Clinical Trials

Clinical Trials

Clinical Trial is defined by the New Drugs and Clinical Trials Rules, 2019 as a means of systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the new drug. Whereas a global clinical trial means any clinical trial which is conducted as a part of multinational clinical development of a drug. The safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country.

A Clinical Trial on a new drug shall be initiated only after the permission has been granted by the Licensing Authority under rule 21 (b), and the approval obtained from the respective ethics committee(s). The Chapter V Part A and Second and Third Schedules of New Drugs and Clinical Trials Rules, describe the information/data required for approval of clinical trial and/or to import or manufacture of new drug for marketing in the country. However the requirements for approval of clinical trials and new drugs may vary depending on nature of new drugs which is defined as per the Rule 2(w) of New Drugs and Clinical Trials Rules, 2019.

For new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I. For new substances discovered in countries other than India, Phase I data as required along with the application. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to repeat Phase I trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently with other global trials for that drug. Phase III trials are required to be conducted in India before permission to market the drug in India is granted; The data required will depend upon the purpose of the new drug application.

Registration of clinical trials in the Clinical Trials Registry India (CTRI) is also necessary as per notification of the Drugs Controller General India (DCGI). The Clinical Trials Registry- India (CTRI), hosted at the ICMR’s National Institute of Medical Statistics is a free and online public record system for registration of clinical trials being conducted in India

Permission to conduct clinical Trial in India is granted by Central Drugs Standard Control Organization (CDSCO)/Drugs Controller General of India (DCGI) in Form CT-06 under the Rule 22 of 2019.

In India, an applicant is required to file application in Form CT-18 and CT-21 or CT-04 along with prescribed fees in the form of Bharatkosh challan and all relevant data as per New Drugs and Clinical Trials Rules, for seeking permission to import or manufacture of new drug substances and its formulations for marketing in the country or conduct of clinical trials in India. The documents include chemical and pharmaceutical information, animal pharmacological and toxicological data, clinical data of safety and efficacy, regulatory status in other countries etc., and results of clinical trials on local population.