Medical writing in India at a crossroads

Abstract

Pharmaceutical regulatory medical writing for document submissions to Western health regulatory agencies has been undertaken in India for almost 10 years. From humble beginnings in a couple of non-Indian pharmaceutical multinational giants – Novartis and Sanofi-Aventis (as it was) – this activity has now expanded into multiple companies and almost a dozen information technology firms and contract research organisations. The biggest advantage is the cost, although this often comes at a ‘price’, in terms of document quality. However, medical writing in India may be turning a corner for the good as a result of the rapidly increasing body of experience in the field.

Keywords:

• Medical writing
• India
• Outsourcing
• Quality
• Cost arbitrage

Additional information

Notes on contributors

Salil Bose

Salil Bose is an Indian Manager of Medical Writing in a pharmaceutical company where he oversees the development of regulatory medical writing documents such as clinical study protocols, investigator brochures, clinical study reports, clinical sections of the common technical document, integrated summaries of efficacy and safety, briefing books, and regulatory responses. His prior experience in medical writing in India is with a large Indian IT company, and a large non-Indian pharmaceutical multinational company. Salil has a Bachelors’ in Human Biology and a Masters’ in Pharmacology and also studied toward his PhD in Cancer Biology.