Pharmabiz Editorial & News
Thursday, 09 September 2010 13:12
Pharmabiz.com
Policy & Regulations
Hospital pharmacy of QPMPA chief raided for no license, IMA endorses Kerala DCA stand
Thursday, September 09, 2010 08:00 IST
Peethaambaran Kunnathoor, Chennai
Even as the Kerala drug control authorities and the state branch of the qualified private medical practitioners association (QPMPA) are yet to resolve their dispute over drug licence, the Kozhikodu division of the DCA on Wednesday raided and seized large quantum of drugs from the hospital of the QPMPA president for violation of 18 (c) of D&C Act.
According to sources, even when there was big pressure from the authorities, the association president, Dr M A Koya remained adamant and did not apply for a licence. Meanwhile, he remitted Rs 3000 in the treasury for licence for a new pharmacy to be opened soon adjacent to his hospital.
While speaking to Pharmabiz, Dr Koya said he would act according to the court's decision. His association has again approached the high court for justice. Dr Koyas hospital in Kozhikodu is the third hospital that is charged with cases for violation of provisions of D&C Act.
Meanwhile, the stand took by the Kerala chapter of Indian Medical Association, with regard to the present issue, came as a bolt from the blue for the QPMPA members. The members feel that they are being isolated from the medical fraternity for waging a war against the drug control authorities of the state.
According to information received, the Kerala IMA has taken a strong stand that it would not support QPMPA in this matter. Until this issue came up in the open, IMA was associating with the QPMPA considering them as a fraternal organization. With regard to the issue, the IMA had come into an agreement with the state government earlier that hospital pharmacy, except run by a doctor couple, required to take drug licences. The private doctors, majority of them own big hospitals, did not agree with this idea and decided to approach the court which paved the way for the present tussle between them and the drug authorities.
Dr Srikumar Vasudevan, president of the Kerala IMA, said based on the D&C Act, the state government has given an advantage to the medical community that if a hospital is run by a doctor couple, it does not require a drug licence for their pharmacy to dispense medicines to their patients. He said if a group of doctors are working in a hospital and it owns a separate pharmacy, it requires licence.
The state secretary of IMA, Dr J Rajagoapalan Nair said the present D&C Act was prepared 45 years ago and many developments had taken place in connection with drugs and policies. So his association's decision in this matter is that any pharmacy attached with a hospital should have a drug licence.
When contacted, All Kerala Chemists and Druggists Association's secretary, Antony Therian, said that wherever drugs are kept and sold, the facility should be a licensed one.
PHARMABIZ.com
Editorial
Licensing Hospital Stores
http://www.pharmabiz.com/article/detnews.asp?articleid=57277§ionid=47
Wednesday, September 08, 2010 08:00 IST
P A Francis
An avoidable tussle is on between some of the medical practitioners belonging to Qualified Private Medical Practitioners Association of Kerala and the state Drug Control Dept there over licensing of private hospital pharmacies. It has begun ever since the verdict by the Kerala High Court on this matter last March. The Court had made it very clear that pharmacies in hospitals should obtain trade licenses for selling drugs as in case of any other pharmacies operating in the state. The state apex court verdict is an affirmation of the state government order issued to the private hospitals in this connection two decades ago. The state government order was then challenged in the High Court but lost and petitioners moved Supreme Court and it directed the state HC hear the case again. And the new verdict again upheld the state government stand. As per the provisions of the Drugs & Cosmetics Act, a drug licence is required to run a pharmacy store whether it is owned by an establishment or an individual. Now, the Drug Control Dept of the state already started acting on the rule following the HC order. The department had already issued an ultimatum to all private hospitals to take licenses before the end of July and asked the wholesalers and distributors not to supply medicines after July 31 to private hospital pharmacies which did not obtain drug licences. It has suspended the operations of some medical stores attached to private hospitals which have been ignoring the order.
Even when the department's action is on against private hospital pharmacies, some members of the QPMPA are arguing that they are entitled to sell drugs without a drug licence. These members are quoting the clauses of Rule 65 of the Drugs & Cosmetics Rules which according to them make clear that the conditions for drug licences are not applicable to a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients. According to them, this rule allows the registered medical practitioners to keep and dispense medicines to their patients without licence. Whatever may be the interpretation of the rule, selling of medicines to patients or public need to be under licence and control of regulatory authorities. That is what is happening in all other states and Union territories in the country today. It is not the job of medical practitioners to sell drugs in medical stores or in their clinics. That is what pharmacists are expected to do under section 42 of the Pharmacy Act. And there cannot be an exemption to this rule in one state just because some medical practitioners are opposed to obtaining a trade licence for pharmacies in hospitals. If there is still any lack of clarity or confusion in this regard to medical profession, that needs to be addressed urgently by the office of DCGI.
Comments
BEFORE YOU FILL THE INK IN YOUR PEN YOU SHOULD HAVE UNDESTOOD THE FOLLOWING FACTS.
DOCTORS ARE NOT SELLING MEDICINES TO THE PATIENTS AS THE COMPOUNDERS DO. DOCTORS “GIVE” MEDICINES TO PATIENTS ONLY TO CURE THE DISEASE AS IT IS OUR PROFESSIONAL TOOL. SELLING MEDICINES IS THE COMPOUNDER’S JOB AND THEIR MEANS TO LIVE.
YOU MAY PLEASE REFER THE HISTORY GIVEN BELOW.
Let me ask you two questions?
1. Have you read the Drugs and Cosmetics Act 1945?
2. Did you understand the “Actual” meanings of the Act?
After seeing the Editorial, I suspect that your answer for these questions will be a big “NO” or you have not understood it fully. I cannot blame you for that. I am expecting only that much from you. The reason is obvious. Since you are an” Editor” I expected little more elevated intelligence for you than from your “Race” (By “race” I meant only “category” throughout this letter) and I expected that you will understand English Language properly. This Editorial proves that you didn’t understand what doctors have understood from reading the entire drugs act. Actually I should not have expected that you will have the capacity to read and will have the ability to understand such a big, 600 pages Act. At least I hope you are able to read the Sections 5 and 5A under Schedule K of the Act and to realize the fact. I am not insisting you to read the entire Act which I know, you can’t and it is too heavy for you. "Lack of clarity" as you said is mainly with all the editors and officials of the DCA in Kerala and in those who advised you.
LET ME TELL YOU SOME HISTORY TOO.
In olden days we employed your “race” as compounders to help us in mixing, compounding and dispensing medicines to the patients. In those days the medicines are compounded from the dispensary attached to the clinics. And from the profit of dispensing the medicines we used to remunerate those compounders. As the Pharmaceutical science developed, your “races” were allowed to sell medicines, keeping separately an open shop, to the patients, ONLY ON THE DIRECTIONS FROM A REGISTERED MEDICAL PRACTITIONER. Still the right of the RMP to dispense medicine to his patients has not been taken away by the rule. That was not for your benefit but it was for the benefit of public to get medicine anywhere at any time. Actually you can SELL MEDICINES only on the prescription of the Registered Medical Practitioners .Understand that you can’t “supply” medicines to patients as you wish, but an RMP can do that. As in the olden days still an RMP is not selling the medicines but only “giving” the medicines to the patients to cure the disease as it is his professional tool to cure the disease.
After that your “race” started doing business, putting independent shops for selling medicines. Later on the compounders made it as a big profitable business and not the doctors. For more profit these compounders started selling spurious, sub standard and adulterated medicines to the public and to the Govt. agencies. In this situation, the Govt. wants to put a control on these people and protect the public from any malpractices from your “race” protecting the right and authority of dispensing medicines by the RMPs to the patients. And hence introduced a control and hence the licensing for drug selling and thereby the Drugs and Cosmetics Act 1940 came in to existence. You must keep in mind that you are still our compounders. Your status has not been changed so far by any rule. As per the Drugs and Cosmetics Act, still you need a prescription from an RMP to sell medicines and you are permitted to compound, dispense and sell medicines as you were doing in the olden days and hence no change in your status.
Keeping these facts in mind, and being an Editor, please at least read the following paragraph and try to understand. I am expecting only that much from you.
Naturally, as you have grown from the olden day’s clinic dispensary to big drug stores and wholesale stores, the olden day doctor’s clinics have also grown to hospitals and Nursing homes. And because of this reason alone the right of the RMP will not vanish and rather it is well protected by the law.
KEEP IN MIND THAT AN RMP IS EXEMPETED FROM ALL THE PROVISIONS UNDER CHAPTER IV OF THE DRUG ACT. ACTION CAN BE INITIATED BY THE DRUG DEPT AGAINST ANY ONE VIOLATING THE DRUG RULES IS ONLY AS PER THE PROVISIONS UNDER CHAPTER IV OF THE DRUG ACT.
Registered medical practitioners are safe so long as section 5 of Schedule K is in force. As the pharmacists are supposed to compound and sell medicines and the drug act is based on this fact. It is to protect the public and the RMPs from the malpractices of the pharmacists. Keep in mind that so long as an RMP abide the section 5 of schedule K in which he or she is exempted from all the provisions of chapter IV of the drug act except that the “purchase 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. Nothing more he can do as per this act and that is not to act against the RMP but only to protect him from any malpractice by the drug dealers (you may please see the details required for the purchase record to be kept by an RMP mentioned in the conditions of the section itself). This is only a final end verification to check whether the purchase is done from an authorized wholesaler having the required drug license and whether he has supplied good quality medicines to the RMP. If not, necessary action should be initiated against the drug dealer who comes under the purview of the drug dept, and not against the RMP. If the drug inspector is authorized for any actions against an RMP, the central Govt. would have clearly specified the same in the act other than in the chapter IV of the Act. The Govt. don’t have to conceal anything or say anything indirectly. The Govt. would have clearly mentioned it in the section 5 itself or anywhere in the Act except in the chapter IV. Drug inspectors can’t make any raids on dispensary conducted by an RMP on suspicious ground or on any anonymous letter so long as the RMP is abiding the section 5 under schedule K of the drug act.
The Drug inspector is not authorized to check for the compliance of conditions of exemptions by the RMP specified in section 5 under schedule K of the drugs act as per the said Act. Nowhere in the act it is mentioned that the drug inspector is the person to inspect the same, except in the chapter IV of the drug act which is, unfortunately, exempted in the case of an RMP.
Oh…. I am sorry…or you to understand this you have to read chapter IV of the Drugs and Cosmetics Act too. Please don’t think it is heavy for you, it is simple and not much to read. So I request you to take some pain to read the Chapter IV of the Drugs and Cosmetics Act 1945 and try to understand it as much as you can. However, that will take you to Rules 61, 65, 123, etc. These things are very heavy duty items. Rule 65 alone covers 10 pages in the Rule book. Rule 123 and Schedule K is heavier still!
Hope you have understood at least something from this. But I can’t help it! The reason is obvious……..
I believe that, as on our colleague told me recently, the only way to resist this kind of threat from the group of compounders is to start wholesale dealing of drug by the doctor’s association as they do have other security wings for their associations. In such case, the patients will get good quality medicines round the clock in discounted rates. (as the motto of the doctors are curing the patients). I urge our association to think about a wholesale medicine dealing wing for the clinics and hospitals in Kerala immediately. A parallel way of drug dealing is very much needed for the benefit of the public. This situation cannot be allowed to continue forever.
YOU THINK A SITUATION, IN ENTIRE KERALA, WHERE NO RMP ISSUING A PRESCRIPTION TO THE PATIENTS TO PURCHASE MEDICINES FROM OUTSIDE DRUG STORES AND RMPS DISPENSE ALL THE MEDICINES REQUIRED BY THE PATIENTS? THEN THE COMPOUNDERS, THE SO CALLED PHARMACISTS, WILL STARVE AND DIE, ISN’T IT? And compounders are living on the mercy of the doctors and the fact that there is a lack of UNITY among the doctors. We know, the compounders are taking advantage of it and they do anything to maintain this situation intact. Otherwise the compounder’s situation will be in danger. The compounders will become an endangered species after some time. I am sure that, after having suffered a lot, the doctors will realize their situation soon and one day the expected unity of doctors will come back. AND WE KNOW THIS FEAR INSIDE THE MIND OF YOUR “RACE” is WORKING AGAINST THE DOCTORS WHICH CREATED ALL THESE PROBLEMS AND ISSUES. PLEASE UNDERSTAND THAT YOUR “RACE” HAVE CREATED THESE ISSUES AND PROBLEMS AND NOT THE DOCTORS.
Dr. Mohan Kumar
doctormohankuma r
(Received from Dr. Mohan Kumar as Email. The same posted at the Phramabiz site as comments.)
PART XI - EXEMPTIONS
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.
In Schedule K, Item 5 under "Class of Drugs" all the Drugs supplied by an RMP to his patients are exempted. The place of work of an RMP is a hospital. Under "Extent and Conditions of Exemption" the RMP is exempted from "All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions: ..."
All the sections in the Act requiring one to take a drug licence is in Chapter IV and kindly note that an RMP is exempted from all that and that means his hospital is exempted.
On reading Item 5A in that Schedule you will note that Govt. Hospitals are not exempted from all the provisions, but only from "The provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence, subject to the following conditions: ..."
It is true that it is an avoidable tussle and could have been avoided if they had taken pains to read and understand that written in the Act & Rules 36 years ago. The issue started in 1974.
Asking doctors to take a drug licence is as absurd as asking our Jawans and Policemen to take Arms Licence to carry a gun.
A Pharmacist is a professional and he can carry out his profession alone. That is true in the case of an RMP and to treat his patients with whatever drug he wants a supervision of a pharmacist cannot be insisted. There are better persons in a hospital like registered nurses who administer all the drugs as directed by the RMP.
Also note that DCA can inspect the place of supply and storage in a Govt. Hospital and is not permitted in the case of an RMP. All that permitted for a DCA in a private hospital is check the purchase records and take sample of drugs if he is suspicious of any item in those bills.
Kindly study the issue involved and write a corrected version soon.
Finally, the DCA officials are more homely with Pharmacists and are shy to face an RMP and that is natural.
Like the DCA you have also read only part of S. 42 of the Pharmacy Act. Kindly read it fully.
Thanking you.
Dr. Jayan, UK
(Received from Dr Jayachandran, UK as Email and the same posted at Pharmabiz site by him.)
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