qwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmrtyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnmqwertyuiopasdfghjklzxcvbnm

Disclaimer: The information contained herein (including any accompanying documents) is confidential and is intended solely for Doctor Community and if you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution or taking any action in reliance on the contents of this message or any accompanying document is strictly prohibited and is unlawful. The Author is not responsible for any damage caused by a virus or alteration of the content by a third party or otherwise.

Doctor know Your Rights !!!

(Dispensing Medicines from Ur clinic / Hospital)

8/8/2009

(By Dr. Aankit S. Sanghvi)

Total Pages: 18 (including pages scanned from Official FDA Law book)

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Date: 8th August, 2009

Dear Registered Medical Practioner,

Since few years, it has been observed by our Doctor Community that many of our nearby Chemists take objection if Doctor / Hospital dispense either medicine or injection or vaccines from their own clinic / hospital. Chemists claim that it is illegal on the part of Doctor to sell medicine to patients as it is only their right to sell medicine because they have Drug License to do the same and Doctors don’t have.

Impact on Doctors: Due to this strong objection & unawareness among Doctors, many of us dispense medicine / injections with fear in our mind.

Reality Check: To check the reality, I researched deep into the subject. I purchased official book on rules from Food & Drug Administration (FDA) office and read it. Second I visited website of Medical Council Of India, which is the highest Governing Authority for all allopathic doctors. Great news is that conclusion of that research is favoring dispensing doctors. Although, I am not a lawyer but still I am of the opinion that all Registered Medical Practioners are exempted from obtaining Drug License from FDA, if they dispense medicine to their own patient. You yourself can conclude on the same line by viewing below given pages in the same order. Text book pages are directly scanned from official book:

Drugs & Cosmetics Act, 1940 and Rules, 1945Fourth Edition: September 2006 (Reprint Feb 2007)

Explanation of disputed issue in legal manner with proof:

(1)Chapter IV (Drugs and Cosmetics Act, 1940): First 3 pages has an index, in which different sections of chapter IV applicable to manufacturers, traders, Distributors & all those who sell medicines are given. Person dealing with medicine has to obey all sections of Chapter IV.

Note: If you wish to save your time, then read only those sections of pages which are underlined with blue pen.

Go to Next Page.

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(2) Section 18(C): Under Section 18 (C) of Chapter IV, all those person who sell medicines are supposed to obtain Drug License (DL) from local FDA. That means we Doctors, should also have DL as we give medicines to our patients. I have attached next 3 pages mentioning various conditions in which section 18(C) is applicable. On page 31 of book, FDA has made it very clear that if Registered Medical Practioner(RMP) satisfies conditions mentioned under entry 5 of Schedule K, then he/she is totally exempted from all provisions of chapter IV, meaning Section 18(C) is not applicable on Doctors and so we Doctors don’t need DL for dealing with medicines..

Go to Next Page.

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(3) Definition of Registered Medical Practioner: See page below.

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As per sub clause (i) in definition of Registered Medical Practitioner, all Allopathic Doctors are Registered Medical Practitioners. Sub clause (ii) and (iii) are confusing but it indirectly says that all Doctors, who satisfies the condition given in Indian Medicine

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Central Council Act, 1970 (Details of Act are given below) are also Registered Medical Practitioners. As per sub clause (iv) and (v), all Dentists and Veterinary Doctors are also considered as Registered Medical Practitioners.

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THE INDIAN MEDICINE CENTRAL COUNCIL ACT, 1970

2. Definitions

(1) In this Act, unless the context otherwise requires,(a) "approved institution" means a teaching institution, health center or hospital recognised by a University or Board as an institution in which a person may undergo the training, if any, required by his course of study before the award of any medical qualification to him;(b) "Board" means a Board, Council, Examining Body or Faculty of Indian Medicine (by whatever name called) constituted by the State Government under any law for the time being in force regulating the award of medical qualifications in, and registration of practitioners of, Indian medicine;(c) "Central Council" means the Central Council of Indian Medicine constituted under section 3;(d) "Central Register of Indian Medicine" means the register maintained by the Central Council under this Act.(e) "Indian Medicine" means the system of Indian medicine commonly known as Ashtang Ayurveda, Siddha or Unani Tibb whether supplemented or not by such modern advances as the Central Council may declare by notification from time to time.

17. Rights of persons possessing qualifications included in Second, Third and Fourth Schedules to be enrolled

Schedule 2

Part I :is applicable to ayruvedic courses like BAMS, MD, GAMS, BIMS, DIMS, DAM,GCIM, ABMS,DSAC, HPA, LAM, DAS, LIM, LAP, AVMS, DTFAM, AVV, MFAM, AT, BSAM, GCIM, MAMS, LAMS, VK, VR, VS, AA,

Part II :is applicable to Unani and ayruvedic medicines.

Schedule 3: is applicable to Unani courses conducted in Lahore.

Schedule 4 : is applicable to ayurveda and siddha courses done in Sri Lanka.

(1) Subject to the other provisions contained in this Act, any medical qualification included in the Second, Third or Fourth Schedule shall be sufficient qualification for enrolment on any State Register of Indian Medicine.

(2) Save as provided in section 28, no person other than a practitioner of Indian medicine who possesses a recognised medical qualification and is enrolled on a State Register or the Central Register of Indian Medicine, -

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(a) shall hold office as Vaid, Siddha, Hakim or physician or any other office (by whatever designation called) in Government or in any institution maintained by a local or other authority;(b) shall practice Indian medicine in any State;(c) shall be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law to be signed or authenticated by a duly qualified medical practitioner;(d) shall be entitled to give evidence at any inquest or in any court of law as an expert under section 45 of the Indian Evidence Act, 1872 (1 of 1872) on any matter relating to Indian medicine.

(3) Nothing contained in sub-section (2) shall affect, -

(a) the right of a practitioner of Indian Medicine enrolled on a State Register of Indian Medicine to practise Indian medicine in any State merely on the ground that, on the commencement of this Act, he does not possess a recognised medical qualification;(b) the privileges (including the right to practise any system of medicine) conferred by or under any law relating to registration of practitioners of Indian medicine for the time being in force in any State on a practitioner of Indian Medicine enrolled on a State Register of Indian medicine;(c) the right of a person to practise Indian medicine in a State in which, on the commencement of this Act, a State Register of Indian Medicine is not maintained if, on such commencement, he has been practising Indian medicine for not less than five years;(d) the rights conferred by or under the Indian Medical Council Act, 1956 (102 of 1956) [including the right to practise medicine as defined in clause (f) of section 2 of the said Act], on persons possessing any qualifications included in the Schedules to the said Act.

(4) Any person who acts in contravention of any provision of sub-section (2) shall be punished with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both.

In short, as per Section 17 (3) (b) of Indian Medicine Central Council Act, 1970, all those Ayurvedic Doctors and Unani Doctors, who have passed out from recognized universities are also considered as Registered Medical Practitioners. Act also says that they should practice their own pathy along with Allopathic practice. They can not practice Allopathic all alone.

Note: List of recognized Universities and Colleges are given on Internet. Please copy and paste http://www.ccimindia.org/colleges.htmlfor further details.

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Till now, we have been able to conclude that All Allopathic Doctors, Dentists, Veterinary Doctors and few Ayurvedic and Unani Doctors (passed out from recognized universities) are considered as Registered Medical Practitioners (as per definition of FDA). Now, let us find out the details of Schedule K.

(4)Schedule K: Schedule K is made for all those who don’t need Drug License provided that certain conditions mentioned are satisfied. As RMP, we will have to see entry no 5 of

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Schedule K given on page 457 which clearly mentions that those RMP who supplies drugs to their own patients are eligible for exemption via schedule K. Here one important point is that RMP can not keep an open shop meaning that he can not give medicine for prescription written by other Doctor. Conditions given on left hand side of page of schedule K are totally exempted from getting drug license. Read entry no 5 of schedule K

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(5)Case Study: In the end I have attached one case study in which person was held guilty for selling medicine & was prosecuted under section 18(C) (To remind you the fact that section 18 (C) is applied if someone does not have Drug License and still sales medicines. In our case study, reason mentioned for prosecution under section 18(C) was

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that person did not have drug license & at the same time he was not a registered medical practioner. This proves that to sell medicine either you have to have either drug license or you have to be a registered medical Practioner.

Go to Next Page.

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(6) Medical Council Of India: Medical Council Of India with previous approval of Central Government has laid down certain regulations relating to the Professional Conduct, Etiquette and Ethics for Registered Medical Practioners in the form of Code of Ethics Regulations 2002.

You can visit and read it by copying and pasting following link in your web browser.

http://mciindia.org/know/rules/ethics.htm

Read point no 6.3 on that page. I have reproduced it below for your ready reference.

6.3 Running an open shop (Dispensing of Drugs and Appliances by Physicians): - A physician should not run an open shop for sale of medicine for dispensing prescriptions prescribed by doctors other than himself or for sale of medical or surgical appliances. It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long as there is no exploitation of the patient. Drugs prescribed by a physician or brought from the market for a patient should explicitly state the proprietary formulae as well as generic name of the drug.

In the end, with the help of above proof, I conclude that Governing Authority for Allopathic Doctors has no problem if Doctor dispenses medicine to his / her own patient provided that there should not be exploitation of patients, and FDA has given exemption to all RMP from obtaining Drug License if RMP is dispensing medicines to own patient. So all of us need not worry at all.

I feel that above explanation will help to reduce anxieties among all those Doctors / Hospital owners, who dispense medicines / injections from their premises to their own patients.

Request to all of you: (1) Please forward this link to each and every Registered Medical Practioners to create awareness about the reality. (2) Print these pages and keep them in your clinic / Hospital to solve problems which might occur in future.

Regards,Dr. Aankit S. Sanghvi Secretary, Indian Medical Association,Mira-Bhayander Branch.

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