DRUG DISPENSING BY DOCTORS-FAQ

DR. A.R. DESHMUKH

PROFESSOR & HOD

DEPT OF SKIN & V.D.

M.G.M. MEDICAL COLLEGE & HOSPITAL, A’BAD

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HOW IT WAS STARTED

MCI ETHICS REGARDING DISPENSING

1.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.

2.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

3.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

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1.Secret Remedies : The prescribing or dispensing by a physician of secret remedial agents of which he does not know the composition,or the manufacture or promotion of their use is unethical and as such prohibited.

2.All the drugs prescribed by a physician should always carry a proprietary formula and clear name.

DRUG AND COSMETIC ACT

Schedule k

CLAUSE V

1)Drugs supplied by a registered medical practitioner to his own patient or any drug specified in SCHEDULE C supplied by a RMP 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 RMP is not

ii.keeping an open shop or

iii.Selling across the counter or

i.Engaged in the importation, manufacture, distribution or sale of drugs in India to a degree which render him liable him provisions of chapter IV of the act and the rules thereunder.

ii.All the provisions of chapter IV of the Act and the rules made thereunder , subject to the following conditions:

● The drugs shall be purchased only from a dealer or a manufacturer licensed 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 manufacterers 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 also take sample for test

●In the case of medicine containing a substance specified in [schedule G,H,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)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 prescription shall be entered at the time of supply in register to be maintained for the purpose;

c) The entry in the register shall be given a number and that number shall be entered on the label of the container

d) The drug will be stored under proper storage conditions as directed on the label

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RULES REGARDING KEEPING & DISPENSING OF DRUGS BY THE RMP

1.Though the RMP enjoy the exemption , they are required to strictly follow the below mentioned condition:

ii.They should not keep an open shop , sale across the counter or keep any banned medications

iii.Drugs shall be purchased from a dealer or manufacturer licensed under DCR

iiii.Records of such purchases should show names and quantities of drugs , batch numbers, name and address of the manufacturer

I.Drug should be stored under proper storage condition as directed on the label

II.Additional conditions :

c) Medicine shall be labelled with name and address of RMP

d)Medicine for external application should be labelled as – FOR EXTERNAL USE ONLY

e)The register and prescription if any shall be preserved for not less than 2 years

PHARMACY V/S DISPENSING

PHARMACY

DISPENSING

Min 110 SQUARE FEET space required

No such space requirement

A registered pharmacist

Not required

Shop act license and other license required

No such license are required

Should be separated from clinic by a solid wall

No such restriction

Separate entrance of clinic and pharmacy

No such criteria

RECORD KEEPING

1.All the purchase bills

2.A register showing following details –

III.Patient’s name

IIII.Contact number

V.Names and quantity of the drugs supplied

VI.Amount

To make a stamp of supplied by ,of your clinic name

To put the stamp on prescription when you dispense the drugs.

TAX IMPLICATIONS

1.All the drug -12% GST

2.All cosmetic shampoo and facewash – 18% GST

3.Applicable income tax

COURT MATTERS

IS IT ILLEGAL FOR A DOCTOR-COUPLE TO DISPENSE DRUGS WITHOUT LICENSE ?

1.One doctor from Kerala was decided guilty on the charges of running of pharmacy without a license from his clinic

2.Kerala FDA found him to be practicing with his wife

3.Kerala FDA interpreted clause V of schedule A as only single doctor can dispense medicine

4.The doctor was fined 1.2 lac and he served the sentence by remaining there till the rising of the court

1.Kerala high court in 2010 clarified in the judgement that every hospital has to take a drug license

2.Update according to the Kerala doctor, the government of Kerala has extended the privilege to dispense drugs without a license given to a single doctor to a doctor couple as well.

TRIAL OF DOCS WHO STOCKED MEDICINE IN CLINIC- HQ QUASHES THE TRIAL

1.Tamil Nadu FDA complaint against two doctors that medicines were stocked up for sale in there clinic without a whole sale valid drug license

2.Petitioner said they were qualified medical practitioner and drugs in there clinic were only for their patients and not meant for sale or distribution

3.Judge observed that , there was no allegation that stocks were exhibited for sale