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Five Key Indian Trial Regulation Play-Outs For 2016

 
• By Anju Ghangurde

India's clinical trial approval numbers may still be well short of the heady years of 2010-12, but the implementation of a set of crucial trial-related regulations and potential tweaks in others are expected to help bring some momentum back to the sector in 2016.

Top officials of the Indian Society for Clinical Research (ISCR), whose members include several large multinational firms and clinical research organizations, have highlighted the responsiveness of the Indian regulator and government towards facilitating quality clinical trials – the only way new treatments options can be made available to Indian patients at the earliest.

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More from India

US Tariffs And Manufacturing Concentration: Double-Edged Sword?

 
• By Anju Ghangurde

India and the US are the major manufacturers of finished dosages for the US market in terms of volume (China accounts for 9% of injectables), though the US relies heavily on India for solid oral dosage forms and specific generics, including lenalidomide and albuterol. Scrip talks to experts on some of the key implications of geographic concentration of production for the US market amid the specter of tariffs.

What Is Fuelling Cell And Gene Therapies In India?

 
• By Vibha Ravi

Bharat Biotech is the latest entrant in India’s cell and gene therapy space, joining majors like Intas Pharma, Sun Pharma, Cipla and Dr. Reddy’s. An indigenously developed CAR-T cell therapy launched last year, what is driving growing interest and success in cell and gene therapies?

Trump Tariffs – Indian Pharma Dodges Bullet, But Sword Still Hangs?

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms and the US consumer are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

How Big Pharma Is Redefining, Scaling India GCCs Amid Tech Advances

 
• By Anju Ghangurde

Senior executives from AstraZeneca, BMS, Novo Nordisk, Takeda and Regeneron outline how big pharma's global capability centers (GCCs) in India are evolving beyond cost efficiency, focusing on innovation, “agile experimentation” and new technology including GenAI, virtual & augmented reality, with some positioned as COEs. Will Indian multinationals use the GCC approach?

More from Focus On Asia

China Deal-Making Matures As Foreign Partners Derisk Asset Acquisition

 
• By Xu Hu

Chinese biopharma companies’ alliance strategies are transitioning from immediate cash needs to more strategic management of portfolios, as MNCs continue to hunt for derisked assets.

Vocal For ‘Glocal’: How Menarini Is Adapting To Outperform In The Asia Pacific

 
• By Anju Ghangurde

Menarini's Asia-Pacific CEO talks to Scrip about how the Italian group is tailoring its portfolio and pricing approach to local markets making strong strides in primary care and consumer health, while also charting a distinct path in rare diseases and oncology. The China market is also a key focus including as a potential source of innovation as is partnering, where the group has a rich history.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.