Financial Daily from THE HINDU group of publications
Tuesday, Oct 25, 2005
Financial Daily from THE HINDU group of publications Tuesday, Oct 25, 2005 |
|
|
|
|
|
|
|
Industry & Economy
-
Pharmaceuticals Experts pool soon for evaluation of clinical R&D data Our Bureau
Hyderabad , Oct. 24 THE Union Government has decided to create a pool of experts that can be put into use for outsourcing for evaluation of clinical research data. According to Mr Ashwani Kumar, Drug Controller General of India, the capacities to evaluate and conduct inspections are two of the major regulatory challenges as the clinical trials activity increases in the country. Data confidentiality was another, he said. He was speaking on the `Emerging regulatory scenario on clinical trials in India' at a national discussion on `Building and managing clinical trial capacity in India - Challenges in ethics, equity and efficiency' here. It was organised by the Administrative Staff College of India (ASCI), the Indian Council of Medical Research (ICMR) and Fordham University (the US). Mr Ashwani Kumar said that it was difficult for the Government to create a pool on its own. "We have decided to rope in scientists and experts from various sectors and create a base to take care of the evaluation needs," he said. He told reporters later that the regulator would examine the issue of publishing protocols of the trials. "We will have our own system," he said. Dr Dhananjay Bakhle, of the Organisation of Pharmaceutical Producers of India, said India had both advantages and disadvantages in clinical research. The increasing number of CROs (clinical research organisations) in non-metros and the relative ease of patient recruitment were some of the advantages. Site infrastructure, data quality and subject protection were issues of major concern that worked against India. Adequate monitoring and an effective mechanism to document everything would prove to be effective solutions.
Article E-Mail :: Comment :: Syndication :: Printer Friendly Page
|
Stories in this Section |
|
The Hindu Group: Home | About Us | Copyright | Archives | Contacts | Subscription Group Sites: The Hindu | Business Line | The Sportstar | Frontline | The Hindu eBooks | The Hindu Images | Home |
Copyright © 2005, The
Hindu Business Line. Republication or redissemination of the contents of
this screen are expressly prohibited without the written consent of
The Hindu Business Line
|
