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 doctors clinic to the patients.
Many issues border the practice of dispensing of medicines by registered
practitioners. It is not uncommon for doctors 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.
Section .42 of the Pharmacy Act
requires mandatory registration of pharmacists selling medicines but exempts
RMPs(doctors) 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(doctors) 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.
Responsibility of RMPs
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.
Conclusion
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.
now with the kerala high court bench judgment,doctors can dispense/sell medicines to their own patients .its very consoling and soothing news for practitioners who have been dispensing in rural& suburban areas since decades.
courtesy: legal service
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