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

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...

More from India

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 

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

 

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By 

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

More from Asia

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By 

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By 

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.

Citeline Japan Awards 2025 - Enter Now!

 

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get your submissions in by this date. Sponsorship opportunities and tables for the event are also available.