The Indian pharmaceutical industry is expected to reach $20 billion by 2015, which would make it one of the world's top 10 pharmaceuticals markets, according to the Associated Chambers of Commerce and Industry in India.

The group also said India's clinical trials business will reach approximately $1 billion in 2011, further solidifying the subcontinent as a preferred destination for clinical trials. This increase has spurred the need to address all aspects of pharmacovigilance, to ensure delivering medical advances to patients quickly and efficiently while protecting public health.

In July 2010, India’s Ministry of Health and Family Welfare (MOHFW) launched a complete roadmap for pharmacovigilance under the Pharmacovigilance Programme of India (PvPI). The goal has been to provide safer medicines for the Indian population.

But the program faces many challenges. "The sheer number of patients in India is quite sizeable and the issues sometimes conflict between the need to provide access to medicines versus the need to provide safer medicines," said Dr. Y.K. Gupta, National Coordinator of PvPI.