LEGISLATION homeopathy pharmacy topic .pptx

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1. LEGISLATION IN RESPECT OF HOMOEOPATHIC PHARMACY BY- DR. AISHAWARYA R. TIMKARE PG PART-I

2. INTRODUCTION :- Legislation means legal part of homoeopathic pharmacy. According to drug and cosmetics act 1940(XXIII of 1940) and drug and cosmetic rule 1945 (amended IN 1969) with effect from 6 th December 1769. The government analyst, drug inspectors and import of homoeopathic medicines are governed by the same rule as applicable for modern medicine. Legal Definition of Homoeopathic Medicines:- Homoeopathic medicines include any drug which is recorded in homoeopathic proving's or the therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative homoeopathic literature of India or abroad, and which is prepared according to techniques of homoeopathic pharmacy but does not include a medicine which is administered by parenteral route.

3. Homoeopathy is included in second schedule of Drugs and Cosmetic Act, 1940. This act covers the standards to be complied with by imported drugs and drugs manufactured for sale, stocked or exhibited for sale or distributed. Misbranded drug- If the drug is so colored or polishes that damage is concealed or if it is made to appear of greater therapeutic value than it really is. • If is not labelled in prescribed manner. • If the label bears any statement which makes any false claim for the drug . Adulterated drug- If drug contains any toxic or putrid matter injurious to health or if stored under unhygienic condition. Spurious drug- If the drug is manufactured under a name which belongs to another drug, or if its label bears the name of company which does not exist.

4. DRUG INSPECTOR :- He is person who fulfills the following eligibilities:- He should be appointed by the central or state government after the notification in the gazzette . He should have the complete knowledge of manufacturing, preserving of homoeopathic medicines, etc. He should not have any monitory interest in the manufacturing of homoeopathic medicines. DUTIES OF DRUG INSPECTOR:- He has full authority to visit any homoeopathic pharmacy any time and can take samples of any drug which is being manufactured or sold. He can ask for any document from the manufacturer of homoeopathic medicine and can inspect any premises where any drug is being manufactured and any process of manufacture and the means employed for standardization and testing of drugs. If he thinks that the manufacturing of homoeopathic medicines is not proper, he has the authority to stop the manufacturing and to cancel the license and can examine any record, register or documents which he thinks reasonable as an evidence of an offence which is punishable. If any one obstructs the drug inspector while doing his duties, the person can be sentenced for 3 years of imprisonment and/or the fine.

5. Manufacture, sale and distribution of homoeopathic medicines are governed by: Drug and Cosmetics Act, 1940 and its amendments. Drug and Cosmetics Rules, 1945 and its amendments. Narcotic Drugs and Psychotropic substances Act and Rules, 1985. Drug and Magic Remedies Act, 1954. Drug and Magic Remedies Rules, 1955. Medicinal and Toilet Preparations Act, 1955. Drugs (Prices Control) Order, 1995. DRUG AND COSMETICS ACT, 1940 It was passed on 10th April, 1940. To regulate the import into, manufacture, distribution & sale of drugs & cosmetics in the country. Registered Homoeopathic Medical Practitioner is a person who is registered in the Central Register or State Register of homoeopathy. It contain the following: - 6 Chapters 2 Schedules- first & second

6. Chapter I - Introductory- short title, extent, commencement, definitions, etc. Chapter II- Drugs Technical Advisory Board, Central Drug Laboratory & Drugs Consultative Committee. Chapter III- Import of Drugs & Cosmetics. Chapter IV- Manufacture , Sale & Distribution of Drugs & Cosmetics. Chapter IVA- Provisions Relating To Ayurvedic, Siddha & Unani Drugs. Chapter V - Miscellaneous First Schedule- Part A- Ayurvedic & Siddha Systems Part B- Unani Tibbs Systems Second Schedule- Standards to be Compiled with By Imported Drugs & By Drugs Manufactured For Sale, Stocked/Exhibited For Sale/ Distributed

7. PART VI A : Sales of Homoeopathic Medicines 67-A- Appointment of licensing authority by state govt. Application for the grant or license renewal in form 19B, with a fee of Rs- 250/- within 6 months of expiry. And after 6 months of expiry there will be charge + 50/- Rs. Damage or loss of license- Duplicate copy may be issued Rs.50/- 67-B- Power to sign licenses and such other powers to any person under the control of licensing authority with the approval of State Govt. 67-C- Forms of licenses to sell drugs by retail or by wholesale in form 20-D or 20- D. 67-D- Sale at more than one place. A separate application & a separate license shall be obtains in respect to each place. 67-E- Duration of license- 5 years from the date it is granted or renewed.

8. 67-EE- Certificate of renewal. Application of renewal of Form 20-C & 20-D shall be issued in Form 20-E. 67-F- Conditions to be satisfied before the license granted 1- premises are clean & the sale premises are in charge of a person who has been dealing in Homoeopathic Medicines. 2- Any person, if aggrieved by the licensing authority may within 30 days from the grant of the receipt of such order appeal to the State Govt. 67-G- Conditions of license- 1-To permit an inspector to inspect & furnish such information as he may require. 2- to maintain record of purchase and sale with name and address of the purchasing parties. 3- to maintain an inspection book in Form 35 to enable an inspector to record his impression. 67-GG- Additional information to be furnished. Documentary evidence in respect of the ownership. 67-H- Cancellation & Suspension of licenses

9. PART VII- A- Manufacture for sale of Homoeopathic Medicines. 85-A- Manufacture on more than one set of premises. 85-B- Application for license to manufacture. Application for grant /renewal of licenses to made in form 24C to the licensing authority appointed by State Govt. 85-C- Application to manufacture New Homoeopathic medicines. No medicines shall be manufactured unless it is approved by licensing authority mentioned in Rule 21. 85-D- Form of license to manufacture Homoeopathic Medicines. License issued in Form 25C

10. 85-E- Conditions for grant /renewal of license Manufacture shall be conducted under the supervision of one time competent technical staff. 2. Premises shall be distinct and separate from the residential area. 3. Shall not manufacture homoeopathic medicines with drugs of other system. 4. Have arrangements of proper storage. 5. Have arrangements for identifying raw materials and testing Qs. 85-E-A- Inspection before grant / renewal of licence . To inspect premises, plantation, appliances, process of manufacturing, standardization, testing and professional qualification. 85-EB- Report by inspector- He should forward detailed report to Licensing Authority. 85-EC- Grant / refusal of license Granted if LA is satisfied, and if not satisfied , LA shall reject the application and inform the applicant of the reasons.

11. 85-ED- Further application after rejection After a period of 6 months from the date of rejection of application for a license, if the applicant inform the LA that the conditions laid down have been fulfilled and deposit an inspection fees of Rs. 250/-, LA after causing further inspection, if he got satisfied , issue a license in Form 25C or Form 26C. 85-EE- Appeal to the State Government- Aggrieved person within 90 days may apply. 85-F- Duration of license- 5 years from the date it is granted or renewed. 85-G- Certificate of renewal. Application for renewal in form 25C. License issued in Form 26C.

12. 85-H- Conditions for license- 1-To comply following conditions in respect of mother tinctures (Qs)- (I)- to identify crude drugs & keep record of identification for 5 yrs. (ii)- to determine total solids in Qs & keep record for 5 yrs. (iii)- to determine alcohol content of Qs & keep record for 5 yrs. (iv)- to use clean neutral glass container (v)- to maintain hygiene during process of manufacture, storage & handling. Not to add any colour to Homoeopathic Medicines. 2- To maintain records of Homoeopathic Medicines containing alcohol & the quantities with name & addresses of parties for 5 yrs. 85-HH- Additional information to be furnished by the applicant to the licensing Authority. Documentary evidence in respect of the ownership / occupation on rental.

13. 85-I- Cancellation & Suspension of the licence . Licensing Authority may, after issuing a show cause notice, cancel or suspend licence for a certain period of time. A licence may apply within 3 months of the date of order against that order to the State Government. PART IX-A Labelling and packing of homoeopathic medicines . 106-A- Manner of labelling homoeopathic medicines. A- the following particulars shall be either printed or written in indelible ink on the label of the innermost container & any other covering of the packing. i - the words ‘homoeopathic medicine. ii- name of the medicine-the drug included in the HPI, HPUS, GHP, the name specified in that pharmacopeia. iii- potency of Homoeopathic Medicines either in decimal, centesimal or millesimal system. iv- name and address of manufacture or seller. v- alcohol in % by volume.

14. B- Label of Homoeopathic Qs shall display the following- A distinctive batch no by the words “ Batch No” or “Lot Number” or “ Batch” or “Lot”. Manufacturing license no by words “ Manufacturing License Number” or “Mfg. 106-B- Prohibition of quantity & percentage No Homoeopathic Medicines containing more then 12% alcohol (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30ml. except that it may sold to hospitals / dispensaries in packing not more than 100ml.

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