Clinical trials plays an important role in development of medical research and innovative pharmaceutical products. A number of factors, including changes to legislation, technological progress and the growth of the pharmaceutical sector, have led to a rapid evolution over the last few years with regard to India's Clinical Trials landscape.
Due to its diverse population, experienced healthcare professionals and cost effective infrastructure, India has emerged as a major destination for clinical trials. This blog looks at the various aspects of the Indian clinical trial landscape, including pharmacovigilance, pharmaceutical clinical trials, new legislation, clinical research organizations (CROs), the clinical trial application process and the role of pharmaceutical database service providers.
Pharmacovigilance in Clinical Trials is a scientific method to monitor and assess the safety of medicinal products, ensuring appropriate identification and management of adverse events. Pharmacovigilance is an essential component for the protection of study participants' wellbeing when it comes to clinical trials on Indian soil.
India has established a strong pharmacovigilance blueprint, with standard regulatory bodies such as the Central Drugs Standard Control Organization (CDSCO) watching safety reporting and monitoring for or during clinical trials. The Indian Pharmacovigilance Programme is established to protect the health of country's population, with a view to ensuring that the benefits of medicinal products outweigh the risks related to their use.
In India, pharmaceutical clinical trials have seen a significant increase and are attracting global pharmaceutical companies in order to speed up the drug development process. A large, heterogeneous pool of patients, experienced researchers and cost advantages in comparison to advanced countries are among the reasons for this increase.
Even after having these advantages, the country still runs very less number of global clinical trials. With regulatory evolution aimed at global harmonization and the beginning of Pharma Clinical Trials in India, more efforts are getting done to increase the number.
In order to align with international standards and improve patient safety, the regulatory environment for clinical trials in India has undergone considerable changes. The approval process has been streamlined, a risk based approach has been introduced, and transparency has been emphasized in recent amendments to the new drug and clinical trial rules.
New Rules for Clinical Trials in India were published by the Indian Ministry of Health and Family Welfare in 2019. These rules apply to the promotion of clinical research and complex topics, such as orphan drugs, post-trial access or pre and post-submission meetings. (Courtesy: RAPS) The new regulations have brought India's regulatory framework in line with international standards making it one of the top choices for global clinical trials. (Courtesy: Fortune India)
Clinical research Organizations provide services ranging from study design to data analysis, and play a key role in carrying out clinical trials. In India, several CROs collaborate with pharmaceutical companies to ensure smooth trial execution, regulatory compliance, and data quality.
In order to achieve success in research results, the efficient management of clinical trial data is essential. Pharma database service providers play an important role in the collection, retention and analysis of data obtained from trials.
The Clival database, a module in the chemxpert database offers up to date clinical trial data from all over the world. It is a valuable tool for the life science industry due to its cutting edge information. Collaboration with the chemxpert database will make it easier for all data to flow and analyse, thereby improving overall effectiveness of studies.
India's Clinical Trials landscape is continuously evolving, driven by a commitment to improve the efficiency, transparency and safety of medicinal products for patients. To achieve this objective, the adoption of pharmacovigilance practices, adherence to new legislation, a critical role for research organizations and their assistance from database service providers will help India become an important player in global Clinical Research.