Dispensing medicines with out any permission!

(With profound thanks to Dr.M.C.Gupta sir& Dr.Sushama anil for their inquisitive inputs).

To whom  the D&C Act imply?

Importers,manufacturers,retail sellers and distributors of medicines& cosmetics.

An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.

So, Its legal to say, that Drugs Act is not to regulate doctors & hospitals dispensing medicines to their own patients.

Is the supply of medicines to patients in a hospital comes under sale?

The supply of a drug to a hospital ward or operation theatre for the purpose of treatment does not constitute sale as defined in rule 2(f) of  the  Drugs and Cosmetics Rules, 1945, which states that—

“Å"retail sale means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person”.

What is meant by sale?

Selling involves a concept of contract (offer; acceptance of offer; consideration) and involves issue of a bill / receipt for goods sold and potentially exposes the doctor to a charge of deficiency of goods .

Is the hospital is the place for sale of goods or service?

The hospital is a place for providing service and not a shop where goods  are sold. The service provided is the treatment of patients. The drugs  are  supplied to patients as a part of service and do not constitute
 independent  sale of goods. This service can even be free.

(As a matter of fact, as  per Social  Jurist, A Lawyers Group vs Government Of NCT of Delhi And Ors., decided  by a  division bench of Delhi High Court on 22 March, 2007, 140 (2007) DLT  698, 25% of OPD patients and 10% of indoor patients are to be treated totally  free, including medicines. It is unimaginable that there can be any law whereby a  shop or a seller of goods can be asked to sell goods without charging the  price. This further supports the fact that hospitals dont sell drugs  but  rather provide services and that the act of supplying drugs to patients  is  incidental to provision of services).

What is the legal and proper meaning of the section 5 under Schedule K?

Registered doctor is exempted from all the provisions under chapter 4, Provided, the doctor  should obey  certain conditions which are clearly mentioned in the section. 

A Doctor,( in terms of schedule K (para 5) of the Drugs and Cosmetics Rules, 1945) can supply drugs to his own patients provided he is not –

 (a) keeping an open shop

(b) selling across the  counter),

 (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 there under.

The above exemption is subject to certain conditions, as follows:

·         The drugs shall be purchased only from a LICENSED  dealer or a  manufacturer  .

·         records of such purchases (showing - names and quantities  with their batch numbers &

 the  names  and addresses of the  supplier  shall be maintained.

 Note: 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. The record keeping as per the schedule K is not to penalize doctors but to help the drug dept to see that the drug traders are not selling spurious /mis-branded/adulterated drugs through the respective channels referred under schedule K.

In the case of medicines of  Schedule G, H or X the following additional conditions shall be complied  by the dispensing Doctor/ hospital:
 (a) the medicine shall be labelled with the name and address of the  Doctor  by whom it is supplied to the patient.

(b) if the medicine is for external application, it shall be  labelled with the words
 (c) the dose prescribed, the name of the patient and the  name of the doctor
(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.

 So, purchase medicines from licensed suppliers & maintain “dispensing medicine register” as follows: 

Name of drug	Supplier address	quantity	Batch number	Date of purchase

 In case of Schedule G, H or X medicines,label the medicine box with prescribed doctor’s name,dosage, way of usage. 

Entry no.	Medicine Batch no.	Patient name.	date of dispense

  

Take home message:

1.Medicines kept by a doctor for his own use (for dispensing to his patients) do not comes under pharmacy or drug store and also doesn't be termed as  the “sale”.

2.In terms of MCI Regulations, 2002 and the Drugs and Cosmetics Act, 1940, doctors are allowed to dispense medicines to their own patients and to store necessary medicines for that purpose in reasonable quantity. You do not need a licence for the same.

3.The Doctor should not sell drugs,as per MCI ACT,CLAUSE 6.3 OF CODE OF ETHICS.

4. With out the bill,the transaction doesn't come under sale.

5. If the sale was happened, it shall be proved by sales tax dept. and on this report only,drug authority can take action on seller of medicines.

so,if the doctor want to sale drugs in his premises, he has to take sales tax license and pharmacist certificate. Otherwise if the doctor want to dispense medicines, there is no need of sales tax license&pharmacist ceretificate.

6.Doctor does not require drug license for  even compounding the  medicines.

7.Remember, sale is different from dispensing. Also remember, trade is different from service.

So, as long as the doctor dispense the medicines to his/her own patients and keeping the relevant records, its legal and ethical.

A doctor can dispense , can compound & can serve the patients,because its  his/her’s bonafide duty. For these, no license is necessary except  registered modern medical degree,purchase of drugs from licensed suppliers ,proper storage of medicines and correct record keeping.

Drug inspectors can check the drugs and can take drugs for quality testing,but they have no monitoring capacity over the dispensing doctors.