Delay in approvals hurting drug development: Kiran Mazumdar

BRAINSTORMING: Biocon CMD Kiran Mazumdar-Shaw at a conference in Hyderabad on Wednesday. She is flanked by Executive Vice-President BIO Alan F. Eisenberg (left), Glenmark Pharmaceuticals Chairman and Managing Director Glenn Saldanha and Eli Lilly Executive Director (Global External Research and Development) Aaron Schact. Photo: Mohammed Yousuf

Undue delay in approvals for clinical trials is hurting the pharmaceutical and bio-technology sector and affecting the general process of drug discovery and development, Biocon Chairman and Managing Director Kiran Mazumdar-Shaw said here on Thursday.

There was need for the industry to engage constructively with the society and adequately inform the stakeholders.

It was important for the media to be properly informed of the processes associated with drug discovery and development, with particular reference to clinical trials, Ms. Mazumdar said on the sidelines of a two-day BIO India International Partnering conference that began on Wednesday.

Ms. Mazumdar said it was accepted that the next big economic growth in India after IT would be in the pharma, bio-pharma and bio-technology sectors and to ensure this, it was imperative that policy enablers were in place. Good regulatory support was a vital ingredient in the process, she added.

Earlier, Glenmark Pharmaceutical Chairman and Managing Director Glenn Saldanha said that with increasing costs of drug discovery, research partnerships with multinational companies were the way forward for Indian pharmaceutical companies.

The costs of approved drug development between 2005 and 2010 were about $2 billion, 50 per cent higher than they were between 1999 and 2004. “Big pharma companies here are looking beyond innovation to branded generics because of prohibitive costs,” he said, adding that alliances with Indian companies were going to be crucial for global companies.

Eli Lilly Executive Director Aaron Schact said contract research and manufacturing services and respect to global regulatory regime were strengths of Indian pharma companies.

BIO Executive Vice-President Alan Eisenberg said the bio-pharma industry in India had grown 25 per cent to $ 4 billion in 2010 and there was a huge potential.

Association of Biotechnology Led Enterprises President Vijay Chandru said that 60 per cent of the $4-billion industry's output came from bio-pharma companies.