Legal Status of Doctors dispensing medicines to their own patients

i. Drugs & Cosmetics Act, 1940

• Section 18(c) under Chapter IV of the Act deals with the Prohibition of manufacture and sale of certain drugs and cosmetics.
• Rule 123 under PART XI of the Drugs & Cosmetics Rules, 1945 reads “The drugs specified in Schedule K 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.”
• Clause No 5 under the said Schedule K reads as under:

• Under the “Conditions of License” section in the format of Licenses granted under Drugs & Cosmetics Rules, the following exception is present:

3(ii) No sale of any drug shall be made to a person not holding the requisite licence to sell, stock or exhibit for sale, or distribute the drug. Provided that this condition shall not apply to the sale of any drug to—

(a) An officer or authority purchasing on behalf of Government, or

(b) A hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients”

ii. Pharmacy Act, 1948:
Under Section 42 of the said Act,

Dispensing by unregistered persons-

I. On or after such date as the State Government may by notification in the Official Gazette appoint in this behalf, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner

Provided that this sub-section shall not apply to the dispensing by a medical practitioner of medicine for his own patients, or with the general or special sanction of the State Government, for the patients of another medical practitioner

iii. Code of Ethics Regulations (Medical Council of India), 2002

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..