India Drug Trials Lag

One of the reasons that many drug companies set up operations in India is the cheap cost of drug trials. Some reports say that developing and testing a drug in India can cost as low as 1/20 the cost of running the same drug trials in advanced economies such as the United States or European Union.

But India’s economy is also growing, and the state is starting to impose more regulations on the drug industry. There have been reports of drug companies tricking patients into participating in trials, as well as patients in those trials suffering illness or unwanted side-effects as the result of taking untested drugs. Now that the state has increased regulations, initiating new restrictions and issuing warnings to several companies, drug trials performed by many pharmaceutical companies have lagged behind schedule.

The added costs of drug testing and development have made many companies start to rethink India as a location for cheap drug trials. One example is Biocon’s oral insulin drug trials, which have suffered setbacks and lengthy delays under new Indian regulation. Reports say that the company believes some of the regulation was put in place to “force” the company to take up drug development outside of the country.

Some of the regulations now include passage by a government committee and the use of government hospitals to perform testing and procedures, along with the taped consent of each patient taking part in the study. Like Biocon, other drug companies are unhappy. Pharmaceutical executive Shoibal Mukherjee called the restrictions “irrational,” and the head of PricewaterhouseCoopers said that the added time and cost of studies meant patients were being denied lifesaving drugs when they need them.

Source:

http://blogs.wsj.com/indiarealtime/2014/01/28/new-restrictions-stall-drug-trials-in-india/