India is not sending the right signals to the global market going by the poor handling of clinical trials and suspension of pioglitazone, said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.
The country has messed up both these issues and left the industry in the lurch. These are absurd ways of working and shows lack of robustness in the regulatory functioning of the country. To begin with, the whole issue of clinical trials in India is murky and no company is clear on the direction it should take. The drug regulatory authority has now clearing the human studies based on case-by-case basis. This is illogical and is delaying all the plans of established companies which have adhered to stringent norms in conducting human studies, Shaw, told Pharmabiz in a telecon post the Q1 results of the company.
The biotech industry is facing considerable external challenges and unless the government acts now it is going to be difficult. Now take the case of the pioglitazone suspension, it was a knee jerk reaction and the decision was taken without taking an opinion of experts. This is illogical and unreasonable. In fact, it is seen as a most unscientific method of operation which has impacted the image of the industry and country. In the end it is the patient who is the ultimate sufferer and his doctor who is left to handle the problem. Pioglitazone for Biocon is not a major revenue earner in our diabetic portfolio like it is a major brand for other companies. Therefore those who have misled the regulatory authority about the side- effects of pioglitazone cannot be merely be permitted to go scot-free, Shaw said.