Drugs Controller finally acted!
Saturday, 14 August 2010 02:15
For the truth and nothing but the truth
Learned that our masters have condemned this website as absurd and planning a ban.
Dr. K. Kishore Kumar, State Secretary, QPMPA
The Drugs Controller has finally decided to act officially on 4.8.10
IMA happy with the letter from Drugs Controller directed members to circulate the letter to Druggists—
Shown above the letter issued to Assistant Drugs Controllers & Drugs Inspectors by the Drugs Controller.
The letter No. L. 10894/2007 DC dated 04.08.10.
Our IMA Kerala leaders must be congratulated for forcing the Drugs Controller to write this letter on 4.8.10 as demanded by them on the same day. (See Ref. shown in the letter.)
Thus IMA also got a copy to withdraw the SLP in Apex Court — the free service offered (or in its words) — without taxing the members! (Visit & see the first letter dt. 5.5.10 - http://www.qpmpa.org/news-and-events/9-drug-licence-case/36-ima-vs-qpmpa-part-2-ima-letters-in-may-2010.html)
From 25 March 2010, the day of Kerala High Court judgment, the Drugs Controller was reluctant to issue anything in writing to implement the High Court orders. Interestingly, none bothered to read the High Court order! (See the Open letter to the Chief Minister and others in the home page.)
The meeting and agreement by the IMA with the Health Minister on 26.5.2010 on a NON-ISSUE was the turning point. See the minutes in http://www.qpmpa.org/news-and-events/9-drug-licence-case/37-ima-vs-qpmpa-part-3-minutes.html
The second para of the above letter will be interesting. See the underlined sentence. Two groups are exempted — "single registered medical practitioners" & "husband and wife as single entity."
A simple sentence in Schedule K, Item 5, copied below, is reinvented as "unmarried & married registered practitioners" with the blessings of our great IMA Kerala at the meeting held on 26.5.2010!
The etymology, origin & importance of "single registered Med. Practitioners & husband and wife as single entity" are interesting in the above letter.
In English, an indefinite article is needed in front of professions — she is an architect and he is a doctor.
The word "SINGLE" is given importance in the above letter and in Annexure P1 — Letter No. DL.16001/90/DC dated 6.12.1990 in our SLP. This may be out of ignorance of the usage of the language or done purposely! I am not a master of this language.
On 16.8.2010, the Apex Court heard the SLPs and dismissed both on two different grounds. The New Indian Express came out with this story on 17.8.2010:-
Instead of considering the above news as a blessing to back-out, the Drugs Controller flashed the following in their website http://dc.kerala.gov.in/ as "New" & "Newsflash" on 19.8.2010, in Malayalam having no faith in English —
The New Indian Express published the English version of the above press release on 19.8.2010—
To see the full text of the Apex Court order dated 16.8.2010 kindly visit
http://www.qpmpa.org/news-and-events/11/25-special-leave-petition-16581-of-2010.html
The Order (gist)
SLP(C) No. 15171/2010
(The case filed by IMA Kerala)
Learned Counsel appearing for the petitioners' states that in view of the subsequent developments, no further orders are required to be passed. The Special Leave Petition shall stand dismissed accordingly.
SLP(C) No. 16581/2010
(The case filed by QPMPA)
SLP(C) ...CC 12508/2010
Learned Counsel for the petitioners' seeks leave of this Court to withdraw these Special Leave Petitions. Leave granted with liberty to the petitioners to approach the High Court and seek appropriate modification of the orders.
"The word(s) 'Dismissed' in the order for SLP 15171 & 'seeks leave of this Court to withdraw' in the order for SLP 16581" when translated to Malayalam insulted the Judges in Court No. 9 in the Apex Court. Let us hope they will not start learning Manglish!
Interestingly, the IMA flashed the Press release by the Drugs Controller, cited, as its greatest achievement to impress all its members and I too got a copy on 20.8.2010.
I was shocked and equally sad on seeing the press release in the Official website of the Drugs Controller and Emailed and faxed the following letter to the Chief Secretary of Kerala, Health Secretary and the Drugs Controller and copied the Emails to the media also—
Letter requesting removal of Newsflash from the Drugs Control Department website http://www.dc.kerala.gov.in/
Dear Chief Secretary, Health Secretary, Drugs Controller, et al,
Drug Licence for Private Hospitals — reg.
The website of the Drugs Controller has a Flash News that Drug Licence is made compulsory for Private Hospitals. http://www.dc.kerala.gov.in/
Kindly withdraw / remove the same as it is against facts and truth.
Copied the order dated 16.8.2010 from the Supreme Court website for the two SLPs on Drug Licence.
SLP No. 15171 belongs to IMA Kerala. Case dismissed.
SLP No. 16581 belongs to the QPMPA. Permitted to approach High Court.
The full order is given at http://www.qpmpa.org/news-and-events/11/25-special-leave-petition-16581-of-2010.html
The QPMPA will approach the Kerala High Court within the permitted period.
The Drugs Controller must patiently wait until then before implementing the dream project of the department.
I can understand the impatience/restlessness of the Department in this issue. 20 years is too long a period to implement something so good for this Gods own country. The courts in this country are the major hurdle for the department! That can be seen in an interview by Mr. George in a website (Pharmabiz) — http://www.pharmabiz.com/article/detnews.asp?articleid=25004§ionid=50
I have given an application for Information to the Drugs Controller on 11.8.2010, requesting a reply in 48 hours.
I have not received the reply until 20.8.2010. Kindly do the needful.
There is acute shortage of life saving medicines in all hospitals and kindly note that the Drugs Department will be answerable for the consequences.
We agree that the Drugs Control Department is there to enforce the Drugs & Cosmetics Act & Rules, a Central one.
If a licence is required they can issue a notice to those concerned quoting the relevant sections in the Act and take action. Playing hide and seek is not the Official procedure in India.
Asking the Drug stores under their spell to stop drug supply is not the right way in a democracy. Sad to note that the Drugs Control Department has not learned that simple truth even after 36 years — note that the department started this game in 1974 and a victory is nowhere in the horizon.
With regards,
Dr. K. Kishore Kumar, State Secretary, QPMPA
Phone: 9447485532
The letters to others with authority to act in a democracy is withheld to reduce the number of foes!
Application under Right to Information Act
Form (See rule 3)
Application for information under Right to Information Act, 2005
(The application fees paid by affixing Rs. 10/- Court fee stamp. Notification S.R.O. No. 385/2006 dt. 9 May 2006.)
To,
Ms. M. Geetha, Drugs Controller (In Charge),
The Appellate Authority of the Department,
Office of the Drugs Controller, Red Cross Road,
Thiruvananthapuram 695035
1. Name of Applicant: Dr. K. Kishore Kumar, State Secretary, QPMPA, Kerala
Ph. (0479) 2445532, Mob. 09447485532
3. Particulars of information required:
I am the State Secretary of QPMPA, a National Organisation of private sector doctors. We have 2,500 members in Kerala, and all are small and big hospital owners. We treat 80% of the patients in Kerala.
Our members are finding it difficult to procure the required medicines from the drug stores — wholesalers & retailers — in Kerala from 1.8.2010
The Drug stores are demanding “Drug Licence number” for the supply of medicines to hospitals. When proof of this denial of supply is demanded, they say that it is on the Oral Orders of the Drug Inspectors in the area.
1. Kindly inform whether there is any such oral order to drug stores not to supply medicines to hospitals?
2. If so kindly inform the relevant sections in the Acts and Rules requiring Drug Licence for hospitals.
3. If you have not issued such orders, kindly look into this matter and inform us the actions you are taking to restore medicine supply to hospitals in Kerala.
4. As the information sought for concerns my life, profession, liberty, and that of 2,500 members to whom I am answerable, the same shall be provided within forty-eight hours of the receipt of this request. (Section 7(1) of the Right of Information Act, 2005.)
4. Year to which the information pertains: “March 2010 onwards.”
5. Other relevant reference, if any: SLP (C) No. 16581/2010 by QPMPA in Supreme Court.
Place: Kayamkulam
Date: 11 August 2010
Cc: The State Information Commission, T. C. 26/298, Punnen Road, Thiruvananthapuram 695039
Three simple questions and the fourth is a request for a reply in 48 hours.
Regret to inform that there is no reply from the Hon'ble Drugs Controller until 22 August 2010. Onam 2010 is more important for those concerned than the life and death issue of the seriously ill patients in Kerala!
The Drugs Controller's dilemma!
3 questions & answer only 2
Question No. 1. If the answer is "YES" then answer Question No. 2 and if "NO" answer Question No. 3.
Question No. 2. If the answer is an "YES" for the question No. 1, the DC must give me a number from the Drugs & Cosmetics Act, 1940 and Rules, 1945.
The Section quoted in Letter No. DL.17323/94/DC dated 17.3.1995 cannot be repeated for the simple reason that the present Drugs Controller has read Rule 65 (5) (1) fully —
"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 that highlighted in yellow and that in light green was alien to all of them for the last 36 years! After 36 years of the struggle the present Drugs Controller read it and so the big silence.
Question No. 3. If the answer is a "NO" for the Question No. 1, then the answer for that will be — "actions will be initiated as per Rule 66, if the allegations are true."
Sad to say that all those maintaining the Drugs Control Department must be crucified to remain on the right track officially. Unfortunately, the leaders of the Drug store owners never dared to ask for a written order to be on the safe side. The letters from the Druggists associations are also published elsewhere in this website. (See News And Events tab.)
By not giving drugs to doctors (unmarried & married doctors exempted) and hospitals the drug store licencees were violating the "Conditions of the Licence" as per Rule 65!
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.
Kindly note that highlighted in yellow and light green above. It is said that aging makes us wiser. That is true for only for simpletons. Bureaucrats and professionals cannot be included in that group. The cited Drug Licence Certificates are issued by the clerks in the Drugs Control Department and those on top of the ladder need not worry about that, and that is true for the last 36 years. Power corrupts and absolute power corrupts absolutely is true in all Departments.
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.
We were silent all these days and have not moved against the Pharmacists, a paramedic, who own the drug stores. We know that they decided to obey the DCD to survive! They still have our sympathy. It is time they realise the truth and kick out all their criminal leaders and start respecting the law of the land. Do not act on oral orders of officials!
Many hospitals, both small and big including Pushpagiri Medical College, Tiruvalla is struggling to save patients for want of life saving drugs, for the simple reason that they all respect this democracy!
For those with authority to wake up and act on genuine issues in this democracy innocent ones must die on our streets. We have inherited that culture.
The medical profession is being harassed for the last 36 years to submit to the illegal demands, whims and fancies of the Drugs Control Department in Kerala. The DCD is there to enforce an Act of the Parliament — The Drugs & Cosmetics Act & Rules. Their duty is to ensure that quality drugs are produced, imported and sold.
Imposing provisions of Drug Licence on doctors and at our place of work — hospitals — highlights the ignorance or vested interest of the officials in the Drugs Department and the Act that empowers them.
A drug licence on hospitals and doctors will not stop the production and sale of spurious drugs as claimed by the DCD to win their side. The simple reason being that all doctors and hospitals are permitted as per the Drugs Act to buy the required medicines only from licensed vendors.
Moreover, the Drugs Department has every authority to inspect all the drugs stored in a hospital or in the consultation of a doctor and take actions if there is violation of the Drugs Act.
The medical profession is there to administer the drugs on the patients and to sell that to the needy as per the directions of the medical profession, we have the pharmacists.
Respecting the Drugs Control Department and the duties vested in them as per the cited Act and Rules, the doctors in the private sector and the QPMPA (the organisation of private doctors and hospitals) has never questioned the right of the department to interpret an Act of the Parliament and then impose it on the medical profession and the private hospitals by dubious means and methods.
Kindly note that interpretation of the laws of the land is the right and duty of the Judiciary and even they do not have the right to go beyond the "literal meaning" in the usual course.
Sad to note that the Hon'ble Drugs Controller of Kerala in 1990 has ignored all etiquettes and found out hidden meanings in the Drugs Act to insult the medical profession and branded us as sellers of spurious drugs, in his enthusiasm to impose Drug Licence on doctors and hospitals to widen the area to maintain his tribe.
For the medical profession to carry out the professional duties nobody can impose the services of a pharmacist as a supervisor!
Kindly help us from going to that level to screw in gumption into all concerned!
Confusion compounded
On 21.8.2010, Malayala Manorama — http://www.manoramaonline.com/cgi-bin/MMOnline.dll/portal/ep/malayalamContentView.do?contentType=EDITORIAL&programId=1073753765&articleType=Malayalam%20News&contentId=7767821&tabId=11&BV_ID=@@@ and Mathrubhumi dailies came out with their own versions of the story and it was a free for all.
The Manorama version irked many of the followers of the Drugs Controller and heard that the Delhi reporter of Manorama was threatened.
The mindset of the media reporters — they have no time to find out the truth!
A reading of the Schedule K Item 5 given below will be helpful —
SCHEDULE K
[ See Rule 123]
Class of Drugs
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.
The ignorance of English usage helped in the misinterpretation of the above sentence.
The "a" attached to "registered medical practitioner" helped 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.
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 importance given to "single medical practitioners and treating of couples as a single entity" is from the misunderstanding of the word "a registered medical practitioner" in Item 5 Schedule K.
If the Drugs Department is asked to define this sentence, they will define it thus — "One judge must have one office and if two of them wants to sit in one room and deliver judgment, then they must be a husband & wife!"
To help our Drugs Controllers the above sentence cannot be written as —
"Judge must have office to deliver...!"
However, the other State Drugs Controllers in India or the Drugs Controller of India never bothered to define "a registered medical practitioner" or "an RMP" during the last 70 years of the enactment as they are not there to read between lines.
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