Meaning of "a registered practitioner, open shop & selling across the counter"

[Kishore Kumar]

Sir,
All the above words/phrases can be seen in “Schedule K” Item No. 5 under “Class of Drugs” column, in Drugs and Cosmetics Rules 1945.

On 29 November 1999, two judges of Kerala High Court, K. Narayana Kurup & T. M. Hassan Pillai, JJ, in O. P. No. 6529 of 1995 with OPs 2273 of 1998, ruled that “Private hospitals must take drug license to run the hospital pharmacy”. Through para 2 of the judgment, they created an impression than “a registered medical practitioner” mentioned in Item 4, Schedule K, means that it is applicable to a “single” registered doctor, and in a private hospital there are many doctors and so must take a “drug license” (2nd sentence in Para 2). Is the meaning of “a registered medical practitioner” “a single doctor”?

The 3rd sentence in Para 2 of the judgment says that doctors are engaged in “sale of drugs across the counter” and so must take a license. (Kindly refer the meaning of ‘wholesale & retail’ in Rule 2 – Definitions and there it is said that hospitals can ‘sell drugs’ as they buy drugs for resale. What is the meaning of the phrase “selling across the counter”? If selling across the counter is not permitted, naturally “selling on the same side of the counter” is permitted in Law (logic). Law books do not give such explanations.

Finally “open shop” – Kindly give the meaning (legal or otherwise). Many doctors, lawyers and even judges believe that it is “a shop kept open” to sell things! All involved are so confident of their knowledge of English and has not bothered to refer any book.

Now in Kerala and almost in all other state, on the strength of the cited judgment, “Single doctors” running a hospital need not take a “drug license” to store drugs. The Health Secretary in Kerala bestowed an additional right ignoring the judiciary, and permitted “couple doctors” running a hospital/clinic not to take a drug license. Many courts in India are punishing RMPs for having a hospital pharmacy without a license and the medical profession is a divided lot and they do not want a legal fight — many of the leaders of the profession are equally ignorant of the meaning of the words mentioned!

Hope I will get the correct explanation.

Thanking you.

Dr. K. Kishore Kumar,
M: 9447485532,
EM: kumarkishoreg@gmail.com

[Dr. Ashok Dhamija]

Though you did not give proper details of the Kerala High Court judgment mentioned by you (such as party names, or link), I could locate it. Broadly speaking, the High Court judgment appears to be correct and on the lines of what the Drug and Cosmetics Rules, 1945 lay down.

The expression “registered medical practitioner” is defined in Rule 2(ee) of the Drug and Cosmetics Rules as under:

“(ee) “Registered medical practitioner” means a person-

(i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or

(ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine 7 excluding the Homoeopathic system of medicine; or

(iii) registered in a medical register, other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or

(iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or

(v) who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;”

It is quite clear from this definition itself that a registered medical practitioner (RMP) can refer ONLY to an individual. It cannot refer to an institution since an institution cannot have an educational qualification and cannot be registered under the Indian Medical Degrees Act or the Indian Medical Council Act, etc.

That RMP refers to an individual only and also that it does not refer to a hospital, becomes also clear from the fact that in Rule 65(5)(1)(b) of the said Rules, the expressions “hospital” and “registered medical practitioner” are used separately in the same sentence, implying that they refer to different things: “…In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner for the purpose of supply to his patients the name…”.

Therefore, the expression “registered medical practitioner” would imply a single person only, and a hospital consisting of several doctors would not be included within the meaning of that expression.

The expression “selling across the counter” has to be distinguished from the expression “to his own patient”. So, an RMP can supply drugs to his own patient, whom he is treating, or he can sell drugs “across the counter” which means he is just selling the drugs to any person even if he is not treating them. It is like selling medicines across a counter without having a doctor-patient relationship. Please do not try to confuse with words such as “selling on the same side of counter” since that would also mean selling “across the counter” if the RMP does not have doctor-patient relationship with him.

The expression “open shop” has also to be understood in the same manner. It is like selling the medicines on a “shop” which is “open” to all, irrespective of whether or not such persons are his patients.

Now, coming back to the Kerala High Court judgment, referred to be you, this judgment [A.N. Thomas (Dr.) v. Union of India, AIR 2000 Ker 325 : (2000) 1 KLJ 900 : (2000) 2 KLT 459] lays down that there is nothing wrong in a private hospital being asked to obtain licence for selling drugs and that there is no discrimination if no such licence is required either by a Government hospital or an RMP. This judgment is broadly speaking based on the specific language used in the Act and Rules on this subject [i.e., the Drug and Cosmetics Act, 1940, and the Drug and Cosmetics Rules, 1945]. There can be very limited grounds to challenge such judgment, and that is on the ground of discrimination only, but the chances of success of such challenge are not that good. This is because the legislative intent appears to be to differentiate between these categories. Article 14 of the Constitution (right to equality, which prohibits discrimination) permits reasonable classification, and while challenging the above differentiation you’ll have to show that this classification is unreasonable and arbitrary. You may consult some good lawyer on these issues with full details of the case, if you want to challenge it. But, please keep in mind, the chances of success are comparatively less.

     

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Dr. Ashok Dhamija is a New Delhi based Supreme Court Advocate and author of law books. Read more about him by clicking here. List of his Forum Replies. List of his other articles. List of his Quora Answers. List of his YouTube Videos.

[Kishore Kumar]

Dear Dr. Ashok Dhamjia,

Thank you very much for the detailed reply. Your complaint that I have not given the details of the case is true. Sorry for that. I know that with the case number one can find out all the details of the case from the web and you have done that.

All I wanted to know is the meaning of three phrases — 1. “a registered medical practitioner”, 2. “open shop” & 3. “selling across the counter”. All these are used in Item 5, Schedule K, Drugs & Cosmetics Rules, 1945, in the Column “Class of Drugs”.

Sir, Before giving the detailed explanation, you failed to read the “Single (ONE) Para” cited or that mentioned at the corresponding level in the other column “Conditions of Exemptions”. Kindly note that the one mentioned in Item 5 – “Class of Drugs” (RMP) is exempted from all the provisions of Chapter IV of the Drugs and Cosmetics Act, 1940.

I thank you for taking pains to study Rule 65 in detail and regret to inform that the explanation given is on the wrong side. That rule is for the Drug stores and it say that they should not insist for a drug license number for selling drugs to a hospital, RMP, etc.

By accepting your views about “a registered medical practitioner”, that refers to a “single” doctor and he is exempted from taking a drug license. By hard luck, if more than “ONE” RMP work together under one roof, and they want to dispense their drugs to their patients from under the same roof, than they must obtain a Drug License to do that dispensing. I hope my conclusion is right, Sir.

In other words, under Indian Laws, “a”/”the” right enjoyed by “an” individual disappears when two or more of them sit together under a roof or in a room. Hope I am right, Sir.

Sir, “a”, “an” and “the” are used in English language freely and are called “articles”. Kindly note that the article “a” is not singular always. In the above Para I have used “a” or “the” and it is right. Kindly note that the meaning of the two sentences given below are not the same – 1. I read “a” book. 2. I read “the” book. Learn more about “articles” to understand them and writing anything.

Now coming to the other two phrases, “open shop & selling across the counter”, you gave a lay mans meaning. But failed to refer any authentic books. The phrase “open shop” is there in all dictionaries and “selling across the counter” is not there even in the world wide web (WWW). The phrase “selling over the counter” (OTC) is there and the meaning of that is not the meaning of the words in it.

Sir, kindly note that the judgment cited is “set aside” by the Hon. Supreme Court on 8 October 2003 by Shivaraj V Patil & B. M. Dearmadhikari JJ in Civil Appeal No. 8216 of 2001 — QPMPA vs State of Kerala.

Hope, I will get a better explanation to question the decisions taken by courts on this “Drug License” issue by the Courts.

Thank you Sir.

[Dr. Ashok Dhamija]

Please appreciate that I have given a pro bono reply after spending considerable time on your query. If you ask a question, you should provide full information in your first question itself.

I stand by what I have stated in my previous reply. So, I don’t want to reiterate the same things. If you are not satisfied with that reply, you are free to hold your opinion. I am not here to give a “specific” reply desired by a querist. You may accept or reject my reply, as you wish. I can only offer what is my considered opinion subject to my limited knowledge.

At the same time, let me clarify your new doubt, if two (or more) doctors under the same roof treat their own patients separately and supply them their individual medicines, this scenario may well be covered under the exemption given to “registered medical practitioner”. However, if a “third” entity, namely the hospital, supplies the medicines then the situation may be different; this is what is apparent from the relevant rules.

Having read the specific Supreme Court decision now mentioned by you (not that I had not searched the Supreme Court decisions earlier), I do not want to offend you by saying that you have apparently misinterpreted the Supreme Court decision when you say that the high court decision is “set aside”. In fact, had that been the situation, your first question itself was redundant. Therefore, I don’t want to question you as to why did you quote the high court decision in the first place (and wanted opinion on that) if it had already been “set aside”.

And, by the way, thanks for telling me that I do not understand English language and that I need to study “a”, “an”, and “the” of English. I am genuinely thinking of joining English classes again as per your kind suggestion.

Sir, I do not want to say anything else since it is quite clear that you already have much more knowledge than me. I bow down before you. With limited knowledge and limited time at my disposal, I cannot match your talents. Thanks, indeed. And, my apologies for not coming up to your expectations due to my limited knowledge. This question is now closed for any further replies.     

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Dr. Ashok Dhamija is a New Delhi based Supreme Court Advocate and author of law books. Read more about him by clicking here. List of his Forum Replies. List of his other articles. List of his Quora Answers. List of his YouTube Videos.

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