Tuesday, 28 February 2017

The Registration Society of Homoeopathy, UK

This organisation was overlooked in a previous post. Rather than update that post, the organisation's website will be considered in more detail, highlighting breaches of both UK and Indian regulations and legislation. It is worth noting that this organisation will be the subject of complaints to various bodies. This post will also make mention of links to other businesses.

It is worth noting that all the information here is in the (very) public domain. 

What is the Registration Society of Homoeopathy, UK
The Registration Society of Homoeopathy, UK (RSHUK) claims to be -
Registration Society of Homeopathy, UK (RSH UK), is a registered, international organization for accreditation of homeopathic professionals. The society represents as a professional and ethical body to recognize and regulate the professional standards of its members by virtue of membership/fellowship and continued medical education. The professional and fellow members undergo examination before awarding the society membership. This enables a competitive and learning environment which helps practitioners gain an edge for their clinical expertise and homeopathic knowledge.
Which doesn't say a lot. 


Who are the Registration Society of Homoeopathy, UK
One of the first places to look to determine who is behind an organisation is Companies House. RSHUK is a limited company and details and filed documents can be found here. Most importantly, it gives the list of directors.
  • Harjit Singh Sidhu - UK resident, no obvious online profile, director of at least two other companies. Former Director of of the Homeopathic Medical Association.
  • Dr Saurav Arora - who is resident in India. Mr Arora has a profile here.
  • Dr Satinder Pal Singh Bakshi - again resident in India. Mr Bakshi has a profile here.
  • Dr Sandeep Paila - India resident, profile here
  • Harsharan Kaur Sidhu - UK resident, no obvious online profile but director of at least 10 other companies. Member of the Council of the HMA. Director of HMA.
Additionally, the "faculty" listing includes -
  • Dr Isabelle Grafin Grote - UK resident, profile here. Would appear to be a naturopath - not GMC registered.
  • Dr Jagjit Ram - UK resident, several directorships. Member of HMA. Former Director of HMA. No obvious online profile.
  • Barbara Sharma - UK resident, possibly this person.
  • Dr Mridul Kumar Sahani - India resident
  • Phil Hughes - UK resident. Member of Alliance of Registered Homeopaths (ARH). Best known for this and this .
  • Hafeez Bhatti - unknown status.
  • Dr Ileana Rindasu - Romania resident. Medical doctor
  • Dr Vasilka Yurukova - Bulgaria resident. Medical doctor. Profile here.
  • Dr Kamal Puri - India resident. No obvious online profile.
  • Dr Surjit Singh Makkar - India resident. Qualified vet. Profile here.
  • Dr Anwar Amir Ansari - India resident. Profile here.
  • Dr Leoni Bonamin - Brazil resident. Qualified vet. No useful online profile.
  • Dr Geeta Rani Arora - India resident. Profile here.
The http://rshuk.com/ domain would appear to have been registered by Saurav Arora.

What do they actually do?
Their purpose is not terribly clear. Their objectives state -

  • To recognize and regulate the professional standards of members by virtue of membership/fellowship: MRSH & FRSH UK respectively.
  • To recognize educational institutions of Homoeopathy located in United Kingdom and other parts of the world.
  • To promote and support facilities for the education of persons desirous of learning homoeopathy and biochemic system of medicine in United Kingdom.
  • To organize seminars & conferences nationally & internationally, for supporting the dissemination of authentic homoeopathic practices worldwide.
  • To establish a Code of Ethics to maintain high professional standards of practice amongst qualified homoeopathic practitioners (See Code of Ethics).
  • To facilitate the exchange of homoeopathic knowledge in the form of International clinical exposure worldwide.
  • To publish an international directory of qualified practitioners of homoeopathy registered with RSH UK.
  • To provide free homoeopathic consultation; to establish charitable clinics and arrange free camps for the needy.
  • To increase public awareness and acceptance of homoeopathy internationally as a safe and effective system of medicine.
So, except for providing free homeopathic consultation, not that different from UK homeopathic trade associations?

Joining the RSHUK is somewhat different to other trade associations. Rather than being accepted purely on the basis on qualifications gained from an "approved" institution (or a cumbersome individual assessment process), RSHUK also requires an online exam. It could be the case that the exam is skewed towards Indian homeopaths, which might make it difficult for UK lay homeopaths to pass. Also, note that taking the fee for the examination is non-refundable. RSHUK talks about -
Eligibility: Candidates applying for the MRSH must have a Diploma or Degree from a recognized school/university/college of homeopathy. In addition, experienced homeopaths who previously had Diploma in homeopathy, and are in regular homeopathic practice for at least 5 years may be accepted for the membership by submitting curriculum vitae, letters of reference and a compilation of 5 case studies. If the basic requirements are met, a written(online) exam/interview will be conducted for granting membership. Applicants need to show competence in written and spoken English and use of computers. C.V., evidence/copies of valid certificates must be appended with the application.
Um. Recognised by who? Also, it appears that the website wants payment for the exam before any checking takes place and sneakily charges a 4% processing fee. 

The fees for membership are for five years. They are not refundable under any circumstances. This is unusual in that other trade associations have annual fees. One problem with this is that the RSHUK may go out of business. Some of the people associated with RSHUK have a history of involvement with failed companies - as will be discussed later. 

There is talk in the terms of use of some sort of "course" -
Cancellations & ReturnsThe membership fee in NOT REFUNDABLE under any circumstance. However, course fee may be refunded as per details below:
Within one month of registration to course: Full amount, subjected to deduction of 5% (Administrative Fee)
Within three months of registration to course: 50% of the total amount
Beyond three months: NO REFUND
But RSHUK do not seem to offer a course. Webinars? Yes but is unclear whether there are any Seminars and conferences? Well, there don't seem to be any scheduled.

RSHUK say that they offer an insurance scheme via Balens. It is not necessary to join a trade body to get insurance but it can result in a discount although that is likely to be more than offset by the cost of being a member of the trade body. Interestingly, RSHUK does not insist on insurance, merely stating that is the responsibility of the member to be insured.

What the RSHUK seems to offer that is unusual are internships.
For full members, we provide a clinical Internship of 3 weeks at following locations*Homeopathy Health Clinic, Hounslow, London, England.Bakson Homeopathic Medical College and Hospital, Greater Noida, UP, India.
The aim of this clinical internship is to provide a clinical exposure to our members at International level. The internship and accommodation shall be provided for free, but a member has to bear the travel and visa formalities on his/her own.
The Homeopathy Health Clinic will be discussed later. Visa formalities may be a problem. For those wanting to do the UK internship, this represents no problem to European Economic Area (EEA) citizens but does for those outside. A Tier 5 visa would be required and may not be permitted. Coming in on a tourist visa would risk deportation. India visa requirements for interns are unclear to say the least.

Problems
Apart from misleading claims in the website, the main problem is that Indian homeopaths registered with the Central Council for Homoeopathy (CCH) would potentially be in breach of the Code of Ethics which forbids professional association with non-registered homeopaths. It is unclear whether the CCH would regard online activities as ultra vires but offering internships in India is a completely different matter.

The RSHUK Code of Ethics could be a problem in itself. 
It is the responsibility of Members to be acquainted with and comply with the Laws of their country, as they apply to the practice of homeopathy. Overseas Members must abide by the laws of the country in which they practice.
This is uniformly a problem with homeopaths in pretty much every country. It is worth bearing in mind that the CCH Code of Ethics has the force of law in India. The section on advertising reads -
Members may advertise their professional services as follows: 
  • Name Plates of a modest size may be displayed outside the Member’s clinic. 
  • No Member may use the title Doctor or Physician in their Homeopathic advertising unless entitled to do so in their country. In the UK unless registered with the General Medical Society. 
  • If the title Dr is used in other forms of advertising, then it must be stated clearly what the qualification refers to (e.g. Ph.D.). 
  • Advertising must be discreet and not designed to mislead the public. 
  • No advertisement may claim or imply any superiority over the professional services provided by other practitioners, nor give the impression that the Member is a specialist in the treatment of a particular disease. 
  • No advertising may be used that claims to cure named diseases in accordance with the laws of their country. 
  • No Member may use their Association membership in the commercialization of any product or remedy.
  • Members who write articles or broadcast homeopathy must make clear that their views do not necessarily reflect those of the RSH UK.
What legislation and regulations permit for UK advertising of homeopathy is well understood. However, what non-UK members may not realise is that breaching advertising regulations in their own country could lead to RSHUK disciplinary action. Although the RSHUK has no power, per se, as the membership fees are non-refundable, it is money down the toilet.

There is also the question of what impact the RSHUK could have on other homeopathic trade bodies. 

Links to other Organisations
So say that the links between various individuals and organisations is complex would be a gross understatement. Some of the individuals named above have been involved with all sorts of schemes, most of which have gone absolutely nowhere. And some of the other people involved in those schemes are linked to other schemes. Any attempt to map this gets out of control so only fairly direct links are considered.

Harsharan Kaur Sidhu is a current/former director of the following companies -
Harjit Singh Sidhu is the current/former director of these additional companies where Harsharan Kaur Sidhu is not.
And there are possibly a few other companies with these two as directors under slightly different names.

Homeopathic Health Clinic


The purpose of the rather obvious doctoring of this photo is unclear but this is the Homoeopathic Health Clinic (HHC), which is presumably where Harsharan Kaur Sidhu is based. The doctored photo shows Baksons UK logo - see above - and also "Dr Herbals UK". There is a Companies House record which shows the company has been dissolved. The drherbalsuk.com domain isn't working but is registered to Harjit Singh Sidhu via Homoeopathic Essentials Ltd. There is a Wix shop. The above photo is fairly high res - the post in the window seems to list Dr Herbals UK products.

It would be easy to poke fun at the website and the associated ones. That is not the purpose of this post.

There is a downloadable brochure associated with the Wix shop. It is easier to examine that the website. Dr Herbals UK show a UK flag on their marketing. It seems unlikely that these products are produced in the UK. The style of the graphics is similar to what is seen in Indian marketing. The packaging shown is not consistent with EU standards for Traditional Herbal Medicines. But it is very, very similar to that of Dr Homoeopaths - Harjit Singh Sidhu again. The guest list for his presentation includes some familiar names, including Jagjit Ram and Shashi Mohan Sharma.

The American Homeo Herbal Inc on the mock up of packaging is a dissolved company listed in California. The name Harjit S Sidhu appears in the paperwork. The purpose of the company was supposedly the manufacturing of herbal products.

Conclusions
It is unsurprising that Indian homeopaths resident in the UK have links to those resident in India. Neither is it particularly surprising that business ventures are attempted, even if most of them seem to come to nothing. 

Importing Indian healthcare and beauty products is a lot more difficult than it might first appear. Licences have to be applied for, GMP certification is required and products may need to be tested or registered in the UK before they can be placed on the market. It's not a quick or easy process. Nor is it inexpensive.

Setting up UK trade bodies for homeopaths is notionally easier (and cheaper) but it does require active attempts at recruiting members. Some evidence suggests that the number of UK homeopaths is in decline. Certainly, the Society of Homeopaths have said that their numbers are dropping as their members retire and there are fewer new homeopaths joining. For India homeopaths in the UK, the Homeopathic Medical Association is a much better option than the RSHUK.

UPDATE:
Mention of a mysterious Bakson College of Homoeopathy UK is being made on various homeopathy websites - an example here. It would be appear, on face value a joint venture between the RSHUK and the Bakson organisation. The article referenced gives a web address to a page on the RSHUK website that currently does not exist. No mention is made of the "college" on either the RSHUK website or the Bakson website.

This does not suggest a thought through marketing strategy.

The office of the Bakson College of Homoeopathy UK would appear to be the shop/clinic above.

There is an "official" opening event to be held at the University of West London or rather in a room rented from them. Some have suggested that groups like RSHUK hold events at universities as opposed to other venues because of the halo effect. Some critics of homeopathy do get upset about this. One argument is that hosting pseudo-scientific medicine events is an offense to academics/scientists/medics who work at the institution. Another is the risk of reputational damage. 

But there is already a "homoeopathic college" in that part of the world - the Hahnemann College of Homeopathy the principal of which is the above mentioned Shashi Mohan Sharma. Would the Bakson College draw away potential students? Unlikely on the basis that the Bakson College of Homoeopathy UK is likely to fail even before it gets started but even so.


Saturday, 25 February 2017

International Concerns about Indian Homeopathy

It may seem curious that a UK-based blog takes an interest in Indian regulation of homeopathy but there are some very good reasons for this. There are some concerns that not only apply to the UK but to many Anglophone countries.

Misrepresentation of Qualifications
Whilst India and a number of other countries recognise homeopathic qualifications, the vast majority do not. This means that in those countries, Indian homeopaths are not considered medically qualified in anyway. Depending on jurisdiction, they may not be permitted to practice at all (medical practice being restricted to those with a medical degree and registration). In some jurisdictions, such as the UK, anyone call practice but they are not allowed to imply that they have a medical qualification. They are treated the same as any other medically unqualified person. Any one can call themselves a "homeopath" without qualifications of any kind. In some of these jurisdictions, the title of "Doctor" or its equivalent is protected by law - only those with the appropriate qualifications can use it. Even if this is not the case, advertising regulators take a dim view of the use of "Doctor" in a healthcare setting as it has the potential to mislead the public.

There is a problem in the UK with Indian homeopaths either practicing here or visiting the UK from India to give lectures, etc, using the "Doctor" title. Some of them are obviously aware of the issue as they include disclaimers in their advertising stating that they are "Doctors of Homeopathy", usually in small print somewhere. It is also known that various Indian homeopaths have be told about restrictions on the use of the title but still go on using it.

There are questions relating to how Indian homeopaths end up practicing in countries that have eligibility criteria for immigration. Their qualifications are not recognised. It could be the case that they can immigrate on the basis of a spouse's qualification but then again, possibly not.

Some Indian homeopaths who appear to be largely resident in the UK seem to retain their registration with the Central Council of Homopathy (CCH) in India. This has the potential to cause problems.

Training and Courses
From the above, any advertising of training and courses that involve an Indian homeopath using the title "Doctor" would be as problematic as in the healthcare scenario. There have been problems with the naming of the qualifications handed out as a result. For example, in the UK only universities have the ability to award degrees. A course run by a listed college etc actually comes from a university.

Diploma mills have existed in the UK and still pop up from time to time but the Internet allows distance "learning" and it is true to say that some Indian homeopaths have been involved with such organisations.

For those Indian homeopaths that still maintain CCH registration, offering courses in the UK is problematic. The Homoeopathic Practitioners - (Professional Conduct, Etiquette & Code of Ethics) places many restrictions on what they can do. Firstly, it is considered professional misconduct if...
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.
This would apply to the Allen College of Homeopathy. "Dr" Banerjea still maintains his CCH registration. Quite likely, it would include any Indian homeopathy with CCH registration involved with any UK homeopathy course.

There is little point in setting up a homeopathy course aimed at potential "practitioners" unless the qualifications are recognised by one or more of the trade bodies in the UK. However the CCH Code of Ethics also states...
20 Association with Unregistered Persons
A practitioner shall not associate himself professionally with any body or society of unregistered practitioners of Homoeopathy.
Which is unfortunate.

It is also the case that some UK resident homeopaths have been involved in schemes to offer Indian resident homeopaths UK qualifications. This is problematic for the UK based ones if they still retain CCH registration (issuing certificates) and for the Indian residents if they do not (consorting with the unregistered). Perhaps the answer lies in this quote -


Q: What are the employment opportunities once we pursue the course??A: As mentioned above the degree will help you to practice in places like US,UK,CANADA,NEW ZEALAND and many such places where homoeopathy is slowly gaining ground. In addition if you don’t practice on the foreign land and decide to stay back in India, the degree will add a prestigious value to your current B.H.M.S OR MD DEGREE. Another important aspect of the same issue is that we will provide post course guidance once the entire course is over and also keep you informed of the possible vacancies owing to which newly passed out homoeopathic graduates can benefit a lot like MD. But MD course will not enable you to practice in US, UK OR EUROPE.
Absolutely not true on all counts. Fortunately, the associated website is dead. However, the organisation behind this still offers distance learning courses including one aimed at Indian homeopaths although it does not make any claims about allowing practice in other countries.

Trade Bodies
The three largest trade associations in the UK are the Society of Homeopaths (SoH), Alliance of Registered Homeopaths (ARH) and the Homeopathic Medical Association (HMA). The latter seems the most popular with Indian homeopaths in the UK. But any Indian homeopaths maintaining CCH registration would breach the Code of Ethics by doing so as would associating with any of these groups in any way.

Interestingly, India homeopaths in the UK have attempted to set up Trade Associations only to fail. The World Homeopathic Association - London is one example but there have been others. The Indian man in the photo is Shashi Mohan Singh who seems very entrepreneurial as well as appearing in a Bollywood film.

It works the other way around with Indian resident homeopaths. The International Homoeopathic Foundation would seem to be an all Indian affair although, again, Shashi Mohan Singh seems to be involved. Membership would appear to be open to non-Indian homeopaths but again this would be a breach of CCH Code of Ethics as are the foreign guests at their conference.

Trips to India
Some UK homeopaths proudly proclaim that they have been to India. This trip did not involve the UK homeopaths treating any patients but associating with members of the HMA would have put the Indian homeopaths in a tricky situation.

The Allen College of Homoeopathy is far more problematic as it offers a programme in India which involves "80+ hours of CPD & Clinical hours Certificate". Subrata Kumar Banerjea maintains his CCH registration. The website breaches multiple regulations and legislation both from a UK and Indian perspective. It would take a voluminous article to describe them all. He is also involved with Bengal Allen homeopathic medicines and has the Bengal Allen Medical Institute - readers of a sensitive nature may find some of the images disturbing.

Export of Homeopathic Medicines
Although as was explained in a previous post, there are no explicit regulations regarding export of homeopathic medicines, purchasers do need to be aware of importation regulations in their own country. This post covered the UK, this one Ireland and most draconian of all, this one covered Norway. What these jurisdictions have in common is the requirement for the manufacturer to have Good Manufacturing Practice (GMP) certification and for the homeopathic medicines to be registered with the medicines regulator. Norway pretty much forbids personal importation but the UK and Ireland do not. However, importing the medicines and placing them on the market in the UK does occur - one example is this and there are some others.

US regulation is different, and will be covered in a future post but the requirement for GMP is there. Also, only a limited number of ingredients are permitted - the ones in the Homoeopathic Pharmacopoeia of the United States and only indications for self-limiting conditions are permitted.

Test Complaints
The attitude towards these problems by regulators is largely unknown. The only way to determine this is by making test complaints. It is suspected that in many cases regulators will be indifferent. 




Monday, 20 February 2017

Regulation in India #3

This post will deal with advertising and consumer protection. Compared to certain Western European countries, legalisation and regulation are much less developed and enforcement is at best haphazard.

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
This is arguably the most important piece of legislation covering advertising of homeopathic medicines as it places absolute prohibition on advertising medicines for certain diseases. Court cases do rarely occur but the sheer volume of advertising that breaches the Act 1954 is indicative.
3. Prohibition of Advertisement of Certain Drugs for Treatment of Certain Diseases and Disorders.– 
Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for –  
a) the procurement of miscarriage in women or prevention of conception in women; or  
b) the maintenance or improvement of the capacity of human beings for sexual pleasure; or 
c) the correction of menstrual disorder in women; or  
d) the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called) which may be specified in the rules made under this Act:  
Provided that no such rule shall be made except,– 
(i) in respect of any disease, disorder or condition which requires timely treatment in consultation with a registered medical practitioner or for which there are normally no accepted remedies, and  
(ii) after consultation with the Drugs Technical Advisory Board constituted under the Drugs and Cosmetics Act, 1940 (23 of 1940) and, if the Central Government considers necessary, with such other persons having special knowledge or practical experience in respect of Ayurvedic or Unani systems of medicines as that Government deems fit.
This is very clear. The Act 1954 allows Central Government to add additional rules forbidding advertising for conditions that require urgent consultation as long as they take advice. The Schedule lists various diseases/conditions.


1. Appendicitis 
2. Arteriosclerosis 
3. Blindness 
4. Blood poisoning 
5. Bright’s disease 
6. Cancer 
7. Cataract 
8. Deafness 
9. Diabetes 
10. Diseases and Disorders of brain 
11. Diseases and Disorders of the optical system  
12. Diseases and Disorders of the uterus  
13. Disorders of menstrual flow  
14. Disorders of the nervous system 
15. Disorders of the prostatic gland 
16. Dropsy 
17. Epilepsy 
18. Female diseases (in general) 
19. Fevers (in general)  
20. Fits 
21. Form and structure of the female bust 
22. Gall stones, kidney stones and bladder stones  
23. Gangrene 
24. Glaucoma 
25. Goitre 
26. Heart diseases 
27. High/Low Blood Pressure 
28. Hydrocele 
29. Hysteria 
30. Infantile paralysis 
31. Insanity 
32. Leprosy 
33. Leucoderma 
34. Lockjaw 
35. Locomotor ataxia 
36. Lupus 
37. Nervous debility 
38. Obesity 
39. Paralysis 
40. Plague 
41. Pleurisy 
42. Pneumonia 
43. Rheumatism 
44. Ruptures 
45. Sexual impotence 
46. Smallpox 
47. Stature of persons 
48. Sterility in women 
49. Trachoma 
50. Tuberculosis 
51. Tumours 
52. Typhoid fever 
53. Ulcers of the gastro-intestinal tract 
54. Venereal diseases, including syphilis, gonorrhoea, soft chancre, venereal granuloma and lympho granuloma.

This list uses obsolete terms for certain conditions/diseases - not that it matters terribly in the context of this post. Some of the terms have very broad scope and potentially cover many different conditions/diseases. Asthma and AIDS were added at a later date.

As mentioned in the previous post, whilst the Drugs and Cosmetics Acts 1940 and the Drugs and Cosmetics Rules 1945 do not forbid the labelling of homeopathic drugs with indications, it would be a breach of the Act 1954 to present advertising that contained images of packaging that displayed indications for the prevention, treatment or cure of any of the above, let alone any textual claims accompanying such images.

The question as to whether a registered homeopathic practitioner could make claims to treat any of the above conditions/diseases without mentioning specific homeopathic medicines is difficult to answer. If the interpretation of the "any medicine" is any specific medicine then, perhaps, it might be permitted but this is a very generous interpretation. It is clear that certain authorities do more broadly interpret "any medicine" as to mean any homeopathic medicine that the homeopathic practitioner may select. Put another way, it is not the specific medicine that matters but the claim to prevent, treat or cure with homeopathic medicine.
4. Prohibition of Misleading Advertisements Relating to Drugs.– Subject to the provisions of this Act, no person shall take any part in the publication of any advertisement relating to a drug if the advertisement contains any matter whicha) directly or indirectly gives a false impression regarding the true character of the drug; or b) makes a false claim for the drug; or c) is otherwise false or misleading in any material particular.
Again, this is very clear and mirrors some of the provisions in Act 1940. "any part" also places responsibility on anyone involved in the creation and publication of an advertisement, which would include newspapers and web hosts, etc. It would also cover distribution of such advertising via email and social media. For example, those retweeting advertisements on Twitter could be send as in breach of the Act 1954.
6. Prohibition of Import into, and Export from, India of Certain Advertisements.– No person shall import into, or export from, the territories to which this Act extends any document containing an advertisement of the nature referred to in section 3, or section 4, or section 5, and any documents containing any such advertisement shall be deemed to be goods of which the import or export has been prohibited under section 19 of the Sea Customs Act, 1878 (8 of 1878) and all the provisions of that Act shall have effect accordingly, except that section 183 thereof shall have effect as if for the word ‘shall’ therein the word ‘may’ were substituted.
The Act 1954 was written long before the advent of the Internet and satellite television. Whilst it would obviously be an offence to import/export documents such as brochures, newspapers and magazines with such advertising, it could be argued that electronic transmission could also be covered by this. In terms of export, it is very unlikely that an advertiser would, say, target only export customers and not also Indian customers. Import though is another rather more complicated issue.
7. Penalty.– Whoever contravenes any of the provisions of this Act or the rules made there under shall, on conviction, be punishable – a) in the case of a first conviction, with imprisonment which may extend to six months, or with fine, or with both; b) in the case of a subsequent conviction, with imprisonment which may extend to one year, or with fine, or with both.
It could be argued that anyone so convicted would lose their licence to sell homeopathic medicines.
9. Offences By Companies.– (1) If the person contravening any of the provisions of this Act is a company, every person who, at the time the offence was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company as well as the company shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly: Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.(2) Notwithstanding anything contained in sub-section (1) where an offence under this Act has been committed by a company and it is proved that the offence was committed with the consent or connivance of, or is attributable to any neglect on the part of, any director or manager, secretary or the officer of the company, such director, manager, secretary or other officer of the company shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly. Explanation.– For the purposes of this section,– 
a) ‘company’ means any body corporate and includes a firm or other association of individuals, and  
b) ‘director’ in relation to a firm means a partner in the firm.
Again, very clear.
14. Saving.–  Nothing in this Act shall apply to –  
a) any signboard or notice displayed by a registered medical practitioner on his premises indicating that treatment for any disease, disorder or condition specified in section 3, the Schedule or the rules made under this Act is undertaken in those premises; or  
b) any treatise or book dealing with any of the matters specified in section 3 from a bona fide scientific or social standpoint; or  
c) any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner; or  
d) any advertisement relating to a drug printed or published by the Government; or  
e) any advertisement relating to a drug printed or published by any person with the previous sanction of the Government granted prior to the commencement of the Drugs and Magic Remedies (Objectionable Advertisements) Amendment Act, 1963 (42 of 1963): Provided that the Government may, for reasons to be recorded in writing, withdraw the sanction after giving the person an opportunity of showing cause against such withdrawal.
Curiously, (d) would allow the Ministry of AYUSH to publish whatever they liked.

The Consumer Protection Act, 1986
This is the most important element of consumer protection legislation. It deals mostly with complaints about defective goods - very little of it deals with misleading advertising and the only sanction available is to order the publication of corrective advertising.

Industry specific legislation does exist, as above.



The Advertising Standards Council of India
The ASCI is a voluntary self-regulator along the line of the UK Advertising Standards Authority (ASA). It  was formed in 1985. Like the ASA it has a code for advertisers - the ASCI Codes. The most relevant sections of which are -


CHAPTER-I TRUTHFUL & HONEST REPRESENTATION 
To ensure the Truthfulness and Honesty of Representations and Claims made by Advertisements and to Safeguard against misleading Advertisements 
1.1. Advertisements must be truthful. All descriptions, claims and comparisons which relate to matters of objectively ascertainable fact should be capable of substantiation. Advertisers and advertising agencies are required to produce such substantiation as and when called upon to do so by The Advertising Standards Council of India. 
1.2. Where advertising claims are expressly stated to be based on or supported by independent research or assessment, the source and date of this should be indicated in the advertisement.  
1.3. Advertisements shall not, without permission from the person, firm or institution under reference, contain any reference to such person, firm or institution which confers an unjustified advantage on the product advertised or tends to bring the person, firm or institution into ridicule or disrepute. If and when required to do so by The Advertising Standards Council of India, the advertiser and the advertising agency shall produce explicit permission from the person, firm or institution to which reference is made in the advertisement. 
1.4. Advertisements shall neither distort facts nor mislead the consumer by means of implications or omissions. Advertisements shall not contain statements or visual presentation which directly or by implication or by omission or by ambiguity or by exaggeration are likely to mislead the consumer about the product advertised or the advertiser or about any other product or advertiser. 
1.5. Advertisements shall not be so framed as to abuse the trust of consumers or exploit their lack of experience or knowledge. No advertisement shall be permitted to contain any claim so exaggerated as to lead to grave or widespread disappointment in the minds of consumers.  
Any advertising of homeopathic medicines or homeopathic services will run foul of these provisions - the essential problem is the one of substantiation of any claim of efficacy or effectiveness. It is not clear what ASCI would accept as evidence though - objective ascertainable fact would appear to rule out anecdotal claims. However, Indian government policy seems to be that homeopathy is efficacious but that does not turn into fact.

Indian consumer awareness of the nature of homeopathy is unknown. There do not appear to have been any surveys or studies. 


CHAPTER III AGAINST HARMFUL PRODUCTS / SITUATIONS
To safeguard against the indiscriminate use of advertising in situations or of the promotion of products which are regarded as hazardous or harmful to society or to individuals, particularly minors, to a degree or of a type which is unacceptable to society at large.
 
3.4. Advertisements should contain nothing which is in breach of the law, nor omit anything which the law requires. 
3.5. Advertisements shall not propagate products, the use of which is banned under the law.  
3.6. Advertisements for products whose advertising is prohibited or restricted by law or by this Code must not circumvent such restrictions by purporting to be advertisements for other products the advertising of which is not prohibited or restricted by law or by this Code. In judging whether or not any particular advertisement is an indirect advertisement for a product whose Advertising is restricted or prohibited, due attention shall be paid to the following:  
(a) Whether the unrestricted product which is purportedly sought to be promoted through the advertisement under the complaint is produced and distributed in reasonable quantities, having regard to the scale of the advertising in question, the media used and the markets targeted. 
(b) Whether there exist in the advertisement under complaint any direct or indirect clues or cues which could suggest to consumers that it is a direct or indirect advertisement for the product whose Advertising is restricted or prohibited by law or by this Code. 
(c) Where Advertising is necessary, the mere use of a brand name or company name that may also be applied to a product whose Advertising is restricted or prohibited, is not a reason to find the advertisement objectionable provided the advertisement is not objectionable in terms of (a) and (b) above.
As might be expected, the ASCI Codes do not permit the use of illegal content. As seen in a previous post, the Central Council for Homeopathy forbids advertising by homeopaths and the Act 1954 forbids the advertising of homeopathic medicines for the prevention, treatment or cure of certain conditions/diseases.

Powers of the ASCI
To quote from the ASCI website -
ASCI's role has been acclaimed by various agencies including the Government. However, it lacked the force of legal recognition. The Government of India has at last, taken note of this and by one stroke on 2nd August 2006 vide a notification in The Gazette of India: Extraordinary {Part II –sec. 3(i)}, made sure that at least as far as TV Commercials go, they abide by ASCI code. The amendment made in Cable Television Networks Rules, 1994 through a Notification dated August 2nd, 2006 now states: "(9) No advertisement which violates the Code for Self-Regulation in Advertising, as adopted by the Advertising Standards Council of India (ASCI), Mumbai for public exhibition in India, from time to time, shall be carried in the cable service".
Acclaim is not the same as having statutory regulatory powers. The Telecom Regulatory Authority of India has those powers. The ASCI complaints process seems to indicate that there is no process for dealing with those who do not abide by their rulings - in other jurisdictions, the case would possible be passed onto a statutory regulator. The point of self-regulation is to avoid cases ended up in court, which is expensive but self-regulation is rendered impotent if there is no backstop.

Impact of the ASCI
This is difficult to determine. The ASCI variously states -
ASCI used to receive and process complaints against around 170 advertisements prior to start of National Advertising Monitoring Service (NAMS), from a cross section of consumers and the general public, and this covers individuals, practitioners in advertising, advertiser firms, media, advertisements Agencies, and ancillary services connected with advertising. Since May 2012 ASCI has started monitoring of all most all newly released print and TV ads in India under the NAMS initiative which tracks down around 120 ads per month on an average for suo moto complaint processing..
And 
ASCI receives relatively much less complaints against advertisements v/s developed countries like like UK whose self regulatory body gets nearly 20000 in year. This is because of various reasons main one being awareness of ASCI among consumers is low given population dispersion in India v/s other smaller, compact geographies, Over the years ASCI has focused on increasing its awareness by releasing mass media campaigns, reporting CCC results via media, coming out with complaint receiving mechanism on line and also thru toll free phone etc. but still complaints received by ASCI were about 2000-2500 per annum for 175 advertisements per year on an average. On the other hand, Government’s Department of Consumer Affairs and Consumer Activists believe there has been increasing instances of misleading advertisements which harm consumer’s interests. Many such advertisements escaped CCC’s scrutiny as complaints against them are not brought to ASCI’s notice. ASCI’s NAMS initiative therefore was launched to ensure that most top Newspapers and all TV Channels are closely monitored to ensure that no ad which makes unsubstantiated, misleading or false claims escapes CCC’s scrutiny.
The concentration on newspapers and television is understandable. Internet use is increasing rapidly in India but print and broadcast are still the media that the majority of Indians encounter. Arguably television is most important given the patchy literacy rates - even if they are improving.

It has been suggested that some do not complain to ASCI as they regard it as toothless.

Partnership with Ministry of AYUSH
In January 2017, it was announced that the ASCI and the Ministry of AYUSH had signed a memorandum of understanding that ASCI would monitor advertising of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy medicines, treatment and related services across print and electronic media. The various reports at the time suggest that the Ministry of AYUSH would refer any complaints they received directly to the ASCI and that the ASCI would report back to them. The reports also suggest that the focus is on advertising in breach of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. No mention is made of what the Ministry of AYUSH would do with such reports as it is not the regulator responsible for the Act 1954. Nor was any mention made of the prohibition on AYUSH practitioners advertising all but changes in address etc - which would fall under the remit of bodies within the Ministry such as the CCH.

This seems very strange as even prior to the announcement the ASCI were investigating some advertising by AYUSH practitioners and ruling against them. From November 2016 -
11. Dr. Batra’s Homeopathy Family Clinic: The advertisement’s claims, “We have provided successful treatments for more than ten lakh patients in 142 cities for hairfall, skin disorder, allergy, breathlessness, gastric disorder, women’s issues, high sugar levels, joint aches, obesity, sexual problems, thyroid and other health problems for people of all ages”, were not substantiated with supporting evidence, and are misleading by exaggeration. Also, specific to the claim related to successful treatment of sexual problems, the advertisement is in breach of the law as it violated The Drugs & Magic Remedies Act. In addition, specific to the claims related to successful treatment for Diabetes (high sugar levels) and obesity, the advertisement is in breach of the law as it violated The Drugs & Magic Remedies Act.
A quick look at the Dr. Batra's website shows that is in breach of the Act 1954 and there have been multiple issues with them in the past.
32. Positive Homeopathy: The advertisement’s claim, “Complete disease cure with Nano pills for the first time across the world using advanced nano medicine and genetic method – Diabetes – Piles - PCOD - Rheumatoid Arthritis”, were not substantiated with clinical evidence, and are misleading by gross exaggeration. Specific to the claims related to complete cure for Diabetes the advertisement is in Breach of the law as it violated The Drugs & Magic Remedies Act (item 9 under DMR schedule). Also specific to the claims related to complete cure for Piles, the advertisement is in Breach of the law as it violated Schedule J (item 42) Rule 106 of The Drugs and Cosmetic Act, 1940 and Rules, 1945.
The reference to Rule 106 is curious as it falls under PART IX LABELLING AND PACKING OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES. 
41. American Homeo Lab: The advertisement’s claims, “Doctors give best treatment for diabetes, sex problem, low semen without any side effects”, and “Effect starts from first day and cure in 1 month”, were not substantiated with clinical evidence, and are misleading. Further the claim, “100% Guarantee”, was not proven with supporting evidence of the customers who have been benefitted by the treatment. Also, specific to the claims related to treatment of sexual problems, low semen, read in conjunction with the advertisement visual, imply enhancement of sexual pleasure, which is in breach of the law as it violated The Drugs & Magic Remedies Act. Even the specific claims related to treatment for Diabetes, the advertisement is in breach of the law as it violated The Drugs & Magic Remedies Act. 
It would seem likely that these rulings apply to advertisements in newspapers. It is clear that ASCI interpret the Act 1954 to prohibit the claim to prevent, treat or cure with homeopathic medicine rather a specific homeopathic medicine.

Future
It is early days for the ASCI/Ministry of AYUSH partnership. It remains to see how well this will function - there is a potential for inaction on the part of the Ministry especially if the issue of the prohibition of advertising by homeopaths is brought up.

There is also the question of whether the recent flurry of publicity will encourage more complaints to be made.

The Ministry of AYUSH may disappear in a proposed streamlining of government. It has been suggested it could be re-absorbed by the Ministry of Health and Family Welfare. The implications of this are unclear for the partnership.


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.