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.

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. 

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.
20	Association 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...

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.

Update 03/04/2017
The SLV has now published the list of registered homeopathic medicines. 
Homøopatiske legemidler tillatt omsatt etter 1.7.2017 - laveste fortynningsgrad
Is what you mean to look at. The associated news item states that these will be the only permitted homeopathic medicines in Norway come the 1st July 2017.

The number, 420 (excluding variations in potency) is surprisingly high - more than the UK. As applications for registration can be made in Danish, Swedish and English, it's no surprise to see products from a Swedish manufacturer, but Austrian and German? It's not known what language their submissions were made in. It may be the case that those manufacturers had already prepared dossiers for registration in other countries (e.g. Denmark and Sweden, both of which are bigger potential markets than Norway) they could simply reuse them. What is telling is that Boiron could not be bothered to register any products. Nor could any of the UK manufacturers. Perhaps Brexit and being outside of the Single Market represented too much risk for them? Speculation is pointless.

Further analysis of the list is required and the SLV do need to be asked some questions but in general, homeopathy practitioners should be happy with the outcome.