• Can doctors legally dispense medicines to their patients?

Hi, I wanted to know if doctors can legally dispense medicines to their patients in India and if yes are there any specific steps required to be taken by the doctor.
Asked 4 years ago in Business Law

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10 Answers

Without registered with MCI, person is just medical graduate/holder of Medical degree, to become eligible to prescribe, enrollment necessary,

Yogendra Singh Rajawat
Advocate, Jaipur
21481 Answers
31 Consultations

4.4 on 5.0

Yes you can legally dispense though you have to follow certain conditions as cannot open shop or cannot import drugs you have to purchase it from registered DCR and then has to keep record of same.

RULES REGARDING KEEPING & DISPENSING OF DRUGS BY THE RMPS

1. A license is required for sale, distribution etc. of drugs as per DCA and DCR. However, considering the nature, manner &

conduct of Medical Practice in India and also considering the emergencies and other related contingencies often encountered

by the RMPs, while treating the patients, the law has exempted the RMPs from having a license in the interest of public

health. This exemption is for the following categories of drugs :-

(a) All drugs supplied by RMPs to his patients only, or

(b) Any drug specified in Schedule C (Biological & Special Products) of DCR, supplied by a RMP on the request of another RMP

if it is specifically prepared with reference to the condition and for the use of the individual patient.

2. Thus, though the RMPs enjoy the exemption, they are required to strictly follow the following conditions when they keep and

dispense the drugs :-

I. RMPs should not (a) keep an open shop or (b) sell across a counter or (c) engage in importation, manufacture,

distribution or sale of drugs in India to a degree which makes him liable to provisions of Chapter IV (It refers to

manufacture, sale and distribution of drugs and cosmetics) of DCA and DCR.

II. (a)The drugs shall be purchased only from a dealer or a manufacturer licensed under DCR and (b) Records of such

purchases showing the names and quantities of such drugs, together with their batch numbers and names and

addresses of manufacturers should be maintained. Such records shall be open to inspection by a drug inspector who

may, if necessary, make enquiries about the purchases of drugs and may also take samples for test.

III. The drug should be stored under proper storage conditions as directed on the label of the drug.

IV. No drug should be supplied or dispensed after the date of expiration of potency recorded on its container, label or

wrapper or in violation of any statement or direction recorded on such container, label or wrapper.

V. Additional conditions in case of medicine containing substance specified in Schedule G, H or X of DCA and DCR :-

(a) The medicine shall be labeled with the name and address of the RMP by whom it is supplied.

(b) Medicine for external application should be labeled with the words ‘For External Use Only’. If it is for internal use, it

should be labeled with 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 the 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 prescription, as the case maybe.

Note: - The law has contemplated the practices followed by RMPs in the past namely, to purchase the drugs in the

bulk and dispense them in small quantities to the patients and at times, compound and dispense the drugs to the

patients. Though this practice is presently on the wane, the conditions given above, at (a) to (e) are still required to

be followed by the RMPs. RMPs may prepare a stamp containing full name, address & registration number and

stamp it on (a) & (b) above, while dispensing. Information regarding (c), (d) & (e) may be kept in soft for inspection of

drug inspector etc.

VI. This also applies to drugs received as Not for Sale Physician’s Samples.

3. The intention of the law, as reflected in the above conditions, is to account and trace the drugs as per the batch number, in

case of any instance of substandard drug & to take further action in accordance with law and also to trace the

consumer/patient who could be a likely victim. Any violation of conditions given in I to VI above is punishable under the DCA.

The concerned State Medical Councils may also take disciplinary action against the RMPs, as they deem fit, if reported by the

regulatory agencies.

Abbreviations: DCA - Drugs and Cosmetics Act, 1940; DCR - Drugs and Cosmetics Rules, 1945; RMP – Registered Medical

Practitioner as defined under DCA

Shubham Jhajharia
Advocate, Ahmedabad
25516 Answers
179 Consultations

5.0 on 5.0

Hello,

After prescribing the medicines the doctors can dispense the medicines and the same is not illegal in India though the same may be considered as immoral.

You may refer to the following article for the details on the said topic:

http://www.indiamedicaltimes.com/2012/10/26/dispensing-medicines-by-doctors-%E2%80%93-how-ethical/

Regards

Anilesh Tewari
Advocate, New Delhi
17940 Answers
377 Consultations

5.0 on 5.0

1. Yes many doctors do. My doctor too gives me his medicine. It depends on the trust between you and your doctor

2. you have the right to ask the doctor what medicines he is giving you and whether there any generic versions of equal efficacy available in the market which can be bought as an alternative to the medicines prescribed by him and which also do the same job as the medicines which he has prescribed to you

3. i do understand your concern for asking the query since nowadays professions have turned into business making entities. Many doctors do have tie ups with medical transcriptionists deployed by medicine manufacturers to pitch their medicines for sale to doctors who in turn would prescribe those medicines to his patients against certain consideration from the medicine company. It is highly unfortunate but the practice cannot be denied.

4. To my knowledge I do not know of any particular steps which a doctor needs to follow to dispense medicines. It is upto the patient whether to buy the medicine from the doctor or from the pharmacy store

Yusuf Rampurawala
Advocate, Mumbai
6882 Answers
79 Consultations

5.0 on 5.0

1) Yes, doctor's are authorized by IMA and they had permission to provide ddispensing.

Ganesh Kadam
Advocate, Pune
12338 Answers
191 Consultations

4.9 on 5.0

Dear Sir,

Qualified Registered Medical Practitioners DO NOT Need A License To Dispense Medicines To Their Patients

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While the crackdown on quacks, and sale of expired drugs is welcome, directorate of drugs control seems to be overextending its mandate and harrasing qualified registered medical practitioners without any basis.

The Times of India dated 14 June 2010 carries an article that states that in the last two weeks the directorate of drugs control has slapped cases against doctors under the Drugs and Cosmetics act for selling drugs to patients without valid license. In this scenario it will become very difficult for the doctors to carry out regular practice properly. A qualified medical practitioner (MBBS or higher qualification) is best qualified to dispense medicines to patients as he is fully educated on effects. side effects, and drug interactions and individual variations, and to deal with all of these - which a pharmacist is not!! So there is absolutely no justication for the regulatory authorities to prevent doctors from dispensing medicines to their patients, and authorising pharmacists to advise patients about drugs.

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http://creative.sulekha.com/qualified-registered-medical-practitioners-do-not-need-a-license-to-dispense-medicines-to-their-patients_475176_blog

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Kishan Dutt Kalaskar
Advocate, Bangalore
6050 Answers
381 Consultations

4.8 on 5.0

The doctors can prescribe medicines but what do you mean by dispense medicines?

You mean selling medicines to their patients?

A qualified medical practitioner (MBBS or higher qualification) is best qualified to dispense medicines to patients as he is fully educated on effects. side effects, and drug interactions and individual variations, and to deal with all of these - which a pharmacist is not!! So there is absolutely no justification for the regulatory authorities to prevent doctors from dispensing medicines to their patients, and authorising pharmacists to advise patients about drugs.

which clearly indicates that private practitioners and hospitals are exempted from obtaining a license for dispensing drugs to their patients.

Rule 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.

SCHEDULE K[ See Rule 123] Class of Drugs

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.

T Kalaiselvan
Advocate, Vellore
78104 Answers
1543 Consultations

5.0 on 5.0

Doctor licences to practice can dispense medicine to patients

Ajay Sethi
Advocate, Mumbai
87947 Answers
6207 Consultations

5.0 on 5.0

1. In-House Clinically prepared (not Branded or packed) loose-medicines can be dispensed to their in-house OPD patients, by a Registered & Licensed doctor.

2. The above is however, restricted and banned to certain types of medicines, which require storage & handling licenses and maintaining registers.

Keep Smiling .... Hemant Agarwal

Hemant Agarwal
Advocate, Mumbai
5612 Answers
25 Consultations

5.0 on 5.0

1. Legally, RMPs do not need a license to dispense medicines to their patients.

2. However as per chapter I Sec. 1(3) of Indian Medical Council Ethics Regulation Act, the RMP shall maintain the medical records pertaining to his/her indoor patients for a period of 3 years from the date of commencement of the treatment.

Niranjan
Advocate, Bangalore
844 Answers
9 Consultations

4.9 on 5.0

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