In an indication of India’s growing importance as a clinical trial destination, multinational pharmaceutical firms are queuing up for approvals to test their new drugs here.

The global clinical research outsourcing market is projected to touch $23 billion by 2011, with consultancy firm KPMG estimating that India will corner 15 per cent of this in two years.

While the industry attributes this to the growing interest of pharma majors in emerging markets like India, some medical experts see “low cost” as the main attraction. They complain India’s regulatory mechanism is not ready to handle the rising number.

India allowed concurrent clinical trials (of the same drug in different locations across the world) four years ago. While the DCGI got around 100 applications for conducting such trials in 2005, this grew to 170 and 200 in 2006 and 2007, respectively. In 2008, the DCGI got over 350 applications. The applications cut across therapeutic areas and come from almost every significant global pharma firm.

CM Gulhati, a medical expert who edits the Monthly Index of Medical Specialities (MIMS), said the increasing number of clinical trials in India should be seen with the decreasing number of such trials in the US. “Data from the 20 largest US companies show that one third of all clinical trials (157 of 509) are being conducted outside the US. A majority of study sites are also outside the US,” he said.

Gulhati added cost is the key attraction for multinational firms. “In second-tier US hospitals, the cost of conducting a clinical trial is over $20,000 per subject, while the cost at a first-rate academic medical centre in India is $1,500 to $2,000 per subject,” he said.

“Clinical trials are an important element of drug research. It is the quality and ethical conduct of clinical trials that’s more important. The companies are eager to tap the emerging market opportunity,” said Ranjit Shahani, managing director, Novartis India.

DCGI Surinder Singh said the approvals were given over several years and steps were being taken to monitor these. “We are aware of the increasing number of clinical trial applications and have taken steps to ensure the ethical conduct of such trials. Registration of all clinical trials will be made mandatory from June. Similarly, there will be clinical trial audits to see if they are being carried out properly,” Singh said.

Gulhati disagrees. “In India, there is no law for investigators to declare conflict of interest; so, an investigator can be the beneficiary of funds and fully-paid-for foreign travel from a drug company and yet conduct clinical trials on the drugs of the sponsoring company.”

Supporting this view is data by the Indian Council for Medical Research) showing that less than 40 of over 250 medical college hospitals have functional ethics committees, he alleges.

Source: Business Standard
Date: 19 March 2009