Approval dates for clinical trial submissions dating back to pre-Covid

By Consultants Review Team Tuesday, 18 June 2024

Industry insiders believe that approval timelines for clinical trials in India have returned to pre-pandemic levels. During the epidemic, trial approval timelines improved by 30-40%, according to industry sources.

According to credible sources, such as Sanjay Vyas, Global SBU Head-Clinical Logistics and Global Safety Services, and Managing Director-India at Parexel, one of the world's largest clinical research organizations (CROs), the Indian regulator has approved approximately 110 clinical trial applications in the last year. Parexel is now working on 30 clinical trials in India as part of its 600-odd projects worldwide. This is despite the fact that the CRO employs over 6,000 individuals in India, accounting for almost 20% of its global workforce. 

According to Vyas, application timelines improved significantly during the pandemic as real-time monitoring and a more decentralized strategy, including remote monitoring, were implemented. Approvals for trials could be granted in as little as 30 days for Covid-19 studies and 45 days for non-Covid-19 patients.

Sanish Davis, President of the Indian Society for Clinical Research (ISCR), agrees: "Regulatory timescales in India are protracted, up to 90 working days, or 4.5 calendar months. Furthermore, there are clearance timelines for ethical committees, which in India range between two and three months, compared to the global average of one to two months. 

He adds that when compared to another Asian country, Malaysia, the timescales are 30 days (for the regulator's approval of a clinical trial application) and the ethics committee process proceeds concurrently, and the study is up and running in around one and a half months.

Davis and other industry insiders blame lack of manpower for regulatory delays. "at the United States or the European Union, clinical trial approvals are handled by approximately 40-50 staff members at the regulator's office. That is not the case with the Central Drugs Standard Control Organization (CDSCO)," Davis notes, adding that timeline delays frequently cause sponsors (pharmaceutical corporations) to hunt for alternative locations to conduct their trials.

An email to the CDSCO regarding this Matter Went Unanswered

However, a November 2023 assessment on the CRO sector in India undertaken by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, found that regulatory delays are a concern. "Regulatory deadlines for clinical trials in India have been a non-starter for international companies looking to conduct clinical trials in India in recent years. The research stated that delays in the approval procedure for clinical trials and drug development have had a substantial impact on the CRO industry. 

The report also stated that regulatory improvements implemented after 2013 and the New Drugs and Clinical Trial Rules of 2019 had partially expedited the approval processes. In addition, other initiatives such as audiovisual consent for patients, ethics committee registration, a new compensation law, and a comprehensive scrutiny mechanism for clinical trial applications have been introduced.

CROs, for their part, are working with the government to approve more Phase I clinical trials in India. Phase 1 trials evaluate the drug's safety and dose in humans.

Davis adds that topic expert committees frequently request Phase-1 trial results before agreeing to launch a clinical trial here.

Worldwide CROs remain optimistic about India, which accounts for only 4% of worldwide clinical trials but contributes up to 15% of the global burden of most high-prevalence diseases.

According to Vyas, running clinical trials in India costs 35% less than in other countries (including investigator fees). But CRO industry insiders do say that cost is not the key determining factor in bringing a study to India, although 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 company, who has worked for more than two decades in several worldwide 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 the diversity and quality of doctors," he says.

Davis claims that due to protracted delays, India missed out on the potential to bring the stalled clinical studies in Russia to India. After geopolitical tensions erupted, at least a couple of hundred trials from Russia were relocated to European sites. 

CROs such as Parexel continue to grow their network in India, where they have 800 site alliance partners and operate with over 240 hospitals.

The CRO business in India is estimated to reach $2.5 billion by 2030, presenting a significant opportunity.

Moving Slowly

During pandemic, the process got speedier and clearance for Covid-19 studies generally came in 30 days

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

Approvals now take 90 working days, or 4.5 calendar months 

Current Issue