As per the minutes of the 56th
Meeting of Drugs Consultative Committee held on 1st JUNE, 2019
at New Delhi, agenda 4, one the proposed amendments has been done in the Drugs
and Cosmetic Rules 1945 and medical practitioners will not be able to dispense
branded drugs to their patient. The amendment is to prevent misuse of the
exemption, which allows them to be out of the schedule H, exemption from
procuring a license to dispense the medicine.
“CONSIDERATION OF THE PROPOSAL
FOR AMENDMENT OF THE EXEMPTIONS PROVIDED UNDER SCHEDULE K REGARDING SUPPLYING
OF MEDICINES BY REGISTERED MEDICAL PRACTITIONERS TO THEIR PATIENTS
DCC was apprised that
Registered Medical Practitioners (RMP) can supply different categories
of medicines including vaccines to their patients as per the exemption provided
with certain conditions under Schedule K of the Drugs and Cosmetics Rules,
1945.
Currently, there is no
specific category which can be supplied by RMP to their patients. It is
proposed that the following additional conditions may be
incorporated under the conditions of exemption to prevent the
misuse of the exemption:
1. The Registered Medical
Practitioner shall supply generic medicines only.
2. The Registered Medical
Practitioners shall supply the ‘Physicians Samples’ at free of cost.
DCC deliberated the
proposal and agreed to amend Schedule K of the Drugs and Cosmetics Rules, 1945
to specify the medicines to be supplied by RMP to their patients.”
Appropriate MCI provisions
3.7.1 A physician shall clearly display his fees and other charges on the board
of his chamber and/or the hospitals he is visiting. Prescription
should also make clear if the Physician himself dispensed any medicine.
6.5 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. All the drugs
prescribed by a physician should always carry a proprietary formula and clear
name.
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.
Drugs and Cosmetic Rules
Schedule K(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 India to a degree
which render him liable to the provisions of Chapter IV of the Act and the
rules thereunder.
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 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
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.
(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 labelled with the words “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 prescription, as the case may be.
3[(3)The drug will be stored
under proper storage conditions as directed on the label.
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
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