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29 Mar 2019

Georgia Bio Industry E-Newsletter on Clinical Trials in India with Ms. Mithra Bindhu

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India makes up one-sixth of the world’s population and therefore has a large portion of the world’s health problems. Many pharma and biotech companies are looking to enter the Indian market and look at the potential of higher revenues based on 1.2 B people. They are conducting trials in India not just to recruit patients but also to market the products in India. In addition to pharma/biotechs, many NGOs like Gates foundation work on specific tropical diseases like Malaria, Leishmaniasis, Tuberculosis etc.

Indian Population is polygenetic and is an amazing amalgamation of various races and cultures. There are many diverse ethnic groups among the people of India. The 6 main ethnic groups are Negrito, Australoids, Mongoloids, Mediterranean or Dravidian, Western Brachycephals and Nordic Aryans. The Indian government has recently overhauled the approval process.

CDSCO is (https://cdsco.gov.in) similar to FDA in terms of role and regulatory oversight. There are more checks and balances that have been put in for certification of sites, ethics committees and limiting # of concurrent trials by a PI. All clinical trials are registered, and information is available online at http://ctri.nic.in . Introduction of Online SUGAM portal and periodic meetings of Subject Expert Committee meetings are making approvals easier and faster. Typcal approval time lines are 3-4 months. Overall - this translates to better a more predictable Clinical Trial conduct.



16 May 2014

Interview with Ms. Mithra Bindhu by Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader

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Mithra Bindhu is the founder and one of the principal investors of Asiatic Clinical Research, a CRO that is headquartered in India. Ed Miseta, Chief Editor, Outsourced Pharma and Clinical Leader spoke with her and the following are the highlights.

Asiatic caters to biotech and small- to medium-sized pharma companies in the U.S. and Europe. Asiatic's primary strength has been in helping companies to rescue clinical trials gone wrong. DCG(I), the regulator in India has recently made an attempt to overhaul the entire system for performing trials in India; the effort has taken too long and has made the system too complicated. However, the positive outcome of the regulatory overhaul is that patient compensation is clear, ethics committees are registered, doctors can conduct only three trials concurrently, and more.

The long term these changes will be good for both the industry and patients. The process to bring medicines to market can be quicker if trials can be more adaptive. Mithra believes several things can help to speed the process - arriving at a success/fail decision faster, reduction in time by using web based technology to capture data and reducing costs by integrating remote monitoring.



May 2010

Mumbai Angels invests in Asiatic Clinical Research

www.mumbaiangels.com
 
 
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