Drugs play a very significant role in the management of ailment and illness in human life and in this context; medical practitioners are given the responsibility of prescribing the various drugs required for respective ailments/illnesses for the appropriate treatment and cure of the same.
In the light of the above mentioned, the Government of India, like most countries of the world, do not treat drugs as any other consumer products and apart from defined procedures of its procurement and sale etc., it is also subject to strict limitations in the manner in which its marketing is to be carried as well.
Current Position in India
In India, the system of regulation, in order to provide checks and balances with regard to the advertisement of drugs, is provided in the Drugs and Magical Remedies (Objectionable Advertisements) Act, 1954 (“Act”). Section 3 (d) of the Act provides that “no person shall take part in the publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule, or any other disease, disorder or condition (by whatsoever name called) which maybe specified in the rules made under this Act.” It can be devised, from the above provision that publication of advertisement of drugs are subject to scrutiny of the above mentioned section 3 (d) of the Act in India. Therefore, publication of any advertisement referring to any drug in terms which suggest or are calculated to lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule or Rules of the Act are prohibited in India.
The Hon’ble Supreme Court of India observed in the Hamdard Dawakhana (Wakf) Lal Kuan, Delhi & Another V. Union of India & Others (1960 AIR 554), that “The object of the Act as shown by the scheme of the Act....is the prevention of self-medication and selftreatment and a curb on such advertisements is a means to achieve that end.”
However, some of the most important definition of terms described in the Act are outdated and require to be revisited in order to provide relevant meaning in today’s context of progress and advancement equivalent to subject matter contained in the Act.
For example, the definition of the term advertisement under section 2(a) in the Act, which includes “any notice, circular, label, wrapper, or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.” It must be considered that in the present situation, medium of communication is not restricted to the abovementioned terms in the definition and has evolved to a large extent, especially in the genre of electronic media and therefore the shall be included in the Act and improvised accordingly to make it easier for the authorities and the person who is taking in the part of the publication of the advertisement to classify such advertisements and understand the extent of its use.
The Act also presents certain provisions wherein the advertisement of drugs can be carried out, subject to the respective conditions laid down section 14, which includes:
- any sign board or notice displayed by a registered medical practitioner on his premises indicating that treatment for any disease, disorder or condition specified in section 3, ;the Schedule or the rules made under this Act, is undertaken in those premises; or
- any treatise or book dealing with any of the matter specified in section 3 from a bona fide scientific or social standpoint; or
- any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner; or
- any advertisement relating to a drug printed or published by the Government; or
- any advertisement relating to a drug printed or published by any person with the previous sanction of the Government granted prior to the commencement of the Drugs and magic Remedies (Objectionable Advertisement) Amendment Act, 1963 (42 of 1963); although the Government may, for reasons to be recorded in writing withdraw the sanction after giving the person an opportunity of showing cause against such withdrawal.
Hence, it can be deciphered from the above that as far as advertisement of drugs directly to consumer is concerned, the same is prohibited unless there is intervention of the government (point d & e above) or in light of education material (point b) from a scientific or social point of view and the only circumstance wherein any advertisement of drugs is permitted to be provided without any restrictions is to registered medical practitioners (point c).
The prescribed manner as mentioned in point (c) above (by which an advertisement is to be provided to a registered medical practitioner), is provided under Rule 5 of the Drugs and Magical Remedies (Objectionable Advertisements) Rules, 1955, (“Rules”), wherein all the documents containing advertisements relating to drugs ought to be sent by post to registered medical practitioner by name and address of such registered medical practitioner being given and that such documents shall bear at the top, printed in indelible ink in a conspicuous manner, the words “For the use only of registered medical practitioners or a hospital or a laboratory”.
It is to be noted that the prescribed manner under Rule 5 for delivery of such advertisement to the registered medical practitioner was incorporated as per the mode of communication that were in practice when the Rules were introduced. Hence the respective Rule has to be revised and include accordingly encompassing in it all the other valid mode of communication in use in the present day or provide specific limitation of use of any particular mode of communication in the light of the objective of the Act as mentioned earlier, whichever is relevant. Absence of improvisation of the relevant sections and rules causes lacuna and dilemma in performing the activities as per the Act. Clear stipulations will assist in providing a better understanding of the options available to carry out the activities as permitted by the Act.
Apart from the improvisations and amendments suggested herein, it is pertinent to mention that the Judiciary time and again clarifies the objective of the Act when such matter is brought before it, like in Amit Singh & Anr V. The State, the Hon’ble High Court of Delhi while deciding the issues i.e. whether the advertisement amounts to advertising a drug within the meaning of Section 3 of the Act or is it only informative of improved methodology and improved equipment availability of the procedure, held that “an attempt to bring to the notice of public at large about the new technology which had been innovated.., the same in no manner can be termed as an advertisement to the sale and use of any particular drug,”.
In, H.T Media Ltd & Ors vs State, [CLR MC 3060/2010] it was held by the High Court of Delhi that in the instant case, admittedly no medicine is being advertised. What is stated by the advertiser is that cure for the high blood pressure and sugar is available by an Ayurvedic drug. Since the name of the drug has not been disclosed and rather the patient has been advised to contact Dr. Bengali(Kishan Malik), it cannot be said that the advertisement is for any drug to be used for diagnosis, cure, etc. etc. of any disease specified in the Schedule.
Although in countries like the United States of America and New Zealand, drugs to be prescribed by medical practitioners are allowed to be advertised directly to consumers/patients and are regulated by the respective department of the Government in charge of drugs in the country, the same practice is not followed or encouraged in India.
It is very apparent by the nature of the Act that there is no opportunity to share information pertaining to a drug with a consumer/patient directly by manufacturers/importers in order to prohibit selfmedication. However, it is suggested that if the Act is amended in a manner to include activities, which educates the patients about drugs, it will encourage them to understand the procedure involved in the treatment administered upon them by the medical practitioners and will ensure patient compliance of the drugs prescribed to them and more importantly will assist in removing social stigma that is associated with certain diseases.