Tuesday, February 27, 2024

Bitter Pill

The National Medical Commission recently put on hold its earlier notification, which made it mandatory for doctors to only prescribe generic drugs. After the rules were notified, the Indian Medical Association and the Indian Pharmaceutical Alliance had expressed concern, saying this was not feasible because of the uncertainty about their quality

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The medical profession is battling a new threat—the Union government. On August 23, the National Medical Commission (NMC) put on hold its notification released on August 2. The new guidelines, the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, had made it mandatory for doctors to only prescribe generic drugs. The NMC in its latest notification further said that meanwhile Registered Medical Practitioners (RMP) will have to follow the rules and regulations notified in the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

The Indian Medical Association and Indian Pharmaceutical Alliance had flagged concerns over the new rules. In fact, the notification was opposed by the Indian Medical Association at a meeting chaired by Union Health Minister Dr Mansukh Mandaviya.

The President of IMA, Dr Sharad Agarwal, said that the Association’s stand regarding the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 was very clear. He added that the NMC has withdrawn its rules, otherwise it would not have been accepted by the medical profession under any circumstances. 

The notification issued by the Commission says: “That for removal of doubts, it is clarified that the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, shall not be operative and effective till further Gazette Notification on the subject by the National Medical Commission.”

There are, however, other pressures, namely the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002” announced by virtue of the powers vested under the National Medical Commission Act, 2019. “It is clarified that Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, shall come into force with immediate effect,” the notification by NMC said.

The NMC’s regulations have been opposed by doctors ever since it was notified. The doctors said that the quality of generic drugs in India is poor and prescribing them may put the patients at risk.

On August 2, the NMC had passed the following guidelines:

  • Every self-employed Registered Medical Practitioner (RMP) shall display the unique registration ID assigned to her/him by EMRB in his/her prescription, certificate, and money receipts given to patients. Employed RMP shall get a seal made by the employer for displaying the unique registration number below the RMP’s signatures.
  • The RMP shall display as suffix to his/her name only NMC recognized and accredited medical degrees/diplomas as provided in the nomenclature of the regulations and listed on the NMC website (List of such Degrees and Diplomas will be on the website and updated regularly). RMPs qualified abroad and seeking registration to practice after clearing FMGE/NEXT must use NMC-approved equivalent medical prefixes and suffixes to provide clarity to patients and the public at large.
  • RMP shall not claim to be a clinical specialist unless he/she has NMC recognized training and qualification in that specific branch of modern medicine (the list of recognized post-graduation and super-specialization degrees/diplomas will be available on the NMC website).
  • Every RMP shall practice the system of medicine in which he/she has trained and certified (for this purpose referred to as modern medicine or allopathic medicine) and shall not associate professionally with any unqualified person to perform any treatment, procedure, or operation.
  • RMP shall not employ in connection with his/her professional practice any healthcare professional who is neither registered nor trained under the relevant Medical Acts in force related to the practice of modern medicine. Provided that having employed any such assistants in the practice, the ultimate responsibility rests on the self-employed RMP or the RMP responsible for administration and recruitment in case of hospital practice.
  • Consultation fees should be made known to the patient before examination or treatment of the patient. A reasonable estimation of the cost of surgery or treatment should be provided to the patient to enable an informed decision. RMP can refuse to treat or to continue to treat a patient if the fees, as indicated, are not paid. At the same time, this does not apply to doctors in government service or emergencies, but the doctor must ensure that the patient is not abandoned. 
  • RMP shall not solicit patients directly or indirectly or as a part of the group of RMPs, or institutions or organizations or hospitals or nursing homes, or corporate hospitals established, owned, controlled, or maintained by the appropriate government, local authority, trust, whether private or public, corporation, co-operative society, organization or any other entity or person.
  • Every RMP should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets.
  • A RMP shall not directly or indirectly participate in any act of division, transfer, assignment, subordination, rebating, splitting, or refunding of any fee for diagnostic, scanning, medical, surgical, or other treatment. These provisions shall apply with equal force to the referring, recommending, or procuring by a RMP of any patient, specimen, or material for diagnostic purposes or other studies/work. However, nothing in this section shall prohibit payment of salaries by a qualified RMP to another duly qualified person rendering medical care under his/her supervision. RMP shall not use online forums or agents for procuring patients.
  • A RMP individually or as part of an organization/ association/society, etc shall not give to any person or to any companies or to any products or to software/platforms, whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report, or statement concerning any drug brand, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or appliance or any commercial product or article with respect of any property, quality or use thereof or any test, demonstration or trial thereof, for use in connection with his name, signature, or photograph in any form or manner of advertising through any mode nor shall he boast of cases, operations, cures or remedies or permit the publication of report thereof through any mode.

There were other provisions related to advertisements:

(A) RMP is permitted to make a formal announcement in any media (print, electronic or social) within 3 months regarding the following: (1) On starting practice, (2) On change of type of practice, (3) On changing address, (4) On temporary absence from duty, (5) On resumption of practice, (6) On succeeding to another practice, (7) Public declaration of charges. 

(B) RMP or any other person including corporate hospitals, running a maternity home, nursing home, private hospital, rehabilitation centre, or any type of medical training institution, etc may place announcements in the print, electronic and social media, but these should not contain anything more than the name of the institution, type of patients treated or admitted, kind of doctors and staff training and other facilities offered and the fees.

(C) RMP is allowed to do public education through media without soliciting patients for himself or the institution.

The guidelines on responsibility of RMP regarding the sale of drugs:

(A) RMP shall not run an open shop to sell medicines prescribed by RMPs other than himself or for the sale of medical or surgical appliances. They are allowed to sell medication only to his/her own patients.

(B) 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.

The NMC stated that India’s out-of-pocket spending on medications accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care.

  • Generic medicines vs Generic names:

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.

Generic drug/medicine: A generic drug is defined as a “drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use”

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.

Any RMP is eligible to provide telemedicine consultation to patients from any part of India. In case of any complaints of misconduct, the complaint will be lodged in the State Medical Council of the State, where the RMP is located at the time of providing tele-consultation. RMPs using telemedicine shall uphold the same professional and ethical norms and standards as are applicable in routine in-person consultations within the intrinsic limitations of telemedicine.

The fact that the proposal regarding usage of generic drugs was put forward by the Ministry, opposed, and withdrawn suggests that it is not a healthy relationship. 

—By Adarsh Kumar and India Legal Bureau

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