Sunday, 19 February 2017

Regulation in India #2

This post will focus on the regulation of homeopathic medicines in India rather than the activities of homeopaths. There may be a few omissions in this post as the legislation/regulations are rather large and complex. Also, it is to be noted that the original documents do contain errors.


Definition of "Homeopathic drug"
The legislation that is important here are the Drugs and Cosmetics Acts 1940 and the Drugs and Cosmetics Rules 1945. They are often presented together.
Part one of the Act 1940 has a definition of a drug -
(b) “drug” includes—
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
(ii) such substances (other than food) intended to affect the structure or any function of human body or intended to be used for the destruction of (vermin) or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ;
Schedule Two states -


Class of Drug
Standard to be complied with
4-A. Homoeopathic Medicines.

(a) Drugs included in the Homoeopathic Pharmacopoeia of India.
Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of India for the time being and such other standards as may be prescribed.
(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic 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 as may be prescribed
(c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homoeopathic Pharmacopoeia.
The formula or list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government

Part four of the Rules 1945 deals with importation of drugs. It seems unlikely that homeopathic medicines would be imported into India in any great quantity if at all. Even so, it has some useful information in it.
Part IV - Import and Registration 
30AA. Import of New Homoeopathic medicine:  
(1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.  
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it. Explanation. —For the purpose of this rule, ‘New Homoeopathic Medicine’ means— 
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or 
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or  
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended.

The it is much more restrictive than might be expected. A "new homoeopathic medicine" is one that does not appear as a monograph in any of the mentioned Pharmacopoeia. Both the US and UK homeopathic pharmacopoeias are moribund. The Homeopathic Pharmacopoiea of the United States (HPUS) is online but access is expensive. The German pharmacopoiea . There is considerable overlap between these pharmacopoieas. The exact number of unique remedies is unknown but likely to be somewhere between 1300 to 2000 and more likely to be towards the lower end. Not the 3000 or even 5000 quoted in various places.

It's also a tautological definition. A homeopathic medicine is what certain homeopathic authorities say is homeopathic. This differs from, say, the EU definition that is based on methods and an amount of dilution. 

The processes for registering a "new homoeopathic medicine" will be discussed later.

Manufacture
The regulation of medicines is split between central and state government bodies in India. The Central Drugs Standard Control Organization (CDSCO) is national body that regulates pharmaceuticals (including homeopathic medicines, to a degree) and medical devices. Its remit is not that different from regulators such as the FDA and MHRA. It is responsible for the approval and licensing of pharmaceuticals but not homeopathic medicines.

Licensing of manufacturers happens at a state level - this diagram is very helpful in understanding the division of roles. This includes the licensing of homeopathic medicines manufacturers. The requirements for licensing of homeopathic medicine manufacturers can be found in Part Seven A of the Rules 1945. Much of it is uninteresting.


PART VIIA MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES
85E. Conditions for the grant or renewal of a licence in Form 25C−Before a licence in Form 25C is granted or renewed the following conditions shall be complied with by the applicant:— 
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee and who is— 
(a) a graduate in Science with Chemistry as one of the subjects with three years‘ experience in manufacture of Homoeopathic Medicines; or 
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or 
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines: Provided that the persons who are already in employment with five years‘ experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.
(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-I:  
Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing. 
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either 
(i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or 
(ii) make arrangements with some institution approved by the Licensing Authority under Part XV(A) of these rules for such tests, wherever possible, to be regularly carried out on his behalf by that institution. 
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes. 
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine. 
(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him: 
Provided that in case potentised preparations are made in a Pharmacy holding licence in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.
Schedule M I is titled "GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR HOMOEOPATHIC MEDICINES". Good Manufacturing Practice (GMP) is very technical area - a detailed discussion would be extremely lengthy. It is worth noting that GMP standards do vary from country to country (although there is some harmonisation). The effectiveness of GMP inspection in India is moot. Inspections by foreign regulators often find non-compliance (see this example). It seems to be a systemic problem.

Part XV(a) relates to the approval of test laboratories and is not important in this context.

The last paragraph is somewhat opaque. It would appear that it allows a pharmacy with a Form 20-C licence to produce small amounts of homeopathic medicines that are made from a "back potency" (presumably purchased from a licensed manufacturer). A "back potency" is simply a less diluted form of a homeopathic medicine.

It is also permissable for a homeopath to compound homeopathic medicines for the use of their clients. It is not permissable for them to place them on the market.

New Products
The Act 1940 and the Rules 1945 do not say very much licensing of new homeopathic medicines.
85C. Application to manufacture "New Homoeopathic medicines." - the other provisions of these Rules Subject to 
(1) no "New Homoeopathic medicine" shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21; 
(2) the manufacturer of "New Homoeopathic medicine", when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.
(3) While applying for a licence to manufacture a "New Homoeopathic medicine" an applicant shall produce along with his application evidence that the "New Homoeopathic medicine" for the manufacture of which application is made has already been approved. 
Explanation. - The term "New Homoeopathic medicine" in this rule shall have the same meaning as in rule 30AA.
There is no definition of the minimum provings or the evidence required by the CDSCO. Examination of lists of medicines approved by the CDSCO do not seem to contain any homeopathic medicines. This press release suggests there is an appetite for some sort of regulation but there has been talk of this for some time. It has been suggested that the CDSCO is uninterested in homeopathic medicines.

The other route would be to submit a monograph to one of the above mentioned homeopathic pharmacopoieas. The UK one is moribund, the German presents a language barrier so HPUS and the Homoeopathic Pharmacopoeia of India (HPI - but be aware that the website has technical issues) are the obvious routes, the former doubly so if the manufacturer wishes to export to the US. HPUS will be discussed in a later post.

The requirements for monograph submissions to the HPI can be found here. Not particularly interesting except that it does by implication exclude some of the more fanciful remedies created by UK lay homeopaths known as Imponderables. It is not exactly clear where monographs should be submitted to on first reading but it turns out to be the Pharmacopoeia Commission of Indian Medicine and Homoeopathy. Which is part of the Ministry of AYUSH although there is no online evidence of such a Commission beyond a handful of mentions. Neither the Central Council for Research in Homoeopathy or National Institute of Homoeopathy make mention of it. However, the Commission is supposedly headed by a Dr Rajeev Kr. Sharma who is one of the authors of this paper and was at the time at the Homoeopathic Pharmacopoeia Laboratory (HPL) which may be part of the Ministry of AYUSH now although this is unclear. The Ministry of AYUSH was created in 2014.

Although no costs are mentioned in submitting a monograph, preparing a monograph to the standards required is time consuming and does require specialist skills, even if they are only being able to research literature and technical writing.

Whilst there does not seem to be any requirement to submit samples of a new homeopathic medicine for testing, regular testing of batches of homeopathic medicines is required to maintain GMP certification, presumably carried out by the HPL.


Packaging and Labelling
Rules 1945 partially deal with packaging and labelling.
PART IXA LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES 
106-A. Manner of labelling of Homoeopathic medicines.— 
(A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed—  
(i) The words "Homoeopathic medicine",  
(ii) The name of the medicine— (a) For drugs specified in the Homoeopathic Pharmacopoeias of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.(b) For other drugs, the name descriptive of the true nature of the drugs. 
(iii) The potency of the Homoeopathic medicine — For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems.  
(iiiA) In case of Homoeopathic medicine containing two or more ingredients the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label. 
(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer—the name and address of the seller: Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label. 
(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label: Provided that in case the total quantity of the pharmacopoeial homoeopathic medicine in the container is 30 millilitres or less, it will not be necessary to state the content of alcohol on the label. 
(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars: − 
(i) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words ―Batch No. or ―Batch or ― Lot Number  or ―Lot No. or ―Lot  or any distinguishing prefix. 
(ii) Manufacturing licence number, the number being preceded by the words ― Manufacturing Licence Number or ― Mfg. Lic. No. or ― M.L. Explanation.−This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.  
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. 
106-B. Prohibition of quantity and percentage.–No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.

There do not seem to be any rules for the naming of combination homeopathic medicines. Nor do there appear to be any rules regarding what indications are permitted. However, there are advertising rules, which will be dealt with in the next post.

The Act 1940 itself does not mention homeopathic medicines but it does mention labelling.

17. Misbranded drugs.— 
For the purposes of this Chapter, a drug shall be deemed to be misbranded,— 
(a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of more therapeutic value than it really is; or 
(b) if it is not labelled in the prescribed manner; or 
(c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.
Interestingly, whilst the Act 1940 mentions that the Government can confiscate and prevent the sale of misbranded drugs, it does not set out specific penalties as if the case with adulterated or spurious medicines. Misleading labelling is certainly a problem - the EU got around it with allowing indications such as "used in the homeopathic tradition for the treatment of condition X" but there is no similar provision in Indian regulation as far as can be determined.

Patient Information Leaflets/Package Insert
In some jurisdictions, it is mandatory for medicines to come with a package insert that advises patients/consumers on the correct usage of a medicine and potential interactions and side effects. This is also the case in India but apparently not for homeopathic medicines.

Wholesale
The wholesaling of homeopathic medicines is dealt with along with sales.

Sale
Again, this is covered by the Rules 1945. Some of elements of the administrative process are of little interest and have been omitted here.

PART VIA SALE OF HOMOEOPATHIC MEDICINES 
67A. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.  
(2) Application for the grant or renewal of a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority... 
67B. A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under his control.
So, it is possible to apply to a central Licensing Authority (presumably the CDSCO) for a licence that allows the sale or wholesale distribution of homeopathic medicines. The CDSCO also has the power to delegate that authority, presumably in the same way as has been done with Manufacturing Licences. Strangely, no direct mention is made of any conditions/qualifications required. The Rules 1945 continue...

67C. Forms of licences to sell drugs. (1) A licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be. 
67F. Condition to be satisfied before a licence in Form 20C or Form 20D is granted.-(1) A licence in Form 20C or Form 20D to to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in Form 20C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines:  
Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.

Form 20C is for sale, Form 20D distribution. The last paragraph is puzzling. Its meaning is unclear. It perhaps means that a homeopath can not sell homeopathic medicines themselves.
67G. Conditions of licence. Licence in Form 20C or 20D shall be subject to the conditions stated therein and to the following further conditions, namely: (1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition. (2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines. (3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed. (4) The licensee in Form 20D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.(5) The licensee in Form 20C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparation in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. 
67GG. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force as the case may be, documentary evidence in respect of the ownership or occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.
67-H. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder: Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the Licensing Authority− (a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (c) if the act or omission was a continuing act or omission that he had not or could not reasonably have had knowledge of that previous act or omission, or(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.
Violations of the Act 1940 or the Rules 1945 can lead to suspension or cancellation of licences.

Both the Act 1940 and the Rules 1945 were originally formulated before the Internet. There is nothing in them that expressly forbids mail order. However, a manufacturer who wishes to sell directly to consumers would need a Form 19B or Form 20C licence. So would an online vendor, such as Amazon.in, would as well and it is likely that there are very many of them.

Export
There are no explicit regulations regarding the export of homeopathic medicines. 

Monday, 6 February 2017

Regulation in India #1

India is one of a handful of countries that recognises homeopathy as medical practice. Indeed, it even goes to so far as recognise qualifications in homeopathy as being equivalent to medical qualifications (although it is moot whether in practice they are regarded as such).

Some background
One thing worth pointing out that private healthcare in a dominant position in the Indian market but that position varies from state to state. The reasons for this are various but include concerns about the poor quality of state funded medicine. Only minority of Indians have private health insurance. The healthcare market is very marketing driven but the lack of enforcement of regulations has lead to all sorts of incredible (and probably illegal) claims being routinely made. It is impossible for a provider to compete effectively in such a market without also making such claims. When Indian vendors venture into international markets, they can sometimes find themselves in trouble with regulators in those markets because they assume that if they can get away with breaking the law in India, they can do so elsewhere.

Complicated
Indian legislation and regulation relating to homeopathy is difficult to read. Partly because of many of documents are longer, partly because there are a number of them but mostly because the legal English used is opaque. Whilst there will be another post or two that examine them in detail, the most important document is the Homoeopathic Practitioners - (Professional Conduct, Etiquette & Code of Ethics) Regulations 1982

Code of Ethics
In short, homeopathy in India has statutory regulation. It is regulated by the Central Council of Homoeopathy (CCH) which has the power to discipline or even strike off homeopaths that do not abide the Code. To quote from the Code -
6.
(1)
Advertising
Solicitation of patients directly or indirectly by a practitioner of Homoeopathy either personally or by advertisement in the newspapers, by placards or by the distribution of circular cards or handbills is unethical. A practitioner of Homoeopathy shall not make use of, or permit others to make use of, him or his name as a subject of any form or manner of advertising or publicity through lay channels which shall be of such a character as to invite attention to him or to his professional position or skill or as would ordinarily result in his self-aggrandisement provided that a practitioner of Homoeopathy is permitted formal announcement in press about the following matters, namely :-
(i)the starting of his practice;
(ii)change of the type of practice;
(iii)change of address;
(iv)temporary absence from duty;.
(v)resumption of practice
(vi)succeeding to another's practice.
(2)He shall further not advertise himself directly or indirectly through price lists or publicity materials of manufacturing firms or traders with whom he may be connected in any capacity, nor shall he publish cases, operations or letters of thanks from patients in non-professional newspapers or journals provided it shall be permissible for him to publish his name in connection with a prospectus or a director's or a technical expert's report


Which effectively forbids any type of advertising than the specified. That it does not mention broadcast or online media is irrelevant. The internet and social media has many Indian homeopaths promoting themselves and their services in a aggrandising manner.

It could be argued that such a prohibition is anachronistic and that Indian homeopaths are in a competitive market and that if they did not advertise, they would get no business. This an argument for changing the Code, not for non-compliance.


12.Acts of Negligence
(1)No practitioner of Homoeopathy shall wilfully commit an act of negligence that may deprive his patient of necessary medical care.
(2)A practitioner of Homoeopathy is expected to render that diligence and skill in services as would be expected of another practitioner of Homoeopathy with similar qualifications, experience and attainments.
(3)His acts of commission or omission shall not be judged by any non-Homoeopathic standards of professional service expected of him but by those standards as are expected from a Homoeopath of his training, standing and experience.
(4)A practitioner of Homoeopathy shall use any drug prepared according to Homoeopathic principles and adopt other necessary measures as required.

This would appear problematic to most people but homeopathy is recognised as a form of medicine in India. It would still be possible for a patient to persue either civil or criminal legal procedings against a homeopath for neglience.
(12A)
Physician to obey law and regulation:-
A physician, -
(a)shall not act contrary to the laws regulating the practice of Homoeopathy;
(b)
shall not assist others to disobey the law regulating the practice of Homoeopathy;
(c)
shall act in aid of the  enforcement of sanitary laws and regulations in the interest of public health;
(d)shall comply with the  provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940), Drugs and Cosmetics Rules, 1945; the Pharmacy Act, 1948 (8 of 1948); the Narcotic Drugs and Psychotropic Substances Act 1985 (61 of 1985); the Medical Termination of Pregnancy Act, 1971 (34 of 1971), the Transplantation of Human Organ Act, 1994 (42 of 1994); the Persons with Disabilities (Equal Opportunity and Full Participation) Act, 1995 (1 of 1996) and Biomedical Waste (Management and Handling) Rules, 1998 and such other related Acts, Rules, of the Central Government or the State Government  or the Local Administrative bodies relating to protection and promotion of public health.
The importance of this will become apparent in the next post.

15.Prognosis
(1)The practitioner of Homoeopathy shall neither exaggerate nor minimize the gravity of a patient's condition. He shall ensure that the patient, his relatives or responsible friends have such knowledge of the patient's condition as will serve the best interest of the patient and his family.
(2)In cases of dangerous manifestations, he shall not fail to give timely notice to the family or friends of the patient and also to the patient when necessary.
Best interests?
17.Upholding honour of Profession
A practitioner of Homoeopathy shall, at all times, uphold the dignity and honour of this profession.
18.Membership of Medical Society
For the advancement of his profession a practitioner of Homoeopathy may affiliate himself with Medical Societies and contribute his time, energy and means to their progress so that they may better represent and promote the ideals of the profession.
19.Exposure of Unethical Conduct
A practitioner of Homoeopathy shall expose, without fear or favour, the incompetent, corrupt, dishonest or unethical conduct on the part of any member of the profession.
20Association with Unregistered Persons
A practitioner [*omitted] shall not associate himself professionally with any body or society of unregistered practitioners of Homoeopathy.
20 is problematic for some India homeopaths who are active on the internet. They do turn up in forums etc that also have non-medically qualified homeopaths present.

38.
.[* The following acts of commission or omission by a practitioner shall constitute professional misconduct and he shall be liable for disciplinary action, namely:-  
 
a)if the practitioner contravenes any of the provisions of these regulations; 
b)if the practitioner fails to display the registration number accorded to him by the State Homoeopathic Council or Board or the Central Council of Homoeopathy, as the case may be, in his clinic;
c)
if fails to maintain the records of prescription and certificates issued by him;
d)if commits the offence of adultery or misbehaves with a patient, or maintaining an improper association with a patient;
e)
if convicted by a court of law for offences involving moral turpitude;
f)
if signs or gives under his name and authority any certificate,  report or document of kindred character which is untrue, misleading or improper;
g)
if contravenes the provisions of law relating to the Drugs and Cosmetics Act, 1940 (23 of  1940) and the rules made thereunder;
h)if sells a drug or poison prohibited by the Drugs and Cosmetics Act,1940 (23 of 1940).
i)
if performs or encourages un-qualified person to perform abortion or any operation;
j)
if issues certificates in Homoeopathy to unqualified or  non-medical persons:
Provided that nothing contained in these regulations shall prevent or restrict the proper training and  instruction of legitimate employees of doctors, midwives, dispensers, attendants or skilled mechanical and technical assistants under the personal supervision of practitioners of Homoeopathy.
k)if affixes a signboard in the shop of a chemist or in a place where he does not reside or work;
l)
if discloses the secrets of a patient that have been learnt in the exercise of profession, except in a court of law under order of the presiding judge;
m)
if contravenes the guidelines issued by the concerned Council :
Provided that nothing contained in these regulations shall apply if he conducts the Clinical Drug Trials or other Research involving patients or Volunteers as per the guidelines of Council constituted for Homeopathy by the Central Government or State Government:
Provided further that in all cases regard shall be had to the ethical consideration.
n)
if publishes photographs or case-reports of patients in any medical or other journal:
Provided nothing contained in these regulations shall apply if the same is published with the consent of the patient or without disclosing his identity.
o)
if exhibits in public  the scale of fees:
Provided that nothing contained in these regulations  shall apply if he displays the same in the physician’s consulting or waiting room;
p)if he uses touts or agents for procuring patients;
q)
if he claims to be a specialist without possessing a special qualification in the branch concerned;
r)
if he contravenes the provisions of sub-regulation (4) of regulation 12;
s)
if he advertises or notifies the name of the institution or clinic in which no facility is offered, names of the diseases not treated;
t)
if he publishes the names or photographs of doctor running or attending the clinic or institution in the advertisement;
u)if he affixes a sign board unusually large in size and having on it anything other than the name of the practitioner and his qualification with the name of the awarding authority;
v)
if he refuses to treat the patients  on the grounds of  religion or caste:
Provided that nothing contained in these regulations shall apply if he writes for laying in the press under Provided that nothing contained in these regulations shall apply if he writes for laying in the press under his own name  in matters of public health, hygiene or occasionally delivers a public lecture, gives talks on television or radio relating to health or hygiene without suggesting specific treatment or prescription;
w)if he issues any certificate referred to in Appendix- 2 which is false, untrue, misleading  or improper, his name shall be removed from the Register of Homoeopathic Practitioners.
J) certainly is a problem with certain Indian homeopaths offering courses and certificates to the non-medically qualified. Yes, mostly outside of India. This is interesting enough in itself to justify a separate blog post. N) could also be problematic as it talks about "journals". Homepaths routinely post photos of patients on their websites and social media.

39.
* Disciplinary Action.—      
 
1)
If a homoeopathic practitioner commits any act of misconduct, the State Board may,.—
(a). take such disciplinary action as it thinks fit;
(b). remove his name from the Register of State Homoeopathic practitioners permanently or for specified period if convicted of any offence:
Provided that no action under this sub-regulation shall be taken without giving the practitioner a reasonable opportunity of being heard: 
Provided further that no complaint of misconduct under this regulation shall be maintained unless the complaint has been made to the State Board or State Council in the form of an affidavit on a non-judicial stamp paper of rupees one hundred, duly attested by a Notary Public or Oath Commissioner.
2)The State Board shall forward its decision referred to in sub-regulation (1)  to the Central Council.
3)
The aggrieved homoeopathic practitioner may prefer an appeal to the Central Council against the decision of the State Board and the Central Council may decide the case after giving the practitioner and the State Board an opportunity of being heard.
4)
The Council may direct the State Board to restore the name of the practitioner in the State Register after the expiry of the period for which the name of the practitioner was removed.
5)
The Council may restrain the practitioner from practicing homoeopathy during the pendency of the complaint.
6)
While deciding the complaint of professional incompetency, the Central Council shall take the opinion of peer group of practitioners as specified by the Central Council of Homoeopathy.
7)
No complaint against a practitioner for misconduct shall be allowed unless it is made within a period of six months from the date of the alleged misconduct.]

Conclusion
In short, advertising by Indian homeopaths is in breach of the CCH Code but it's not the only thing it is in breach of...

Thursday, 22 December 2016

Norway and Homeopathy

Currently, Norway has no specific legislation relating to homeopathic medicines. This is will change and will have major implications for Norwegian lay homeopaths.

Norway and the European Union
Although Norway is not a member of the EU, it is a member of the European Economic Area. In short, Norway implements much of EU law in order to gain access to the European Single Market. It has some key exemptions though that relate to fisheries and agriculture.

Regulatory Background
Norway does permit the practice of alternative therapies by the non-medically qualified although this is a recent innovation. Lov om alternativ behandling av sykdom mv (Law on Alternative Treatment etc) is the law in question. Fortunately, Google Translate does a very good job of turning it into English.

The key point about this law is that it prohibits the non-medically qualified from  -

  • Performing treatments or interventions that carry a serious health risk
  • Treatment of communicable diseases (although it does permit treatment to alleviate symptoms there of or side effects of conventional treatment - but only a medical professional can treat the disease itself.
  • Treatment of serious conditions and diseases (although, again, alleviation etc are permitted)
Where Norwegian law differs from UK law is that it makes doing any of the above a criminal offence, carrying possible fines and prison sentences. It also regards a patient not seeking proper treatment as the fault of the non-medical practitioner as well as making ignorance of putting a patient at danger inadmissible as a defence.

There are also restrictions on advertising which can only be a factual description of the business.

Norwegian medicines law does make mention of homeopathic medicines. Lov om legemidler m.v. (legemiddelloven) (Law on Medicinal Products, etc (Medicines Act)) is the main law but it doesn't explicitly mention homeopathy. Forskrift om rekvirering og utlevering av legemidler fra apotek (Regulations relating to the requisition and provision of medicines from pharmacies) mentions homeopathic medicines very briefly to say that they must carry a statement that the effects of the medicine are not "considered" or "rated". It talks in terms of homeopathic medicines that are available without prescription.

Forskrift om legemidler (legemiddelforskriften) (Regulation on Medicinal Product (Medicinal Products Regulations)) is probably the most important law. It came into force in January 2010. Again, Google Translate does a very good job of making sense of it. Some of it is very familiar, which is unsurprising. A cursory examination of the references reveals reference to EU Directives.

The law requires medicines to have a Marketing Authorisation. There are exceptions. The most important from the perspective of this article are -

  • Magistral formulas - medicines compounded by a pharmacy on according to a specification provided by a customer (although the nature of that customer is not clear ie medical professionals only?)
  • Officinal formulas - medicines compounded by a pharmacy in accordance with a pharmacopoiea for dispensing to customers of the pharmacy only.
  • Homeopathic medicines - providing them meet specific requirements.

This law allows the import of homeopathic medicines into Norway as long as they are registered in another EEA member country for a period of seven years. It also creates a Simplified Scheme for the registration of homeopathic medicines in the same manner as EU regulations. Norway does not have any homeopathic medicine manufacturers itself.

It places restrictions on the advertising of homeopathic medicines. As no claims are permitted, essential only flat lists are permitted.

Although the law provides exemptions for doctors and dentists to obtain medicines other than authorised/registered in Norway, in the case of homeopathic medicines it only allows those registered in other EEA member states.

It's also worth pointing out that Norway takes a strong line on the personal importation of medicines - effectively only allowing what is authorised/registered in Norway . Medicines can be seized and destroyed.

What is about to happen?
The seven year period is about to expire on 12/01/2017. The Statens legemeddelverk (SLV) will publish a list of homeopathic medicines registered up to that point. After a three month transition period, anything not on that list will not be permitted to be sold. How many registered homeopathic medicines will be on that list is unknown. Whilst the registration fees are set at a nominal level, the preparation of documentation is onerous (even if SLV will accept English). Norway is a small market and homeopathy is much less common than some other EEA member states. It does not seem likely that many products will be registered.

The supply of homeopathic medicines could be restricted to a handful of products. This has implications for both lay and medical homeopaths. It could make practice very difficult if not impossible.







Tuesday, 6 December 2016

Regulation in Eire

Irish law relating to homeopathic medicines is similar to UK law. This is not surprising given a lot of it comes from EU Directives. However, Irish law is structured differently. The situation in Eire is potentially more problematic than in UK.

Recognition of Homeopathy
The situation regards the recognition of homeopath is largely the same as in the UK. As a partly common law jurisdiction, Eire does not prohibit the practice of homeopathy but does not it recognise it or its practitioners. A lay homeopath in Ireland has no special status. They are just another member of the public. Medically qualified homeopaths are recognised because of their qualifications and registration.

Medicines Regulation
Eire, like the UK, implemented EU Directive 92/73/EEC which was replaced by 2001/83/EC. Both are long documents. Article 13 of the later states
1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.
This also imposes the duty on Member States to ensure that unregistered or unauthorised homeopathic medicines are not placed on the market. In the case of Eire, these duties fall to the Healthcare Products Regulatory Agency. This Directive also provides an exemption for medicines prepared in a pharmacy under certain conditions.

In terms of Irish legislation the Medicinal Products (Control of Placing on the Market) Regulations 2007 is a good place to start. Irish legislation is a little hard to follow as it comes in multiple regulations.

PART 2 AUTHORISATION AND CERTIFICATION FOR PLACING ON THE MARKET
Requirement for an authorisation or certificate to place a medicinal product on the market.
6. (1) Subject to the provisions of these Regulations, a person shall not place a medicinal product on the market unless such product is the subject of—
(a) a marketing authorisation,
(b) a Community marketing authorisation,
(c) a certificate of registration, or
(d) a certificate of traditional-use registration,
and, in each case, such authorisation or certificate is for the time being in force.
(2) A person shall not in the course of a business carried on by him, sell, supply, manufacture, or procure the sale, supply or manufacture or have in his possession a medicinal product unless he or she has reasonable cause to believe that the product was or is intended to be—
(a) placed on the market in compliance with paragraph (1), or
(b) placed on the market in another EEA State in accordance with the corresponding provisions as required by that State pursuant to the 2001 Directive.

A certificate of registration is for homeopathic medicines.

Authorisation of homeopathic medicinal products under national rules.
11. (1) Notwithstanding the provisions of Regulations 9 and 10 insofar as those provisions relate to the requirements for pre-clinical tests and clinical trials, the Board may grant a marketing authorisation in respect of a homeopathic medicinal product other than a product referred to in Article 14.1 of the 2001 Directive.
(2) For the purposes of obtaining an authorisation in accordance with this Regulation and subject to paragraph (3), the applicant shall demonstrate to the satisfaction of the Board—
(a) that the product is a homeopathic medicinal product which conforms with the principles and characteristics of homeopathy as practised in the State;
(b) that the indication sought is appropriate to such a homeopathic medicinal product;
(c) that any such indication shall be suitable for use without the intervention of a registered medical practitioner for diagnostic purposes or for prescription or for the monitoring of treatment;
(d) that the efficacy of the product shall be established on the basis of evidence that the particular class of homeopathic medicinal product has been in use in the State as a homeopathic treatment for the indication sought; and
(e) that the safety of the homeopathic medicinal product has been established in the manner set out in paragraph (3).
(3) For the purpose of this Regulation and subject to subparagraph (4), the safety of the homeopathic medicinal product shall be demonstrated—
(a) by reference to relevant published literature or original data having regard to the proposed route of administration and the dilution involved; or
(b) in the case of stocks derived from substances commonly used in food, by means of a statement setting out the homeopathic nature of the product and the absence of any change to the route of exposure for the substance concerned; or
(c) in the case of an active principle used in allopathic medicinal products, by establishing that the dilution of the stocks is at least 1 in 10,000 of the mother tincture or not more than one hundredth of the smallest dose of the said active principle as used in allopathy; or
(d) by establishing that the medicinal product contains not more than one part per 10,000 of the mother tincture.
(4) In regard to the active principles referred to in subparagraphs (3)(c) and (d), the Board may refuse to grant an authorisation where it is satisfied that the active principle concerned is toxic and as such would present concerns in regard to the safety of the product. For the purposes of this subparagraph, the Board may publish and update from time to time a list of the substances that it considers to be in this category.
(5) A homeopathic medicinal product that is placed on the market on foot of a marketing authorisation granted in accordance with this Regulation shall, in addition to compliance with the requirements of Regulation 16 (relating to labelling and package leaflets), be presented in such a manner as to show—
(a) that the product is a homeopathic medicinal product in respect of which an authorisation has been granted in accordance with this Regulation;
(b) that any evidence of efficacy on the part of the product has not been based on the outcome of clinical trials;
(c) that use of the product is only intended for the symptomatic relief of the condition to which the indication specified relates; and
(d) that the user is advised to consult a doctor or other healthcare professional if the symptoms persist.

This is roughly the same as the National Rules scheme in the UK.

SCHEDULE 1 EXEMPTIONS FROM THE AUTHORISATION AND CERTIFICATION REQUIREMENTS OF REGULATION 5
2. The provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to the sale or supply of a medicinal product in response to a bona fide unsolicited order, formulated in accordance with the specifications of a practitioner for use by his individual patients on his direct personal responsibility, in order to fulfil the special needs of those patients, but such sale or supply shall be subject to the conditions specified in paragraph 3.
3. The conditions referred to in paragraph 2 are that—
(a) the medicinal product is supplied to a practitioner or for use in a pharmacy under the supervision of a pharmacist, in accordance with paragraph 2;
(b) no advertisement or representation relating to the medicinal product is issued with a view to it being seen by the general public in the State and that no advertisement relating to the product, by means of any catalogue, price list or circular letter is issued by, at the request or with the consent of, the person selling the product by retail or by way of wholesale dealing or the person who manufactures it, and that the sale or supply is in response to a bona fide unsolicited order;
(c) the manufacture of the medicinal product is carried out under the supervision of such staff and such precautions are taken as are adequate to ensure that the product is of the character required by and meets the specifications of the practitioner who requires it;
(d) written records as to the manufacture in accordance with subparagraph (c) are made and maintained and are available to the Board on request;
(e) if the medicinal product is manufactured in the State, or imported into the State from a third country, the product—
(i) is manufactured or imported by the holder of a manufacturer’s authorisation which relates specifically to the manufacture or import of the medicinal product to which paragraph 2 applies; or
(ii) has been manufactured or imported as an investigational medicinal product by the holder of a manufacturing authorisation granted by the Board in respect of such products under Regulation 37 of the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 or Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007; and
(f) the medicinal product is distributed by way of wholesale dealing by the holder of a wholesaler’s authorisation or by the person who has manufactured or imported the product, being the holder of a manufacturer’s authorisation which relates specifically to the manufacture or importation of the medicinal product concerned.
4. (1) Subject to the following subparagraphs, the provisions of paragraphs (1) and (2) of Regulation 6 shall not apply to anything done—
(a) by a practitioner which relates to a medicinal product specially prepared by him, or to his order, for administration to one or more of his patients, and consists of procuring the manufacture of a stock of the product with a view to administering it to such patients; or
(b) in a pharmacy and is done there by or under the supervision of a pharmacist, and consists of procuring the manufacture of a stock of medicinal products with a view to dispensing them in accordance with paragraph 2.
(2) The exemption conferred by subparagraph (1) shall not apply to procuring the manufacture of medicinal products unless those products are to be manufactured by the holder of an authorisation referred to in Article 40 of the 2001 Directive which relates specifically to the manufacture of the medicinal products to which paragraph 2 applies.
(3) The exemption conferred by subparagraph (1) shall not apply to anything done by a practitioner in relation to a stock held by him or her of such medicinal products in excess of 3 litres of fluid and 1 kilogram of solids of all medicinal products to which that subparagraph relates.

Critically the definition of a "practitioner" is given as "a registered dentist or a registered medical practitioner".


4 Exemptions from the requirement that medicinal products be licensed

4. The provisions of article 3 shall not apply as respects —
(a) the sale of a medicinal product by a person lawfully keeping open shop for the dispensing or compounding of medical prescriptions or for the sale of poisons under the Pharmacy Acts, 1875 to 1977 where such sale is carried out and the product is extemporaneously compounded by or under the supervision of a pharmacist for such particular sale;
(b) the importation or sale of a medicinal product by or to the order of a registered medical practitioner or registered dentist for the treatment of a patient under his care;
(c) the importation of a medicinal product by any person for his own personal use, not being an importation resulting directly from a mail order advertisement directed to members of the public;
(d) the importation or sale of a medicinal product solely for the purpose of its being exported;
(e) the manufacture or importation of a medicinal product which is intended for use in the conducting of a clinical trial, in accordance with a permission granted under section 4 of the Control of Clinical Trials Act, 1987 (No. 28 of 1987).

(a) would appear to grant an exemption to pharmacies. The meaning is not entirely clear. It could be read as applying only to transactions that take place in a pharmacy. The Regulations 1998 do not provide a definition of "medical prescription" but it could be understood as a prescription provided by a registered medical practitioner.

8 Homeopathic medicinal product

8. (1) The Board may grant or renew a certificate of registration in respect of any homoeopathic medicinal product which satisfies the conditions set out in sub-article (2) to any person who makes application in writing for such certificate and for such purpose the information, documents, samples and other material required by the Board shall be as specified in the Third Schedule.
(2) Subject to sub-article (3), the conditions to be met for the purpose of registration under sub-article (1) are that the homoeopathic medicinal product shall be such that-
(i) it is intended to be administered orally or externally;
(ii) no specific therapeutic indication appears on the labelling of the product or in any information relating thereto; and
(iii) there is a sufficient degree of dilution to guarantee safety.
(3) The homoeopathic medicinal product shall not be considered to have a sufficient degree of dilution to guarantee safety if -
(i) in the case of a medicinal product containing an active principle the presence of which in an allopathic medicinal product would, by virtue of the Medicinal Products (Prescription and Control of Supply) Regulations, 1996 (S.I. Nos. 256 and 309 of 1993), require the presentation of a prescription issued by a registered medical practitioner in order that the said product may be supplied, if it contains either more than one part per 10,000 of the mother tincture or more than one hundredth of the smallest dose of the said active principle as used in allopathy, or
(ii) in any other case, if it contains more than one part per 10,000 of the mother tincture.
(4) The registration referred to in sub-article (1) shall be subject to the conditions specified in the Fourth Schedule.
(5) Unless sooner revoked by the Board, the aforementioned registration shall normally remain in force for a period of five years and may be renewed on application made by the holder thereof not later than three months before the date of expiry of the certificate concerned.
(6) The provisions of Articles 5 and 9 shall apply to homoeopathic medicinal products to which this article relates as if the references in those articles to efficacy and therapeutic efficacy had been omitted.
Which is the equivalent of the UK Simplified Scheme.

The Problem
It would appear that the supply to and by lay homeopaths of unregistered homeopathic remedies in Eire is of dubious legality.

There would appear to be no pharmacy that compound homeopathic medicines and even if there were, it seems unlikely that they could supply lay homeopaths.

There appears to be one manufacturer of homeopathic medicines in Eire. New Vistas Healthcare and it has the most curious website. It restricts access to certain product listings to those registered with the site. There is an application form on the site which includes the curious wording.
Approved users are able to access the secure Practitioner Support section. Approved users will also be able to access the full product range on the online shop. All customers wishing to buy products need to be approved as legally we are only permitted to ship to an end user who is under the guidance of a trained therapist or a qualified and approved professional themselves.
This would appear not to be the case. It would appear that they can only supply registered medical practitioners.