Unethical pharmaceutical advertising practices have for long been a bone of contention for the Government as well as patient right groups. Time and again, the pharmaceutical industry has been accused of adopting questionable practices in relation to the marketing of their products. The main focus of attention in this respect has been suspect interactions between pharmaceutical companies and healthcare practitioners/ providers (“HCPs”). So much so that the Draft Pharmaceutical Policy,2017 also notes that unethical practices deployed by pharma companies is an area of concern.
Unfortunately, the language of the prohibition under Drugs and Cosmetics Rules (DCR) sheds no light on the following crucial aspects of Direct-to-consumer (DTC) pharmaceutical 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?
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.
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.
