Hyderabad: Expressing concerns over the bureaucratic bottlenecks involved in conducting clinical research and trials in biotechnology sector in India, the industry experts on Wednesday appealed to the regulatory authorities to stick to the “rule book” rather than “subjectivity”.
According to Kiran Mazumdar Shaw, chairman and managing director of Biocon, the delays and repeated approvals involving clinical trials are hurting the industry in terms of investment overruns and time.
“The way the trial approvals are given, it does not mirror what is happening in other parts of the world. For every protocol change, we need to seek new approval. So as a result trial which requires x amount and time is going up by three to four times. Many companies feel that it is not optimal to do these studies in India because time is money,” Shaw told media persons here.
She was speaking on the sidelines of the second annual meeting of the US and Indian Biotechnology industry heads at the BIO India International here.
Shaw said the trend was a big concern for the industry and the regulatory authorities need to go by the rules rather than subjectivity.
“Suddenly some NGO makes an issue and the authorities go by that,” she added.
“This puts lot of question marks. We are doing things as per regulation and ethical standards as expected of us. But there is no reciprocity from the regulatory authorities when it comes to things when there are issues then they go by subjectivity,” Shaw said.
Asserting that the future economic growth will stem from the biotechnology industry next to IT and Pharma, she said the country has basic ingredients to make this happen.
The delegates agreed upon that lack of clarity and consistency in clinical trials and regulations is a significant barrier to research and development, commercialisation and investment for both innovative and generic medicines in India, which in turn impacts the availability of important therapies for patients.