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Subsequent to reports indicating the Union Health Ministry’s request for revisions to the National Medical Commission (NMC) Registered Medical Practitioner (Professional Conduct) Regulations, 2023, the Ethics and Medical Registration Board (EMRB) of the Commission has decided to suspend the implementation of these regulations.
Through a gazette notification released on August 23, 2023, the NMC Ethics Board has explicitly announced that the NMC RMP 2023 regulations will not be operational and effective until a subsequent Gazette Notification is issued by the NMC. In lieu of the suspended regulations, the Commission has opted to adopt the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002,” immediately putting them into effect.
The notification underlines, “The National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect.” It further emphasizes that the regulations will remain inactive until a future Gazette Notification from the National Medical Commission.
As a result of this decision, the older MCI 2002 regulations will continue to remain in force. The notification also explicitly states, “The National Medical Commission hereby adopts and makes effective with immediate effect the ‘Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002’, as if the same have been made by the Commission by virtue of the powers vested under the National Medical Commission Act, 2019 (Act No. 30 of 2019).”
Furthermore, the notification reinforces the commencement of the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002,” without any delay.
The issuance of the gazette notification promptly follows the correspondence from the Union Health Ministry to the Commission, urging them to revise the recent NMC Registered Medical Practitioner (Professional Conduct) Regulations 2023. The requested changes pertain to several matters, including the clause mandating doctors to prescribe generic drugs.
Ever since their official publication on August 02, 2023, the NMC RMP Regulations 2023 have been enmeshed in a range of controversies. A pivotal point of contention raised by medical professionals revolved around the rule mandating the prescription of generic medicines.
Medical Dialogues had previously reported that doctors had voiced strong objections to the new NMC regulations, specifically the provision requiring doctors to exclusively prescribe medications using generic or pharmacological names.
Chapter 1, Section 8 of the NMC RMP Regulations 2023 stipulates, “Prescribing Generic Medicines: Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets. (L1 and/or L2) (Generic Drugs and Prescription guidelines).”
Section 12 (b) of the same regulations states: “RMP can prescribe or supply drugs, remedies, or appliances as long as there is no exploitation of the patients. Drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug. (L2)”
Furthermore, the “Guidance to RMPs” section emphasizes “Prescribe drugs with ‘generic’/’non-proprietary’/’pharmacological’ names only.”
Significantly, the new Code of Conduct places strong emphasis on doctors exclusively prescribing medications using generic names. Violation of this mandate could result in punishment, including license suspension for up to 30 days.
However, these regulations were met with opposition from the medical community, and the Indian Medical Association (IMA) had previously urged for the implementation of the NMC regulations mandating generic drug prescriptions to be deferred. The IMA highlighted that the primary challenge with such medicines is the uncertainty surrounding their quality. The association emphasized that only a minute fraction (less than 0.1 percent) of drugs manufactured in India are tested for quality, and they emphasized that patient care and safety cannot be compromised.
In recent developments, a meeting was convened by Union Health Minister Mansukh Mandaviya to address the concerns raised by the regulations. The meeting included representatives from the Indian Medical Association, the National Medical Commission, the Union Health Secretary, and the Director General of the Indian Pharmaceutical Alliance. The intention of the meeting was to discuss the “issues” stemming from the regulations.
Following the meeting, the Indian Medical Association (IMA) addressed a letter to the Union Health Minister, outlining its reservations about specific sections of the regulations. Notably, the IMA asserted that since it is registered under the Societies Act, it should not be subject to the jurisdiction of the NMC. Consequently, the IMA called for an exemption from the NMC RMP Regulations 2023.
Within the same letter, the IMA articulated the collective concerns of the medical community. It urged the Union Health Minister to rescind the mandatory nature of the regulations pertaining to the prescription of generic drugs, and instead, make digitalization an optional and desirable practice.
Furthermore, the association emphasized the importance of permitting professional medical organizations to utilize pharmaceutical funding for Continuing Medical Education (CME) programs, educational initiatives, and research endeavors in a transparent and legitimate manner.
