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‘Drug approvals in India drop 11-fold in 2013’

Clinical trials drop to 19 from 500 in 2011

Ahmedabad |
Updated: February 5, 2014 6:07:04 pm

Controversies surrounding clinical trials has put a stranglehold on the number of new drug discoveries in India. Only 23 new drugs were approved in India in 2013, which is a 11-fold drop compared to the 2008 figures, said Y K Gupta, professor and head of Department of Pharmacology at All India Institute of Medical Sciences (AIIMS), New Delhi.

“About three years ago, India was considered to be a global clinical trial hub. However, the number of clinical trials has dropped sharply from 500 in 2011 to 19 in 2013,” said Gupta, while delivering a keynote address at an international conference organised by the Institute of Pharmacy at Nirma University on Thursday.

Drug companies were drawn to India for several reasons — a technically competent workforce, patient availability and low costs. However, the booming clinical trial industry in the country has been pushed to the second position by China, said Gupta, who specialises in clinical pharmacology and drug development, and is also the National Scientific Coordinator, Pharmacovigilance Programme of India, Union Ministry of Health & Family Welfare.

“Clinical research has come to a standstill. The pipeline of new drugs have almost dried-up, because the approval process has become much more stringent. In 2013, only 23 new drugs were approved; in 2008 the number was 270 ,” Gupta said, adding that the fast eroding confidence in clinical research institutes in the past three years have taken a toll.

The laws surrounding clinical trials have also been tightened. Without sharing the number of adverse events or deaths that have occurred due to such trials in the country, Gupta said clinical research organisations should understand the changing regulatory scenario where “ethico-regulatory environment” in the country stands changed.

Gupta said 600 registered ethical committees in charge of approving and monitoring the clinical trial process across the country will now be given a formal training. “This was decided at a meeting held three days ago,” he added.

He also told the gathering that compensation for people who opt to be part of clinical trials has been raised, and varies between Rs 4 lakh to Rs 73.60 lakh.

Another speaker at the conference, Dr Sourav Pal, the director of Pune-based National Chemical Laboratory (NCL), observed that Phase-I and Phase-II drug trials were not taking place in India anymore, and that multinational drug companies opted the country only for human trials.

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