Dr Milind Antani, Anay Shukla and Darren Punnen from Nishith Desai Associates, give an insight on the scope of laws that regulate direct to patient advertising in India
Direct-to-Consumer (DTC) advertising is key to any business. However, DTC advertising has always been a challenge for pharmaceutical and medical device companies in India. Any marketing professional from either of these industries, will admit that there is an instinctive hesitation to advertise medicines and medical devices before the end consumers. This begs for the question – what is the basis of this hesitation? Do laws in India stop DTC advertising of medicines and medical devices? In the paragraphs below, we have explored the scope of laws that regulate direct to patient advertising in India.
In India, the business of medicines is regulated by the Drug and Cosmetics Act, 1940 (DCA) and the Drugs and Cosmetics Rules, 1945 (DCR). Until 2015, the DCA and DCR did not regulate DTC advertising except for the content that appeared on the label of the product. The DCR now prohibits the manufacturers of medicines identified in Schedule H, H1 and X of the DCR from indulging in any form of advertisement. The language used to prohibit DTC advertising makes it amply clear that ‘public interest’ is not a cushion any longer to advertise medicines.
Unfortunately, the language of the prohibition under the DCR sheds no light on the following crucial aspects of DTC advertising:
1. What is the scope of the expression ‘advertisement’? Does spreading knowledge and awareness of facts such as the results of successful clinical trials before patients amounts to an advertisement? Do patient testimonials constitute an advertisement? Can the presence of facts and testimonials on the global website of a pharmaceutical company amount to an advertisement of the drug in India?
2. Whether the restriction on advertisement applies to distributors and marketers? In India, several medicines are only imported and several others are manufactured on a contract basis by third-party manufacturers. The DCR defines the activities that would amount to ‘manufacture’ and leaves out import and distribution from the definition. This clearly implies that importers and marketers of medicines should not be referred to as manufacturers under DCR. So, is it fair to assume that DCR gives a free hand to importers and marketers to advertise their medicines directly to the end consumer? Does this fulfil the objective?
Interestingly, from January 1, 2018, the business of certain notified medical devices is regulated by a set of new rules called the Medical Devices Rules, 2017 (MDR). The MDR has absolutely no restriction for the advertisement of medical devices. Does that mean that manufacturers of medical devices can advertise their medical devices directly to consumers under the provisions of DCR?
Apart from the restrictions on advertising certain drugs, there are restrictions on advertising cure for certain stipulated diseases and conditions using medicines and medical devices. The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMRA) and Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955 (DMRR) identifies certain diseases and conditions whose diagnosis, cure, treatment, prevention and mitigation cannot be advertised by a medicine or a medical device. Unlike DCA, the DMRA and DMRR apply to all individuals and not just manufacturers of the medicines.
However, the sad truth is that DMRA and DMRR have become anachronistic and irrelevant. For example, it is well known that Cataract can be cured and Asthma can be mitigated. Does DMRA permit the advertisement of the intra-ocular lens for treatment of Cataract and corticosteroids-inhalers for mitigation of Asthma? It just doesn’t, period. Thus, it may not be an overkill to state that DMRA AND DMRR is fairly out of sync with the advancements in the field of science and medicine. The problem doesn’t end there. Some of the diseases and conditions identified in DMRA and DMRR are described broadly and are capable of misinterpretation by the regulator. Take for example a condition called ‘rheumatism’. Many doctors are of the view that rheumatism and rheumatoid arthritis are totally different. However, the regulator believes that rheumatoid arthritis is a subset of rheumatism and has prosecuted companies who have advertised a treatment for rheumatoid arthritis. Such liberty in interpretation taken by the regulator is a serious cause of concern.
Given the questions on the applicability of restrictions on direct to patient advertisement under DCA and irrelevancy of DMRA, one wonders whether the drug and medical device industry has matured enough to self-regulate against unwarranted advertising. This will, perhaps, allow the government to concentrate its resources on enforcement and updation of rules that govern critical aspects of business such as quality of medicines and medical devices.
In fact, the Organization of Pharmaceutical Producers of India (OPPI) had published a ‘Code of Ethics for the members for the Advertisement of OTC drugs in India’ long time ago. The language of the code feels in-tune with time and one wonders why the government has hesitated to adopt it into a full-fledged law. It contained very forward-looking guidelines such as prohibition on using statements in advertisement that may create fear or apprehension in the minds of the public (eg. a person may suffer from ailment by not using a product), prohibition on implying that a medicine is recommended by health professionals, prohibition on offering rewards or other inducement leading to excessive use of the drug by a consumer, prohibition on giving impression that a medical consultation or surgical operation is necessary, mandatory use of warning such as “use only as directed” etc.
This piece would be incomplete without referring to broadcasting laws. Basically, in addition to the laws that restrict DTC advertisements by businesses, there are laws and guidelines that restrict broadcasters of radio and television from accepting advertisement of drugs and medical devices. For instance, there is a code called ‘Code for the Self-Regulation of Advertising Content in India’ (ASCI Code) published by the Advertising Standards Council of India. It does not prescribe restrictions on advertisement of medicines and medical devices but stipulates that the content of advertisements should not be misleading or offensive to the public. ASCI Code is to be mandatorily complied with by the television networks only owing to the Cable Television Network Rules, 1994. However, its compliance is not mandatory for pharmaceutical and medical device industry.
It would be improper to conclude that the hesitation within the pharmaceutical and medical device businesses to undertake DTC advertisement of medicines and medical devices is misplaced. The fact is that the laws in India have not matured with time to allow DTC advertisement, unlike the science and people around it. The pharmaceutical and medical devices companies today suffer from over-regulation of DTC advertisement, unlike sister industries such as healthcare, food as well as many non-healthcare sectors. However, it is very much possible even today to educate consumers about the advances in the field of medicine and medical devices within the four corners of law. It is also possible to enter into arrangements with stakeholders who are not governed by the aforementioned laws to gauge their interest in undertaking consumer education and awareness.
The time has arrived for the government to act and give the necessary cushion to the industry to do what is not only required for the industry to grow but also for the patients to remain educated about their health. After all, we all aspire for Ayushman Bharat (i.e. healthy India)!