LEGISLATION OF HOMOEOPATHIC PHARMACY IN INDIA Prepared by

LEGISLATION OF HOMOEOPATHIC PHARMACY IN INDIA Prepared by Dr. SREEJA. S

LEGISLATION OF HOMOEOPATHIC PHARMACY �DRUGS & COSMETICS ACT – 1940 �DRUGS & COSMETICS RULE – 1945 �DRUGS & MAGIC REMEDIES ACT-1954 �MEDICINAL AND TOILET PREPARATION ACT – 1955 �DANGEROUS DRUGS ACT – 1930 �PHARMACY ACT – 1948 �POISONS ACT - 1919

THE DRUGS AND COSMETICS ACT, 1940 ( 10 TH April, 1940) Homoeopathy is included in the Second Schedule of The Drugs and Cosmetics Act, 1940. The act covers the ‘ Standards to be complied with by imported drugs and by drugs manufactured for sale, stocked or exhibited for sale or distributed ’.

THE DRUGS AND COSMETICS ACT, 1940 �The act was implemented to regulate the quality of Homoeopathic medicines manufactured, stocked or exhibited for sale �Quality of drugs are given a standards of quality �The drugs manufactured must comply with the standard set out in the Second Schedule

MISBRANDED DRUG �If the drug is so coloured or polishes that damage is concealed or if it is made to appear of greater therapeutic value than it really is �It is not labelled in the prescribed manner �If the label bears any statement which makes any false claim for the drug

ADULTERATED DRUG �If the drug contains any filthy, toxic or putrid matter injurious to health �If drug has been prepared, packed or stored under unhygienic conditions �If the container of the drug is composed of any poisonous material which may make the contents toxic �If it contains a colour other than one prescribed

SPURIOUS DRUG �If the drug is manufactured under a name which belongs to another drug �If the drug resembles another drug in it’s label or appearance �If the label bears the name of an individual or company which does not exist �If the drug is claimed to be the product of a manufacturer of whom it is not truly a product

According to Part II, 'The Central Drugs Laboratory', the functions of the laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathic Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.

THE DRUGS AND COSMETICS ACT, 1940 PART I �SHORT TITLE : Drugs and Cosmetics Act , 1940 �EXTENTION : Whole India �COMMENCEMENT : 10 -04 – 1940 �The act passed by central Government after notification in official gazette, Appoint �DEFINITIONS : Homoeopathic Medicine, Registered Homoeopathic Medical Practitioner

THE DRUGS AND COSMETIC ACT, 194 O ‘Homoeopathic medicines’ include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route.

THE DRUGS AND COSMETIC ACT, 194 O Registered Homoeopathic Medical Practitioner is a person who is registered in the Central Register or State Register of Homoeopathy PART II Deals with The Central Drugs Laboratory The functions of the laboratory shall be carried at the Homoeopathic Pharmacopoeia Laboratory, Gaziabad Functions are carried out under the supervision of Director of Laboratory PART III - Omitted

IMPORT � 30 -AA PART IV : Import of New Homoeopathic medicines � 32 -A : Packing and labelling of Homoeopathic medicine

GOVERNMENT DRUG ANALYST, INSPECTOR, LICENSING AUTHORITY �PART V �RULE 21: �Central Govt or State Govt may by notification in the official Gazette appoint such persons as it thinks fit, having the prescribed qualifications to be inspectors �Powers exercised performed by him by an inspector and duties

GOVERNMENT DRUG ANALYST, INSPECTOR, LICENSING AUTHORITY �No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be inspector �Every inspector shall be deemed to be public servant as per IPC Section 21

SALE OF HOMOEOPATHIC MEDICINES PART VI A � 67 -A : Application for grant of license � 67 -B : Power of licensing authority � 67 -C : Forms of licenses to sell drugs � 67 -D : Sale at more than one place � 67 -E : Duration of licenses � 67 -EE : Certificate of renewal � 67 -F : Conditions to be satisfied before a license in Form 20 -C or Form is granted 20 -D

� 67 -G : Conditions of license � 67 -GG : Additional information to be furnished by an applicant for license or a licensee to the licensing authority � 67 -H : Cancellation and suspension of licenses

� 67 – A : 1. Appointment of licensing authority State government appoints licensing authority who grants license for the purpose of sale of homoeopathic medicines in specific areas 2. Application for the grant or renewal of a license to sell, stock or distribute homoeopathic medicine shall be given in Form 19 – B and a fee of Rs 250 should be given along with the application

�In the case of renewal of license if the application is given after it’s expiry date but within 6 months then Rs 250 + Rs 50/month should be given �License shall be expired if application for renewal is not made within 6 months after it’s expiry date 3. If the original license is damaged or lost a duplicate copy may be issued on a fee of Rs 50

� 67 – B : Power of Licensing Authority �A licensing authority, with the approval of state government by an order in writing can transfer the power to sign license to any other person under his control � 67 - C : Forms of license to sell drugs �License to sell, stock or distribute homoeopathic medicine by retail or wholesale shall be issued in FORM – 20 C or FORM – 20 D

� 67 – D : SALE AT MORE THAN ONE PLACE �If drugs are sold or stocked for sale at more than one place a separate application shall be made and a separate license shall be obtained in respect of each place � 67 – E : DURATION OF LICENSE : An original license is valid for a period of 5 yrs from the date on which it is granted or renewed. License shall be deemed to expired if a renewal application is not made within 6 mon

� 67 - EE : CERTIFICATE OF RENEWAL �Renewed license is issued in FORM – 20 E � 67 – F : CONDITIONS TO BE SATISFIED BEFORE A LICENSE IS GRANTED 1. A license in Form 20 – C or 20 – D to sell, stock or distribute homoeopathic medicines shall not be granted to any person unless the licensing authority is satisfied that the premises where the medicines are sold is clean and hygienic

2. The sale premises should be in charge of a person (preferably a registered homoeopathic medical practitioner) who is competent to deal with homoeopathic medicines � 67 – G : ADDITIONAL CONDITIONS OF GRANT OF LICENSE 1. Premises where the homoeopathic medicines are stocked for sale or sold and hygienic are to be maintained clean

2. Sale of homoeopathic medicines shall be done under the supervision of a person competent to deal with homoeopathic medicines 3. The licensee should permit an inspector to inspect the premises and give necessary information to the inspector which help him to ascertain whether all the requisites of the Act and Rules are provided there

4. The licensee shall maintain records of purchase and sale of homoeopathic medicines containing alcohol together with names and address of parties to whom medicine is sold 5. No records of sale of homoeopathic potentised medicines in containers of 30 ml or lower capacity and mother tinctures in quantities upto 60 ml need be maintained

6. The licensee shall maintain an inspection book in Form 35 to enable an inspector to record his observations and defects that he notice � 67 – GG : Additional Information to be given by an applicant for grant of license 1. Documentary evidence in respect of the ownership of the premises where medicine is sold 2. Constitution of the firm

67 – H : CANCELLATION OF LICENSE Before cancelling the license the licensing may give the licensee an opportunity to correct the reasons or circumstances which may lead to cancellation of license. The cancellation is passed by an order in writing stating the reasons for cancellation if the licensee has failed to comply with any of the provisions of the Act and Rules

REASONS FOR CANCELLATION OF LICENSE : 1. An act or omission of an act was done by the licensee which is not in accordance with conditions of Act and Rules 2. The licensee had been guilty of an act or omission within 12 months before the date on which the act in question took place and the licensee had knowledge of that offense 3. If the act or omission was a continuing act

Licensee whose license has been suspended or cancelled can appeal to the state government with 3 months of the date of issue of cancellation order State government will appoint an inspector to inspect the premises and based upon the report the final decision will be taken

MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES � 85 -A PART VII A : Manufacture on more than one set of premises � 85 -B : Application for license to manufacture Homoeopathic medicines � 85 -C : Application to manufacture 'New Homoeopathic medicines'

� 85 -D : Form of license to manufacture Homoeopathic medicines � 85 -E : Conditions for the grant or renewal of a license in Form � 85 -EA : Inspection before grant or renewal of license � 85 -EB : Report by Inspector � 85 -EC : Grant or refusal of license � 85 -ED : Further application after rejection � 85 -EE : Appeal to the State Government 25 - C

• • 85 -F : Duration of license 85 -G : Certificate of renewal 85 -H : Conditions of license 85 -HH : Additional information to be furnished by an applicant for license or a licensee to the licensing authority. • 85 -I : Cancellation and suspension of licenses

• 85 –A : MANUFACTURE ON MORE THAN ON PLACES • If homoeopathic medicines are manufactured in more than one premises a separate application shall be made and separate license is needed in respect of each premises

• 85 – B : APPLICATION FOR LICENSE TO MANUFACTURE HOMOEOPATHIC MEDICINES • For manufacture of Homoeopathic medicines shall be made to the licensing authority appointed by the state government the application is made in the FORM 24 - C

• Application in Form 24 – C shall be accompanied by a fee of Rs 200 for manufacture of both mother tincture and potentised medicines • Along with this an inspection fee of • Rs 100 for first inspection and Rs 50 as inspection fee for renewal of license • Rs 50 for duplicate copy of license if original is damaged or lost

• If a person applies for renewal of license after it’s expiry date but within 6 months of such expiry, the fee payable for the renewal of such a license shall be Rs 200 plus an additional fee at the rate of Rs 100 per month and an inspection fee of Rs 50 for the manufacture of homoeopathic mother tinctures and potentised medicines

85–C: APPLICATION TO MANUFACTURE NEW HOMOEOPATHIC MEDICINE New homoeopathic medicine : A homoeopathic medicine not included in HPI, HPUS, GHP, Authoritative books of MM and efficacy is not proved 1. No new homoeopathic medicine shall be manufactured unless it is approved by the licensing authority

2) When the manufacturer applies for a license for the manufacture of new homoeopathic medicine he should provide the necessary details as required by the licensing authority for assessing therapeutic efficacy of the medicine including the minimum proving carried out with it

85 – D : FORM OF LICENSE TO MANUFACTURE OF HOMOEOPATHIC MEDICINE The license for manufacture of homoeopathic medicine is granted in FORM 25 C to pharmacies

85 – E : CONDITIONS FOR THE GRANT OR RENEWAL OF A LICENSE IN FORM 24 C 1)Manufacture of homoeopathic shall be conducted under the supervision of competent technical staff who is a a)Graduate in science with 3 yrs experience in manufacture of homoeopathic medicines b)A graduate in pharmacy with 18 months of experience in the manufacture of

c) With qualification of BHMS with 18 months of experience in manufacture of homoeopathic medicine d) Persons who are already in employment with 5 yrs experience in the manufacture of homoeopathic medicine 2) The premises should have the requirements as specified in Schedule M - I

3) Applicant for manufacture of homoeopathic mother tincture shall either a) Provide adequate staff, premises and laboratory equipments for identifying the raw materials or testing the mother tincture or b)make arrangement with some institution approved by the licensing authority where these tests can be done on behalf of the manufacturer

4) Premises where homoeopathic medicines are manufactured shall be far away from the residential area 5) Homoeopathic medicines shall not be manufactured with drugs of other systems of medicine 6) Applicant shall make arrangements for proper storage of homoeopathic medicine prepared by him

7) The licensee shall ensure to the licensing authority that the products he manufactured conform to the claims made on the label 85 – EA INSPECTION BEFORE GRANT OR RENEWAL OF LICENSE Before the grant of license premises where the manufacture is proposed has to be inspected by inspectors Inspector shall examine all areas of premises, plant and pharmaceutical appliances

Process of manufacture, methods for standardisation and inquire the professional qualification of technical staff who are employed 85 EB - REPORT BY INSPECTOR Inspector shall give detailed report after inspector along with recommendations for grant or rejection of license to the licensing authority

85 EC - GRANT OR REFUSAL OF LICENSE 1)If the licensing authority is satisfied with the inspection license is granted or renewed in FORM 25 -C or 26 – C 2)If the licensing authority is not satisfied, he shall reject the application

85 -ED FURTHER APPLICATION AFTER REJECTION OF FIRST APPLICATION If within 6 months from the time of rejection of an application for a license, the applicant informs the licensing authority that the conditions must be satisfied before a license is granted is being fulfilled now and deposits an inspection fee of Rs 250. The licensing authority, after inspection will issue a license in FORM 25 -C or FORM 26 - C

85 – EE APPEAL TO THE STATE GOVERNMENT Any person who is not satisfied by the rejection order passed by the licensing authority may within 90 days from the date of receipt of such order, appeal to the state government. State government will now make an inspection and pass an order as it thinks suitable

85 – F DURATION OF LICENSE Original license or a renewed license is valid upto 5 yrs on and from the date on which it is granted or renewed. License is valid if the application for renewal is made within the date of expiry or within 6 months after the date of expiry after payment of fee. License shall be deemed to have expired if application for it’s renewal is not made within 6 months of it’s expiry

85 - G CERTIFICATE OF RENEWAL Certificate of renewal of license shall be issued in FORM 26 - C 85 – H CONDITIONS OF GRANT OF LICENSE IN ADDITION TO CONDITIONS AS PER RULE 85 E A)The licensee shall provide and maintain staff and premises as specified in Rule 85 E B)The licensee shall allow an inspector to enter any premises where manufacture of homoeopathic medicine is carried on to inspect

the premises and to take samples of the manufactured homoeopathic medicine c) Licensee shall allow an inspector to inspect all registers and records and shall provide all information as he may require d) The licensee shall maintain an inspection book in Form 35 in which the inspector records his impressions and defects noticed e) The licensee shall comply with the following conditions in respect of mother tincture preparation

1)The crude drug used in the manufacture of mother tincture is identified and records of identification shall be kept for a period of 5 yrs 2)Total solids in mother tincture shall be determined and records kept for 5 yrs 3)Alcohol content in mother tincture determined and records kept for 5 yrs 4)Containers of mother tinctures shall be made of glass. Bottles should be clean, hygienic and neutral in reaction 5)Hygienic measures should be adopted during

manufacture, storage and handling of mother tincture ea)No colour shall added to any homoeopathic mother tincture f) Records maintained of names of homoeopathic medicines containing alcohol and quantities sold together with names and address of parties to whom sold. Such records shall be maintained for a period of 5 yrs

85 – HH ADDITIONAL INFORMATION TO BE GIVEN BY AN APPLICANT FOR LICENSE TO THE LICENSING AUTHORITY Licensee should give documentary evidence in respect of the ownership of the premises and also constitution and management of the firm

85 – I CANCELLATION OF LICENSE 1)Before the cancellation licensee is given an oppurtunity to correct the defects which may lead to cancellation of license. Thereafter licensing authority passes the order in writing stating the reasons for cancellation of license 2) Licensee whose license has been cancelled may within 3 months of the date of issue of the order can appeal against the order to the state government which will take the final decision

LABELLING & PACKING OF HOMOEOPATHIC MEDICINES � 106 -A � 106 -B PART IX A : Manner of labelling of Homoeopathic medicines : Prohibition of quantity and percentage

LABELLING & PACKING OF HOMOEOPATHIC MEDICINES PART IX A � RULE 106 A – No Homoeopathic medicine shall be imported unless it is packed and labeled in conformity With Rules in PART IX A � LABELING OF HOMOEOPATHIC MEDICINE – The following particulars shall be either printed or written in indelible ink and shall present on the label of innermost container of medicine and on every covering in which container is packed

LABELLING & PACKING OF HOMOEOPATHIC MEDICINES PART IX A �RULE 106 B – �No Homoeopathic medicine having more than 12% alcohol content shall be packed and sold in bottles more than 30 ml �For Hospital/Dispensaries 100 ml packing is allowed

STANDARDS � 126 -A : Standards of ophthalmic preparations including Homoeopathic Ophthalmic preparations PART XII

�SCHEDULE A : Forms �SCHEDULE FF : Standards for ophthalmic preparations �SCHEDULE M-I : Good manufacturing practices and requirements of premises, plant and equipment SCHEDULES