Janssen Pharmaceutica, Long-Acting Risperidone and Public Health Program of India.

Within the ambit of the National Mental Health Program, the Government of India has mandated long-acting risperidone, a patented molecule of Janssen Pharmaceutica. We contest that the healthcare system of India is ill-equipped (due to its weak infrastructure) to monitor side effects, regulate the use, and ensure informed consent. The process of including patented Risperdal Consta into the Indian formulary has lacked transparency and suggests undo favor towards Janssen. Janssen Pharmaceutica is known for its aggressive marketing strategy resulting in off-label use of oral risperidone in the US. Moreover, the lax regulatory structure for pharmaceutical dispensing in India coupled with Janssen's aggressive marketing is a potential cause of concern. We are critical of the decision to include a costly and patented molecule in a publicly financed health program otherwise sourced by generic drugs.