Medical prescription guidelines: Go for well-calibrated adoption

livemint.com:

Indian market is a predominantly generics market: Branded, trade and INN. All these three categories are me-too drugs but marketed and distributed differently. Branded generics are promoted to doctors, while trade generics are sold through the trade network (with higher margins), and usually not promoted to doctors.

The NMC has asked RMPs to switch from branded to INN, which is a major shift. There has been a pushback from pharma companies and RMPs. To understand why, we need to consider the structural factors that led the Indian pharma market to its domination by branded generics.

India is an out-of-pocket healthcare expenditure dominated market, one where patients have always had an inherent trust in doctors. From our conversations with multiple doctors, there is clear hesitation in prescribing INN generics due to a lack of confidence in the quality of products and reputation of manufacturers. In terms of quality standardization in India, bio-equivalence criteria are mandatory only for the first four years after a molecule enters the market.

Subsequent introductions can get approvals by just submitting stability data. By comparison, in Western markets such as the US, all generics must match active-pharmaceutical-ingredient (API) characteristics and bio-availability with those of the original drug innovators, which enables prescribers to trust drug quality and prescribe INN drugs post patent expiry. Doctors in India have years of experience with branded generics and feel more confident about clinical outcomes.