homoeopathic Drugs, suitable provisions have been made in the drugs & cosmetics act 1940 & rules 1945.

Status of Homoeopathic Medicines in Drugs and cosmetics act, 1940 and rules, 1945 and status of Homoeopathic Pharmacopoeia Laboratory.

1.  

Homoeopathic medicines are defined under rule 2 (dd) of Crugs and Cosmetics rule, 1945.

2.

Standards of Homoeopathic Medicines to be complied for manufacture, for sale, distribution or import are covered under second schedule of the drugs & cosmetic act (item no. 4a).

3.

New homoeopathic medicines are included under rule 30 aa and rule 85-c.

4.

Minimum requirement for good manufacturing are included in schedule m1.

5.

Standards of ophthalmic preparations come 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 sections 26.

8.

Under section 26 a central govt. Can cancel license of manufacturing a drugs, if therapeutic claims are not genuine.

9.

Procedures for labeling and packing of Homoeopathic Medicines are included in rule 32 a, rule 106 a and rule 105 b (part ix - a).

10.

Rule 85b covers manu-facture 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.

Manufacture by pharma-cists (shop keepers) of potencies is allowed 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 license for Homoeopathic Medicines lies with the state government as per rule 67 a & 85 b.

  16.

Schedule k, item 31 provides permission for sale of some selected Homoeopathic Drugs through any registered retail dealer of medicine licensed under rule 61. Item 31 (schedule k) includes some 32 single homoeopathic medicines in pills in 30 c potency in original sealed packs; 12 biochemics tissue remedies; 4 ointments and arnica hair oil.

Standards of Homoeopathic Drugs
VOLUME
NO OF MONOGRAPHS 
YEAR OF PUBLICATION
HPI VOL. I
180
1971
HPI VOL. II
100
1974
HPI VOL. III
105
1978
HPI VOL. IV
107
1984
HPI VOL. V
114
1987
HPI VOL. VI
104
1991
HPI VOL. VII
105
1999
HPI VOL. VIII
101
 2000
TOTAL
916
 

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