QPMPA Press Release
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 marketeers as projected by the Drugs Control Authority and we are not ready to have a Pharmacist to supervise our profession as demanded!
Sad to note that there are spineless ones in the profession, like in all professions, who are ready to swallow everything lying down. We can only sympathise with those selfish colleagues who doesn't know the rights they have in the society and they can be ignored!
Sad to note that M/s. Rajendra Nursing Home at Kozhikode and the Chazhikkat Hospital at Thodupuzha were raided on Friday, 3 September 2010, and terrorised by the Drugs Control Department goondas for not taking a Drug Licence that is not legally binding on us and thousands of Drugs stores in Kerala are penalised for selling drugs to hospitals as per the Conditions of Licence issued by the department.
Inspection of hospital pharmacies is a legally permitted activity of the DCA and when that is carried out 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 marketeers and thereby force hospitals to take Drug Licence, after misreading / misunderstanding / misinterpreting "Item 5 and 5A of Schedule K" in the Drugs and Cosmetics Act, 1940 and Rules, 1945, that is a highly irresponsible act by the bureaucracy and must be condemned.
They know 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.
By imposing Drug Licence on hospitals, the department gets a backdoor entry into hospital pharmacies and can manipulate the drug purchase policies of hospitals. Drug business is a very profitable one, the profit margin varies from 100 to 2000%, and many in the drama do have a stake!
It is unfortunate to note that they do not even understand what is written in Conditions of Licence they issue to the Druggists.
For information that 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... "
Condition No. 3 in Form 20B copied and made bold above may be read. The Officers miserably failed to read anything beyond No. 3 (i). They cannot take any action against Druggists who sold medicines to doctors and hospitals, if they have read and understood what it means. I am no authority to judge their level of comprehension.
It is reported that we 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:
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.
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.
Kindly note that 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 7excluding 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 & Rules. 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 D & C Act, 1940 and Rules, 1945 applies to "registered medical practitioner" 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 search, and naturally as we all react, they, the DCA also decided to act to impose the Act using third degree methods on the unsuspecting 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!
In short "a person" that is "registered medical practitioner" [Rule 2 (ee)] must obtain Drug Licence as per Section 18 (c) and Rule 65 (5) and that is copied –
"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.
The DCA so eager to shackle the medical profession, read only 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!
However, the efforts of the IMA Kerala convinced the Health Department and forced them to give a concession to "hospitals owned and maintained by a single doctor and also couples" from taking a Drug Licence.
Ironically, this great 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" theoryis by the misinterpretation of a single sentence in Rule 123, Schedule K, Item 5 copied --
Item 5 - Schedule K - Rule 123: — 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.
The ignorance of English usage helped in the misinterpretation of the above sentence.
The "a" attached to "registered medical practitioner" helped DCA, Health Department and the IMA Kerala in reinventing a new meaning to that — "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.
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;
I, Dr. K. Kishore Kumar, humbly request all those concerned to back out of this now, silently and uprightly as the relevant Act and Rules cited are not at all in their favour.
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 by them after 70 years of the enactment. However, a close reading of 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) from going ahead.
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, authorityor 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!
I have only sympathies for all those concerned, and I do not expect everyone to be in my wavelength!
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 and you have every right to take necessary and appropriate actions. That need not be projected as a threat on our right to store drugs as required. In that case 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.
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 conerned 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
Go to http://cdsco.nic.in/ for a copy of Drugs & Cosmetic Act.pdf corrected up to 2005
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