New Delhi: Biocon, an Indian company dedicated to develop drugs for India is trapped in a state of perplexity. Indian authorities have ordered Biocon to move its projects out of India and to conduct them further in US and Europe.
Now, these cumbersome steps will not only double their problems but expenses too.
It is estimated that if they shift their tests to US, Europe then their estimated cost will increase by 10-20 times.
Due to this forceful decision imposed by Indian authorities, the company has delayed its various drug development projects as well.
A spokesperson of Biocon said, there have been a set of challenges, amid which they have completed clinical studies for Itolizumab, already been launched in India.
However, their ongoing research programme, including their oral insulin (IN-105) programme, are taking a much longer time than anticipated. This adds to the cost of development.
Moreover the company is facing challenges for conducting clinical trials with Indian patients for the development of a vaccine along with US-based Advaxis to treat human papillomavirus-associated cervical cancer in women also.
The basic problem rising in their testing is that it can use the low-cost advantage to conduct clinical trials in India to develop drugs that can be sold in the country.
Still Biocon will have to conduct few tests in India to ascertain compliance with the variance in the gene pool.
This has not been the first time that any company has been forced to leave the country for such trials.
In the past two years, companies like Piramal Enterprises and Lupin were forced to go abroad for conducting clinical trials, as the approval process became very slow and uncertain with the matter being challenged in court.
The process of conducting clinical trials in India has become more stringent after the Supreme Court pronounce its guidelines and making companies liable for the death or injury caused to any human trial subject.
