India Trials And Tribulations: J&J, IQVIA Execs Offer Potential Solutions

Real and perceived barriers have bogged down the Indian clinical trials segment. Senior leaders of J&J, IQVIA and 5AM Ventures say many COVID adaptations should be codified, while a member of India’s NITI Aayog indicates an openness to find solutions to some pain points.

Clinical trials in India
What can help India realize its potential as a venue for clinical trials? • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

A cross-section of biopharma experts deliberated at a recent summit what’s holding back foreign sponsor interest in clinical trials in India and sought to address some of the “hurdles” and “perceptions” that are currently weighing things down.

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Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

US Tariffs: With 50% Of US Generics From India, Industry Ponders If MAHA Will Trump MAGA

 
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US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.

What India’s Digital Personal Data Protection Norms May Mean For Clinical Trials, Big Pharma GCCs

 

Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader talk about compliance requirements that pharma and global capability centers may need to consider as India strengthens the framework for the protection of digital personal data.

Why Big Pharma Will Continue To Choose India For Clinical Research In 2025

 
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Faster approvals and regulatory flexibility are among moves India has made to draw clinical trial investments. As MNCs seek to replace products close to patent expiry with new blockbusters and domestic companies tap unmet needs, how will the R&D landscape shape up in 2025?

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China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
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The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.

Japan Recommends Beyonttra, Raises Enhertu Price

 
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.

Japan PM Delays Revision Of High-Cost Healthcare Benefit After Patient Protests

 
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A plan to reduce benefits under Japan's financial safety net for patients contributing to the costs of their long-term medical care is being reconsidered by the government following protests from patient and doctor groups.