Recently, our Prime Minister Shri Narendra Modi hinted in one of his speeches about bringing a regulation for doctors for prescribing drugs by generic names, as against prescribing by brand names, which is the currently prevalent practice. This has caused a stir among the doctors' fraternity. In this article, I will discuss the legal side of this issue. It should be noted that this article does not comment upon whether the policy of compelling doctors to prescribe drugs using generic names is good or bad. This article focuses purely on the interpretation of current legal provisions about the issue at hand.
Before the day 08 Oct 2016, the clause 1.5 of MCI Ethics Code Regulations, 2002 read as follows --
"1.5. Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs."
Plain reading of the above clause clearly conveyed that prescribing drug by generic names was more of an advisory for registered medical practitioners (RMP), rather than an absolute compulsion.
However, on 08 Oct 2016, the clause 1.5 was substituted vide a central government notification published in the Gazette of India, as under:-
“Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.”
Thus, the words "as far as possible" were removed from the clause 1.5.
Now the obvious question that arises is -- Does the word "should" (as used in clause 1.5 stated above) make it mandatory for RMPs to prescribe drugs by generic names, or does it act as a mere advisory? In strict legal sense, the words "shall" or "must" imply an obligation. Even in the MCI Ethics Code Regulations, the word "shall" has been used in many clauses, which make these clauses mandatory for RMPs to follow. But in the case of clause 1.5, the word "should" has been used instead of "shall". So, if the word "should" is taken as indicating advice rather than casting an obligation, then how does the removal of the words "as far as possible" during the amendment make any difference? The advisory nature of the word "should" if presumed would automatically render the amendment in the wording of clause 1.5 legally meaningless. But is that really the case? A bit of English grammar can help us here.
Please bear with me while reading the next few lines. I promise, the grammar-class won't last long.
In English grammar, "modality" is a word or expression used by a speaker or a writer to express certainty, possibility, willingness, obligation, necessity, ability, desire and contingency. Modality can be expressed by using modal verbs. Modal verbs are a type of auxiliary verbs. There are nine types of modal verbs in English viz; can, could, may, might, must, shall, should, will, would. Modals can be classified as Deontic and Epistemic.
Deontic modals - They indicate how the world ought to be according to certain norms, expectations, speaker desire, etc, and used by the speaker to give permission.
example- A physician should be an upright person.
Epistemic modals - They indicate the degree of likelihood of a particular outcome or state of affairs in the context of the world under consideration, and used to express the opinion of the speaker.
example- He should reach his destination by morning.
Thus, "should" is a deontic as well as epistemic modal verb. The word "deontic" has its origin in the Greek word deon which means "duty" or "obligation".
Armed with this background information, when we view the use of the use of the word "should" in the clause 1.5 of MCI Code of Ethics Regulations, 2002, one would be inclined to interpret that the word "should" has been used as a deontic modal verb i.e. it casts a duty upon the RMP. This interpretation is further strengthened by the objective behind the removal of the words "as far as possible" from clause 1.5. Since the MCI Ethics Code Regulations is a legally binding code for physicians, the breach of its provisions is considered as breach of duty, and thus an unethical act, which is punishable by State Medical Council and MCI. In appropriate settings, Consumer and Civil courts have in the past considered breach of provisions of the Ethics Code Regulations by RMPs as the basis to conclude deficiency in service, and even medical negligence for that matter.
Doctors are thus advised to get used to writing generic names of drugs in their prescriptions, so as to avoid any legal hassles that may potentially arise from failing to do so.
(This write-up is only a general advisory and not a substitute for qualified legal opinion. Reader discretion is therefore recommended. If you find this write-up useful, please share it with your doctor-friends. TechnoScope Systems is a venture by doctors, for doctors. To know more about how we can assist you, please visit our website. You can write to the author at: firstname.lastname@example.org)