The Association of Biotechnology Led Enterprises (ABLE), and the Association of Contract Research Organisations (ACRO) India have cautioned the DCGI to preserve confidentiality of the patients.  The industry bodies have also requested to retain the existing Clinical Trial Registry of India (CTRI) website for clear visibility of human studies  in the country.

The request follows the need for suggestions from CDSCO on its notification issued on July 28, 2014 to improve its clinical trials management through application of information technology (IT).

Expressing his view, Dr P M Murali, president, ABLE said, “India's pharma & biotech industry has the potential to generate combined revenues of more than $100 billion by 2025 from approx. $ 25 billion as of today. To realise this quantum of growth, the right policy framework needs to be put in place. The sector must be provided with incentives through a number of tax-friendly measures to make it globally competitive.”

D A Prasanna, chairman, Association of Contract Research Organisations (ACRO) India said, “while it is a good move to implement IT enabled system for clinical trials, the proposed guidelines are not in favour of protecting patient privacy. It is critical not to discourage the participation in clinical trials. Hence the guidelines need to be more specific as to how the personal details would be kept confidential for the reassurance of all stakeholders involved.”

Various concerns are already affecting the quality of skilled labour as several companies have moved their clinical trials outside the country. It is imperative to set up a quick, time-bound, fact-supported mechanism that uses scientific methods and reasoning to resolve issues. As per the Industry Associations, clinical trials represent an example wherein all stakeholders can and should work together with a common goal of making the whole clinical research process safe and transparent.