Doctors Should write generic, non-proprietary, pharmacological names only: NMC Prescription Guidelines
Violation can bring penalties ranging from advisory or warning to even suspension of license for 30 days
New Delhi: Doctors should prescribe medicines with "generic"/"non-proprietary"/"pharmacological" names only, the recently released draft Prescription guidelines by the National Medical Commission (NMC) have stated.
The Prescription guidelines form an integral part of the draft of the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2022 recently released by the NMC.
Besides noting that "generic"/"non-proprietary"/"pharmacological" names have to be prescribed, the guidelines reiterate the point by again stating that physicians should "Avoid prescribing "branded" generic drugs". The guidelines however lay down that In the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, this practice can be relaxed.
Moreover, the guidelines go a step further, adding that doctors should "Encourage patients to purchase drugs from Jan Aushadhi kendras and other generic pharmacy outlets" and should "Advocate for hospitals and local pharmacies to stock generic drugs."
"Prescribe only those generic medicines that are available in the market and accessible to the patient," the guidelines state
In the recently released draft regulations, the Ethics and Medical Registration Board (EMRB) of the National Medical Commission (NMC) has directed the doctors practicing in India to prescribe generic names of medicines and write the same in a legible manner.
Listing down the Professional Conduct of the RMPs, NMC in the recently released Draft Registered Medical Practitioner (Professional Conduct) Regulations, 2022 has discussed in detail the duties and responsibilities of the doctors and in this regard it has advised doctors to avoid unnecessary drugs and irrational fixed-dose combination tablets.
In this regard, Section 8 of the Regulations states,
"Prescribing Generic Medicine: Every RMP is expected to prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1, L2)."
Since the Apex Medical Body has recommended Level 1 (L1) and Level 2 (L2) disciplinary action for the violation of this rule of prescribing generic medicines, the doctors might get warnings and instructions or advisories that can be issued in this regard. However, if charged under Level 2 violation, their license can be suspended for up to one month, as specified in the Regulations.
A generic drug has been defined by NMC as a "drug product that is comparable to brand/reference listed product in dosage in dosage form, strength, route of administration, quality and performance characteristics, and intended use".
While formulating the Guidelines for Doctors regarding the prescription of Generic Medicine, the apex medical body has pointed out that India's out-of-pocket spending on medications accounts for a major proportion of public spending on health care. Further, generic medicines are assumed to be 30 to 80 % cheaper than branded drugs.
"Hence, prescribing generic medicines may overtly bring down health care cost and improve access to quality care," the Apex body opined in the new Draft Regulations.
Another point specifically mentioned in the guidelines deal with rational prescriptions stating that " Both overprescribing and underprescribing are to be avoided keeping in mind possible drug interactions". Given the recent rise of the use of Fixed-dose combinations (FDCs), most of which do not have any rationality, the guidelines reserved a special mention for these FDCs stating that "Only approved and rational fixed-dose combinations are to be prescribed."
Responsibility of RMP regarding the sale of drugs:
A. A RMP shall not run an open shop to sell medicine prescribed by RMPs other than himself or for the sale of medical or surgical appliances. They are allowed to sell medication to his/her own patients. (L2)
"B. RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by a RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2)."
Guidance to RMPs:
NMC in the new Regulations have recommended Level 1 (L1) and Level 2 (L2) disciplinary action against doctors if they are found to be violating the rules regarding prescription of generic medicines. Guideline 4 of the Regulations mentions that when the State Medical Council or EMRB or NMC investigates a case, the disciplinary action will be awarded while keeping in mind the severity of the act of commission of omission.
These Regulations have graded the disciplinary actions at five levels. As per the Guidelines, Level 1 penalty is given in the form of Reformation that "may be awarded singly or in conjunction with other levels, in the form of advisory, instruction or warning."
On the other hand, Level 2 penalty "may be awarded even when the role of the doctor in causing direct harm was not conclusively proved but the doctor was found to have breached any of the codes listed above."
The Guidelines stated in case of L2 penalty, "The maximum action is a suspension of the license to practice for up to one month (30days)."
Therefore, if the doctors are found to be not complying with the rules regarding the prescription of generic medicines, either they might get a warning, instruction, advisory in this regard, or they can be suspended for a period up to 30 days.
Generic medicines vs Generic names defined in NMC guidelines
What is a generic name?
Generic Name: Non-Proprietary or approved name of a drug is also known as the generic name of the drug. Non-proprietary name is the name accepted by a competent scientific body/ regulatory authority.
What is Generic drug/medicine?
A generic drug is defined as a "drug product that is comparable to brand/reference listed product in dosage in dosage form, strength, route of administration, quality and performance characteristics, and intended use"
What is Branded Generic drug?
A branded generic drug is one which has come off patent and is manufactured by drug companies and sold under different companies' brand names. These drugs may be less costly than the branded patent version but costlier than the bulk manufactured generic version of the drug. There is less regulatory control over the prices of these "branded" generic drugs
