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Lack of research data is one of the major challenges identified in traditional medicine (TM). Further, there is an urgent need to strengthen and streamline clinical research processes as well as develop research databases in TM. The Clinical Trials Registry-India (CTRI), a free, online primary register of the WHO's International Clinical Trials Registry Platform, undertakes registration of all clinical trials being conducted in India, including TM trials. However, as the CTRI data set items are primarily designed to capture information of interventional trials of the conventional system of medicine, key fields relevant to the TM system are not adequately captured in the CTRI.The current study was conceptualized with the objective to review the type and quality of trials registered in the CTRI as well as identify the specific data set items in CTRI which may be customized as perThe trials registered from July 1, 2018, to March 31, 2020, were analyzed to decipher the kind of research being undertaken in the field ofThe fields which were identified and need tweaking and customization were the fields "health condition" and "intervention/comparator agent."These modifications in the CTRI would enable the capture of more effective

An article published in this journal analyses the deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India. We wish to rebut some of the inferences and highlight the pitfalls of a purely automated analysis of registry data as posited by the authors.

OBJECTIVE: To present a descriptive analysis of the clinical studies registered in the Clinical Trials Registry – India (CTRI) and deduce its impact. METHODS: We searched the CTRI database for all registered clinical studies from July 20, 2007 to May 31, 2018. Extracted data were analyzed in three time periods i.e., Periods 1, 2, and 3 based on the major activities and milestones of the CTRI. In addition, comparative registrations of the various Primary Registries of the WHO were compiled and registration policy of Indian journals with regard to trial registration assessed. RESULTS: A total of 20,160 clinical studies were submitted to the CTRI in the designated study period. Of the registered 14,341 clinical studies, 10,485 (76.3%) were interventional trials which were either regulatory (n = 2004), academic non-regulatory (n = 3855), or those conducted as part of PG thesis (n = 4626) trials. Regulatory trials registration numbers varied according to the Indian regulatory scenario. PG thesis trial registrations showed a steep rise, although unlike regulatory trials, these were mostly retrospective registrations. CTRI registration numbers were comparable to that in other Primary Registries. Instructions to authors of 48% indexed Indian journals made a mention of trial registration. CONCLUSIONS: The CTRI has a strong global presence and has enhanced the transparency of regulatory trials as well as academic research particularly thesis-based work. The latter is expected to help improve standard of research and prevent repetitive research. Additional support from Indian journal editors by strict implementation of prospective registration is crucial for increasing compliance by researchers.

The Clinical Trials Registry – India (CTRI), launched over 10 years ago, is a free, searchable online platform for registration of clinical trials being conducted in India and as well as countries which do not have a Primary Registry of their own. The objective of the present article is to appraise the current status and the new developments of CTRI, which registers all types of clinical studies, including postgraduate theses. The CTRI which was until now allowing both prospective and retrospective registration is moving towards only prospective trial registration. From April 1, 2018, only those trials where the first patient enrollment has not yet commenced will be registered. Further, the CTRI is in the process of implementing structured summary results disclosure of all interventional clinical trials in the near future.

Since the beginning of the year, the deadly coronavirus pandemic, better known as coronavirus disease 2019 (COVID-19), brought the entire world to an unprecedented halt. In tandem with the global scenario, researchers in India are actively engaged in the conduct of clinical research to counter the pandemic. This review attempts to provide a comprehensive overview of the COVID-19 research in India including design aspects, through the clinical trials registered in the Clinical Trials Registry - India (CTRI) till June 5, 2020. One hundred and twenty two registered trials on COVID-19 were extracted from the CTRI database. These trials were categorized into modern medicine (n=42), traditional medicine (n=67) and miscellaneous (n=13). Of the 42 modern medicine trials, 28 were on repurposed drugs, used singly (n=24) or in combination (n=4). Of these 28 trials, 23 were to evaluate their therapeutic efficacy in different severities of the disease. There were nine registered trials on cell- and plasma-based therapies, two phytopharmaceutical trials and three vaccine trials. The traditional medicine trials category majorly comprised Ayurveda (n=45), followed by homeopathy (n=14) and others (n=8) from Yoga, Siddha and Unani. Among the traditional medicine category, 31 trials were prophylactic and 36 were therapeutic, mostly conducted on asymptomatic or mild-to-moderate COVID-19 patients. This review would showcase the research being conducted on COVID-19 in the country and highlight the research gaps to steer further studies.

The Clinical Trials Registry - India (CTRI), an online system ( www.ctri.nic.in ) for the registration of clinical trials being conducted in India, has its secretariat at the National Institute of Medical Statistics of the Indian Council of Medical Research in New Delhi. The primary objective of the CTRI is to ensure that all clinical trials conducted in India are registered in order to bring transparency, accountability and access to clinical trials. Since its launch on 20 July 2007, the CTRI has gone from strength to strength and, as of January 2013, more than 3,300 trials had been registered. Although initiated as a voluntary exercise, registration of trials requiring approval by the drug regulatory authority in India has been made mandatory. Editors from 11 major biomedical journals in India require submission of the clinical trial registration number as a prerequisite for publication. In addition, several ethics committees also insist upon trial registration. The CTRI is a primary registry of the WHO’s International Clinical Trials Registry Platform. This article discusses the challenges encountered during the setting up of the CTRI and the strategies adopted, and also explains the steps to trial registration in the CTRI.

Publisher Summary This chapter discusses the Indian Regulatory Framework. The Indian pharmaceutical sector has witnessed a remarkable growth, from around $1 billion in 1990 to $20 billion in 2009–2010. In India, the import, manufacture, sale, and distribution of medical devices are regulated under the Drugs and Cosmetics Act, 1940, and Rules, 1945. Those medical devices that are notified by central government in the official gazette are regulated by Central Drugs Standard Control Organization (CDSCO) that grants permission for the conduct of global clinical trials in India. To enhance the transparency, accountability, and accessibility of clinical trials, registration of a clinical trial in the ICMR's Registry, the Clinical Trials Registry – India (CTRI), was made mandatory by the DCGI's office with effect from June 15, 2009. The CTRI data set includes all the 20 data set points of the WHO. For clinical trials to be conducted in India with foreign collaboration, approval of the Government of India through the Health Ministry's Screening Committee (HMSC) is mandatory. The application is to be submitted to the International Health Division (IHD) of ICMR, which is the secretariat of HMSC. The Act and Rules are liable to undergo amendments. Furthermore, in view of the number of new initiatives and policies under active consideration, interested sponsors are advised to go through the detailed version of the Drugs and Cosmetics Act and Rules as well as the amendments that are notified from time to time and displayed on the CDSCO website.