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Patient Safety First But India’s ‘Interim Compensation’ Trial Rule May Spook Sponsors

 
• By Anju Ghangurde

India’s draft new drugs and clinical trials rules come with a prickly "no claims" clause pertaining to payment of “interim compensation” by sponsors in specific circumstances, based on an initial causality assessment by ethics committees (ECs). The new rules, at least in their current form, also give ECs near "quasi- regulatory powers" say some experts.

Clinical trial
INDIA'S TRIAL COMPENSATION RULES MAY PUT OFF SPONSORS

India’s draft New Drugs And Clinical Trials Rules 2018 includes several progressive measures aimed at ensuring time-bound regulatory approvals, but contentious norms around compensation payable towards serious adverse events (SAEs) during a clinical trial may put off sponsors, some industry experts say. Blanket medical management requirements for trial participants by sponsors is another key sticking point.

The draft new rules, currently in an advanced stage of consideration, stipulate that sponsors will need to pay an interim...

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More from India

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• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
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Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

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More from Asia

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Japan Reimburses 11 New Drugs But Slashes Price Of Others By Up To 20%

 
• By Lisa Takagi

Japan's NHI program continues to give and take as 11 new drugs are granted reimbursement, while the prices of others - including three ophthalmic therapies - are cut by up to 20% under a Market Expansion Repricing scheme.