The legislative requirements of pharmacovigilance in India are guided by specifications of Schedule Y7 of the DC Act and the DC Rules thereto. It sets forth, for example, regulations pertaining to preclinical and clinical studies for the development of a new drug, as well as clinical trial requirements for the import,manufacture and receipt of marketing approval for a new drug in India. It also includes the approval procedures for clinical trial and other documentation to be submitted with the sponsor’s application, with attention to the responsibilities of the sponsor, requirements of informed consent, responsibilities of Ethics Committees and details of the four phases of trials. Schedule Y also requires compliance with Good Clinical Practice Guidelines issued by CDSCO, the Directorate General of Health Services and the government of India.
Global Pharmacovigilance Laws & Regulations: The Essential Reference 156 Schedule Y underwent thorough review several years ago. Its latest amendment, dated January 20, 2005, aimed to underscore the continued commitment of DCGI to ensure pharmaceutical companies’ adequate compliance with pharmacovigilance obligations. The amended Schedule Y also attempts to better define the responsibilities of pharmaceutical companies for their marketed products, as well as responsibilities for reporting adverse events from clinical trials. For a complete understanding of reporting responsibilities specific to clinical trials conducted in India, Schedule Y should be read along with Rules 122A,122B, 122D, 122DA, 122DA and 122E of the DC Rules.
As specified in Schedule Y, a pharmaceutical company holding one or more marketing licenses in India should ensure that it has in place an adequate pharmacovigilance system for its product(s). When two or more marketed products are identical in all aspects except their trade names, each pharmaceutical company holding a marketing license is obliged to independently meet their own pharmacovigilance obligations. This includes the establishment and maintenance of appropriate systems to collect, collate and evaluate information
about suspected adverse reactions. A pharmaceutical company can achieve this either by setting up in-house systems for pharmacovigilance or by entering into contractual agreements with Contract Research Organizations (CROs) specializing in pharmacovigilance functions.
