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 -

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. 

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..
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.

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.