Message from the Chairman

"ACRO India supports regulatory agencies to evolve unambiguous guidelines, run a transparent process of approvals and create capacity to give timely decisions."

Dear Stakeholder,

Responsible clinical research has made a significant contribution to bring new vaccines, drugs and medical diagnostics to patients in India and the world at a significantly lower cost. Eradication of polio is an example of big strides made by Indian vaccine makers. There is so much more to do in making accessible expensive medicines in fighting cancer and other ailments which not only take life but also put families in great economic distress across the world. Research has focused on Biologics, cell therapies, biosimilars, new chemical entities, medical devices in the last decade.

In the last three years, researchers, clinical investigators, pharmaceutical companies, CRO’s, regulators have come under severe criticism from some of the stakeholders, about whether issue of patient safety has received required attention. This has led to issues stuck in courts, conservatism in decision making

by authorities, undue delay in approvals where specified conditions are met, hesitation by Doctors and Scientists to engage in research, putting the core objective of bringing cost effective medicines to patients in jeopardy.

In this context ACRO India plans to work with all stakeholders to conduct responsible and safe clinical research and rebuild an enthusiasm for drug development in India. ACRO India supports regulatory agencies to evolve unambiguous guidelines, run a transparent process of approvals and create capacity to give timely decisions. ACRO India will strive and advocate Indian clinical research practice and regulation to be harmonized with the best global practices. We will work with groups like Indian Pharmaceutical Alliance(IPA), Association for Biotechnology led Entrepreneurs (ABLE) other professional bodies to build a vibrant eco-system.

Equally important objective of ACRO India will be to raise the level of research practice within CRO’s to the highest level and to the satisfaction of key stakeholders from patients to investigators to regulators to sponsors. In this direction, ACRO India will communicate with stakeholders including opinion leaders to build higher confidence in responsible clinical research in India.

Pl feel free to share your ideas, concerns and suggestions with ACRO India at info@acroindia.org or call me or any of the executive council members.

D A Prasanna

(Chairman)