Red tapism hurting India's biotech industry: Biocon

Expressing concerns over bureaucratic hurdles in conducting clinical research and trials in India, Biocon today said they are leading to time and cost over-runs, hurting the biotechnology industry.

It appealed to the regulatory authorities to stick to the "rule book" rather than go by "subjectivity".

Delays and repeated approvals involved in clinical trials are hurting investments in the industry and leading to time over-runs for crucial projects, said Biocon Chairman and Managing Director Kiran Mazumdar Shaw.

"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," Mazumdar said.

"Many companies feel that it is not optimal to do these studies in India because time is money," she added.

Mazumdar was speaking on the sidelines of the second annual meeting of the US and Indian biotechnology industry heads at the BIO India International.

Shaw said such issues are a big concern for the industry and the regulatory authorities need to go by the rules rather than their subjectivity.

"Suddenly some NGO makes an issue and the authorities go by that," she added.

"This puts a 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.

Various delegates also said that the lack of clarity and consistency in clinical trials and regulations was a big barrier to R&D, commercialisation and investment for both innovative and generic medicines in India.

This, in turn, impacts the availability of important therapies for patients, they added.