The National Medical Commission (NMC) has put on hold regulations that would have made it mandatory for doctors to prescribe generic drugs.

The Registered Medical Practitioner (Professional Conduct) Regulations, 2023, were published on August 2.

The NMC in its ‘Regulations relating to Professional Conduct of Registered Medical Practitioners” stated that all doctors must prescribe generic drugs, failing which they will be penalised, and even their license to practice may also be suspended for a period. It also asked doctors to avoid prescribing branded generic drugs.

A drug that goes off-patent becomes a generic medicine and can be made available under an official international non-proprietary name or brand.

‘Not sure of quality’

Incidentally, the Indian Medical Association (IMA) and Indian Pharmaceutical Alliance (IPA) had expressed concern claiming that the regulations were not feasible because of the uncertainty about their quality.

Members of the IMA and IPA met the Union Health Minister, Mansukh Mandaviya, earlier this week in a bid to put these guidelines in abeyance and also get their concerns heard.

In a notification issued Thursday, the NMC said, “National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, are hereby held in abeyance with immediate effect.”

It further added 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.”

The “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002” however will come into immediate effect. the notification said.

Other regulations

According to the regulations, registered medical practitioners and their families must not receive any gifts, travel facilities, hospitality, cash or monetary grants, consultancy fees or honorariums, or access to entertainment or recreation from pharmaceutical companies or their representatives, commercial healthcare establishments, medical device companies, or corporate hospitals “under any pretext”. This does not include salaries and benefits that registered medical practitioners may receive as employees of these organizations.

Also, these practitioners should not be involved in any third-party educational activity like CPD, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector.

For the first time, the term emergency has been defined as a ‘life and limb saving procedure”. In case of medical emergencies, efforts should be made to make the medical records available at the earliest.

According to the regulations, any request for medical records to a registered medical practitioner responsible for patient records in a hospital either by the patients or authorized attendant has to be duly acknowledged and documents have to be supplied within 5 working days instead of the existing provision of 72 days.