The last three years saw a drop in clinical research being done in India on account of regulatory uncertainty, judicial and social activism and some media sensationalism. This made the clinical research fraternity apprehensive and concerned over how this would translate into delayed access to new therapies for Indian patients. Over the last year and a half, the Ministry of Health and Family Welfare has taken steps to address the challenges posed by regulatory uncertainty and take on board concerns voiced by stakeholder. Regulations were amended and further guidance was given on existing ones. These were significant movements forward and a reiteration of the regulator’s commitment to clinical research in the country.
The changes that began in 2014 now need to be sustained. The inclusive approach adopted by Indian regulators in which multi-stakeholder feedback has been actively sought and acted upon in many cases, must continue. We need to build on an emerging regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society. These developments send out a strong signal to the global clinical research community that we are committed to a robust regulatory environment with a focus on collaboration, transparency and, most importantly, patient safety and protection.
Here we would like to flag a few noteworthy measures taken by the regulators that give us confidence that we are moving forward on the right track:
Amendments to Compensation Guidelines:
In December 2014, amendments were made to earlier contentious clauses of Rule 122 DAB of the Drugs and Cosmetics Act (released in January, 2013) on compensation, making the regulation less prone to misuse and litigation. The revised guidelines rationalised compensation and medical management for injuries caused during and because of the participation in clinical research, bringing in a balance between the interests of patients and innovators, and at the same time giving us more clarity in the process. What is also important to note is that for the first time in the world, formulae have been introduced by the regulators for calculating the financial compensation based on the ‘no fault’ principle. This provides ease of implementation and consistency and helps the sponsor of the trial understand the maximum possible liability and to plan appropriately to protect patient well-being.
Predictable approval timelines with the expansion of the Subject Expert Committees
The Ministry of Health and Family Welfare, Government of India has created 25 panels of experts for various therapeutic areas to be known as Subject Expert Committees (SECs). They evaluate the various categories of applications received for clinical trials, new drugs and new medical devices. In strengthening the SECs, the Ministry has addressed an industry concern that the SECs were not run as efficiently as envisaged because of an inadequate representation of subject matter expertise and the lack of availability of members for meetings. Feedback from the industry is that this has resulted in reduced approval timelines which are averaging six to seven months from submission to final approval as compared to 18 months earlier.
Governance over clinical research conduct at sites
The mandated registration of Ethics Committees (EC) with the CDSCO has been another important step towards providing EC oversight at trial sites. The inspection drive by the CDSCO has led to a clear indication that there is intent to improve quality and vigilance. Though the purpose, process and the outcome reporting of these inspection drives has been much discussed and debated, from 2014 onwards most companies and clinical trial sites have recognised the fact that there needs to be a culture of “inspection readiness at all times”, which certainly is a step in bolstering stakeholder confidence.
Clearly the value of clinical research in India is being appreciated more but its full potential has yet to be realised. Several limitations still exist that either delay clinical research or curb its scope. One of our greatest challenges is to instil confidence and trust amongst global stakeholders about the evolving and more scientific regulatory environment in India and the fact that there is now a more conducive environment for clinical research in the country.
There is a need for investment by the regulators in capacity building and infrastructure to ensure better governance and management of clinical research in the country. We also hope that the proposed accreditation of Clinical Research Sites, Investigators and Ethics Committees will come into place soon and the cap limit for investigator initiated trials lifted vesting the final decision with the Ethics Committees.
At ISCR, an association that aims to facilitate the growth of clinical research in the country, we hope that Indian authorities will continue to play a proactive role in encouraging local research and innovation. We have made good progress and should continue this momentum. Millions of patients are waiting in the hope of better and more effective treatment. If we have to find better and more cost effective cures for existing and new diseases, we need to make clinical trials work in our country.
Source: Article by Ms. Suneela Thatte, President, Indian Society for Clinical Research (ISCR), sourced from Financial Express. (link for article)