To, The Chief Minister, Health Minister & important Officials of Kerala: Dear Sirs, Non-availability of Drugs --
I request the Chief Minister, Health Minister of Kerala, and all those conerned to step in and help bring back the Drugs Controller back to sense. If not thousands of patients will suffer all over Kerala.
All Private Hospitals in Kerala to close in a few days –
want of medicines – Act immediately!
The case – known as Drug License case – WP (C) No. 38494 of 2003 (Y) – was dismissed by the Hon’ble Kerala High Court on 25 March 2010 paving the way for the Drugs Controller of Kerala to implement his directives dated 17 March 1995.
However, the Drugs Department is in a dilemma and are helpless. They won the case by misinterpreting one sentence in the Drugs & Cosmetics Act, 1940, a 671-page document. That is-
Schedule K - 5.A Drugs supplied by a hospital or dispensary maintained or supported by Government or local body. (See page 168 of the Act.)
The Drugs Controller of Kerala after seeing the item cited – Schedule K – 5A. – found out that it means that Govt. Hospitals are exempted and Private hospitals are not exempted and so must take drug license, way back in 1990, and issued orders to that effect. Having won the case they are now trying to implement the High Court verdict through Drug stores by telling them not to supply medicines to hospitals without a license.
The news that appeared in Pharmabiz is copied hereunder – (Kindly note the Para marked blue) –
| DrugsControl.org | |
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| Drugs News | |
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| Kerala Drugs Control Dept orders private hospitals to obtain licences for pharmacies from May 1 | (3/5/10) | ||
| Chennai, 3 May: Following the verdict of March 26, 2010 by the High Court of Kerala, the Drugs Control Department of the state has started giving instructions to all the private hospitals operating own pharmacies to obtain drug licences after April 30. However, the department has not issued any written circulars in this regard to the hospitals but instead directives were given orally, said the drugs controller in-charge M Geetha. She said there are some technical problems in giving written orders, but it will be done in future if necessary. According to sources in the department, officials in the rank of assistant drug controllers have passed on the direction to the respective hospital managements directly and over telephone in their jurisdiction. The sources said that the new order puts the hospital managements as well as the enforcement officers in a dilemma as to how many licences the super speciality hospitals should obtain since many of them are having more than one pharmacy in their hospitals. "The ward pharmacies attached to all the specialities in a super speciality hospital are centralized with a general pharmacy store and medicines from each of the subordinate pharmacies are dispensed by pharmacists only. So each ward pharmacy has to be reckoned as a retail outlet. If so, the hospital management has to apply for drug licences depending up on the number of ward pharmacies," an ADC told Pharmabiz. But he said so far no concrete decision on this aspect was taken by the department and the discussion is going on at the higher level. Revi S Menon, the ADC of Eranakulam said within days of the court order, the hospitals started applying for licences. He said the narcotic permit order given to certain hospitals previously have been now stopped in the cases of those hospitals which have not taken drug licenses or applied for fresh ones. The offices of ADCs in Kerala are giving the order of allotment of narcotic drugs, ND 3, to hospitals for Morphine, Pethidine and Fentanyl Citrate for the purpose of pre-anaesthetic medication. Revi said his office received more than hundred applications with in one week of the announcement. According to K E Mohanan, ADC Kozhikodu, instructions for fresh drugs licenses have been given to all the major and minor hospitals operating pharmacies to apply for license afresh. When contacted M R Pradip, ADC of Thiruvananthapuram, said that he already instructed all the hospitals in his zone which need order for narcotic allotment to get the drug licence beforehand. Regarding new applications only for hospital pharmacies, he said he has not started instructing private hospitals for fresh licenses as he has not received any order from the higher authority. The officials said the major problem the hospitals have to encounter is with regard to the appointment of qualified pharmacists in the stores as there is a severe shortage of Diploma or B Pharm holders in Kerala. According to drugs controller Geetha, for a retail pharmacy a hospital management must remit Rs 3000 to the government treasury and the space must be of 10 square meters. For an outlet a refrigerator and inverter are made mandatory for getting licence. About 3000 private hospitals in the state have to apply for fresh licences as per the court order or they have to close down their pharmacies after the deadline. | |||
| Pharmabiz | |||
| For the details -- http://www.drugscontrol.org/newsprint.asp?id=5293 |
Qualified Private Medical Practitioners’ Association (QPMPA) -- the organisation of private sector doctors in Kerala was fighting this issue for the last 20 years. The QPMPA is moving the Supreme Court once again, and we never want it to be a battle royal. We expect an honourable retreat by the Drugs Controller, though late.
The motives of the Drugs department are many and the hospitals do not want to include one more department to their unaccounted pay rolls. Nearly 50 departments are plundering the hospitals regularly and adding one more is not the issue involved.
The most important reason is that the Drug Licenses are issued in the name of registered Pharmacists and not in the name of the doctor or the hospital. Whenever the services of a pharmacist are terminated, the Drug License of that institution will vanish or disappear with the Pharmacist concerned. If that pharmacist is close to the Drugs Department officials, they usually are, then the hospital is forced to oblige to the demands of the department.
Therefore, to be on the safe side and run a hospital peacefully, the doctor or the hospital owner must have a pharmacist as spouse!
Most of the Drug manufacturers in Kerala are retired Drugs Control Department officials or are very close to them. The major hurdle of these small drug manufacturers is marketing. No one can compete with the multinational drug companies in marketing.
With the ill-gotten right to impose Drug License on hospitals, the department is getting additional control over more than 5,000 drug outlets in Kerala. The Kerala Drug Manufacturers’ Association is having close rapport with the department. Majority of the private hospitals do not patronise drugs from small manufacturers. They all go for branded items.
Therefore, a Drug License is a well-planned trap, noose or snare for hospitals and with that, the Department can manipulate medicine purchase by Private Hospitals and help their friends prosper in the business. (Having learned the tricks of the trade from the North Indian lobby, we do not want to brand all of them as producers of spurious drugs.) More than 30% of the medicines coming to Kerala are dispensed through hospitals.
For the kind information of the Drugs Department of Kerala, there are thousands of one-man show clinics managed by Homeopaths and others buying the cheapest drugs available in the market from licensed Drug Stores and selling it at the cost of branded drugs. Hope that the Pharmacy Council will quote this information in the Impleadment Petition we expect them to file in the Apex Court!
Unfortunately, the QPMPA and the IMA (Indian Medical Association) who is also a party in this case or their advocates failed to read the Drugs & Cosmetics Act, 1940, and Rules, 1945, above or below Schedule K – 5A, and fight it on the other grounds readily available and so the case dragged on for 20 long years.
I, Dr. K. Kishore Kumar, aged 62 years, S/o. Late Mr. Kumara Pillai, of Ashoka Bhavan, Kayamkulam 690502, the State Secretary of the QPMPA, which is now a National Organisation of Private Hospitals, humbly request the Drugs Controller of Kerala to have a rethinking on this Drug License issue, though legally on the right side, with the blessings of the Hon’ble High Court of Kerala.
Ms. M. Geetha, the Drugs Controller now, having read the Drugs & Cosmetics Act & Rules in full, and having assimilated the true position and having expressed that to Pharmabiz, (cited), I, Dr. Kishore Kumar, on behalf of the QPMPA, as its State Secretary, request you to withdraw the Letter No. L-17323/94/DC from the Office of the Drugs Controller, Thiruvananthapuram – 37, dated 17.3.1995.
If the department is not prepared to back out, we (QPMPA) will be forced to prove that the Drugs Controllers or Pharmacists in Kerala are not smarter than all others in India.
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 back the Drugs Controller back to sense. If not thousands of patients will suffer all over Kerala.
State Secretary, QPMPA,
Ashoka Bhavan, Near MSM College,
Kayamkulam 690502
Ph. 0479 2445532
Mob. 9447485532
Dear Sirs,
Kindly go through the following points given below to substantiate my views cited above:
Copied below, are the views of senior doctors on Drug Licence. Kindly go through the points.
Views from a well-wisher-- (1)
Dear Dr. Kishore,
There are several valid points to be contested.
One is that the treatment of a patient to a given illness cannot differ according to the owner of the Hospital / Clinic or whose fund is being used.
The MCI Act refers to ‘A’ Registered Medical Practitioner and his privileges. It does not give any distinction between doctor employed by private management or Govt., or self - employed practitioner or who funds him.
This issue was there in 1980s in connection with a G.O. issued while Vaylar Ravi was the Home Minister of Kerala, saying that private practitioners cannot treat injuries and accident cases. Later on, the Govt. withdrew the G.O. Now every doctor must attend Traffic Accident patients, and report the case to the Police.
The contention that "a" doctor giving drugs to his patients need not take licence was in the context of 1940, when there were no antibiotics and 90% of medical procedures, diagnostic/therapeutic were not known.
Medical sciences were passing from the pathophysiology of organ changes like fatty degeneration of liver, to studying the cellular changes. By 1970s, doctors started to learn more about the intracellular and molecular changes. Twenty years later medical sciences are learning about the sub-molecular changes and genes influence on disease.
In short, in 60 years time since the original Act was passed the total knowledge of human ailments, its causes and possible remedies including prevention has quadrupled and it is almost doubling itself in each decade. No one doctor alone can treat any disease or give adequate health care to anyone.
A physiological phenomenon like pregnancy in woman needs more than one doctor to have adequate care. Obstetrician can initially examine. Then, her blood group including ‘Rh’ factor has to be determined by a laboratory supervised by a Clinical Pathologist, and then it is necessary to have an Ultrasound Radiologist to diagnose any foetal anomalies. If there is history of certain inherited or familial diseases, then amniotic fluid has to be withdrawn and studied by Immunologist or Geneticist.
If all goes well, at the time of delivery apart from the Obstetrician, it is necessary to have an Anaesthetist available to resuscitate the baby if needed and a Paediatrician to examine the baby to determine any anomalies, which should be corrected. In 1940, this might have been taken care of by a midwife or a family doctor. For better care or less damage to both brain and other vital organs of the infant and the mother about half a dozen doctors are needed at present. Hence, "a" doctor should be substituted for team of doctors and hospitals.
More over singular often can mean entire humanity like a man has certain fundamental rights in a democracy means men, women and children, in fact all citizens.
As illustrated above when an emergency occurs like postpartum bleeding the doctors have only few minutes before the woman bleeds to death. When they are busy, the Drug Inspector happens to be inspecting and demands the doctors to give certain explanation. Here the choice allows the patient to bleed to death or face criminal charges from the Drug Inspector in not helping him to properly carryout his duties.
Under such an environment, most human beings will take the least harmful course by asking the clerical staff to give drug inspector Rs. 500/-, which he will readily accept and go way. This is what is happening in practice.
It is worth recalling that hardly a decade ago to get a telephone connection one has to wait years. Once you have it, for that to function properly, the services of telephone lineman’s regular visit is an absolute necessity. In a City like Cochin, having in 1990s about two lakhs telephone connections, on an average requires two monthly visits by the telephone linesman to give life to the dead phone, which happen frequently. Nobody can refute that one has to pay at least Rs.50/- per visit if it is a minor problem. That is the Telephone linemen were collecting Rs. Two crores every year from a City like Cochin. Since that licence / permit raj has ceased to exist the use of telephone has increased 100 fold with no corruption. Now every other Indian is having a telephone. The total number of phones in India now is 59 crores and the share of our License Rajas is less than four crores.
It is worth remembering that since Sir Thomas Babington MacAulay drafted the Indian Penal Code in 1834, not much happened to improve the law enforcement system. In these 170 years, literally, our Parliament and State Legislatures have passed thousands of enactments and number of Court Cases has accumulated in millions. In order to get civil suit properly adjudicated it will take the lifetime of two generations for ordinary citizens of India.
Under these circumstances if the Indian Parliament in their finite wisdom passes an Act saying that most of the problems are due to the use of incorrect language, with bad grammatical and idiomatic construction of sentences leading to enormous appeals going to Superior Judicial Forums, therefore it is enacted that all judgements in all Courts in India must be first reviewed by the Govt. High School English teacher and certified before it can be pronounced by the Hon. Judicial Officer.
What will be the reaction of the Judiciary in India!
In the above case of delivery, the doctors caring for the young woman have a combined medical education and training of more than 60 years and a drug inspector who is not even a registered medical practitioner should oversee his use of proper drugs of proper potency is to say the least is ridiculously absurd. It is also worth remembering that in the last 100 years the medical profession has eradicated scourges like smallpox, contained polio, malaria, plague, cholera, etc. Have the legal system anywhere in this world has been able to prevent one crime!
Another point to add is the quality control of the drug must be done before it is sending for the manufacture. The Drug Controller of India has totally failed to assure good quality drugs in India. Let them give a report of how many qualitative analyses have taken place in a year. How many Atomic Spectrometers the department have to analyse the entire elements and quantities in a given drug.
In order to follow the transit and ultimate utilisation of these drugs it is better to use the computer digital technology for which India is well known on this Earth. They can create a barcode for every drug pack or foil and follow by computer-aided scan at every stage. It will be 100% accurate, corruption free and cost effective.
Our solution is political decision at the level of Govt. of India.
With best regards.
XXX
Views from Dr Sushama Anil -- (2)
Dear Kishore
I am sending you the details of laws regarding the manufacture, distribution and sale of medicines in India. In my opinion, if we argue that the doctors need not take any drug license may be rejected by the court. Because for the handling of any dangerous article the Govt. expects a control over it, hence the judiciary will always support the license and this.
We have to argue that we are ready to take the drug license in the name of the doctor in charge of a hospital but without the need of a pharmacist. Isn’t it? That means that the Drugs and Cosmetic Act must be amended. That argument may stand in the court. Am I correct? Pls Think...
Regards
Sushama Anil
Views from Sushama Anil (3)
Second Letter from Dr. Sushama --
Dear Kishore
Pls see the attached file. In addition, you may follow the link mentioned in the file. A few lines from the file are quoted below.
From the file attached:
Advisory Tasks
Since pharmacists posses maximum knowledge about the complexity and potential side effects of various drugs, they are very often employed to advise medical practitioners on the selection and side effects of the drugs.
They also perform a number of administrative duties in hospitals and other medical establishments.
Now a days the advisory job mainly carried out by medical representatives from the medical companies. Therefore, if the govt wants to strengthen the advisory job, then the medical representatives should have pharmacy qualification. At first govt should make a rule to eliminate unqualified advisors, i.e., the usual medical representatives from the medical manufacturers. I believe the govt does not have any rule to regulate the appointment of medical representative, who are delivering a very responsible function, i.e., introducing the medicines and providing information about it to the doctors. That means, as mentioned above, it is the role of a pharmacist to do it. The medical representatives must have a pharmacy qualification. Isn’t it?
Still, in the modern medical store in a hospital there is no need of a pharmacist. Many of the hospital medical stores are computerised now a days. Hence, the billing and stock keeping is also computerised and precise.
In addition, another important - - very important -- aspect of your letter: - you rightly mentioned about the unity among doctors. Actually, my slogan is “THINK, UNITE AND REACT” which I have mentioned in many of our local IMA (Balussery Branch) meetings. In addition, the success behind other professional communities is none other than their UNITY. So…. at least in the present situation pls ask our comrades to UNITE and REACT and for them I give my wholehearted support.
Regards,
Sushama Anil
Views of Dr. Kishore
Hereunder, I am giving my views after studying the Drugs Act & Rules (617 pages available at http://cdsco.nic.in/html/Copy%20of%201.%20D&CAct121.pdf) and the important points are copied hereunder and has given my comment in boxes. The page numbers quoted are as in the above pdf file.
Drugs & Cosmetics Act, 1940
http://cdsco.nic.in/html/Copy%20of%201.%20D&CAct121.pdf
Page 21
CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS 1[AND COSMETICS]
16. Standards of quality. —3[(1) For the purposes of this Chapter, the expression “standard
quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in 4[the
Second Schedule], and
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Page 23
18. Prohibition of manufacture and sale of certain drugs and cosmetics. —From such 1date 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 2[or for distribution], or sell, or stock or exhibit 2[or
offer for sale]—
2[(i) any drug which is not of a standard quality, or is misbranded,
adulterated or spurious;
XXX
(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 2[or offer] for sale, or distribute any drug 3[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 2[or for distribution], or sell, or stock or exhibit 2[or offer] for sale, or distribute any drug 4[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 condition of small quantities of any drug for the purpose of examination, test or analysis:
Provided further that the 5[Central Government] may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the 2[manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale or distribution] of any drug or class of drugs not being of standard quality.
Page 24
7[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.]
My comments on the above Section 18A:
Kindly note the lines highlighted. Hospitals do not manufacture any of the drugs dispensed or sold in the hospitals and are not the AGENTS for DISTRIBUTION thereof. All that is required from hospitals or persons keeping drugs, if required, shall disclose the details. The next Rule 18B is for those holding license. This section clearly says that any person can store medicines and must obey the Inspector.
8[18B. Maintenance of records and furnishing of information. —Every person holding a licence under clause (c) of section 18 shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.]
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.
Page 25
(2) 1[For the purposes of section 18 a drug shall not be deemed to be misbranded or
adulterated 2[or spurious] or to be below standard quality nor shall a cosmetic be deemed to
be misbranded or to be below standard quality] only by reason of the fact that—
(a) there has been added thereto some innocuous substance or ingredient because the
same is required for manufacture or preparation of the drug 3[or cosmetic] as an article of
commerce in a state fit for carriage or consumption, and not to increase the bulk, weight
or measure of the drug 3[or cosmetic]or to conceal its inferior quality or other defects; or
4* * * * * *
(b) in the process of manufacture, preparation or conveyance some extraneous
substance has unavoidably become intermixed with it: Provided that this clause shall not
apply in relation to any sale or distribution of the drug 3[or cosmetic] occurring after the
vendor or distributor became aware of such intermixture.
5[(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 .]
My comments:
S 19(5) clearly says that anyone can store drugs and do whatever he wants.
6[20.Government Analysts. — (1) The State Government may, by notification in the
Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to
be Government Analysts for such areas in the state and in respect of such drugs or 7[classes
of drug or such cosmetics or classes of cosmetics] as may specified in the notification.
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(2) of this section.]
Page 26
21. Inspectors. —(1) The Central Government or a State Government may, by notificationin the Official Gazette, appoint such person as it thinks fit, having the prescribed
qualification, to be Inspectors for such areas as may be assigned to them by the Central
Government or State Government, as the case may be.
(2) The powers which
XXX
6[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, —
5[(a) inspect, --
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(i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and
2[(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.]
My comments:
Drug Inspectors are given vast powers and a license is not mandatory for him to check a place where drugs are stored as per the above Section.
1Ins.by Act 35 of 1960, s. 5(w.e.f. 16-3-1961)
2Amended by Act 68 of 1982 (w.e.f. 01-02-1983)
28
(3) If any person willfully obstructs an Inspector in the exercise of the powers conferred
upon him by or under this Chapter 1[or refuses to produce any record, register or other
document when so required under clause (cca) of sub-section (1)], he shall be punishable
with imprisonment which may extend to three years, or with fine, or with both.]
Page 28
23. Procedure of Inspectors.
33.3[Power of Central Government to make rules. —(1) The Central Government may after consultation with, 1[or on the recommendation of,] the Board and after previous publication by notification in the Official Gazette, make rules for the purposes of giving effect to the provisions of this chapter:
XXXX
(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs 2[or cosmetic or class of cosmetics];
[CHAPTER V
MISCELLANEOUS
2[333P.] Power to give directions. The Central Government may give such
directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder.]
My Comments:
The Central Government has not taken any action during the last 20 years, though they were a party in this case. Silence was their Hallmark.
Page 53
DEPARTMENT OF HEALTH NOTIFICATION
New Delhi, the 21st December 1945
No. F. 28-10/45-H (1). __In exercise of the powers conferred by Sections 6(2), 1[12, 33 and
33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central Government is pleased to make the following Rules: __
RULES
PART I__PRELIMINARY
1. Short title, extent and commencement. ___(1) These Rules may be called the Drugs and
Cosmetics Rules, 1945.
2(2) They extend to the whole of India.
2. Definitions.___ In these Rules, unless there is anything repugnant in the subject or context___
(a)“the Act” means
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Page 54
2[(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 practicing the modern scientific system of medicine
3excluding the Homoeopathic system of medicine; or
(iii) registered in a medical register, 3other than a register for the registration of
Homoeopathic practitioner, of a State, who although not falling within subclause
(i) or sub-clause (ii) declared by a general or special order made by the
State Government in this behalf as a person practicing the modern scientific
system of medicine for the purposes of this Act; or
(iv) registered or eligible for registration in the register of dentists for a State under
the Dentists Act, 1948 (16 of 1948); or
(v) who is engaged in the practice of veterinary medicine and who possesses
qualification approved by the State Government.
Page 81
PART VI -- SALE OF DRUGS OTHER THAN HOMOEOPATHIC
MEDICINES
59. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part
for such areas as may be specified.
1(2) Applications for the grant or renewal of a licence 2[to sell, stock, exhibit or offer for sale
or distribute] drugs, other than those included in Schedule X, 3[shall be made in Form 19
accompanied by a fee of rupees one thousand and five hundred or Form 19-A. accompanied by a
fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X
shall be made in Form 19-C accompanied by a fee of rupees five hundred, to the licensing
authority:]
Page 87
65. Condition of licences. __ Licences in 1[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[(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 2[registered Pharmacist]
(2)The supply, otherwise than by way of wholesale dealing, 3[* * *] of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a 2[registered Pharmacist].
4(3) (1) The supply of any drug 1[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,
5(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.
________________________________________________________________
Page 90
2(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.
The most quoted and irresponsible letter from the Drugs Controller of Kerala to his friends running Drug Stores. It is unfortunate to note that the Drugs Controller of Kerala in 1990s took over the right vested with the Supreme Court of India – Interpret Laws of this Country!
Letter from the Drugs Controller, Kerala dated 17.3.1995
Annexured in the SLP as Annexure P - 3
attached as Schedule B in the Stay Order
No. L-17323/94/DC Office of the Drugs Controller,
Thiruvananthapuram - 37
dated: 17/3/1995
From
The Drugs Controller.
To
The Secretary,
All Kerala Chemists & Druggists Association,
Chemist Bhavan, Ernakulam (South),
Ernakulam.
Sir,
Sub: Drugs and Cosmetics Act 1940 and Rules thereunder
Sale/supply of drugs by private Hospitals --
Requirement to take out Drugs Licence --
As you are aware, the Drugs and Cosmetics Act, 1940 and Rules prescribe Drugs Licences for stocking for sale, selling and Distribution of drugs by any person. Exemption to this are provided in Schedule K of the Drugs and Cosmetics Rules, 1945. Item 5 of the Schedule exempts all Registered Medical Practitioners and Items '5A' exempts hospitals or dispensaries maintained or supported by Government or local bodies. No exemption is provided to private hospitals from taking out Drugs licences and the exemption formerly given to hospitals and dispensaries run by Charity or Voluntary subscription has also been withdrawn by the Amendment to the schedule made by Government of India as per G.S.R. No. 812 (6) dated 14/11/94. Though steps were taken to require private hospitals to take out Drugs licence in 1990, the actions were challenged in the High Court and the Hon' High Court directed the Government to take a decision in the matter. Government in August, 1994, decided that Hospitals which were not exempted, were to take out Drugs Licences. Time till 31/3/1995 for making applications and granting Drugs licences had been fixed earlier by this Department. The time is now extended till 30/4/1995. My object in writing this letter is to advise the members of your Association to quote Drugs license Numbers of Hospitals in the invoice/Bills issued for supply of drugs as prescribed in rule 65 (5) (i) for supply of any drugs after 30/4/1995.
Yours faithfully,
Sd/-
for Drugs Controller.
sn/18-3
The most interesting part is that the Kerala Govt. and the Drugs department never bothered to read Rule 65 (5) (1) (b) (shown above) in 1995.
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.
(Page 91 of Act )
2[(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;]
My Comments on the above:
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.
The move to impose Drug License for hospitals is to take away the record keeping job of Drug Store Pharmacists the friends of Drug Inspectors.
Page 168)
PART XI-EXEMPTION
123. The drugs specified in schedule K shall be exempted from the provisions of
Chapter IV of the Act and the Rules made thereunder to the extent and subject to the
conditions specified in that Schedule.
(Page 446)
SCHEDULE K
[ See Rule 123]
Class of Drugs Extent and Conditions of Exemption
4[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 the provision of
Chapter IV of the Act and the
rules thereunder.
(Honouring the prescription of a colleague
is not a crime, but permitted.)
Extent and Conditions of Exemption
All the provisions of Chapter IV of the Act
and the Rules made thereunder, subject to the
following conditions:
5[(1)The drugs shall be purchased only from a
dealer or a manufacturer licenced 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.
Page 447 of the Act
(2) In the case of medicine containing a
substance specified in 1[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 labeled with the words 2[* * * ]
“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 prescrip tion as the case may be.
3[(3) The drug will be stored under proper storage
conditions as directed on the label.]
(The question of a qualified person do not appear Anywhere in the conditions cited above in Item 5.
On the other hand “the supervison of a Qualified Person is the first requirement in Item 5A.)
5.A Drugs supplied by a hospital or
dispensary maintained or
supported by Government or
local body 4 [* * *]
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 :
448
(1) the dispensing and supply of drugs shall be
carried out by or under the supervision of a
qualified person;
(2) the premises where drugs are supplied or
stocked shall be open to inspection by an
Inspector appointed under the Drugs &
Cosmetics Act who can, if necessary, take
samples
(3) the drugs shall be stored under the proper
storage conditions.
1[(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.]
2[5.B Whole Human Blood I.P.
and/or its components stored for
transfusion by a First referral
Unit Community Health Centre,
Primary Health Centre and
Hospital
The provisions of Chapter IV of the Act and
the rules made thereunder which require
obtaining of a licence for operation of a blood
bank or processing Whole Human Blood and,
or its components subject to the following
conditions, namely.
(1) The First Referral Unit, Community Health
Centre, Primary Health Centre and/or any
Hospital shall be approved by the State/Union
Territory Licensing Authority after satisfying
the conditions and facilities through
inspection.
(2) The captive consumption of Whole Human
Blood I.P or its components in the First
Referral Unit, Community Health Centre,
Primary Health Centre and/or any Hospital
shall not be more than 2000 units annually.
1 Ins. as per G.O.I. Notification No. GSR 648(E) dt 16.9.2002 w.e.f.01.10.2002.
2 Ins. as per G.O.I. Notification No. GSR 909(E) dt 20.11.2001
Page 449
Class of Drugs Extent and Conditions of Exemption
(3) The Whole Human Blood and/or its
components shall be procured only from
Government Blood Bank and/or Indian Red
Cross Society Blood Bank and/or Regional
Blood Transfuion Centre duly licenced.
(4) The approval shall be valid for a period of two
years from the date of issue unless sooner
suspended or cancelled and First Referral Unit,
Community Health Centre, Primary Healthy
Centre or the Hospital shall apply for renewal to
the State Licensing Authority three months
prior to the date of expiry of the approval.
(5) The First Referral Unit, Community Health
Centre, Primary Health Centre and/or any
Hospital shall have the following technical staff
for storage of blood or its components:-
(a) A trained Medical Officer for proper
procurement, storage and cross matching
of blood and/or its components. He/she
shall also be responsible for identifying
haemolysed blood and ensure non-supply
of date expired blood or its components.
(b) A blood bank Technician with the
qualification and experience as specified
in Part XII B of Schedule F or an
experienced laboratory technician trained
in blood grouping and cross matching.
(6) The First Referral Unit, Community Health
Centre, Primary Health Centre and Hospital
shall have an area of 10 sq metres. It shall be
well lighted, clean and preferably airconditioned.
Blood bank refrigerator of
approximate capacity fitted with alarm device
and temperature indicator with regular
temperature monitoring shall be provided to
store blood units between 2oC to 8oC and if the
components are proposed to be stored,
specialized equipments as specified in Part XII
B of Schedule F shall also be provided.
450
Class of Drugs Extent and Conditions of Exemption
(7) The First Referral Unit, Community Health
Centre, Primary Health Centre and Hospital
shall maintain records and registers including
details of procurements of Whole Human Blood
I.P and/or blood components, as required under
Part XII B of Schedule F.
(8) The First Referral Unit, Community Health
Centre, Primary Health Centre and Hospital shall
store samples of donors blood as well as patients
sera for a period of seven days after transfusion.]
(In total 32 items are exempted under Schdule K)
(Read pages 446 to 450 in Schedule K in the Drugs Act & Rules cited.)
My Comments:
The Item 5A was included in 1945 to protect the Govt. Institutions as there were no doctors in most of such Institutions. On the other hand a private hospital is always blessed with a qualified hand. A reading of all the Items in Schedule K will make the position of private hospitals clear. In fact it is said at many places that “Any Hospital” is exempted. The most important Extent and Conditions of Exemption seen in 5A is that the drugs must be handled by a qualified person in a public institution. This point or condition is not mentioned in Item 5 in Schedule K.
Central Drugs Standard Control Organization
Dte.GHS, Ministry of Health and Family Welfare, Government of India
3. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
This Act is meant to control the Advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities and to provide for matters connected therewith.
The Drugs and Magic Remedies Act prohibits a person from taking part in publication of any advertisement referring to any drug which suggests use of the drug for:
a) the procurement of miscarriage in women or prevention of conception in women; and
b) the maintenance or improvement of the capacity of the human being for sexual pleasure;
c) the correction of menstrual disorders in women;
Factories Act
d) the diagnosis, cure, mitigation, treatment or prevention of any venereal disease. It is prohibited to directly or indirectly give a false impression regarding the true character of a drug or make false claim for it or to convey any false or misleading information in any material particular about it. No person shall import into or export from
Whoever contravenes the provisions of this Act shall, on conviction, be punishable with imprisonment which may extend to six months, with or without fine. In case of subsequent convictions the imprisonment can be extended to one year. The document, article or thing which contains the offending advertisement can be seized and confiscated.
If the person contravening any of the provisions of the Act is a company, every person who at the time the offence was committed was in charge of the business of the company shall be deemed guilty.
The prohibition under this Act does not apply to: a) any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease, b) any treaties or book dealing with any of the matters from a bona fide scientific standpoint, c) any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory, and d) Government advertisements.
(RMPs are exempted in this issue also!) Hope the Drugs Controller will have a rethinking in this issue at least after 20 years.
K. Kishore Kumar, State Secretary, QPMPA
