Bureaucratic Terrorism - 3rd September
Saturday, 04 September 2010 01:08
QPMPA Press Release — 4 September 2010
Bureaucratic Terrorism on Hospitals —
Hospitals raided & Drug Stores penalised
The Health Department wants to take the Healthcare Industry back to the STONE AGE!
Doctors and their hospitals are not sellers of spurious drugs or black marketers as projected by the Drugs Control Authority and we are not ready to have a Pharmacist to supervise our profession as demanded!
M/s. Rajendra Nursing Home at Kozhikode and the Chazhikkat Hospital at Thodupuzha were raided, ransacked and terrorised from 8 am to 6 pm on Friday, 3 September 2010, by the Drugs Control Department officials for not taking a Drug Licence that is not legally binding on them. Hundreds of Drugs stores in Kerala are penalised and threatened for selling drugs to hospitals as per the Conditions of Licence issued by the DCA.
Inspection of premises where drugs are manufactured, stored or sold is a legally permitted activity of the DCA under the provisions of Chapter IV, Sections 22 & 23 of the Act. As per Rule 123 of the Act, the place for exhibiting that mania is not a hospital. When such raids are carried out in a hospital with a vengeance under the full glare of the media, police and public to insult and humiliate hospital owners as sellers of spurious drugs and black marketers and thereby coerce hospitals to take Drug Licence, that too, after misreading / misunderstanding / misinterpreting "Item 5 and 5A of Schedule K" in the Drugs and Cosmetics Act, is a highly irresponsible act by the bureaucracy and must be condemned. Kindly note that Drugs & Cosmetics Act is not meant for registered medical practitioners and hospitals. The raids on hospitals at Kozhikode and Thodupuzha violated the basic principles of the Drugs Act and Rules. The DCA is not having any authority to take away life saving drugs worth lakhs from hospitals purchased from licensed drug stores and accounted. Responsible officials should not be swashbucklers.
The Drugs & Cosmetics Act is an Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. It is there to help the medical profession get good quality drugs freely. The State Drugs Control Departments are there to regulate the said activities in the states. It is the duty of the DCA to see that all the registered medical practitioners, their hospitals and other related institutions are getting all the required drugs freely as per the provisions of the Drugs Act & Rules.
The DCA knows very well that the QPMPA has approached the Apex Court with an SLP against the verdict of the Kerala High Court and the QPMPA has already filed a Review Petition No. 794/2010 in Kerala High Court on 30 August 2010 as directed by the Supreme Court. The raids and confiscation of life saving drugs amount to contempt of Court by the bureaucracy. It is shocking to note that the bureaucracy too has stooped to levels like the followers of the legislature in Kerala.
By imposing Drug Licence on hospitals, the department gets a backdoor entry into hospital pharmacies and can manipulate the drug purchase policies of hospitals and so the haste in implementing the Hon’ble High Court orders without reading it fully.
As per the provisions of the Drugs Act, licenses are issued to the Druggists. The details in Form 20B is copied --
"FORM 20B [See rule 61 (1)]
Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale, drugs other than those specified in Schedules C, C (I) and X
Conditions of Licence
1. This licence shall be displayed in a prominent place in part of the premises open to the public.
2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force.
3 (i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer.
(ii) No sale of any drug shall be made to a person not holding the requisite licence to sell stock or exhibit for sale, or distribute the drug. Provided that this condition shall not apply to the sale of any drug to—
(a) an officer or authority purchasing on behalf of Government, or
(b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or... "
Kindly note the Condition of Licence No. 3 in Form 20B shown above and made bold. They have taken actions against Druggists who sold medicines to doctors and hospitals.
It is reported that hospitals have violated Section 18 (c) of the D & C Act. That is copied –
Section 18. Prohibition of manufacture and sale of certain drugs and cosmetics.—From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf—
(c) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter:
Provided that nothing in this section shall apply to the manufacture, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis:
18A. Disclosure of the name of the manufacturer, etc.—Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic.
19. Pleas.—(1) Save..
(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall not be liable for a contravention of section 18 if he proves—
(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor or dealer thereof;
(b) that he did not know and could not, with reasonable diligence, have ascertained that the drug or cosmetic in any way contravened the provisions of that section; and
(c) that the drug or cosmetic, while in his possession, was properly stored and remained in the same state as when he acquired it.
The most important part in section 18 is made bold. That says that "no person shall himself or by any other person" sell or stock any medicine except under, and in accordance with the conditions of a licence issued for such purpose.
All the important words used in the Act and Rules are defined at the respective places in the Act. It is true that the Drugs Act and Rules do not give a definition for "a person, no person, or any other person". Interpreting these words literally means “an Indian or any Indian”.
The DCA also failed to read Section 18A and understand the rights of "every person" keeping drugs!
However, "a registered medical practitioner" is well defined in the Drug Rules, and copied —
Rule 2. Definitions.___ In these Rules, unless there is anything repugnant in the subject or context ___
(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 excluding the Homoeopathic system of medicine; or
Kindly note that "a person or any person" mentioned in Section 18 is not "a registered medical practitioner" as defined in the Rules of the D&C Act That may be true for ordinary mortals like us. We will continue to read Rule 2 (ee) (i) & (ii) and then only conclude.
That need not be true in the case of bureaucrats empowered to enforce Acts and Rules on ordinary individuals like us. As a blessing in disguise, the search for the meaning of the word "a person" during the last 36 years took the DCA to Rule 2, sub-rule (ee) cited and they found out "Registered medical practitioner" means a person__ (cited).
Fortunately, the search by the Kerala Drugs Department and Health Ministry ended there and they unanimously concluded that "no person or any person" mentioned in Section 18 of the Drugs Act, is the "registered medical practitioner" defined in Rule 2 (ee) and decided to impose Drug Licence on all doctors in Kerala!
One cannot resist the enthusiasm on finding a loophole in something written in 1940, and that too, after a 70-year-long search! Thus, the DCA decided to impose the Act on hospitals using third degree methods on the unsuspecting registered medical practitioners in Kerala. The raid drama enacted at Kozhikode and Thodupuzha on 3.9.2010 is only a feeler and a warning to the medical practitioners and Drug stores to fall in line and to start learning to behave or be docile to the dictates of DCA!
"Rule 65. Condition of licences. — Licences in Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B shall be subject to the conditions stated therein and to the following general conditions —
(5)(1) Subject to the other provisions of these Rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered —
(a) the date of sale,
(b) the name, address of the licensee to whom sold and his sale licence number. 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 and address of the authority, institution or the Registered Medical Practitioner as the case may be,
(c) the name of the drug, the quantity and the batch number,
(d) the name of the manufacturer,
(e) the signature of the competent person under whose supervision the sale was effected.
xxx
(9) (a) Substances... .
(b) The supply of drugs specified in Schedule H or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years.
The DCA so eager to shackle the medical profession, read only the first part of the Rule and that made bold above [Rule 65 (5) (1) (b)] is alien to all of them for the last 36 years!
The Drugs Act and Rules also defines a retail sale and a sale by a wholesaler.
The DCA failed to see these two sub-rules before embarking on the conquering spree of new pastures badly wanted and dreamt!
Rule 2. Definitions.___ In these Rules, unless there is anything repugnant in the subject or context___
(f) “retail sale” means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person other than a sale by way of wholesale dealing;
(g) “sale by way of wholesale dealing” means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution;
Ironically, this immunity is not applicable to a hospital owned and maintained by a mother & son, a father & daughter, and so on. The DCA went a step ahead and considered "couples as a single entity!"
The genesis of "a single doctor and couples as a single entity" theory is by the misinterpretation of a single sentence in Rule 123, Schedule K, Item 5 copied —
Item 5 - Schedule K - Rule 123: —
Class of Drugs Exempted: —
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.
Extent and Conditions of Exemption: —
All the provisions of Chapter IV of the Act and the Rules made thereunder,
subject to the following conditions: —
(1)The drugs shall be purchased only from a dealer or a manufacturer licensed under these rules and records of such purchases showing the names and quantities of such drugs together with their batch numbers and the names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, make enquiries about purchases of the drugs and may also take samples for test.
(2) In the case of medicine containing a substance specified in Schedule G, H or X the following additional conditions shall be complied with:
(a) the medicine shall be labelled with the name and address of the registered medical practitioner by whom it is supplied;
(b) if the medicine is for external application, it shall be labelled with the words “For external use only” or if it is for internal use with the dose;
(c) the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient and the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose;
(d) the entry in the register shall be given a number and that number shall be entered on the label of the container;
(e) the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case may be.
(3)The drug will be stored under proper storage conditions as directed on the label.
Class of Drugs Exempted: —
5A. Drugs supplied by a hospital or dispensary maintained or
supported by Government or local body.
Extent and Conditions of Exemption: —
The provisions of Chapter IV of the Act and the Rules thereunder which
require them to be covered by a sale licence, subject to the following conditions:
(1) the dispensing and supply of drugs shall be carried out by or under the supervision of a registered pharmacist;
(2) the premises where drugs are supplied or stocked shall be open to inspection by an Inspector appointed under the Drugs and Cosmetics Act who can, if necessary, take samples for test.
(3) the drugs shall be stored under the proper storage conditions.
(4) The drugs shall be purchased from a manufacturer or a dealer licensed under these rules or received as transferred stocks from hospital stores for distribution. Records of such purchases or receipts shall be maintained.
The ignorance of English usage helped in the misinterpretation of the sentence in Item 5.
The "a" attached to "registered medical practitioner" helped DCA and the Health Department in reinventing a new meaning for “a registered medical practitioner” = "married & unmarried registered medical practitioners."
What is an article?
Basically, an article is an adjective. Like adjectives, articles modify nouns.
English has two articles: the and a/an.
"The" is used to refer to specific or particular nouns; "a/an" is used to modify non-specific or non-particular nouns.
We call "the" the definite article and "a/an" the indefinite article.
the = definite article
a/an = indefinite article
a = indefinite article (not a specific object, one of a number of the same objects) with consonants — She has a dog, or I work in a factory.
an = indefinite article (not a specific object, one of a number of the same objects) with vowels (a,e,i,o,u)— Can I have an apple? or She is an English teacher.
The most frequent use of the indefinite article is to denote any one of a class or group of objects: consequently, it belongs to singular words.
"A" and "an" are also used to refer to a particular member of a group or class.
The = is called a definite article.
The word "a" registered medical practitioner is used at two places in Item 5 of Schedule K.
Those involved found out that the "a" used there meant "only one" (a singular usage) and the confusion started there.
"a" is an Indefinite article and is — A determiner (as 'a' or 'some' in English) that indicates nonspecific reference.
I, Dr. K. Kishore Kumar, humbly request all those concerned to back out of this controversy now, silently and uprightly as the relevant Act and Rules cited are not at all in favour of the DCA.
Insult and humiliation in a Court will be a permanent black mark and record of the misdeeds of the bureaucracy in Kerala.
For the kind information of the DCA, hospitals and doctors are not Drug Sellers and black marketers as found out after 70 years of the enactment. However, a close reading of the Class of Drugs Exempted in Schedule K Item 5 will show that we can keep open shops, sell over the counter and even import to a degree which render us liable to the provisions of Chapter IV. I do not know how many of them will fully understand the meaning of "to a degree which render him liable", and the limitations imposed on them (DCA) in defining that “degree” and from going ahead with their present plans.
When the confusion in the "class of drugs exempted" in item 5, Schedule K is over, we will land in the "Extent and Conditions of Exemption" to item 5 and 5A.
The DCA may kindly note that the place of work of “a registered medical practitioner” is a "hospital" and there is no natural justification in separating them and in considering them as two entities! A right enjoyed by an RMP will not vanish for the simple reason that two or more of them joined together in one place. With much coaxing the IMA has achieved that for spouses and that need not be only two as some blindly believe!
For Item 5 in Schedule K:-
Extent and Conditions of Exemption: —
All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions: —
And for Item 5A in Schedule K:-
Extent and Conditions of Exemption: —
The provisions of Chapter IV of the Act and the Rules thereunder which require them to be covered by a sale licence, subject to the following conditions:
The Hon’ble DCA Officials implementing Section 18 (c) on a war footing may kindly note the vast difference in the Extent and Conditions of Exemptions allowed to an RMP and to a Government hospital shown above.
Sir, an RMP or a hospital owner, is a criminal now as projected by you before the media and the world to implement your selfish and hidden agenda. For your information as per Rule 123 he is exempted from “All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions: —“. That is something that you have never bothered to imbibe during the last 36 years of your planning, and that is what I have said in Para 2 above, and hope you are convinced at least now.
Out of 33 items in Schedule K, only 6 items enjoy this vast freedom from Chapter IV. The items are 1, 5, 10, 20, 24 & 30. You may kindly learn to respect those involved in item 5 and 24.
There are 31 sections in Chapter IV starting from Sections 16 to 33A and I have no idea of the number of Rules involved. Dear Sir, you cannot charge anyone of those sections on a hospital or an RMP. Ignorant of these facts in the Act you arrested Dr. Sumathy of Kozhikode in 1974, the starting point and in 2010 you did that again to Dr. Rajendran of Kozhikode. For more on this harassment and molestation from DCA read "The Story" in Drug Licence Case in News and Event in this site. Let us hope the drama on 3rd September 2010 was the closing ceremony with media cover.
Dear Friends, that being the truth in the Act and Rules entrusted with you, kindly spare the members of the medical profession, till the same is amended to suit your desire. Till then enforce all that said in it sincerely on your friends and colleagues and try to give us better medicines to save the poor Indians at your mercy. In a way, we are all indebted to you. If you cannot deliver quality medicines to us, poor Indians will suffer and our good names will be tarnished. As said in my open letter to CM in May, let us be friends and not foes.
That given above is the legal truth and the ball is now with the DCA. We are part of a team – health care delivery team. Divert your energies to improve the drug supply. To make my points and views clear, I know that I had gone beyond the “Lakshman Rekha” and I am sorry for that.
It is true that the State is authorised by the Central Government to enforce the D&C Act and has asked them only to do what is written in it by taking the literal meaning. The DCA has no right, authority or business to search for hidden meanings and enforce hidden agenda. Hope that is clear to all concerned.
If the hospitals decide to close down the pharmacies, it shall be the responsibility of the DCA to see that all required life saving drugs is made available in front of all hospitals round the clock. If not it will be the Health Department and DCA that will be held responsible for the life of innocent people and not the hospital owners or doctors!
Kindly note that as per Section 22 of the D&C Act, the DCA has every right to inspect all places where drugs are stored, including hospitals and you have every right to take necessary and appropriate actions. Kindly note that RMPs, are totally exempted from the provisions of Chapter IV of the Act and includes their hospitals also. The DCA is permitted to check the records and take samples for test from a private hospital. On the other hand in a Govt. Hospital you are permitted to inspect the premises and stock of medicines for the simple reason that it is managed by a Pharmacist. You have no right as per the Act to touch the drugs stored in a private hospital. You have unknowingly or under pressure from superiors violated the Act and will be answerable. Our right to store drugs as required cannot be questioned. All that we are required to fulfil is to prove that the drugs with us are purchased from licensed drug stores or manufacturers and they are properly stored. You can come alone and check our drug purchase records and we do not have any objection.
As said in my Open Letter dated 22 May 2010 to the CM and others available in our website www.qpmpa.org Let us be on a collusion and not collision course!
I, once again, request the Chief Minister, Health Minister of Kerala, and all those concerned to step in and help bring the Drugs Controller back to sense. If not thousands of patients will suffer all over, Kerala and the authorities will be held responsible.
Dr. K. Kishore Kumar,
QPMPA Secretary
Mob: 9447485532
Go to http://cdsco.nic.in/ for a copy of Drugs & Cosmetic Act.pdf corrected up to 2005