Health care partner Mark Barnes lends his insight to an article published by FDANews’ Drug Industry Daily on Jan. 6 concerning draft legislation proposed in India that would expose investigators to the risk of jail time for certain violations.
Speaking on the likelihood of the legislation passing, Mr. Barnes suggests that this legislation stands a better chance than past efforts as it enjoys the support of India’s majority party. Mr. Barnes also notes that, should the legislation pass, drug makers are likely to struggle to find top-tier investigators willing to assume the risk of conducting trials in India and adds that India’s clinical trial regulations are “complex and ambiguous.”
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