Drug License for Doctors and their Hospitals

Drug License for Doctors and their Hospitals

Under Schedule K, of Drugs and Cosmetics Rules, 1945, the registered medical practitioners (RMPs) are exempted from taking license from the Drugs Control Department for stocking and dispensing of drugs to their own patients.

The Registered medical practitioner (RMP) is not only exempted from taking Drug License, but from all the items in Chapter IV of the Drugs and Cosmetics Act, 1940.

The Drugs Controllers, the Courts and the bureaucrats failed to read the one sentence in Item 5, Schedule K of Drugs Rules and the same copied --

Class of Drugs (Schedule K)

Item 5. [Drugs supplied by a registered medical practitioner to his own patient] [or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient] [provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in India] [to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder.]

That given above is in the left hand side of Schedule K, Item 5 and on the right hand side the rule says that if an RMP follows all that said above is exempted from Chapter IV of the Drugs Act, 1940.

The above sentence has four parts –

Part 1 – [Drugs supplied by a registered medical practitioner to his own patient]

Part 2 – The second part says thus contradicting the first part – [or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient]

Part 3 – The third part of the sentence on first reading pleased the Judiciary & bureaucrats, and the truth is different. The same copied – [provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in India]

The third part of the sentence says that the RMP (the doctor) can only do that said in first & second parts of the above sentence if they are not doing that said in the third part!

The third part of the sentence cited has three subdivisions and they are –

3.1. [provided the registered medical practitioner is not (a) keeping an open shop

3.2. or (b) selling across the counter

3.3. or (c) engaged in the importation, manufacture, distribution or sale of drugs in India]

All the above 3 subdivisions cited is part of one sentence in Item 5 of Schedule K and the logical and literal meaning (as per Indian standards) –

3.1. That an RMP can “keep a closed shop” (What is prohibited is an Open Shop – Unfortunately, all involved failed to understand what is meant by “an open shop”; and the word is there in all dictionaries!);

3.2. An RMP can “sell under the counter” (Unfortunately, there is no word/phrase “selling across the counter”. There is a “selling over the counter” and so we can also “sell under the counter”.)

3.3. The third subdivision says that an RMP to enjoy all that said in the first two parts of the sentence (copied) – Item 5. [Drugs supplied by a registered medical practitioner to his own patient] [or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient]

Should not or (c) engaged in the importation, manufacture, distribution or sale of drugs in India]

Part 4 – The above parts are without any confusion and are OK. However, the fourth part of the sentence [to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder.]

However, the Drugs and Cosmetics Act, 1940 and Rules, 1945 do not define the “degree which render him liable to provisions of Chapter IV of the Act and the rules thereunder.”

If we present it in a different way – Up to 70 kms. per hour is normal speed. If we exceed that, we are booked for over speed. Similarly, the Drugs Act/Rules do not spell out the level at which an RMP violates the Act & Rules for the issues mentioned in Part 3 of the sentence!

It is true that the Rule says –“to a degree which render him liable” and the indefinite article “a” used with the word degree can be taken as “one degree” by our judiciary as educated by the public prosecutor of the Drugs Controller – “a registered medical practitioner” means that “a” is “numero UNO” and so “ONE”.

This fourth part can be applied to the whole sentence or only to item (c) in the third part of the sentence in Part 3. It is up to the people involved and authorised to do the interpretation of the ACT & RULES in India.

The activities mentioned in Part 3 of the above sentence cannot be carried out from the consultation room of an RMP and that means the place of work of the RMP is involved and exempted. Some drug inspectors have given wider meaning to Part 1 of the sentence and directed some doctors that the Pharmacy must be in his/her consulting room and the doctor must dispense it directly to the patients! A Pharmacist can keep an illiterate assistant in his shop and roam around after hanging the certificate in the shop. But a Doctor cannot do that, if the Judiciary is taken seriously.

For the Health Secretary in Kerala "a registered medical practitioner" can also be "a couple doctors" and they can run the hospital without a "drug license" but a "father and daughter" or a "mother and son" cannot run a hospital without a "drug license" -- may be because they sleep in different beds unlike the "couple". Soon Drug Inspectors will be checking the bedrooms of couple doctors to find out whether they sleep together or not, to impose Drug License for their hospitals!

However, the indefinite article “a” in “a registered medical practitioner” is taken as “a single doctor” by the judiciary/bureaucracy and thus they found out or say decided that “a single doctor” is exempted from taking Drug License and if “two or more” such registered medical practitioners sit together in a place/hospital/clinic they will not enjoy the exemption applicable to “a registered medical practitioner”!

The QPMPA tried to teach the judiciary this fundamental in English grammar, and they were aggrieved and agitated. So imposed a penalty of Rs. 10,000 on QPMPA, to impress the world that Indian Judiciary is always “a” right combination of what not! This can be called Judicial escapism! Hide the truth. Cremate the Act! For them an "open shop" is a pan shop kept open to the road to sell things. No time to refer a lexicon!

For the convenience of the Judiciary we can ignore all that said in Drug Rules 65 (5) (1) and in "Conditions of License" in the Drug License Certificates hanging in all Medical Shops all over India. All the rulings are based on Section 18 (c) of Chapter IV of the Drugs Act, 1940 and the Judiciary is not ready to consider that said in Schedule K, that RMPS are exempted from Chapter IV. Medical Ethics do not permit a doctor to run a Drug Store appointing a Pharmacist -- the greatest fun -- The Drug License for the hospital is issued in the name of a Pharmacist and not the Doctor or owner of the Hospital! For the doctor drugs are like their spouse. IMA leaders being more dedicated, hand other their spouses to security guards for safe custody!

I wish the medical profession all the best as it is full of intelligent ones and the associations full of irresponsible leaders! They are shy to close down hospital pharmacies even for an hour in protest. Interestingly, the Drug Inspectors are doing that all over Kerala on flimsy grounds.

Achievement by IMA Kerala leaders:

Agreement with Health Secretary - 1  Agreement with Health Secretary - 2  Agreement with Health Secretary - 3  Collusion with Drugs Dept. - 4

 

Dr. K. Kishore Kumar

M. 9447485532

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