Patient Access

Patients with serious, life-threatening health conditions and who have no available treatment alternatives, often want to know if and how they can receive early access to investigational products, sometimes even before they are approved by the regulatory agencies. “Expanded access programme” (EAP), also referred to as “compassionate use programme” or “managed access programme”, is a […]

Traditionally, the pharmaceutical industry has always been dependent upon the ‘push’ strategy for successful market access for products. The drug approval process, involving submission of data on efficacy, safety, and tolerability to the regulatory agencies, used to be simple; which ended with the drug being marketed to the targeted physicians and dispensed by pharmacies post approval. […]

What could be the better time – to talk about patients with rare diseases – than today, on the occasion of 11th Rare Disease Day! (1) The term ‘rare disease’ is defined as, ‘a disease or disorder affecting less than 1 in 2000 people’. (2) Rare diseases make up for one of the most scientifically […]

Following the recent announcement by PM Narendra Modi hinting at a legal framework for doctors to prescribe generic medicines cheaper than equivalent branded generic drugs, doctors appeared to welcome the move and opined that it will benefit patients as the life-saving drugs could be obtained at much cheaper rates. (1,2) In reality, India being the […]