India’s Generics-Only Rx Rule: Not What The Doctor Ordered Or What Pharma Wants?

New norms call for generics-only prescriptions and prohibits doctors from engaging in third-party educational activity backed by pharma in India. Will pharma need to rethink its branded generics strategy in India or is a tempering/deferment of the norms on the cards?

New Headwinds For Pharma In India? • Source: Shutterstock

A generics-only prescription diktat that forms part of India’s new rules pertaining to the professional conduct of registered medical practitioners (RMPs) has doctors up in arms, with pharma in a tizzy over what that may mean for its established branded generics business.

Update – NMC regulations suspended

That National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, has now been held in abeyance and will not be operative and effective till further gazette notification on the subject by the commission. 

This follows hectic parleys and strong protests by stakeholders and a meeting with Mansukh Mandaviya, India’s Minister for Health and Family Welfare.The National Medical Commission has now adopted and made effective with immediate effect the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”. Under these rules, which cover a gamut of aspects, a physician is required to, “as far as possible, prescribe drugs with generic names” and ensure that there is "rational prescription and use of drugs".

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