Inordinate delays and ‘subjectivity' in the drug approval process, besides lack of clarity in regulations governing clinical trials are hurting pharma companies in India, according to participants at the BioIndia International conference.

Briefing newspersons on the outcome of the US-India industry dialogue on the first day of the conference which began here today, Ms Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Ltd, said the industry was now considering conducting trials outside India.

“The time taken from filing an IND (investigational new drug) to conducting clinical trails is three to four times longer than what it is in developed countries,'' she said.

On an average the time taken by the Drug Controller General of India (DCGI) to grant approval ranged from three months to one year, while in the US approval was normally given in 30 days, she added.

Mr Glenn Saldanha, CMD of Glenmark Pharmaceuticals Ltd, said the delay was due to the lack of robust systems and the challenges being faced by DCGI in terms of manpower and expertise.

Mr Vijay Chandru, Chief Executive Officer, Strand Life Sciences, said the industry was submitting a representation to the Government to speed up the approval process.

(This article was published on September 21, 2011)
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