Press Release 29 August 2010
Sunday, 29 August 2010 17:14
Bureaucratic Terrorism — Drug Stores penalised
Go to http://cdsco.nic.in/ for a copy of Drugs & Cosmetic Act.pdf corrected up to 2005
The Health Department wants to take the Healthcare Industry back to the STONE AGE!
Doctors and their hospitals are not drug sellers and we are not ready to have a Pharmacist to supervise our profession!
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 thousands of Drugs stores in Kerala are penalised and terrorised by the Licencing Authority (Drugs Control Department) for selling drugs as directed by the department.
The Drugs Department is carring out inspection of hospital pharmacies (a legally permitted activity) with a vengeance to 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 and the licenses they issue under Rule 65 of the Drugs Act.
The word "a registered medical practitioner" used in Item 5 in Schedule K is mistaken as "a SINGLE" doctor, and everyone in the Health Department and the leaders of the Indian Medical Association still believe it even after 36 years of the tussle between the QPMPA & Drugs Department.
On 4.8.2010 the Drugs Controller informed her subordinates to HAUNT / TERRORISE all Drug Stores and Hospitals and see that all these CRIMINALS are falling in line with the DICTATES of the Hon'ble Drugs Controller of Kerala. On the strength of the letter dated 4.8.2010, the Drug Inspectors started harassing Drug Stores and directed them to stop supply of drugs to hospitals. Those who violated the dictates were penalised to make others fall in line. Details in http://www.qpmpa.org/news-and-events/9-drug-licence-case/41-drugs-controller-finally-acted.html
I am no one to analyse or dissect the wordings in the minutes and the letter cited, but cannot resist from saying this much — "The Drugs Controller and Health Department will permit a 'husband and wife' without a licence and 'a mother and son' will be permitted with a licence."
Insulted by the news that appeared in the New Indian Express daily on 17.8.2010, the Drugs Department gave a press release in Malayalam, knowing fully well their limitations in handling English, and the New Indian Express daily published it on 19.8.2010, modifying(!) their views dated 17.8.2010.
Adding insult to injury, the Malayala Manorama and the Mathrubhoomi came out with different stories on 20.8.2010. It is understood that some from the Department threatened the Manorama reporter at Delhi for the news published.
It is true that the Kerala High Court dismissed the petitions of QPMPA and the IMA on 25.3.2010. Unfortunate to note that those eager to implement the High Court ruling never bothered to read it! Both the parties approached the Apex Court with SLPs (Special Leave Petitions). On 16.8.2010 the SLP of the IMA was dismissed and that by the QPMPA was remanded to the Kerala High Court for getting modification of the orders.
Ignoring this Order of the Apex Court the Drugs Control Department has intiated actions against the Drug Stores and hospitals to trap as many as possible.
First it was the politicians who defied the orders of the Court in Kerala and now the bureaucracy has followed suit!. May God save this Democracy, before the people take Law into their hands. If the educated ones ruling us cannot honour the laws of the land, may be the ignorance of the language in which it is written, what should be the mental state of the millions of idiots in this country who do not know how to read and write? All the details are there in http://www.qpmpa.org/news-and-events.html
If the Officers entrusted to enforce the Drugs Act and Rules had the minimum gumption they should have tried to read and understand Rule 65 of the Drugs Act fully and that is copied —
The relevant Rules applicable to Drug Stores are copied.
As per Rule 65 of the Drugs Act all shops must give medicines to doctors and hospitals.
"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.
All those concerned eager to shackle the medical profession with the blessings of the Indian Medical Association, read only part of the Rule and that highlighted (yellow) was alien to all of them for the last 36 years! After 36 years of the struggle the present Drugs Controller read it and there was a big silence till 4.8.10.
The Drug Licences are issued in the Forms cited and one such form 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
1...............................................is hereby licensed to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs other than those specified in Schedules C, C(1) and X on the premises situated at...............subject to the conditions specified below and to the provisions of the Drugs and Cosmetics Act, 1940, and the Rules thereunder.
2. The licence shall be in force from................................to...............................
3. The sale shall be made under the personal supervision of a competent person (Name of the competent person.) .........................................................
Date............................... Licence No.................. Licensing Authority.
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
(c) a manufacturer of beverages, confectionery biscuits and other non-medicinal products, where such drugs are required for processing these products.
4. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution.
Rule 66 of Drugs & Cosmetics Act
66. Cancellation and suspension of licences. __ (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder:
Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority—
(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or
(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.
(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.
66A. Procedure for disposal of drugs in the event of cancellation of licence.—(1) In case a licensee, whose licence has been cancelled, desires to dispose of the drugs he has in his possession in the premises in respect of which the licence has been cancelled, he shall apply in writing to the licensing authority for this purpose, giving the following particulars, namely:—
(a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture, as the case may be, held by him,
(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a).
(2) The licensing authority may, after examination of the particulars referred to in sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal.
Rule 66 says that the Licence shall be cancelled if conditions of licence is violated. Unfortunately, Drug Stores in Kerala is now in a dilemma — as in the proverbial "Devil & Deep sea". They are being penalised for acting as per the Conditions of the Drug Licence. That is democracy Indian style!
Kindly note that doctors and their hospitals cannot be equated with drug sellers and we need not require a licence to administer whatever drug we decide on a patient.
Think of a situation if we collectively decide not to store any drug and prescribe it as and when required the Drugs Department and the Health Ministry will be answerable to thousands of deaths that can be prevented within hospitals.
That is, for example, a patient is coming with chest pain at 2 am. and the doctor on duty prescribes the required drugs and ask the patient to go and get it from the drug store open.
Kindly read and understand what is there in the Act and Rules that you are authorised to enforce and act as responsible Officers for the country.
If time permits kindly read Item 5 in Schedule K of Rule 123 and find out what is written in that and that is a single sentence! Copied hereunder —
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.
A plain reading of Rule 123 shows that all registered medical practitioners can (a) keep an open shop or (b) sell across the counter or (c) engage in importation and so on in India (kindly note that it is "India" and not "Kerala").
The Department claims that we (Hospitals) are doing all these illegal activities and so comes under the provisions of Chapter IV and Rule 65.
Unfortunately, the Department has failed to define the level (or say, the degree) which render us liable to the provisions of Chapter IV of the Act and rules.
A clarification on this "level/degree which render us liable" will help us withdraw the Review Petition filed in the Hon'ble Kerala High Court.
Dr. K. Kishore Kumar,
State Secretary, QPMPA
Ph. 09447485532