NMC Puts New Medical Practitioner Conduct Rules on Hold

August 26, 2023

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Last Updated on December 31, 2023 by The Health Master

National Medical Commission

In a move that has stirred controversy among various stakeholders, including medical professionals, pharmaceutical companies, and medical device manufacturers, the National Medical Commission (NMC) has taken a step back from implementing the recently introduced regulations governing the professional conduct of Registered Medical Practitioners (RMPs).

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Regulation Held in Abeyance

The NMC, through a notification released on August 23 and published on August 24, has declared the suspension of the “National Medical Commission Registered Medical Practitioner (Professional Conduct) (Amendment) Regulations, 2023,” with immediate effect.

This decision comes in response to widespread criticism and concerns expressed by various quarters.

Download National Medical Commission Registered Medical Practitioner (Professional Conduct) (Amendment) Regulations, 2023

Status of the Regulation

The “National Medical Commission Registered Medical Practitioner (Professional Conduct) (Amendment) Regulations, 2023” will remain inactive and ineffective until a subsequent Gazette Notification on the matter is issued by the NMC, the NMC stressed for clarity.

In the meantime, the “Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002” will be reinstated and enforced.

Download Indian Medical Council (Professional Conduct, Etiquette, and Ethics) Regulations, 2002

Controversial Guidelines and Backlash

The Ethics and Medical Registration Board (EMRB) of the NMC had previously introduced the “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023” on August 2.

Download National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023

These regulations included provisions urging medical practitioners to avoid prescribing branded generic drugs and instead prioritize generic, non-proprietary, and pharmacological names when prescribing medications.

Additionally, the guidelines restricted RMPs from participating in third-party educational activities, such as seminars, workshops, and conferences, that received sponsorships from pharmaceutical companies or the allied health sector.

This move was met with strong opposition from doctors, pharmaceutical companies, and medical device manufacturers.

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Stakeholder Response

The Indian Medical Association (IMA), the apex body representing medical professionals in India, vehemently protested against the regulations.

They advocated for the implementation of a ‘one drug, one quality, one price‘ system instead, asserting that less than 0.1% of drugs manufactured in India undergo quality testing.

The IMA emphasized that the quality of drugs is a major concern and urged the government to defer implementation until comprehensive quality assurances are in place.

Similarly, the medical device industry criticized the guidelines for placing impractical restrictions on third-party educational activities.

The Department of Pharmaceuticals (DoP) has been working on developing a more rational code of marketing practices.

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SME Pharma Industries Confederation’s Perspective

The SME Pharma Industries Confederation (SPIC) expressed concerns about the potential consequences of the guidelines.

They argued that the directive to prescribe only generic medicines could lead to job losses for around 20 lakh people and adversely impact the pharmaceutical industry.

SPIC highlighted that generic drugs without brand names are limited in the market, and the existing Jan Aushadhi stores are insufficient to meet the demand.

Government Intervention and Future Outlook

In response to the mounting criticism, the Union health minister, Dr. Mansukh Mandaviya, engaged with stakeholders, including IMA and the Indian Pharmaceutical Alliance (IP Alliance), on August 21.

The meeting allowed stakeholders to present their perspectives, and while the guidelines were defended on the basis of reducing healthcare costs and improving access to quality care through generic prescriptions, exceptions were recognized for drugs with narrow therapeutic indexes and exceptional cases.

Expert Insights and Potential Challenges

According to credit rating agency Fitch Ratings, the guidelines face implementation challenges. Branded generics maintain a significant market share, and the shift to prescribing only generic names could impact the profitability of Indian pharmaceutical companies.

Fitch Ratings expressed concerns about variability in drug quality due to less stringent quality norms in India and the potential shift of decision-making from physicians to pharmacists.

Conclusion

The decision by the National Medical Commission to suspend the implementation of the “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023” reflects the complexities and concerns associated with prescribing generic medications exclusively.

While the intention to reduce costs and enhance access to quality care is laudable, the current state of drug quality control and the practical challenges associated with the transition necessitate further consideration and consultation with all stakeholders before any final decision is made.

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