Generic prescription controversy: NMC regulations for doctors held back

The National Medical Commission (NMC) has put on hold the regulations that make it mandatory for doctors to prescribe only generic molecule names instead of brand names for drugs, a health ministry notification said on Thursday.

In a notification dated August 21, the ministry said the NMC-Registered Medical Practitioner (Professional Conduct) Regulations, 2023, were to be held in abeyance with immediate effect. They will remain inoperative and ineffective till further Gazette Notification. It also said the NMC adopted and made effective with immediate effect the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”.

The NMC, a government body regulating medical education and professionals, initially issued the regulations on August 2. This led to an uproar in the pharmaceutical industry and among doctors. The pharma industry lobby asserted that the quality of drugs could become an issue if doctors were restricted from prescribing branded generics.

The Indian Medical Association (IMA), representing approximately 400,000 doctors, expressed concern, stating that this directly impacts patients' care and safety. They argued that if the government genuinely wanted to implement generic drugs, it should not license branded drugs and simultaneously ensure the quality of generic drugs.

The prescription of only generic medicines or molecule names by doctors would allow chemists to offer patients the cheapest option, reducing their costs. Some industry insiders view the move as a step towards the implementation and codification of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP), a voluntary guideline that currently prevents pharma companies from offering freebies to doctors.

On Monday, representatives from the pharma industry and doctors advocated for permitting both generic (molecule) names and brands in prescriptions during a meeting with senior Central government officials in Delhi. After a two-hour discussion, IMA representatives reported that the government had noted the suggestions.

India is known for its branded generic drugs market, where pharma companies sell copy-cat drugs (off patent) under various brands. This means that the same molecule may be sold under different brand names.

In its recently released 'Regulations relating to Professional Conduct of Registered Medical Practitioners,' the NMC stated: “Every RMP should prescribe drugs using generic names legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets."

An IMA representative told Business Standard: “The doctors and industry have suggested that brand names should be mentioned in the prescription along with writing the molecule name. Otherwise, the power shifts to chemists instead of a medical practitioner."

The representative added that industry conferences should be permitted to continue, as these platforms facilitate the exchange of ideas and ensure the continuity of medical education.