Friday, July 11, 2014

Clinical regulatory challenges in India

India is an ideal place for clinical trials for many reasons.  However, there are many regulatory hurdles that companies face when considering going into the country to start their trials.  Pharma Focus Asia recently broke down a few of the issues they see in terms of regulatory challenges in the country:

  • - Shortage of regulatory experts: While there are regulatory documents, the country does not release guidance to help the professionals interpret the documents.  Experts often come to multiple conclusions about the guidances.
  • -There is a difference between Indian GCP and ICH-GCP.  India has specific rules including consent procedures, compensation for participation, as well as the roles and responsibilities of foreign sponsors conducting clinical trials in India.
  • -Phase 1 studies can not be conducted in India if the research on the medication has not been done within the country
Throughout the article, they also look at the challenges of the ethics committees, the liabilities of clinical trials (whether they lay on the sponsor or the CRO), access to drugs for the patients after the clinical trial, and no acts or laws to monitor clinical trial progress in the country.

Regulatory challenges follow clinical trials wherever they go.  This fall at the Partnerships in Clinical Trials Asia event, regulators from Vietnam, India, Malaysia and Nigeria will join us for the panel Global Regulatory Updates for Clinical Trials to share insights on their countries and discuss topics such as the different regulatory standards, international standards, ethical and cultural diversity issues and more.  Find out more about this session by downloading the agenda.  If you'd like to join us September 16-18 in Shanghai, as a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate.

What is your company's biggest challenge when it comes to facing different regulatory rules across different countries when conducting clinical trials?




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