According to the World Health Organization, dispensing refers to the practice of preparing and giving medicine to a person based on a prescription from a registered medical practitioner (RMP). Dispensing of medicines by an RMP has been legalized for the convenience of the patients. It allows the availability of consultation, treatment-related supplies, prescription and drugs under one roof, i.e. the doctor’s clinic to the patients. Many issues border the practice of dispensing of medicines by registered practitioners. It is not uncommon for RMPs to exercise the option of prescribing as well as dispensing medicines, especially in semi-urban and rural areas yet this dual practice of prescribing and dispensing medicines raises many ethical and legal concerns.
Can Medical Practitioners dispense medicines?
The question of whether clinical specialists should sell medicines at their clinic has been raised on several occasions but still remains unanswered. In India, the manufacturing, storing, transportation, conveyance, and administering of drugs and medicines are governed under various statutes, including the Drugs and Cosmetic Act, 1940; Indian Medical Council Act, 1956; the Pharmacy Act, 1948; and the Narcotic Drugs and Psychotropic Substances Act, 1985. S.42 of the Pharmacy Act requires mandatory registration of pharmacists selling medicines but exempts RMPs from this requirement. Recently, the Pharmacy Council of India had unanimously adopted a resolution requiring an amendment of S.42 of the Pharmacy Act permitting RMPs to sell medicines to their patients. Rajan B Rajan, former President of the Kerala State Pharmacy Council, also demanded following up on the implementation of this resolution. It is argued that since RMPs are unregistered drug specialists, they should not be allowed to sell drugs.
Rules governing dispensing of medicines by RMPs in India
Primary legislation dealing with the dispensation of drugs by medical practitioners is the Drugs and Cosmetics Act, 1940 (DCA). Form 20B of the DCA discharges the RMPs from procuring a license to dispense medicines. The rules framed under DCA, namely the Drugs and Cosmetic Rules, 1945 (hereinafter referred to as ‘Rules’), extensively lay down the requirements that allow an RMP to commence dispensing medicines. Schedule K of the Rules regulates the selling of medicines by medical practitioners. RMPs can supply drugs to their own patients provided the following conditions are fulfilled:
- The RMP must not keep an open shop
- He must not sell across the counter
- He must not be engaged in the import, manufacture, distribution or sale of drugs in India to such an extent that makes him liable for the breach of provisions of Chapter IV, DCA or the Rules.
- The drugs must be purchased by a licensed manufacturer or dealer, and records of such purchase should be maintained and shall be open for examination at all times by the Inspector appointed under DCA.
- The drugs must be stored under proper conditions as prescribed on the label.
- No drug shall be sold beyond its expiry date mentioned on its label or wrapper.
These conditions also apply in case a drug mentioned in Schedule C of the Rules is provided by the RMP to another medical practitioner at their request.
In Schedule K of the Rules, additional conditions have been prescribed if the medicine to be dispensed is mentioned in Schedules G, H or X of the Rules. These are:
- The medicine must bear a label mentioning the name and address of the RMP to whom it is supplied.
- Route of administration is also to be labelled
- A register has to be maintained by the RMP, listing out the name of medicine or ingredients of preparation and quantities, the dose prescribed, the name of the patient, date and time of supply, and the person who prescribed the medicines.
- Each entry in the register shall be numbered, and such a number must be written on the label of the container.
- The register and the prescription upon which the medicines were issued shall be preserved for at least two years from the date of the last entry in the register or the date of the prescription.
Non-compliance with these conditions will render the RMP liable for penalty under Chapter IV of the DCA. According to S.27(d), any person acting in contravention of the Rules shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to two years and with fine which shall not be less than twenty thousand rupees. Furthermore, the State Medical Council can proceed against the RMP.
Although RMPs are not required to obtain a license for dispensing medicines to their own patients if the drug to be dispensed is a controlled drug declared under S.2 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act), the RMP needs to secure a license to procure, transport, stock and dispense these controlled drugs. Furthermore, the Narcotic Psychotropic Substances Rules, 1985, govern the dispensation of controlled drugs by RMPs. Under Rules 52H and 52R, every RMP is required to maintain a separate record for each patient in Form no. 3E. Form no. 3D is to be filled detailing a day-to-day account of all transactions of essential narcotics. RMPs are also required to maintain a record of all receipts and disbursements of essential drugs in the manner prescribed in Form No. 3H.
Sabira M. v. State of Kerala and Ors. is a landmark judgement of the Kerala High Court wherein the Court held that “no person other than a registered pharmacist shall compound, prepare, mix or dispense any medicine on the prescription of a medical practitioner. However, the said provision shall not apply to dispense by a medical practitioner of medicine for his/her own patients, or with the general or special sanction of the state government for the patients of another medical practitioner.”
Ethical guidelines for Registered Medical Practitioner dispensing medicines
There has been a debate regarding the practice of RMPs to sell medicines in their own clinic. It is regarded as an ethical violation as doctors would benefit by prescribing expensive medicines to the patients. There is an inherent conflict of interest in this dual role as prescriber and seller of medicines of the RMP. In India, it is not unethical or illegal for an RMP to sell medicines to his patients, provided certain conditions are fulfilled. The Medical Council of India, with the approval of the Central Government, has notified regulations regulating the professional conduct of RMPs in India under S.33(m) of the Indian Medical Council Act, 1956. This code is known as the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. According to these regulations, RMPs should not run an open shop to sell medicines prescribed by him. This restriction does not apply in the case of the sale of medical or surgical instruments. The aim of this prohibition is to prevent the RMP from exploiting his patients. Subsequent to the amendment in 2016 to these regulations, the RMP is now required to legally prescribe drugs with their generic names, preferably in capital letters. Furthermore, it is now the responsibility of the RMP to ensure rational prescription and use of drugs.
There is an inherent danger of the profit motive of the medical practitioners in dispensing medicines. The RMP selling medicines to people has a dual interest in making profits as well as treating his patients. One must maintain a balance of interests for an ethical and efficient medical practice. Besides fulfilling the conditions prescribed by law, RMPs must disclose all relevant information to the patient. They should clearly reveal the name of the medicine, its efficacy, side-effects, economically friendly alternatives or substitutes of the prescribed medicines. The RMPs should refrain from taking any share in the profit from the sale of the medicines. The medical practitioner should not, under any circumstance, pressurize the patients into purchasing the medicines from him.
As there is a great deal of ambiguity present in understanding this matter, the Indian Medical Association has also requested the Government to form an ordinance for ‘one drug-one company-one price’ to curtail the practice of prescribing expensive medicines in order to make profits by the RMPs and to govern this issue under.