* Clinical trials using Gardasil and Cervarix Human Papilloma Virus (HPV) vaccines are abruptly stopped by the government in April this year after the deaths of six tribal girls in Andhra Pradesh and Gujarat

* An infant in Bangalore, who had a pre-existing cardiac disorder, died during a clinical trial for an advanced pneumonia vaccine by US drug maker Wyeth in November 2008

* The All India Institute of Medical Sciences (AIIMS) paediatrics department in New Delhi conducted 42 sets of clinical trials on 4,142 babies since January 1, 2006. As many as 49 babies died during the trial period spanning two-and-a-half years.

India might be emerging as one of the most sought-after destinations for global pharmaceutical companies to move their key clinical trials and data management here, but the harsh reality of this drug business is difficult to ignore. Deaths during clinical trials are increasing at a rapid pace in the country. As many as 310 persons died in 2009, while 270 persons succumbed to faulty trials in 2008. In 2007 too, as many as 150 persons fell victims due to several trials conducted in the country, claim non-governmental organisations (NGOs) and human rights groups as they assert that the numbers are much higher and it is only when deaths occur that such instances of trials come under public scrutiny. However, there is a silver lining for the industry to improve its image in the global markets if it follows the regulations.

More than 650 clinical trials are currently taking place in the country and all the leading global pharmaceutical companies such as Astra Zeneca, BMS, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer and Sanofi Aventis have started moving their key trials to India. India has a large number of patients in ?currently? hot areas for clinical research, like diabetes, cardiovascular disease, HIV and oncology.

It is obvious that the staff at Central Drugs Standard Control Organisation (CDSCO), has a tricky task at hand?to bring in transparency and accountability. The global clinical

research market is pegged at around $20 billion with India?s share being about $485 million. The latter is projected to cross the $1 billion mark by 2015, estimates Frost & Sullivan. Clinical trials are needed and new medicines are imperative, but more than the investment that would come in, the bigger task at hand is to ensure safety of volunteers and generate quality data.

Drug Controller General of India (DCGI) Surinder Singh says, ?We want to establish a robust and dynamic mechanism for clinical trials. Soon, we will be dividing the country into zones to conduct audits of all sites where clinical trials are being conducted. We will also check whether clinical trial sites have the standard infrastructure to ensure volunteer safety.?

With transparency a major issue in the clinical trials industry, DCGI has firmed up plans to issue guidelines for regulation of clinical trials, approve ethics committees and lay down norms for sites where clinical trials would be conducted in an efficient and transparent manner. Regular inspections of trial sites is high on the agenda. Accordingly, the Indian drug regulator?s special teams comprising drug inspectors, pharmacologists and clinical trials experts will carry out the onsite inspections to make sure that norms are adhered to. They plan to cancel or suspend the license for trials if discrepancies are found during the trial phase. Drug inspectors are expected to audit the trial sites in Bangalore, Mumbai, New Delhi, Hyderabad, Kolkata and Chennai to checkwhether mandated protocols while conducting trials are being adheredto.

Since June last year, the government has made it mandatory for all clinical trials to be registered with the drug regulatory authority. DCGI has brought a notification to this effect informing the applicants to register the trial in Clinical Trial Registry, India (CTRI) before initiating the trial process. Healthcare analysts feel that CTRI has many advantages as it gives an up-to-date information about the number of trials happening in India, along with the sites. It acts as a one-stop shop for those seeking information about clinical trials in the country.

Suven Lifesciences chairman Venkat Jasti says, ?Making registration mandatory will bring in those un-listed companies under scanner which were the root cause for damaging the clinical trials industry. The accountability factor increases and ethics in the entire trial processes will be adhered to. This would bring in fair processes in the auditing procedures of the companies.?

Washington-based Association of Clinical Research Organisations (ACRO), representing world?s leading clinical research organisations (CROs), feels there is significant potential to accelerate the growth of clinical research in India provided the regulatory environment is simplified paving way for faster clearances. John J Lewis, vice-president of public affairs, ACRO, says, ?In the US, the term ?outsourcing? is generally viewed negatively, especially when applied to the manufacturing sector where American jobs are being lost. Outsourcing of clinical research, however, is purely about efficiency. Drug development is a global enterprise so the research that is being conducted in India, or elsewhere, would not necessarily be conducted in the US. Accessing a global population for research, and a global network of well-trained physician investigators, is critical to drug development.?

He adds: ?We believe Asia Pacific region, and China and India have immense scope to grow in clinical research. However, the time for clearances needs to be brought down.

The other issue of focus is on the need to protect intellectual property of companies, which is acquired after years of research. Some companies have expressed concern over data protection in India as opposed to China. The government control is strong in China and penalties are very severe and there is less concern over data leak.?

While the clinical trials market in India has grown rapidly over the past few years, the growth saw a slowdown last year due to the confusion surrounding the regulatory system. Lewis insists that while India is the best place to conduct such trials because of the very high quality of research available, other countries including China are taking big strides towards dominating the clinical trials market.

The recent challenge of the global recession and its financial implications on the clinical research industry cannot be ignored. Besides the fact that the US market recovery is taking time, the recent news from Europe is also not encouraging. From the clinical market research perspective however, this recessionary trend will put further pressure on global pharmaceutical companies thus compelling them to outsource more to emerging markets and countries like India. While Indian CROs are poised to gain in terms of increment work coming their way, good news is that the government is bringing in accountability and transparency into the controversial yet highly lucrative clinical trails market.