The Union health minister Ghulam Nabi Azad has expressed concern over the image of the Indian pharma manufacturing sector following the prohibition by the US FDA on drugs of certain companies in the country. He was also equally anxious about the clinical trial sector which has not been able to conduct any human studies for over the last one year.
“It is also gathered that there is a lurking fear among the developed countries including the US on India’s capability in development of the pharmaceuticals which could have led to a slew of bans and 483 warning letters,” Azad told Pharmabiz.
In the case of the pharma manufacturers being hauled by the US FDA it was a serious implication and was a not the right thing to happen. “My ministry is working to ensure that such a thing does not happen,” said Azad who was in Bengaluru for the Baxter Global Research Centre opening at the Syngene block in the Biocon Park.
“In the case of clinical trials, what we need to do is to strike a balance between the regulatory authority apprehensions and the industry concerns. While we are happy on the 15 of the 30 proposals of the Prof. Ranjit Roy Chaudhury Expert Committee and are now presently issuing the norms for the clinical trials sector the industry is still seen to be discontented,” he said.
“It is a fact that India which was once the base for conducting clinical trials, more than half of this business has been come down. Many Indian companies are looking to conduct clinical trials abroad and this is a serious apprehension. My ministry is doing all it can to revive the Indian clinical trials industry. All that can be stated now is that the new clinical trials norms are in the interest of the country and there is need to care for the patient when he undergoes a such a study,” Azad said.
Therefore the ministry of health and family welfare is now looking to ensure that innovation of drugs and devices will not be hindered. We need to make certain that no company could fall short of permissions to conduct clinical trials and prevent industry from going abroad for human studies, stated Azad.