India must revise its clinical trial regulations to capture a larger share of the global clinical research market, taking cues from countries like China and Australia, according to healthcare experts at the BioAsia conference in Telangana.
India’s Global Position in Clinical Trials
As of 2022, India accounted for just 8% of global clinical trials, compared to China’s 29%, the U.S.’s 25%, and 38% for the rest of the world, according to PwC data. Experts argue that simplified regulations, faster approvals, and financial incentives could significantly improve India’s standing in the industry.
“There’s a lot to learn from what other countries have done to make them clinical trial destinations,” said Smruthi Suryaprakash, Partner at BCG India. She noted that China’s regulatory reforms led to increased innovation, while Australia’s tax incentives have made it a preferred clinical trial hub.
India’s Expanding Clinical Research Market
India’s clinical trials sector is expanding rapidly, driven by cost-effective research, a diverse patient base, and a strong hospital network. GrandView Research estimates that India’s clinical trial market revenues could exceed $2 billion by 2030.
However, experts highlight that speed is crucial to attract more trials.
“India will be able to capture the clinical trial market if we can really work on the speed. Sponsors want faster approvals from regulators and quicker patient recruitment,” Suryaprakash added.
Regulatory Efforts to Improve Trial Approvals
India’s Drugs Controller General, Rajeev Raghuvanshi, acknowledged that the government is working to streamline clinical trial approvals based on industry feedback.
“We have aligned things every year on average for the last three years,” he stated, emphasizing that the revamped 2019 trial regulations have resulted in about 160 trial approvals in the past three years.
Improving Patient Recruitment in India
A key challenge in India is raising patient awareness about ongoing trials. Experts suggested allowing trial sponsors to advertise experimental studies, a practice already followed in countries like the U.S. and U.K..
“Patients are often unaware that these trials exist, making recruitment difficult,” said Padmaja Lokireddy, oncologist at Apollo Hospitals. This is particularly critical for rare disease patients, who often have limited treatment options.
Also read: India’s CRDMO Sector Demands Regulatory Relief
Challenges in Clinical Trial Infrastructure
Other experts pointed out additional hurdles, including:
- Preparing trial sites to meet global safety standards.
- Ensuring patient eligibility and proper recruitment.
- Strengthening regulatory compliance for global trials.
With policy revisions, better patient outreach, and improved site readiness, India has the potential to position itself as a global leader in clinical research, accelerating the development of new therapies and life-saving treatments.
(This article was first reported by Reuters.)
