Subject: Proposed Amendment in Drugs and Cosmetic Act, DCC Meeting 1st June 2019.


The Hony Secretary General


New Delhi

Subject: Proposed Amendment in Drugs and Cosmetic Act, DCC Meeting 1st June 2019.

Dear Sir

Greetings from IMA Haryana!

I wish to draw your attention towards the proposed amendment in the Drugs and Cosmetics Act , as recommended by the Drugs Consultative Committee in its meeting held on 1st June 2019.

I am reproducing the decision as under:

“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.


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.”

Please take up the matter, with concerned authorities, because it amounts to discrimination between medicine dispensed by a medical professional versus sold by a chemist.

Whereas, chemists not only usually subsitute medicines prescribed by the doctor; they also sell brands of their choice to the less knowledgeable patients ( depending upon their margin of profits).

On the other hand , qualified doctors shall be forced to dispense ONLY generics medicines ; the QUALITY of which may not be consistent from one company to another.

Also, all types of medicines are not available in generic versions. Some of the Vaccines dispensed by paediatricians may not be available in generic versions. Some surgical medications and good quality ointments too may not be available in generic versions. Thus, medical professionals shall not be able to serve their patients in a smooth way. The patient may have to buy some medicines from chemist only, thus encouraging the MONOPOLY of CHEMISTS. This shall be against the principles of natural justice and in legal parlance may come under Monopolies and Restrictive Trade Practices.

In view of the logic vide supra, you are requested to look into the matter and do the needful at the earliest.

Hoping for a POSITIVE response.



M.B.B.S. ( Medallist) , M.S. ( Gen.Surg.)

SETIA HOSPITAL and Piles Clinic

Delhi Road, HISAR 125001 , Haryana

.Patron IMA Haryana State 2019

.State President IMA Haryana 2017

.Best State President, National Awardee 2017

.IMA Doctor of the Year 2018, National Awardee

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