Restrictions on advertisement of Ayurveda and other Pharmaceuticals: The critical legal analysis

Reading time : 12 minutes

INTRODUCTION

In a country like India where large chunk of citizens (especially from rural part) still lack the awareness about various drugs, its impact on their health, and tend to self-medicate without knowing the possible consequences, it is important for the state to regulate Pharmaceutical advertisement so that no one is being duped to a medicine that could prove fatal to his health.  Most of the people who cannot afford the medical advice by a qualified doctor tend to fall for advertisements that claim to cure life threating disease but has got multiple side effects.

Any rumour mongering related drugs could prove very dangerous and could cost lives, so it is the responsibility of the government to monitor and regulate Pharmaceutical advertisement and make sure that no one is duped. Recently, many doctors of IMA (Indian medical ASSOCIATION) accused yog guru ramdev for doing a negative publicity of the allopathic medicines and spreading the fake news about the miracle effects of Ayurveda medicine, which are still not scientifically proven. In this article we will look into the various legislations that regulate pharmaceutical advertisement in the country and how Ayurveda promoters not only go against public morality but also violate the competition related codes in the process of defaming and comparing allopathic medicines with Ayurveda

THE RECENT CONTROVERSY

Not a very long ago, A major controversy broke out when the famous yog guru Baba ramdev made some controversial statement regarding the efficiency and efficacy of the English (allopathic) medicine and surgical processes. In the  statement Baba ramdev mentioned -“it has been brought to my notice that  many  people have died after taking allopathic medicines, and  number of people dying because of the allopathic is much more than  people who  actually died for the lack of oxygen cylinder and ICU beds ,While reading a What Sapp post ,he went on to call English medical procedure as  an out dated ,stupid procedure, and calling it  as a  tamasha (Mockery)[1].

Some of these statements of yog guru didn’t go too well with the members of IMA (INDIAN MEDICAL ASSOCIATION) who came in direct loggerhead with ramdev and asked him to take back his statement citing that the statement of baba ramdev is not only defamatory but it also demoralises the morale of doctors who are working day and night for the betterment of mankind. The IMA also made an official complaint regarding the statement of yog guru to the health ministry for unnecessarily over promoting Ayurveda medicines, later the yog guru took a U- turn and said that he has full respect for allopathic medicines and he was only reading a What Sapp forward during the press conference, after getting an objection letter from union  health minister Dr Harsh Vardhan,  yog guru ramdev finally withdrew the controversial statement.

Drugs have proved vital in the on-going pandemic in curing and managing covid-19  related complications ,but few  criticised the allopathic medicines stating that doctors are themselves confused about the covid-19 treatment and keep changing  the forms of treatment from remdesivir to plasma therapy and  to steroids ,with steroids also proving to be life threating in few cases, But doctors defend these constant change in procedure by mentioning that covid-19  is a new phenomenon and forms of treatment changes as the research progresses and also depending upon the nature of the individuals.

WHY THERE IS A NEED TO REGULATE THE AYURVEDA PHARMACEUTICAL ADVERTISING

There is no denying to the fact that when it comes to certain lifestyle disorders  such as – high blood pressure, Diabetes , constipation , stress , anxiety etc. Ayurveda is one of the most effective techniques to cure them without any major side- effects. When Ayurveda medicines are consumed along with performing yoga, they produce some spectacular results. It is further said that Ayurveda is a process which takes time   to cure as it treats the root cause of the diseases rather than just the symptoms. Ayurveda medicines are mostly produced from natural substances which gives them an edge over other forms of treatment with regard to side- effects.

The problem of Ayurveda

The diagnosis mechanism in ayurveda is very limited and still depends on some of the out-dated diagnosis techniques such as X-RAY [2],nerve reading ,pulse  checking etc.moreover,This phenomenon of curing the root cause at a much slower pace when compared to the allopathic counterparts is a double edged sword -as it promises to  treat the  disease permanently but does not provides  emergency treatment  to the life threating diseases which needs an urgent cure. Moreover, due to insufficient availability of natural resources (which act as a raw material for the production of Ayurvedic medicines), the manufactures are forced to use their chemical  alternatives which are produced in labs, and these alternatives contradict the  main USP of Ayurveda i.e It is derived from natural substances.

The problem with the over advertising of Ayurveda medicines done by yog guru Baba ramdev and others is that  to promote their product, they do a comparative advertising with allopathic medicines which is not only unethical ,immoral but also illegal. One gets notion after listening to various promoters of Ayurveda -that they want a monopoly of aurverdic medicines in market rather than trying to coexist with the allopathic medicines. The other factor that goes against Ayurveda is that it has barely got any surgical procedures to cure the disease that needs an urgent attention. Apart from all these problematic concerns, most of the claims made my Ayurveda still lack scientific backing.

The recently launched Coronil By Baba ramdev -owned Ayurveda  pharma company patanjali is marketed as an effective medicine to treat COVID-19 but again ,these claims of ramdev are not completely backed by any institutions ,with world health organisation  and other reputed health related institutions  not approving Coronil , neither the AYUSH ministry under government of India has approved the coronil as a drug for covid-19 and has put it  into the category of food supplements. Ayurveda promoters must understand that they can’t promote their products at the cost of defaming the allopathic and other medical procedures so due to the above mentioned concerns regarding the advertising of Ayurveda medicines ,it is only appropriate for the governments to regulate these tall claims by ramdev regarding efficiency and efficacy of Ayurveda medicines, which still lacks any modern science backing.

THE NEED FOR RESTRICTION AND REGULATION

The state and the various stakeholders of patient welfare associations have concerns regarding the   marketing and advertising practises which are unethical and go against public morality. In the last few years the drug manufacturing companies have been accused for the nature of their advertisements, unethical practises by pharma companies and medical practitioners have received great flak. In the Draft Pharmaceutical Policy of 2017 these practices were discussed as a great matter of great concern.[3]

It has been further seen that few big medical practitioners and hospitals recommend a certain brand of medicines earning them commissions. Top hospitals in the country have helped few brands to create a monopoly of the medicines which in turn increases the cost of few basic medicines .due to some of the unethical process mentioned above not only the health of the patients it at risk but the affordability of the  drugs is also compromised.

On television and other print and electronic media we see a lot of advertisements of the medicines. Customers, on the other hand, continue to have trust on these medicines without actually knowing the legitimacy of these commercials. The various legislation regulating the pharmaceutical advertisement like – the Drugs and Cosmetics Rules 1945, Drugs and Cosmetics Act 1940 the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955, the Drugs and Magic Remedies (Objectionable Advertisement) Act 1954, and some of the landmark  judicial precedents are analysed in this article .

THE LEGAL FRAMEWORK REGULATING PHARMACEUTICAL ADVERTISING

Though there are no of codes mentioned above regulating the pharmaceuticals advertising but the main legislation is DMRA 1954 and DCA and DCR 1955 , The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (“IMCR”). PHARMACY practices regulation 2015  etc. DMRA not only lays down the procedure for the regulation but it also defines few of the related terms such as advertisement[4], publication etc.

PROVISIONS UNDER DMRA THE (THE DRUGS & MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT

SECTION 3 of the (The Drugs & Magic Remedies (Objectionable Advertisements) Act 1954) [5]puts restriction on the advertisement of new drugs responsible for treating few specific illnesses.  The list of disorders for which advertisement cannot be telecasted  or published is  also mentioned in the DMRA rules of 1954.

It includes any commercial ad relating to a medicine used for:

The method of miscarriage of pregnant ; it  bans   the prevention of conception among girls, it also includes .the preservation of a person’s capability for sexual pleasure; treatment of women’s menstruation cycle disorders ; or Any of the other disease, illness  ailment, or a medical condition indicated in the schedule’s diagnosis, cure, mitigation, treatment, or prevention

SECTION 4 of the (The Drugs & Magic Remedies (Objectionable Advertisements) Act 1954) forbids duping and confusing drug advertisements if they: create a confusing and deceptive impression about the originality of the drug whether directly or indirectly, or if they make a drug claim that is fake ; or In any of the  other material respect, are false or if its misleading.

Section 5 of the (The Drugs & Magic Remedies (Objectionable Advertisements) Act 1954) also prohibits the marketing of miracle/magical cures for the treatment of specific diseases that claim to be efficient for any of the purposes listed in Section 3 of this act  directly or indirectly.

The role of the judiciary

The main intent, objective and the purpose of the (The Drugs & Magic Remedies (Objectionable Advertisements) Act 1954), was highlighted by the supreme court of india in the case of Hamdard Dawakhana (VAKF board ) Delhi v. Union of India [6]where the court prohibited citizens from self-medicating and self-curing  from various life threatening diseases. This case proved to one of the landmark judgment in the field formed the basis of many judgements in the future  

Self-medication ( which means to medicate oneself without any advice from a qualified medical practitioner ) for  the life threatening disease listed in the DMRA 1954  and DMR 1955 Rules has listed medicines which could have a bad  impact on community health and people’s well-being.

The courts After finding out that few medicines had a tendency to dupe citizens to self-medicate themselves as a result of over advertising, so keeping all this in mind it was decided that- for the interests of public health, the telecast of medical advertisement was completely put to ban. And the drug manufacturers were forced to route their products only through recognised channels.TheSupreme Court had further argued that the DMRA as a whole, not only prohibited commercials advertising for medicines and medicines which are related to diseases expressly mentioned in the Section 3 of the DMRA Act, but it also came up with the list including advertisings that are -immoral, objectionable and unethical which promotes the self-treatment.

With regard to Section 14 of the act, the of the advertisements are allowed :

Any signal board or any signboard pasted in  the area of the of a licensed/certified medical professional describing the treatment for any of the illness, bodily disease, physical ailment, or a medical condition mentioned in Section 3 of this Act. Any pamphlet or a book written by proven scientific or social standpoint dealing with the list of topics mentioned in the Section 3.Any commercial of  a medicine  given to the  a certified/registered medical professional  in confidence.

 All the advertisements that are by the state or federal governments. Any commercial for a medicine that had been given to print or for telecasting with a with the central  government’s pre approval consent.

The government of India through the  Ministry of Health and Family Welfare(MOHFW) had issued various notification  permitting  marketing of the few special type of drugs.

The government of India had issued a notification that few of the provisos of section 3 clause (a) of DMRA act in regard to the prevention of conception in girls, and as those belonging to the of Section 6, will not be applied to any advertisement for contraceptive pills, with a prerequisite that the advertisement wholly refers to the  contraceptives that are granted approval  through the legitimate  central government agencies .

The types of advertisements are allowed, but only with certain restrictions:

  • The upper  packaging of the drug including content, pamphlet or items
  • .Drug advertisements in medical, pharmaceutical, scientific, and technological publications
  • Therapeuticative indexes printed by authorised pharma makers, exporters, and wholesalers.
  • Books on medicine distributed by authorised medical detailers engaged by drug exporter

Promotion of medicines by the means of gift, sample copy to consumers or other free inducement is also prohibited.

The giant pharmaceutical manufacturer Ciplaa pvt.ltd was accused for marketing  the sirf AK Pill, an anti-pregnency tablet, in this case of  the Ciplaa private Ltd vs state of Tamil Nadu,[7] petition was  quashed by the Chennai High Court in the year 2019. Those drugs which were included were Levonorgestrel 1.5 mg, but the Ministry of health and women welfare ‘s notification dated 30.04.1992 permitted the advertising of tablets having Levonorgestrel 0.15 mg. Drug controller general of india  granted the petitioner’s approval, which was ultimately withdrawn . but, because the approval granted by drug controller general of India(DCGI) was effective on the day of said offense took place , the petitioner was allowed a  relief.

In a public interest legislation (PIL) filed by mahossh ramnath in the famous ase of Mahesh Rammnath Sonawaane vs. government  of India[8], petitioner  pleaded to stop the advertising of many popular tablets including -, cyruph D Cold and D Coughe, Gelushil MPS an antacid tablet, Glykodin Cough cyrup, and Bennadryl Cough Formulae and capsule D’ Cold complete on various TV channels in this case  the meaning of “drug” mentioned  in Section 2(b) DCA 1941, was identified to be an inclusive definition with a big and a wider scope. And as an after effect , this is not limited to any single specific type of capsule. As a result of this, the marketing  of any substance should not  be used to promote self -induced -treatment.

The concerned set of authorities must first check if all the drugs or medicines can be marketed through such channels, and if then, what kind of content could be included in that TV commercial. The contents of the ad, in any case must not contradict the Section 3 and Section 4 of DMRA, Act of 1954. If such advertisements are permitted, then the fact that whether they are promoting the self-medications must be carefully examined, with a suitable disclaimer regarding the precautions may be necessary in this regard. This writ petition by Mahesh ramanath was allowed , with some regulatory guidelines put up by the supreme court for the authorities to follow in future, while examining any of the advertisement related to pharmaceuticals .

Position under the 1940 Drugs and Cosmetics Act and the 1945 Drugs and Cosmetics Rules:

The  union government amended Rule seventy eight  as well as seventy four of the  DCR ,1955 (Drugs & Cosmetic Rules, RULING that no commercial add for Schedule H, H1 or X can be issued without pre grant  approval from the concerned authorities under GOI[9].

Advertisement of Ayurveda Drugs

Most of the so called Ayurveda medicines are not approved by government as a drug it is rather put up in a category of food supplement by the ayush ministry. The Drugs & cosmetics Rule, of 1945 was amended by the union  Government, and Rule one seventy  was included into Part 19 to curb the advertisement of Ayurveda , Sidhaa, and Unanii drugs until a separate id no. is obtained from the certifying body.

The governments have been very careful in promoting the ancient treatments such as Ayurveda, homeopathy, unani, sidhi drugs as unlike modern science, very less studies have been conducted on their efficacy and efficiency. Most of these studies related to efficiency are conducted by the manufacturers internally which are not fully reliable. Hence a proper government intervention is needed to give these ancient treatments a modern science backing so that their efficacy could be quantified.

CONCLUSION AND SUGGESTIONS

There is no doubt that various legislations existing today i.e Drugs & Cosmetics Act, 1940, Drugs & Cosmetics Rules, 1945, and Drugs and Magical Remedies (objectionable) Act 1954 etc etc have tried their best regulate the advertising policies of the pharmaceutical manufacturers with an intent to protect the health of citizens but then, there is still a room for improvement in these codes for better implementation in today’s fast paced world. After reading all the related provision regarding the advertising of pharmacy product, we can conclude that almost all types of advertisement related to pharmacy are prohibited except for the cases when they have prior approval from the concerned authorities.

These laws  need a proper implementation to make them achieve the desired results , The most open  violation of the   law could be seen on the  late night television ads where sex-power enhancing drugs are advertised despite  the   DMRA act of 1954 under section 3  categorically prohibiting  products that claim to enhance sexual drive ,unless recommend by any recognised medical practitioner. The DMRA and DCA also lack any direct power to restrict the further advertising/publication of ads which are violating of  the related codes. Though few judicial precedents gives them the indirect power to do so, moreover, the other problematic provision is that there is no obligation on the part of manufactures/advertisers to get the content approved before the publication.

The ACT also fails to prescribe SOPs to be followed by advertisers before giving it to publication. The penalties for  violation  too sounds a peanut when compared to the profit that could be generated with lucrative advertisements ,the current legal regime prescribes just 6 months of imprisonment  with  a fine ,for violation of any rule under DMRA,1954. The possible corruption in granting pre-approval for publication of advertisement could not be ruled out in a country that ranks so high in global corruption index[10]. The other aspect which stumbling block includes absence of  any law which regulates and recognises the advertising done through internet. in a time when many people are surf and browse internet it’s important to regulate the content that is being served to E- customers. There is no linkage between the existing DCA and DMRA act with any cyber law.  Some provision of Internet law needs to be merged with DMRA and DCA rules for proper regulation of E- advertisement. Moreover, The legislation is silent on setting up of websites mechanism system which would alert the consumer if suspicious inducement is propagated. Clearly the government is trying its best to implement these law properly, with a section of government also demanding an increase in the penalties for the violation of the related codes, There have been instances of violation of the code  rules by manufacturers and they still going caught free. Therefore the judiciary also needs to be a bit stricter relating to the implementation of codes. UCPMP needs a alternative which should have a legal binding and not just act as wooden tiger.

SUGGESTIONS

The existing legal regime on pharmaceutical clearly needs an emergency overhaul with bringing changes such as – increase in penalty for violation of code, settings up SOPs for manufactures and advertisers, linking internet advertisement with DMRA,DCA etc , recognising the E- prescription, keeping check on corruption related to pre- approval grants, strengthening the implementation, Settings up awareness campaign about drugs and Their uses, restricting comparative advertising and implementing other competition commission laws .The legislative, executive and judiciary must come together to curb the negative impact of pharmaceutical advertising and improving health awareness among citizens.

REFRENCES

STATUTES

THE CONSTITUTION OF INDIA, 1950

The legislations governing the restriction and regulation of Ayurveda and other medicines –

  • The Drugs & Magic Remedies (Objectionable Advertisements) Act 1954 (“DMRA”) and the Drugs & Magic Remedies Rules 1955 (“DMRR”).
  • The Drugs & Cosmetics Act 1940 (“DCA”) and the Drugs & Cosmetics Rules 1945 (“DCR”).
  • The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (“IMCR”).
  • The Pharmacy Practice Regulations 2015 (“PPR”).
  • The Sales Promotion Employees (Conditions of Service) Act 1976 (“SPEA”).
  • The Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”), which is a self-regulating code unlike the above mentioned codes
  • The Code for Self-Regulation of Advertising content in India (“CSRA”), published by the Advertising Standards Council of India (“ASCI”).
  • The OPPI Code for Pharmaceutical Practices 2019 (“OCPP”), published by the Organisation for Pharmaceutical , this applies to the foreign companies operating in India

LIST OF CASES

  • M/S.Ciplaa pvt Ltd vs The Tamilnadu State –Represented  By on 11 December, 20199 (Crl.O.P.No.21919 of 2008)
  • Humdard Dawakhana (Wakf) Lal . vs Union Of India And Others on 18 December, (1959 1960 AIR 554, 1960 SCR (2) 671)
  • Mahesh ramnath sonawane vs union of india ( civil appeal no 10001 of 2002)

ARTICLES


[1] English translation of quote given by ramdev in hindi (aajtak.in)

[2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3611633 (last visted 20th june 2021)

[3] https://ww.helplinelaws.com/businesss-law/PAIW/pharmaceutical-advertising-in-india-whether-prohibited-or-regulated-under-drug-laws-in-india.html (last visted 24th june 2021)

[4] The CSRA defines advertising as a “paid-for communication, addressed to the public or a section of it, the purpose of which is to influence the opinions or behaviour of those to whom it is addressed.  Any communication which in the normal course would be recognized as an advertisement by the general public would be included in this definition, even if it is carried free-of-charge for any reason

 

[6] 1960 AIR 554, 1960 SCR (2) 671

[7] Crl.O.P.No.21919 of 2008

[8] Writ petion 1001 of 2002 ,Bombay high court

[9] Government of india has the power to amend any law under union list by the provision of constitution

[10] 86TH RANK https://economictimes.indiatimes.com/news/economy/indicators/indias-rank-slips-to-86th-in-corruption-perception-index-2020/articleshow/80512814.cms  ( last vistited 24th june 2021)

Author: Himanshu Kumar, ALLIANCE UNIVERSITY

Editor: Kanishka VaishSenior Editor, LexLife India.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s