Hospital Drug Licence & Pharmacists
Wednesday, 11 August 2010 16:52
The Druggists & Chemists in Kerala
The Pharmacists licenced to run Drug Stores are an enervated group in Kerala and are under the mercy of the Drugs Control Department and Drug Store Owners!
For Declarations & Certificates to be displayed and submitted before Drug Stores regularly — kindly go to the end of this page.
The Drug store Owners Association is very rich as they collectively pocket a profit of 30% for every drug sold in Kerala.
A Drug Company, with the best medicines available will not sell even a tablet in Kerala without the blessings of the Chemists & Druggists Association in Kerala.
All the Drug Store Owners are members in the Association, and Pharmacists have no say, though the licence is in their name.
The Drugs Control Officers having some allegiance to pharmacists want to help them get a new avenue of employment with authority wanted hospitals to take licence in the name of pharmacists for all hospitals.
The allegations raised are that doctors are selling medicines over the counter, and suprious drugs — an act done by all Drug stores! In fact doctors are permitted to buy drugs only from Licensed Drug Stores and ard can give medicines to the patients of other doctors as per Schedule K.
The Act and Rules applied on Doctors and Hospitals are:-
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 —
(a) manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale —
(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;
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(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made there under;
(b) sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made there under;
(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 :
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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 as hereinafter provided in this section, it shall be no defence in a prosecution under this Chapter to prove merely that the accused was ignorant of the nature, substance or quality of drug 7 or cosmetic in respect of which the offence has been committed or of the circumstances of its manufacture or import, or that a purchaser, having bought only for the purpose of test or analysis, has not been prejudiced by the sale.
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(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 .
65. Condition of licences. — Licences in Form 20, 20-A, 20-B, 20-F, 20-C, 21, and 21-B]shall be subject to the conditions stated therein and to the following general conditions —
(1) Any drug shall, if compounded or made on the licensee’s premises be compounded or made under the direct and personal supervision of a registered Pharmacist.
(2) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a registered Pharmacist.
(3) (1) The supply of any drug other than those specified in Schedule X on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register: —
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the prescriber,
(d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use.
(e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof,
(f) in the case of a drug specified in 1[Schedule C or Schedule H] the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any,
(g) the signature of the 2[registered Pharmacist] by or under whose supervision the medicine was made up or supplied.
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(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,
My comments:
Rule 65. Condition of licenses. - Subsection (5) (1) (b) shown above says that it is the duty of a licensee to give the drugs to all hospitals and registered medical practitioners. The Drug stores or the licensing authority has no business to go after the fate of such drugs purchased from such licensed Drug stores by a doctor or hospital – they may sell or swallow it! All that the drug stores are expected to maintain are the records of the purchaser and the Drugs Department has no legal right to demand a hospital or registered medical practioner to take a license to do this purchase from a licensed drug store!
The law makers in 1940/45 were not irresponsible like those manning this democracy now and never wanted RMPs running hospitals to supply drugs to their patients free of cost.
At odd hours hospitals being the only place open, they used to give the required drugs on demand and that cannot be condemned or construed as sales over the counter as found out in 1990 by the masters in Kerala and insist for a Drug License for hospitals. That sale is done purely on humanitarian grounds.
Unfortunately, the lawmakers never anticipated such a twist to what they wrote in 1940 and they be pardoned after 70 years. In 1940 they never expected that criminals will take over the reins of this holy country, especially in God’s own land.
Refusing to give drugs to hospitals is violation of the conditions cited and it is the duty of the Drugs Department to see to that.
Unfortunately the present Drugs Controller Ms. Geetha is in a dilemma having read & understood(!) Rule 65(5)(1)(b) & Rule 65(9)(b) (given below) and so cannot issue any written orders. That is the what we read in Pharmabiz.
http://www.drugscontrol.org/newsprint.asp?id=5293
(9) (a) Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in schedule X, the prescriptions shall be in duplicate,one copy of which shall be retained by the licensee for a period of two years.
(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;]
In short the Licensed Drug stores are there to dispense drugs to the public as directed by a Registered Medical Practioner as per Rule 65 (9)(a). The records for Schedule X drugs must be maintained for two years.The above Rule 65 (9)(b) is clear in all ways as far as RMPs and Hospitals are concerned. They have the right to buy and stock, dispense or sell any drug available in the market from a licensed shop. The Drug Store must maintain the records for two years.
Drug Licence not required to inspect hospitals & book doctors
22. Powers of Inspectors—(1) Subject to the provisions of section 23 and of any rules made by the Central Government in this behalf, an Inspector may, within the local limits of the area for which he is appointed, —
(a) inspect, --
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(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and
(2A) Every record, register or other document seized under clause (cc) or producedunder clause (cca) shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts there from certified by that person, in such manner as may be prescribed, have been taken.
Schedule A of the Drugs Rules 1945
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,
Unfortunately, the Drugs Controller so eager to impose a Drug Licence out of the way is having some ulterior motives and so conveniently failed to see what is printed in all the certificates they issue to Drug Stores.
The cited conditions are also there in:
FORM 20BB (See rule 62-D) -- Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other than those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle
FORM 20D (See rule 67-C) -- Licence to sell ... Homoeopathic medicines by wholesale
FORM 20G [See rule 61(3)] -- Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X
FORM 21B [See rule 61(2)] -- Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X
FORM 21BB [See Rule 62-D] -- Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle.
Pharmacy Act
The Pharmacy Act governing the Pharmacists is also against the Pharmacists when it comes to their services in Private Hospitals. The relevant section is copied from the Pharmacy Act —
“S. 42. Dispensing by unregistered persons.—(1) On or after such date as the State Government may by notification in the Official Gazette appoint in this behalf, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner;
Provided that this subsection shall not apply to dispensing by a medical practitioner of medicine for his own patients, or with the general or special sanction of the State Government, for the patients of another medical practitioner.”
The Druggists Association of Kottayam circulated the letter copied
Then came the letter from Kochi group with declaration
The other Declarations & Display signs for doctors
Soon every doctor will be asked to sign and give another declaration to prove that the other doctor working with you, of the same or opposite sex, is your legal spouse (not your boy/girl friend), and a copy of the marriage certificate and wedding photo be attached for our perusal and permission to help you buy drugs to manage your profession.
Kindly display your marriage certificate and wedding photo in a prominent place in your establishment for the information of the public and patients!
By accident if your children decide to join your establishment, then the concession that you enjoy as a couple will disappear and then you have to obtain a Drug Licence to carry on the profession. So be on guard.
To be signed by the Hon'ble Drugs Controller, Kerala