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.

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 -
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.
Physician to obey law and regulation:-
A physician, -
(a)shall not act contrary to the laws regulating the practice of Homoeopathy;
shall not assist others to disobey the law regulating the practice of Homoeopathy;
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.

(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.

.[* 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;
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;
if convicted by a court of law for offences involving moral turpitude;
if signs or gives under his name and authority any certificate,  report or document of kindred character which is untrue, misleading or improper;
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).
if performs or encourages un-qualified person to perform abortion or any operation;
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;
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;
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.
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.
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;
if he claims to be a specialist without possessing a special qualification in the branch concerned;
if he contravenes the provisions of sub-regulation (4) of regulation 12;
if he advertises or notifies the name of the institution or clinic in which no facility is offered, names of the diseases not treated;
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;
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.

* Disciplinary Action.—      
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.
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.
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.
The Council may restrain the practitioner from practicing homoeopathy during the pendency of the complaint.
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.
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.]

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...

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