Regulatory requirements for conducting Clinical Trials in India

[7] 2.1.2 Documents required[8] * Clinical trial application form * Treasury Challan * Source of bulk drugs * Information in chemicals and pharmaceutical drugs * Pharmacology data of Animals * Toxicology data of animals * Clinical pharmacology information * Regulatory conditions in other countries * Information given/ prescribed * Protocol for quality control * Protocol for clinical study * Investigator's Brochure * Case Report Form * Patient data sheet and informed consent form * Investigator list in India and site address 2.1.3 Clinical Trial agreements: According to new rules, The Drug Controller, India is referred as Central Licensing Authority (CLA). According to GSR 227(E), it is mandatory to register BA/BE studies of investigational new drugs under CTRI before enrolling patients for clinical trials. 4.4 Archival of records and retention samples: According to GSR 227(E), it is mandatory to maintain the data and records for 5 years once trial completes or BA/BE study or at least two years after the expiration date of the batch of the new drug product, whichever is later.