Approval timelines for clinical trial applications back to pre-Covid days

During pandemic, process was faster and nods for Covid-19 trials came in 30 days

Industry insiders feel that approval timelines for clinical trials in India have slipped back to the pre-pandemic days. During the pandemic, trial approval timelines had significantly improved by 30-40 per cent, claim industry insiders.

Speaking to Business Standard, Sanjay Vyas, Global SBU Head-Clinical Logistics and Global Safety Services, and Managing Director-India at Parexel, one of the largest clinical research organizations (CROs) in the world, says that in the last 12 months, around 110 clinical trial applications have been approved by the Indian regulator. Parexel is working on 30 clinical trials in India at the moment out of the 600-odd trials it is conducting worldwide. This is despite the fact that the CRO employs more than 6,000 people in India, or about 20 per cent of its global workforce.

 

Vyas says application timelines had seen a significant boost during the pandemic when real-time monitoring and a more decentralized approach was taken, including remote monitoring. Approvals for trials could then come in as fast as 30 days or so for Covid-19 studies and around 45 days for non-Covid-19 subjects.

Sanish Davis, President, Indian Society for Clinical Research (ISCR), agrees: “Regulatory timelines in India are long – up to 90 working days, or 4.5 calendar months. On top of this, there are ethics committee approval timelines too, which in India is around two-three months as against the global average of one-two months.”

He adds that when this is compared with another Asian country Malaysia, it has timelines of 30 days (for regulator’s nod to an application for clinical trial) and the ethics committee process runs parallel with this, and in around one-and-a-half months, the study is on the ground and going.

Davis and other industry insiders point out lack of manpower as an issue behind the regulatory delays. “In the US or EU, around 40-50 staff in the regulator’s office look after clinical trial approvals. That is not the case with the Central Drugs Standard Control Organisation (CDSCO),” Davis says, adding that timeline delays often force sponsors (pharmaceutical companies) to look for other geographies to conduct their trials.

An email sent to the CDSCO on this matter went unanswered.

However, a November 2023 study on the CRO sector in India conducted by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, had noted that regulatory delays are indeed a challenge. “Regulatory timelines for clinical trials in India are a non-starter for foreign companies exploring India as a destination for clinical trials in the recent past. Delays in the approval process for clinical trials and drug development have significantly impacted the CRO industry,” the report said.

The study also added that regulatory reforms after 2013 and the introduction of New Drugs and Clinical Trial Rules of 2019 have partially streamlined the approval processes. In addition, some other initiatives like Audio Visual consenting of patients, Ethics Committee registration, new compensation law and robust scrutiny system for clinical trial applications have been implemented.

On their part, CROs are engaging with the government to allow more Phase-1 clinical trials in India. Phase-1 trials test the safety and dosage of the drug in humans.

Davis adds that often subject expert committees ask for Phase-1 trial data before they give nod to conduct a clinical trial here.

Global CROs are still bullish on India, which roughly accounts for 4 per cent of global clinical trials but contributes upwards of 15 per cent to the global burden of most high-prevalent diseases.

Vyas says as such the cost of conducting clinical trials in India is 35 per cent cheaper than global sites (including investigator payments, etc.). But CRO industry insiders do feel that cost is not the major determining factor in bringing a trial to India, while speed is.

“Each day of delay in starting a trial results in loss of hundreds of thousands of dollars in potential revenue,” says the promoter of a clinical research outfit, who has worked for more than two decades in various global CROs. “India is also not the biggest market for patented drugs, and hence several sponsors would think twice before bringing in their trials to India. Companies are coming to India for diversity and quality of doctors,” he adds.

Davis says long timelines resulted in India losing the opportunity of getting the stalled clinical trials in Russia here. At least a couple of hundred trials that were happening in Russia went to European sites after the geopolitical tension broke out.

CROs like Parexel are nonetheless expanding their network in India – it has 800 site alliance partners here and is working with over 240 hospitals.

The CRO sector in India is expected to touch $2.5 billion by 2030 and thus represents a huge opportunity.

Moving slow
 

During pandemic, the process became faster and approvals for Covid-19 trials often came in 30 days

For non-Covid trials, approvals took 45 days during the pandemic

Approvals now take 90 working days, or 4.5 calendar months