Hridkamal Roy, Assistant Managing Editor, India Pharma Outlook
Clinical development services organization Fortrea has launched a new research and development arm that aims at creating artificial-intelligence-driven clinical trial technologies that make studies speedier, safer and more efficient. The CRO stated that it is launching the AI Innovation Studio that will come up with and test out AI and machine learning tech. In the ever-evolving world of pharmaceuticals and medical devices, shortening the duration from development to market launch is essential for triumph. A principal tactic to accomplish this is by utilizing worldwide clinical trial resources. India has risen as a pivotal contributor in this arena, providing distinct benefits that can be utilized to fast-track the creation and sanctioning of novel treatments. In this regard, Roche Pharma India has announced the launch of its clinical trial excellence project that aims to strengthen the capabilities of public health institutions to do clinical trials and drug research in the country.
“Such initiatives represent a commendable stride towards advancing the healthcare sector. Upskilling of clinical trial capabilities will help India’s public health institutions to conduct world class research and help patients in India gain access to innovative products from across the globe within the aegis of these public institutions. Patients will not have to travel abroad to seek treatment for unmet medical needs”, mentioned Dr Viraj Suvarna, Chief Medical Officer, Roche Pharma India to the media.
This piece delves into the diverse aspects of India's clinical trial strengths and the ways they can be employed to accelerate the market introduction of new products.
Over the last decade, the regulatory environment in India for clinical trials has witnessed considerable enhancements. The Central Drugs Standard Control Organization (CDSCO) and the Drug Controller General of India (DCGI) have been successful in dynamically refining the approval mechanisms for all kinds of clinical trials that are now resulting in shorter approval times. Enactment of the New Drugs and Clinical Trials Rules, 2019 has streamlined the regulatory procedures and has set definitive timelines for obtaining approvals.
To give an example, fast-track approvals are being implemented for medications that are in urgent demand or cater to previously unaddressed medical needs. Such reforms are continuously helping boost the consistency and predictability of the clinical trial process, making India an attractive destination for international trial sponsors.
“If you look at the number of studies that were done prior to the pandemic and the number of studies that are being done currently, there’s definitely an uptick in the number of studies”, said Dr. Sanish Davis, President, Indian Society for Clinical Research to businessline.
One of the standout benefits of hosting clinical trials in India is the economic aspect. The expenses associated with running trials in India are often much less than those in Western nations. Reduced operational expenses: This encompasses aspects like site administration, enlisting patients, and their subsequent oversight. The availability of adept professionals at a lower cost relative to their peers in more developed nations. These financial advantages can lead to significant cost reductions, enabling trial sponsors to distribute their funds more judiciously throughout their development initiatives.
In this regard, Syneos Health stands out as a prominent provider of economic infrastructure for clinical trials in India. Recognized worldwide, it is an organization that offers comprehensive biopharmaceutical solutions, specializing in both clinical development and commercial outsourcing services.
“India has become an industry leader from a generics manufacturing perspective but the cost-effectiveness of clinical trials has a significant impact in terms of its relativity in the western countries. When one invests in an investigator site in India, the cost of it reduces by 30-60 percent”, mentioned Sanjay Vyas, MD & Country Head, Parexel India.
India boasts a proficient clinical research workforce, well-versed in GCP (Good Clinical Practice) and knowledgeable about ICH (International Council for Harmonisation) standards. The nation offers a vast array of seasoned investigators with a history of involvement in international trials. There are also Certified Clinical Research Associates (CRAs) who guarantee thorough supervision and adherence to protocols. Such a skilled workforce is crucial in upholding the accuracy and dependability of data from clinical trials.
To give an example, Parexel is a distinguished entity that supplies a proficient workforce for clinical trials within India. As a foremost international clinical research organization (CRO), it delivers an extensive range of services in drug development and regulatory consultancy. With its considerable operations in India, Parexel provides an adept team adept in overseeing and executing clinical trials in a multitude of therapeutic domains.
“India is growing as a global hub for clinical research. It is growing into an attractive destination for global pharmaceutical companies and even CROs. A lot of industry-academia partnerships are also taking place in terms of conducting research on new molecules. India has overcome all the historical challenges and has become a hub of innovative treatment”, mentioned Sanjay Vyas.
The clinical trial landscape in India offers a persuasive advantage for companies in the pharmaceutical and medical device sectors aiming to hasten their products' journey to the market. The synergy of an advantageous regulatory setting, cost-effectiveness, a varied patient demographic, top-tier infrastructure, and a competent labor force positions India as a prime location for clinical trials. Utilizing these strengths allows sponsors to not just fast-forward their development schedules but also guarantees swifter delivery of new treatments to patients, thereby improving health outcomes worldwide.
.jpg)
.jpg)
, CDSCO.jpg "Fostering a Quality Culture in the Pharmaceutical Industry")