India Releases Draft Guidance on Clinical Trial Requirements for Stability Data
On 21 December India's Central Drugs Standard Control Organization (CDSCO) released a new draft guidance titled, Requirement of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval of Clinical Trials / BE Studies.
The draft guidance clarifies the CDSCO's thinking regarding rules 122A, B, D, DA, DAA, and E of the Drugs and Cosmetics Rules, and Appendix I, IA and VI of Schedule Y. These rules govern the information and data necessary to approve a clinical trial, import a product, or manufacture a new product for in-country marketing.
"This guidance document has been prepared to specify the requirements for submission of chemical and pharmaceutical information including stability study data for approval of clinical trial / BA-BE studies. This guidance will ensure that sufficient data is submitted to CDSCO to assess the safety as well the quality of the proposed clinical trials from chemical and pharmaceutical information perspective."
The guidance explains the necessary stability data requirements for Phase I, II, and III clinical trials.
Comments are due on 20 January, 2012.