Union health minister Ghulam Nabi Azad on Wednesday said that there is a need to strike balance between the interests of all the stakeholders with regard to the country?s regulatory policy on clinical trials, noting that innovation should be encouraged. Pharma firms have complained that India’s new regulations for clinical trials were too stringent and some of them are in the process of moving trials overseas despite the higher costs involved.
?The industry feels that the regulations that we have made are too difficult. But there had been complaints from parliamentarians, from NGOs, and the Supreme Court had taken notice. I think what we need to do is to strike a balance between the two,? Azad told reporters after inaugurating the Baxter Global Research Centre set up in Bangalore in collaboration with Biocon, the country’s largest biotechnology company. Biocon is one among those wanting to take some of its trials abroad.
While Azad said that the health ministry was satisfied with the new regulatory regime, he felt that the industry’s viewpoints also ought to be accommodated. ?What we are hearing from the industry is that the number of clinical trials which were taking place has dropped to more than half. While we are happy that the new dispensation is in the interests of the country and the patients on whom trials were taking place, at the same time we should also see that new innovations should come and the whole industry should not fall short of holding clinical trials,? Azad said.
?Having gone through the observations made by the SC, NGOs and parliamentarians, we have done our bit. But at the same time, I think we will have to accommodate the viewpoint of the industry also,? he added.
