Biocon chief outlines path to global recognition

Streamlining the regulatory mechanism for approval of biotech products and enhancing industry-academia research linkages will put India on a global biotechnology map, Kiran Mazumdar Shaw, CMD of Biocon Group, said at a press meet on Wednesday.

"The policies are not directed at viewing the global dimension of biotechnology. The regulatory procedure is such that an industry is made to approach multiple agencies for clearance of any product, which leads to a lot of time being spent before commercialisation," she said.

"There should be one body for approval and all agencies should have a defined role with a time-bound approach," she said.

Shaw stressed that there is a strong need for dynamic interface between scientists at academic laboratories and researchers within the industry.

"India has to develop its own financial and granting models to encourage linkages between industry and academia," she said.

India must formulate incentivised plan where scientists must be encouraged to create and market their intellectual property with an entreprenuerial aspirations, she said.

Reacting to a controversy related to approval of clinical trials of a pharmaceutical product produced by her company based on recombinant technology, she claimed that clinical trials had been approved by the drug controller.

Since there is no clarity on regulatory mechanism, the genetic engineering approval committee (GEAC), a body that clears genetically modified products into the environment, had come into the picture, she said.

GEAC approval is needed only for release of living GM products, she said adding clinical trials for a recombinant product, which is a dead protein, do not need its approval.