Updated on 29 August 2013
India enacted several changes in its policies, in an attempt to bolster its clinical research sector. However, these policies seem to be doing more harm than good
Everything does not seem to be well in the pharmaceutical industry of Asia's third largest economy - India. Although the largest democracy of the world, which boasts of a population of 1.27 billion, has managed to acquire the status of being the world's foremost generic drug making powerhouse; the nation's drug research sector is yet to catch up. India's drug discovery experienced a boom much later than that of the generics boom, picking up momentum only during the later part of 2005 when the country relaxed restrictions on trials.
A look at the bigger picture, based on data tracking by the website www.clinicalresearch.gov, reveals that out of the 120,000 trials that are taking place in 178 countries, 90 percent are conducted in developed countries of North America and Western Europe. Meanwhile, less than 2,000 (2.20 percent) are being held in India as compared to 9,352 (2.83 percent) in China. Although India has 16 percent of the world's population and 20 percent of the global disease burden, yet only less than two percent of global trials are conducted in the Indian subcontinent. India's market share in this sector, as per global analysis, stands at 2.20 percent, while China accounts for 2.83 percent.
Despite this meager market share, India has attracted a lot of investments from global big pharma. This is mainly due to India's unrivaled genetic diversity, accompanied by other favorable factors for drug research such as, increasing and varied disease prevalence rates; availability of medical, pharmacy and science graduates; appropriate infrastructure facilities; comparative cost advantage and a lax regulatory framework.
Any company that plans to launch a new drug in the market would require a $1 billion investment. By outsourcing this work to developing nations, drug firms were able to reduce their research costs drastically. A clinical trial for a standard drug in the US can cost about $150 million, while the same drug tested in India would bring down costs by almost 60 percent. The factor of cost efficiency is one-of-the main reasons that has helped craft the success story of India's clinical research industry. Today more than 150,000 people in the country are involved in at least 1,600 clinical trials, conducted on behalf of British, American and European firms.
Despite witnessing a substantial growth over the last decade, the industry has seen a steady decline in the number of approved trials. As per statistics provided by the Clinical Trial Registry of India (CTRI), the number of approved clinical trials in India dropped from 500 in 2010 to 321 in 2011 and to 262 in 2012. This year, barely a few pending trials, where amendments were suggested previously, have been approved. So at a time when India should be applying its resources to pump in more investments in its pharmaceutical research and development (R&D) sector, which has since its inception promised great potential, the country is now re-looking its regulatory processes and in the melee driving business from the sector down to almost zilch.