1.     The Food and Drug Administration (FDA) has been asking doctors to follow the Drugs and Cosmetics Act 1940 verbatim, and even launched an educational and awareness campaign, especially in taluka places. The act has always been clear with directions for practicing doctors. It is to ensure that these directives are being followed strictly. "Every doctor must maintain a detailed purchase and use record of every schedule H and G medicines, which includes drugs like antibiotics, sedatives and general drugs. They also need to store the drugs as per rules and keep a record of every drug dispensed / consumed by patients,".

2.    Doctors are expected to maintain bills of each purchase and not sell the medicines procured as samples from medical representatives or sell them across the counter.
"However, in case of any discrepancies, FDA cannot directly take action against the doctor since they are not directly licensed to sell drugs, nor do they require a licence. The details wanted by FDA are already present in every purchase bill and doctors should just maintain an inward drug registry.

3.    According to Drugs & Cosmetics Act 1940 and Drugs & Cosmetics Rules 1945, no person shall himself or any other person on his behalf can sell, stock, exhibit, offer for sale or distribute any drug except under and in accordance with the condition of a license issued for such purpose under the Act, with the result that none without a license could purchase the drugs from the licensed dealer, as immediately after purchase of the drugs without license such possession would be illegal.

4.    Some of the provisions of Drugs & Cosmetics Rules have sought to mitigate the rigour of the provisions contained in section 18(c). Drugs & Cosmetics Rules 123 exempts the doctors/registered medical practitioners (RMP) from the provision of necessity of license for stock of the drugs/medicines subject to the condition specified in Schedule K of the Act.

5.    Doctors/registered medical practitioners have to dispense the medicine to their patients by himself or through a qualified compounder or registered pharmacist. Any person who is not qualified pharmacist has no right to sell the drugs anywhere. In the present context, the mother of the medical practitioner not being a qualified person/pharmacist has no right to dispense/sale the medicine to anyone.

6.    If a doctor/registered medical practitioner sells the drugs from his shop situated in his clinic without a valid license, he is liable to be prosecuted under section 18(a)(i) punishable under section 27(b)(ii) and liable to be punishable with imprisonment for a term which shall not be less than three years but which may be extended to five years and with fine which shall be not less than one lakh rupees or three times of the value of the drugs confiscated whichever is more and if the drugs found adulterated or spurious than he also liable for a imprisonment mentioned under section 27(a), 27(b)(i), 27(c) and 27(d) as the case may be.

What the law prescribes

A.   Doctor allowed to dispense medicines to patients, does not require any drug license.

B.   Drugs shall be purchased only from licensed dealer or manufacturer, and records of such purchases showing names and quantities of drugs, batch numbers and names and addresses of manufacturer should be maintained.

C.   Doctors should not keep an open shop or sell across the counter or engage in import, distribution, manufacture or sale of drugs without valid FDA license.

Legal opinion is based on THE DRUGS AND COSMETICS ACT, 1940 as amended by the Drugs (Amendment) Act, 1955, the Drugs (Amendment) Act, 1960, the Drugs (Amendment) Act, 1962, the Drugs and Cosmetics (Amendments) Act, 1964, the Drugs and Cosmetics (Amendments) Act, 1972, the Drugs and Cosmetics (Amendments) Act, 1982, the Drugs and Cosmetics (Amendments) Act, 1986 and the Drugs and Cosmetics (Amendments) Act, 1995. AND THE DRUGS AND COSMETICS RULES, 1945.

PLACE : JABALPUR

DATED : 23.09.2016                   [VIJAY RAGHAV SINGH]