Clinical Trial is defined by the Drugs and Cosmetics Rules, 1945, in Part X-A, after rule 122-DA 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 Rules 122A, 122B, 122 DA, 122E of Drugs and Cosmetics Rules and Appendix I, IA and VI of Schedule Y, 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 122E of Drugs and Cosmetic Rules 1945.
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 for NOC to conduct clinical Trial in India is granted by Central Drugs Standard Control Organization (CDSCO)/Drugs Controller General of India (DCGI) under the Rule 122DAC of Drugs and Cosmetic Rules 1945.
In India, an applicant is required to file application in Form 44 along with prescribed fees in the form of treasury challan and all relevant data as per Schedule Y of Drugs and Cosmetics 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.