1
DRUGS AND MAGIC REMEDIES ACT AND ISSUES IN ADVERTISING
MODULE 4
Post Graduate Diploma in Media Laws
By B. Phanindra Kumar, MLH20_07
NALSAR Proximate Education NALSAR University Of Law Hyderabad
Contents:
2 1.Introduction……………………………………………………………..……3 2. Research Methodology…………………………………………………..….4 Methodology…………………………………………………..….4 3. Drugs and Magic Remedies………………………………………………....5 4. Advertisements of Drugs in foreign countries……………………………...9 5. Case Laws……………………………………………………………………1 Laws……………………………………………………………………10 0 6.Conclusion……………………………………………………………………11
INTRODUCTION
3 Advertising communication is a mix of arts and facts subservient to ethical principles. In order to be consumeroriented, advertisement will have to be truthful and ethical. It should not mislead the consumer. If it so happens, the credibility is lost. In order to enforce an ethical regulating code, the Advertising Standards Council of India was set up. Inspired by a similar code of the Advertising Standards Authority (ASA) UK, ASCI follows the following basic guidelines in order to achieve the acceptance of fair advertising practices in the interest of the consumer: •
To ensure the truthfulness and honesty of representations and claims made by advertisements and to safe guard against misleading advertising;
•
To ensure that advertisement are not offensive to generally accepted standards of public decency;
•
To safeguard against indiscriminate use of advertising for promotion of products which are regarded as hazardous to society or to individuals to a degree or of a type which is unacceptable to society at large; and
•
To ensure that advertisements observe fairness in competition so that the consumers need to be informed on choices in the market places and canons of generally accepted competitive behaviour in business are both served.
Research Methodology
4 Drugs and medicine is not a matter of public interest unlike all other matter printed, published and disseminated to the public. In fact, it is a matter of human health and welfare. Hence, advertising Drugs and medicines is considered as a crime under Drugs and Magic Remedies(Objectionable Remedies(Objectionable Advertisements) Act, Act, 1954. For the following project I have adopted a qualitative research methodology. Several distinguished Law books on medicine and Press were very fruitful and helpful to me in completing this project successfully besides websites of Dept. Of Health of several states which was also of great help to me in knowing the exact statistics, history and also amendments of the laws from time to time along with the case studies. In the recent past a great number of Objectionable advertisements relating to alleged cures for venereal diseases, , sexual stimulants and alleged cures for diseases and stimulants and conditions peculiar to women have been published in various newspapers, magazines and otherwise. Due to these advertisements ignorant and unwary persons have have resorted to self medication with harmful harmful drugs and appliances. appliances. People People indulging in such activities can be a real threat to the society if left unnoticed. In order to stop such advertisements and save the ignorant and unaware masses, The Drugs and Magic Remedies (Objectionable Advertisements) Bill was introduced in the Parliament. This project covers a detailed analysis of the Act and the issues in the advertisement.
Drugs and Magic Remedies:
5 Before the English medicine entered, India only knew about ayurvedic medicine for the cures of all possible ailments. An ayurvedic doctor then was called as a sage who used to do reasearch on the medicinal plants. No one actually knew what kind of medicine was used on them. However, it is known that that ayurvedic medicine was given only to protect an individual and had no intention of business. "Till now, only advertising of medicines was not allowed. After the amendment comes out, advertisement of false treatment treatment modules modules will also be banned. People People have started to openly advertise advertise cures for untreatable untreatable diseases. The ministry does not want citizens to be taken for a ride by such quacks. The amendments should be through in the next six months." 1 For example one swami, yoga guru Baba Ramdev, promised a cure for dreadful diseases like cancer and AIDS. On the other Hand the Drugs and Magic Remedies Act states that no medical practitio practitioner ner should should give a claim for cure. So, the ministry ministry issued several several notices notices to Baba Ramdev Ramdev for these claims. The amendment would seek to curb similar advertisements, officials said. The penalty has been enhanced. Because the offence entailed a paltry Rs 500 fine, very few offenders were made accountable. Drug controllers found it hard to enforce the Act and failed to create deterrence. Now, the amendments will empower regulators to put offenders to task. In the year 2001, to strengthen the magic remedies Act, a 11 member committees was formed for it which was headed by Dr Ranjit Roychoudhury. The committee that included drug controllers from four states, doctors and pharma association representatives. This committee gave an interesting statement of compulsory imprisonment for advertisements on medical cure. “We also found several false advertisements being sent to Gulf countries by Indian doctors and quacks. We want to regulate all such ads." 2The Act presently defines "magic remedy" as that which includes a talisman, and any other so-called charms which allegedly possess miraculous powers of diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals. So, in addition to amending the law, the government should provide for an independent mechanism to monitor the implementation of the law and ensure its stringent enforcement. Corrective advertisements are also absolutely essential. As it stands, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, basically prohibits four kinds of advertisements pertaining to drugs and magical cures. Section 3 of the Act says that no person shall take any part in the publication of any advertisement promoting a drug or leading to the use of a drug for the procurement of miscarriage in women or prevention of conception in women; the maintenance or improvement of the capacity of human being for sexual pleasure; and correction of menstrual disorders in women. Section 3 further prohibits any advertisement promoting drugs for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule. The schedule lists a number of diseases, disorders or conditions such as diabetes, cataract, cancer, fevers (in general), obesity, rheumatism, impotence, high or low blood pressure, female diseases, epilepsy, stature of persons, venereal diseases, glaucoma, 1
Anbumani Ramadoss, Union Health Minister
2
Dr. Ranjit Roy Choudhary.
6 sterility in women, dropsy, etc. Section 4 of the Act prohibits those advertisements relating to a drug if they contain any matter which directly or indirectly gives a false impression regarding the true character of the drug or makes a false claim for the drug or is otherwise false or misleading. Section 5 of the Act prohibits advertisements of magic remedies for treatment of certain diseases and disorders. Violation of the law attracts imprisonment for six months or fine or both, for first conviction and for subsequent conviction, imprisonment for a year or fine or both. The Union Ministry of Health has said that the amended law would not only tackle advertisements on the electronic media, but would also provide for severe punishment to those that violate the law. The move is welcome, but it would be far more effective if the law were to provide for corrective advertisements — in fact this is absolutely necessary to ensure that the impression created by a false or misleading advertisement is corrected through a series of advertisements. But amendment of the law is only one part of the solution. Despite the Magic Remedies Act, RK Gupta advertised with impunity his clinic and claimed that he was offering a sure cure for epilep epilepsy. sy. Ironic Ironicall ally, y, way back in 200 2000, 0, the the Indian Indian Medica Medicall Associ Associati ation on had declar declared ed him him a quack quack after after a committee had found that he was giving his patients toxic drugs in high doses. Then in May 2003, following a complaint from a consumer, the Advertising Standards Council of India had held that the advertisement violated the Drugs and Magic Remedies (Objectionable Advertisements) Act. Yet, he continued to advertise and the drug control departments failed to act, resulting in thousands of consumers falling prey to these advertisements. In fact there are a number of advertisements in the print media itself, promoting indigenous cures or medicines for a variety of ailments listed in the Schedule of the Act and no action whatsoever is taken against any of them. If only the enforcement agencies were active, there would not be cases like the one that went before the State Consumer Disputes Redressal Commission in Kerala some years ago. Young Nadiya, who was short, was attracted to an advertisement that promised to convert a dwarf into Amitabh Bachchan. Fathima Hospital, which had issued the advertisement, promised her that she would gain 10 cm in six months through surgery, costing Rs 32,000. 32,000. The so-called so-called correction correction surgery surgery left her bedridden bedridden.. Eventuall Eventually, y, she approached approached Apollo Hospital, Hospital, Chennai, which could restore her movement, but not completely. If the state Health Department had done its job, the girl would not have had to go through so much of physical and mental pain and anguish. So, in addition to amending the law, the government should provide for an independent mechanism to monitor the implementation of the law and ensure its stringent enforcement. Corrective advertisements are also absolutely essential.
In the popular imagination, India is the land of mystics - of ropemen, babas and sadhus. And if babas and sadhus are not in ready supply, there are any number of fakes and frauds who are happy to fill in. Every once in a while, one come across bizarre, often horrifying headlines - 'Child sacrificed to help woman conceive'; 'Woman branded as witch'; 'Man sacrificed to find treasure'. Far more frequently, there are a re reports of gullible people being deceived
7 by men and women claiming c laiming to possess magical powers. Frankly speaking, there has not been a law promulgated specifically to prosecute those making false spiritual claims and duping people of their money. This is the lacuna that the Maharashtra government hopes to fill with its Maharashtra Eradication of Black Magic and Evil and Aghori Practices Bill, which was introduced in the 2005 winter session of the State Assembly. The Bill is likely to be passed in the 2006 winter session, and has been delayed so far f ar only because of extraneous emergencies in the state. When passed, this law will make it punishable to practice, promote or propagate black magic and other acts of superstition. The Bill seeks to bring under its ambit 'sinister practices' that intend to exploit people or harm them physically, mentally or financially. "We have been working against quackery and black magic in the state for the past 22 years, but the main hurdle we kept coming up against was that there was no law against such practices. This law will go a long way in helping us educate people and fighting the superstitious practices that are used to dupe the masses. Even law enforcing agencies were unable to help us, because the law of the land was not with them." Needless to say, the Bill and its sweeping implications found many detractors. None of the political parties - except for the rightwing Shiv Sena have openly opposed the Bill. The Hindu Janajagruti Samiti has emerged as its strongest critic. They said that the lack of specificity in the original Bill could lead to a clamping down on all religious activities. The draft Bill was subsequently watered down and specific instances of the practices criminalized by the law were detailed. However, even the proposed law leaves many questions unanswered. Have faith healing practices - like pranic healing and reiki - been brought under the ambit of the law? And most important of all: does the law impinge on the constitutional rights of an individual? Does it restrict a person's religious freedom? Does it restrict individuals from performing religious rituals? The questions are many, and the law - in spite of its efforts to cite specific instances - remains far from precise in its scope and application. For instance, neither 'black magic' nor 'witchcraft' are defined in the law, even though both are criminalized. However, specific instances are given: 'preventing a person from taking medical treatment in case of a dog, snake or scorpion bite and instead giving him treatment like mantra-jantra, ganda-dora or such other things' is criminalized. Similarly, 'claiming to perform surgery with fingers or claiming to change the sex of a fetus in the womb of a woman' is also punishable. While these instances are helpful, critics say that the law needs even greater specificity. "We believe that the Black Magic Bill was not really required in the first place. It is anti-constitutional anti-constitutional and anti-religion. In any case, we feel that it will not help in abetting such crimes. Only education can stop people from blindly following somebody," somebody," says Ramesh Shinde of the Mumbai-based Hindu Janajagruti Samiti, which claims to work for the betterment of the Hindu faith. However, Anand Grover, co-founder of Mumbai- and New Delhi-based Lawyers' Collective, asserts that the Bill in its present form does not impinge on any constitutional rights of an individual. "In fact, considering the extent of quackery prevalent in society, it won't be wrong to say that there is a need for such a
8 law. My only contention is that it is not drafted properly. It is very generic. Drafting a law is an art and there are a number of loopholes in this one, which might m ight make it difficult to implement." The Bill makes the practice of black magic a cognizable, non-bailable offence. A person convicted of an offence under the proposed law can be imprisoned for a period between six months and seven years, and can be fined upwards of Rs 5,000. Further, only a high-level police official - the vigilance officer - will be equipped to handle these cases. The detractors of the Bill point out that India has laws - the Indian Penal Code and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 - that could be used to tackle such crimes. "What is the need for another law? In any case, a law alone will not stop these crimes. There is a law against dowry; has it stopped the practice? Law cannot stop people from blindly believing in something. Only education and awareness generation will bring about a change," Shinde says. Grover disagrees. He explains that the existing laws are unable to punish the practices identified in the proposed Bill, and that there is a need to deal with such practices. Manav says that the Bill became necessary when the State found it difficult to prosecute charlatans for religious fraud. " At present, the Bill restricts itself to narrow, specific instances in order to minimize abuse or misuse. Manav says that while miraculous acts will not be punishable, turning them into money-spinners will be. He also asserts that religious practices do not come under the ambit of the law, unless they are performed with the intention of harming somebody.
Advertisements of Drugs in Foreign Countries:
We know that the pharmaceutical industry spends enormous sums on promoting its products (about twice the amount spent on research and development),3 but most data on the effect of advertising on prescribing are unpublished, and have been gathered by advertising companies. The Association of Medical Publishers (AMP), a
9 US-based organisation whose membership includes the publishers of nearly 200 biomedical journals, boasts "advertising in medical publications alone... can generate sales for both new and more-established products." AMP reports a number of studies that have shown a significant increase in market share and retail sales as a result of medical journal advertising, which is reported to provide a return on investment (ROI) of about US$5.00 for every dollar spent, greater than detailing (ROI US$1.72) and direct-to-consumer advertising (ROI US$0.19). Most advertisements are for new and expensive drugs, so increased use due to promotion will contribute to the financial pressures on the Pharmaceutical Benefits Scheme ( PBS). Although there is a substantial body of research on the effects of pharmaceutical industry promotion generally, generally, relatively little involves printed advertisements in medical journals. In a landmark study, Avorn and colleagues studied physicians' beliefs about the efficacy of two classes of drugs (propoxyphene analgesics and central/peripheral vasodilators) vasodilators) that were being heavily promoted as effective, despite evidence that they lacked any efficacy and offered no advantages over existing treatments. The authors found that, even though doctors reported paying little attention to drug advertisements, most doctors believed that these agents were effective. The Australian Competition and Consumer Commission (ACCC) is currently examining an application for reauthorisation of the Code of Conduct of the Australian Pharmaceutical Manufacturers' Association (now Medicines Australia). As part of the examination of the relationships between pharmaceutical industry participants, the ACCC is investigating claims in the media about some practices and whether they are in the best interests of the community (Lin Enright, Director, Public Relations, ACCC, personal communication). The ACCC should heed the results reported here. It is only two years since the review of direct-to-consumer advertising of pharmaceutical products in Australia. Australia. Although the review recommended against direct-to-consumer direct-to-consumer advertising, the subject is under continuing review, and some within the pharmaceutical industry are still pressing for change, maintaining that such a facility would enable them to provide important educational information about drugs to the public. Similar moves to relax laws relating to direct-to-consumer advertising are also occurring in Europe and Canada.8 The information reported by Loke et al on journal advertisements suggests that direct-to-consumer advertising is likely to be uninformative and promotional rather than educational in nature. Where should we look for guidance on appropriate standards for advertising pharmaceutical products? Medicines Australia polices a voluntary code of conduct that aims to set "standards of conduct for the activities of companies when engaged in the marketing of prescription products".9 This document places more emphasis on what not to do when promoting medicines, rather than offering guidance on how to provide balanced advice to clinicians about the efficacy and safety of medicines. Perhaps we should pay more attention a ttention to the advertising standards maintained in other industries. Generally, advertisements for technologically sophisticated products include prominent displays of their specifications, performance and selling price. Is it too much to ask that advertisements
10 for modern drugs provide similar information? In an era of evidence-based medicine this should include data on the absolute effects of therapy, such as the response rates with and without treatment, and the number needed to treat, in order to avoid the ambiguities of relative measures such as the relative risk reduction. It would be best if this information related to comparisons with established therapies, not just placebo. Clinicians should also be told the dispensed price of the drug under the Pharmaceutical Benefits Scheme. Case laws: Hamdard Dawakhana v/s Union Of India:
In Hamdard Dawakhana v/s Union Of India the Supreme Court held that if there is a restriction on advertisement to promote the drugs, it was held to be valid restriction and such an order would not violate the freedom of expression. There is no doubt that the commercial advertisement has the elements of commerce and trade and is no way connecte connected d with with nob noble le though thoughtt and would not come come und under er the freedom freedom of expres expressio sion n as not not all advertisements come under freedom of speech and expression as contained in Article 19(1) (a)
Conclusion
Promising the cures fro certain ailments through advertisements is not only limited to the pnewspapers but also to electronic media and new media or internet. These advertisements normally normally tend to target the sensitive sensitive audience by trying to exploit through excited words that their medicines would be helpful in toning the physical body. Mostly people suffering from inferiority complex will get victimized for these advertisements. Inorder to tackle these problems a strick enactment The Drugs and Magic Remedies (Objectionable Advertisements) Act has been
11 passed. passed. As it stands, stands, the Drugs Drugs and Magic Remedies (Objectionab (Objectionable le Advertisem Advertisements) ents) Act, 1954, 1954, basically basically prohibits four kinds of advertisements pertaining to drugs and magical cures. Section 3 of the Act says that no person shall take any part in the publication of any advertisement promoting a drug or leading to the use of a drug for the procur procureme ement nt of miscar miscarria riage ge in women women or preve preventi ntion on of concep conceptio tion n in women; women; the mainte maintenan nance ce or improvement of the capacity of human being for sexual pleasure; and correction of menstrual disorders in women. Section 3 further prohibits any advertisement promoting drugs for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule. The schedule lists a number of diseases, disorders or conditions such as diabetes, cataract, cancer, fevers (in general), obesity, rheumatism, impotence, high or low blood pressure, female diseases, epilepsy, stature of persons, venereal diseases, glaucoma, sterility in women, dropsy, etc. Section 4 of the Act prohibits those advertisements relating to a drug if they contain any matter which directly or indirectly gives a false impression regarding the true character of the drug or makes a false claim for the drug or is otherwise false or misleading. Section 5 of the Act prohibits advertisements of magic remedies for treatment of certain diseases and disorders. Violation of the law attracts imprisonment for six months or fine or both, for first conviction and for subsequent conviction, imprisonment for a year or fine or both. The Union Ministry of Health has said that the amended law would not only tackle advertisements on the electronic media, but would also provide for severe punishment to those that violate the law. The move is welcome, but it would be far more effective if the law were to provide for corrective advertisements - in fact this is absolutely necessary to ensure that the impression created by a false or misleading advertisement is corrected through through a series series of advertise advertisements ments.. But amendment amendment of the law is only one part of the solution. solution. What is equally important is its strict implementation. Despite the Magic Remedies Act, RK Gupta advertised with impunity his clinic and claimed that he was offering a sure cure for epilepsy. Ironically, way back in 2000, the Indian Medical Association had declared him a quack after a committee had found that he was giving his patients toxic drugs in high doses. Then in May 2003, following a complaint from a consumer, the Advertising Standards Council of India had held that the advertisement violated the Drugs and Magic Remedies (Objectionable Advertisements) Act. Yet, he continued to advertise and the drug control departments failed to act, resulting in thousands of consumers falling prey to these advertisements. In fact there are a number of advertisements in the print media itself, promoting indigenous cures or medicines for a variety of ailments listed in the Schedule of the Act and no action whatsoever is taken against any of them. If only the enforcement agencies were active, there would not be cases like the one that went before the State Consumer Disputes Redressal Commission in Kerala some years ago. Young Nadiya, who was short, was attracted to an advertisement that promised to convert a dwarf into Amitabh Bachchan. Fathima Hospital, which had issued the advertisement, promised her that she would gain 10 cm in six months through surgery, costing Rs 32,000. The so-called correction surgery left her bedridden. Eventually, she approached Apollo Hospital, Chennai, which could restore her movement, but not completely. If the state Health
12 Department had done its job, the girl would not have had to go through so much of physical and mental pain. This shows that the Government should aptly act with the legislation inorder or make the laws happened in reality and should serve the needy in time.
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