New Delhi: After the move of the Medical Council of India directing its registered medical practitioners to prescribe generic only, the government is now going to ensure that doctors dispense generic medicines as well, by making requisite amendments to the Drugs and Cosmetic Rules, 1945
The matter was recently brought up before the Drugs Consultative Committee (DCC) of the Central Drugs Standard Control Organisation (CDSCO) that took a note of Schedule K of the Drugs and Cosmetics Rules, 1945, that specifies drugs that 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.
The schedule (point5) includes 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 practioner 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.
The schedule further specifies the conditions and extent of exemptions to registered medical practitioner, and in effect lay down the conditions and rules governing the dispensing of medicines by medical practitioners.
A proposal was received by the CDSCO committee wherein the 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. However, currently there is no specific category which can be supplied by RMP to their patients.
It was 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.
If the amendment comes to play, it would imply apart from being held liable for violation of MCI Ethics rules for not prescribing generic, doctors would also be in violation of Drugs and Cosmetics Rules if they supply or dispense non-generic, aka branded medicines to patients
The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.