As per the minutes of the 56th Meeting of Drugs Consultative Committee held on 1^st 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