A few months ago, the Ministry of Health and Family Welfare announced that it was planning to amend the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954. A draft of the amendments was published along with the notice and comments were invited from the general public. It has become quite rare for government to conduct pre-legislative consultation these days and we at CASEM were grateful for an opportunity to contribute to this important policy exercise. Our comments can be accessed over here.
History of the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954
This law was originally enacted in 1954 and was inspired by three goals. The Health Minister who introduced the Bill in 1954 made the following comments during the introduction in the Rajya Sabha:
“In recent years there has been a great increase in the number of objectionable advertisements relating to certain diseases and these advertisements border on the obscene—in fact they are obscene— and in addition they cause the ignorant and the unwary to resort to self-medication with very harmful drugs and appliances and even to resort to quacks who indulge in such advertisements and offer treatment which causes very great harm.”
From the Minister’s comments, it appears that the primary aim of this legislation was to discourage the publication of advertisements that were “objectionable” from the perspective of the Victorian morality that prevailed across India in the fifties. For example, three categories for which advertisements are specifically banned under Section 3 include drugs that can be used as birth control or for abortion; drugs that purport to improve sexual pleasure and any drug that claims to correct menstrual disorders in women. These prohibitions were more of a censorship measure than a means to protect public health. A fourth category of advertisements that are prohibited, appear in the schedule to the legislation. This schedule includes 54 conditions including cancer, diabetes etc. for which advertisements of drugs are not allowed. The inspiration behind this prohibition is likely a combination of the fact that many of these diseases did not have a ‘cure’, as well as the fact that Parliament wanted to discourage self-medication.
In addition to the above prohibitions, Section 4 prohibits false and misleading advertisements for any drugs while Section 5 specifically prohibits the advertisements of ‘magic remedies’ for conditions mentioned in Section 3. These provisions are likely inspired by a combination of protecting patients as well as upholding a certain standard of scientific rationale in treatments being the subject of such advertisements.
The penalties under this law for the publication of advertisements include a period of imprisonment that may extend to six months or a monetary fine.
The changes proposed by the draft Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Bill, 2020 and the inadequacies of the proposal
The draft amendment bill published by the Health Ministry proposed modest changes to the law. To begin with, the definition of advertisements was changed to include electronic and digital advertisements. Secondly, the penalties under the law were increased with a possible time of imprisonment to two years and a fine of Rs. 10 lakhs, which on a subsequent conviction could increase to five years and Rs. 50 lakhs. Thirdly, the list of diseases for which advertisements are prohibited was increased to 78 items. Lastly, the bill also requires the government to consult with the Ayurveda, Siddha and Unani Drugs Technical Advisory Board before making any rules under this law prohibiting advertisements related to AYUSH drugs under this law.
There are several problems with the proposed amendments.
The first is that it does little to tackle the fundamental design flaw of the Drugs & Magic Remedies Act. There is no sound scientific rationale for some of the more pointed prohibitions against drugs that can be used for birth control or to ‘correct menstrual disorders’ or to ‘improve sexual pleasure’. Another design flaw is the vague language used in the existing law wherein misleading advertisements that make false claims are not permitted. It is not clear about the standard against which “misleading” or “false” claims will be measured. Ideally, pharmaceutical companies should not be allowed to make any claims over and above what has been approved on their labels by the regulatory authority. If a drug has not been approved by a scientific regulatory process (as is the case with most AYUSH drugs) they should not be allowed to advertise it.
A second problem is that the proposed amendment does little to offer clarity on the many overlaps with other legal frameworks. For example Rule 106 of the Drugs & Cosmetics Rules, 1945 read along with Schedule J of that law states that it will be permissible for any drug to claim that it can cure or prevent 51 named diseases or ailments. This is very similar to the Schedule to the Drugs & Magic Remedies Act, except the latter forbids advertisements for many more diseases and ailments. It is not clear why two similar provisions exist in different laws. In fact as per the minutes of the 57th meeting of the Drugs Consultative Committee (DCC), there was an expert committee setup under Dr. Mahapatra to study the overlap between Rule 106 and the Drugs & Magic Remedies Act. The DCC has however not made this report public.
Apart from the aforementioned overlap, there is also an overlap between the Drugs & Magic Remedies Act and an amendment to Rule 170 of the Drugs & Cosmetics Rules that was carried out by the Ministry of Ayush in 2018 to prohibit all new advertisements of AYUSH drugs. The provision reads as follows:
“The manufacturer or his agent, of Ayurvedic, Siddha or Unani drugs, shall not participate in the publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition.”
Further all existing advertisements are required to go through a registration process subject to a number of conditions including a prohibition against misleading or exaggerated claims about the effectiveness of the said drug. These amendments, which were inspired by scathing comments from the Parliamentary Standing Committee on Health in one of its reports, have been challenged in court by AYUSH manufacturers. The larger question is why the Ministry of Health and the AYUSH Ministry are working towards the same policy goals through very different legislative mechanisms?
The way forward for drug advertising laws in India
In our comments on the amendment, we stress on the importance of the government to reimagine the existing framework for advertising framework for drugs. In our opinion, the issue of advertising begins from labeling, product inserts and trade names of drugs. Yet Indian law does not prescribe a rigorous regulatory framework for these basic elements. On the issue of paid advertisements, we caution against allowing any kind of advertising for prescription drugs. Even for non-prescription drugs, we caution the government against allowing for advertisement of brand names. Rather we advocate for allowing advertisements only of the generic names. These advertisements can be funded by either individual companies or consortia of generic companies. This is in order to prevent unnecessary expenditure on advertisements to a general population. Exceptions can be made for medical journals and trade journals for the medical professions. We also prescribe procedural changes in the law that shifts the burden of proof during a prosecution for false advertising to the pharmaceutical companies, requiring them to establish the scientific basis of their advertisements.
The future of drug advertising in India cannot be governed by tweaking an ancient law written in the fifties. It is time to rethink the law entirely.
2 thoughts on “The proposed amendments to the Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954”
I fail to understand rationale why should a manufacturer not be allowed advertising for his brands ? Brands in pharmaceuticals are as different as in consumer goods industry
Perhaps you should read the petition first. I am advocating for pooled advertisement consistent with what the label says for the generic salt. There is no reason why individual manufacturers of the same salt form to advertise, there is no differentiation. On the other hand, if there is a specialized formulation, like extended release, branding should be allowed and regulated; but it ought to be consistent with the claims made on the label. This does not happen today. Most branding is promotional and the claims made have nothing to do with what is actually approved by the regulator after review of data from clinical studies.